FATE Fate Therapeutics Inc.

71.6
+5.09  (+8%)
Previous Close 66.51
Open 67.14
52 Week Low 35.4
52 Week High 121.16
Market Cap $6,815,213,565
Shares 95,184,547
Float 68,051,331
Enterprise Value $5,745,604,220
Volume 2,060,422
Av. Daily Volume 1,022,011
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Drug Pipeline

Drug Stage Notes
FT538
Acute myeloid leukemia (AML) / multiple myeloma.
Phase 1
Phase 1
Phase 1 initiated patient enrollment September 15, 2021.
FT819
B-cell Leukemias and Lymphomas
Phase 1
Phase 1
Phase 1 initiation of dosing announced August 2, 2021.
FT596
B-Cell Chronic Lymphoma, chronic lymphocytic leukemia
Phase 1
Phase 1
Phase 1 interim data released August 19, 2021. 10/14 patients (71%) achieved an objective response; 7/14 (50%) complete responses.
FT516
Acute Myelogenous Leukemia / B-cell Lymphoma
Phase 1
Phase 1
Phase 1 interim data presented August 19, 2021. 8/11 (73%) achieved an objective response, 6/11 (55%) complete responses. 5 patients (45%) maintained their response without further therapeutic intervention.
ProTmune - PROTECT
Acute graft-versus-host disease (GvHD) undergoing hematopoietic cell transplantation (HCT)
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint.
FT596 With Rituximab
Non Hodgkin Lymphoma
Phase 1
Phase 1
Phase 1 interim data released December 4, 2020. 2/4 complete responses and one partial response.
FT500
Solid tumors
Phase 1
Phase 1
Phase 1 data presented at SITC meeting November 2020.

Latest News

  1. SAN DIEGO, Sept. 15, 2021 (GLOBE NEWSWIRE) --  Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, announced today the publication of preclinical data demonstrating that its off-the-shelf, multiplexed-engineered, iPSC-derived NK cell product candidate FT538 exhibits significantly enhanced serial killing and functional persistence compared to peripheral blood NK cells. The superior anti-tumor activity of FT538 was attributable to its novel engineered components, including the knockout of CD38 and the expression of IL-15/IL-15R fusion protein, which were shown to improve metabolic fitness, increase resistance to oxidative…

    SAN DIEGO, Sept. 15, 2021 (GLOBE NEWSWIRE) --  Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, announced today the publication of preclinical data demonstrating that its off-the-shelf, multiplexed-engineered, iPSC-derived NK cell product candidate FT538 exhibits significantly enhanced serial killing and functional persistence compared to peripheral blood NK cells. The superior anti-tumor activity of FT538 was attributable to its novel engineered components, including the knockout of CD38 and the expression of IL-15/IL-15R fusion protein, which were shown to improve metabolic fitness, increase resistance to oxidative stress, and induce transcription of proteins that control NK cell activation and effector function. The data were published in Cell Stem Cell in an online article entitled "Harnessing features of adaptive NK cells to generate iPSC-derived NK cells for enhanced immunotherapy".

    "The NK cell community has long sought to improve NK cell activation, cytotoxicity, functional persistence, and tumor targeting for cancer immunotherapy. Our preclinical data demonstrate that the synthetic features of FT538 uniquely harness all these therapeutic attributes and significantly improve NK cell anti-tumor activity," said Bob Valamehr, Ph.D., Chief Research and Development Officer of Fate Therapeutics. "We are excited to bring FT538 to patients for off-the-shelf treatment of hematologic malignancies and solid tumors, and to continue to leverage its multiplexed engineered backbone as the foundation for development of multi-antigen, CAR-targeted product candidates."

    The studies in the Cell Stem Cell publication were conducted as part of a collaboration between scientists at Fate Therapeutics and the laboratory of Jeffrey S. Miller, M.D., University of Minnesota, and were led by Frank Cichocki, Ph.D., University of Minnesota. The Miller laboratory has previously shown that a rare subset of NK cells with memory-like properties that arise in response to cytomegalovirus, known as adaptive NK cells, have a genome-wide epigenetic profile and recall response that parallel cytotoxic effector CD8+ T cells. These adaptive NK cells persist long term, exhibit a unique metabolic profile with elevated mitochondrial oxidative phosphorylation and glycolysis as well as increased levels of ATP, and have enhanced cytotoxicity.

    The peer-reviewed paper describes preclinical studies showing that FT538 shares metabolic, transcriptional, and functional features with adaptive NK cells. The data demonstrate that FT538 persists in vivo at high levels for more than six weeks in the absence of cytokine support after adoptive transfer, whereas adoptively-transferred peripheral blood NK cells required the co-infusion of either IL-2 or IL-15 to achieve low-level persistence for up to two weeks. Additionally, in sequential killing assays, FT538 was shown to have robust serial killing and functional persistence, which were not observed with peripheral blood NK cells. FT538 also incorporates a novel high-affinity, non-cleavable CD16 Fc receptor as a third functional component, which was shown to mediate potent in vivo anti-tumor activity in combination with the CD38-targeted monoclonal antibody daratumumab against MM.1S myeloma cells.

    FT538 is being investigated in a multi-dose Phase 1 clinical trial for the treatment of acute myeloid leukemia and in combination with daratumumab for the treatment of multiple myeloma (NCT04614636). In addition, the Company has initiated patient enrollment in a multi-dose Phase 1 clinical trial of FT538 in combination with certain monoclonal antibodies targeting EGFR, HER2, and PDL1 for the treatment of solid tumors.

    About Fate Therapeutics' iPSC Product Platform

    The Company's proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company's first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company's platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics' iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

    About FT538

    FT538 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components: a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; an IL-15 receptor fusion (IL-15RF) that augments NK cell activity; and the deletion of the CD38 gene (CD38KO), which promotes persistence and function in high oxidative stress environments. FT538 is designed to enhance innate immunity in cancer patients, where endogenous NK cells are typically diminished in both number and function due to prior treatment regimens and tumor suppressive mechanisms. In preclinical studies, FT538 has shown superior NK cell effector function, as compared to peripheral blood NK cells, with the potential to confer significant anti-tumor activity to patients through multiple mechanisms of action. FT538 is being investigated in a multi-dose Phase 1 clinical trial for the treatment of acute myeloid leukemia (AML) and in combination with daratumumab, a CD38-targeted monoclonal antibody therapy, for the treatment of multiple myeloma (NCT04614636).

    About Fate Therapeutics, Inc.

    Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company's clinical studies and preclinical research and development programs, its ongoing and planned clinical studies, including its clinical investigation of FT538, and the safety and therapeutic potential of the Company's product candidates, including FT538. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company's product candidates may not demonstrate the requisite safety or efficacy to achieve regulatory approval or to warrant further development, the risk that results observed in prior studies of the Company's product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company's product candidates or in the initiation of, or enrollment of patients in, any clinical studies, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, the amount and type of data to be generated, or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company's ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company's product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission, including but not limited to the Company's most recently filed periodic report, and from time to time in the Company's press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

    Contact:

    Christina Tartaglia

    Stern Investor Relations, Inc.

    212.362.1200

    christina@sternir.com



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  2. SAN DIEGO, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, today announced that the Company will present at the following upcoming investor conferences:

    • 2021 Virtual Wells Fargo Healthcare Conference on Thursday, September 9, 2021, at 10:40 am ET
    • Morgan Stanley 19th Annual Global Healthcare Conference on Friday, September 10, 2021 at 11:00 am ET
    • H.C. Wainwright 23rd Annual Global Investment Conference available on demand on Monday, September 13 at 7:00 am ET
    • Baird's 2021 Global Healthcare Conference on Wednesday, September 15 at 12:15 pm ET
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit…

    SAN DIEGO, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, today announced that the Company will present at the following upcoming investor conferences:

    • 2021 Virtual Wells Fargo Healthcare Conference on Thursday, September 9, 2021, at 10:40 am ET
    • Morgan Stanley 19th Annual Global Healthcare Conference on Friday, September 10, 2021 at 11:00 am ET
    • H.C. Wainwright 23rd Annual Global Investment Conference available on demand on Monday, September 13 at 7:00 am ET
    • Baird's 2021 Global Healthcare Conference on Wednesday, September 15 at 12:15 pm ET
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Wednesday, September 22 at 4:35 pm ET
    • 2021 Cantor Virtual Global Healthcare Conference on Wednesday, September 29 at 10:40 am ET

    A live webcast, if recorded, of each presentation can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com. The archived webcast will be available on the Company's website shortly after the event.

    About Fate Therapeutics, Inc.

    Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

    Contact:

    Christina Tartaglia

    Stern Investor Relations, Inc.

    212.362.1200

    christina@sternir.com



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  3. 10 of 14 Patients in FT596 Single-Dose Escalation Cohorts 2 and 3 Achieved Objective Response; 7 Patients Achieved Complete Response, including 2 of 3 Patients Treated with FT596 in Combination with Rituximab Following Autologous CD19 CAR T-cell Therapy

    8 of 11 Patients in FT516 Multi-Dose Escalation Cohorts 2 and 3 Achieved Objective Response, including 6 Patients that Achieved Complete Response; 5 of 8 Responders Continue in Ongoing Response at Median Time of 5.2 Months

    FT596 and FT516 Treatment Regimens were Well-tolerated; No Dose-limiting Toxicities, and No Adverse Events of Any Grade of ICANS or GVHD, were Observed; Two Low-grade Adverse Events of CRS were Reported in FT596 Single-Dose Escalation Cohorts 1 and 2

    Management to Host

    10 of 14 Patients in FT596 Single-Dose Escalation Cohorts 2 and 3 Achieved Objective Response; 7 Patients Achieved Complete Response, including 2 of 3 Patients Treated with FT596 in Combination with Rituximab Following Autologous CD19 CAR T-cell Therapy

    8 of 11 Patients in FT516 Multi-Dose Escalation Cohorts 2 and 3 Achieved Objective Response, including 6 Patients that Achieved Complete Response; 5 of 8 Responders Continue in Ongoing Response at Median Time of 5.2 Months

    FT596 and FT516 Treatment Regimens were Well-tolerated; No Dose-limiting Toxicities, and No Adverse Events of Any Grade of ICANS or GVHD, were Observed; Two Low-grade Adverse Events of CRS were Reported in FT596 Single-Dose Escalation Cohorts 1 and 2

    Management to Host Virtual Event Today at 4:30 PM Eastern Time

    SAN DIEGO, Aug. 19, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, today highlighted positive interim clinical data from the Company's FT516 and FT596 programs for patients with relapsed / refractory B-cell lymphoma. FT516 is the Company's universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. The Company's FT596 program incorporates both the hnCD16 Fc receptor and a chimeric antigen receptor (CAR) targeting CD19, which is designed to enable multi-antigen targeting of tumor cells, as well as an IL-15 receptor fusion (IL-15RF) to enhance NK cell activity and survival.

    "We are very pleased with the interim safety, response rates, and durability of responses observed in our ongoing clinical studies of FT516 and FT596 for the treatment of patients with relapsed / refractory B-cell lymphomas. These data continue to demonstrate that our off-the-shelf, iPSC-derived NK cell product candidates can uniquely deliver substantial therapeutic benefit and expand patient access to cell-based cancer immunotherapies," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "At this time, we are initiating multiple indication-specific, dose-expansion cohorts to broadly assess FT516 in combination with CD20-targeted monoclonal antibody regimens, including in patients that have experienced disease progression following autologous CD19-targeted CAR T-cell therapy. In addition, early clinical data with the single-dose FT596 treatment schedule have shown robust 30-day response rates and we look forward to further assessing both single-dose and multi-dose treatment regimens to validate its potential best-in-class therapeutic profile."

    FT596 Program

    The ongoing clinical trial in relapsed / refractory B-cell lymphoma is assessing a single dose of FT596 as monotherapy (Monotherapy Arm) and in combination with a single dose of rituximab (375 mg/m2) (Combination Arm) following three days of conditioning chemotherapy (500 mg/m2 of cyclophosphamide and 30 mg/m2 of fludarabine). As of the data cutoff date of June 25, 2021, 10 patients in the Monotherapy Arm and 10 patients in the Combination Arm were evaluable for assessment of safety and efficacy in the first, second, and third dose cohorts of 30 million cells (n=3 each), 90 million cells (n=4 each), and 300 million cells (n=3 each), respectively (see Table 1). Patients had received a median of four prior lines of therapy and a median of 2.5 prior lines containing CD20-targeted therapy. Of the 20 patients, 12 patients (60%) had aggressive B-cell lymphoma, 10 patients (50%) were refractory to most recent prior therapy, and seven patients (35%) were previously treated with autologous CD19-targeted CAR T-cell therapy.

    In the second and third single-dose cohorts of the Monotherapy and Combination Arms comprising a total of 14 patients, 10 of 14 patients (71%) achieved an objective response, including seven patients (50%) that achieved a complete response (CR), as assessed by PET-CT scan per Lugano 2014 criteria on Day 29 following FT596 dosing. Eight of 10 patients (80%) that had not previously received CD19-targeted CAR T-cell therapy achieved an objective response, including five patients (50%) that achieved CR. Two of four patients (50%) that had previously received CD19-targeted CAR T-cell therapy, both of whom were treated in the Combination Arm, achieved a CR. In the first single-dose cohorts of the Monotherapy and Combination Arms comprising a total of six patients, only one patient achieved an objective response, suggesting dose-response treatment effects for FT596. The ongoing dose-escalation study of FT596 is currently enrolling patients in the fourth single-dose cohort of 900 million cells in each arm.

    Table 1. FT596 Interim Phase 1 Data – 1 Dose x 1 Cycle
    Dose Escalation CohortMonotherapy 

    (n=10)
    Combination 

    (n=10)
    Total 

    (n=20)
    Single Dose, Single CycleORCRORCRORCR
    DC1 = 30M1/3 (33%)00/3 (0%)01/6 (17%)0
    DC2 = 90M3/4 (75%)22/4 (50%)25/8 (63%)4
    DC3 = 300M3/3 (100%)12/3 (67%)25/6 (83%)3
    ≥ 90M FT596 cells(n=7)(n=7)(n=14)
    aCD19 CAR T Naïve6/6 (100%)32/4 (50%)28/10 (80%)5
    Prior aCD19 CAR T0/1 (0%)02/3 (67%)22/4 (50%)2
    Total6/7 (86%)34/7 (57%)410/14 (71%)7
    aCD19 = autologous CD19-targeted CAR T-cell therapy; CR = complete response; DC = dose cohort; M = million; OR = objective response

    a Interim FT596 Phase 1 results are as of June 25, 2021 data cutoff date. Data subject to source document verification.

    b Response assessment for three patients was entered into database subsequent to data cutoff.

    c Objective response (OR) and complete response (CR) are based on Cycle 1 Day 29 protocol-defined response assessment per Lugano 2014 criteria

    The FT596 treatment regimens were well tolerated. No dose-limiting toxicities, and no treatment-emergent adverse events (TEAEs) of any grade of immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GVHD) were observed. Two low-grade adverse events (one Grade 1, one Grade 2) of cytokine release syndrome (CRS) were reported, both of which occurred concurrently with other confounding clinical events and resolved on the same day of onset.

    FT596 Patient Case Studies

    The multi-antigen targeting functionality of FT596 is designed to uniquely address tumor heterogeneity and overcome antigen escape, and has the potential to drive responses in patients that might not effectively be treated with single-antigen targeted modalities, such as monoclonal antibodies, bispecific engagers and CAR T-cell therapies. The following are two case studies from the clinical trial:

    • Patient 2014. In the Monotherapy Arm, a 78-year-old woman with splenic diffuse red pulp small B cell lymphoma, who had received four prior therapies including three CD20-targeted regimens, presented with CD19High and CD20Null tumor cells indicative of CD20 antigen escape. The patient achieved a CR after single-dose, single-cycle treatment at 90 million FT596 cells as monotherapy with resolution of all metabolically active disease including clearance of baseline bone marrow involvement, demonstrating the activity of the product candidate's CAR receptor.
    • Patient 2016. The Combination Arm included a 68-year-old male with transformed indolent lymphoma who had received six prior therapies, including three anti-CD20-containing regimens and autologous CD19-targeted CAR T-cell therapy. The patient achieved a CR after single-dose, single-cycle treatment at 300 million FT596 cells in combination with rituximab with resolution of all metabolically active disease, suggesting that the product candidate's hnCD16 receptor can synergize with rituximab to drive complete responses in patients that have progressed following CD19-targeted CAR T-cell therapy.

    Re-treatment with Second FT596 Cycle

    The FT596 protocol currently allows for the re-treatment of eligible patients with a second, single-dose cycle subject to consent of the U.S. Food and Drug Administration (FDA). All requests by the Company for re-treatment were approved by the FDA. Of note, based on review of data submitted to date to the FDA, the Company is amending its FT596 clinical protocol at the FDA's recommendation to allow for re-treatment with a second FT596 cycle without requiring the agency's consent.

    In second and third single-dose cohorts of the Monotherapy and Combination Arms as of the data cutoff date, four patients with CR at the end of the first single-dose cycle were re-treated, all of whom remained in CR following disease assessment at the end of the second cycle, and an additional four patients were re-treated and had not yet been assessed for response. The second, single-dose FT596 cycle was well tolerated, and no events of any grade of CRS, ICANS, or GVHD were observed.

    FT516 Program

    The clinical trial in relapsed / refractory B-cell lymphoma is assessing FT516 in an off-the-shelf treatment regimen of up to two cycles, with each cycle consisting of three days of conditioning chemotherapy (500 mg/m2 of cyclophosphamide and 30 mg/m2 of fludarabine), a single dose of rituximab (375 mg/m2), and three weekly doses of FT516 each with IL-2 cytokine support. The FT516 treatment regimen is designed to be administered in the outpatient setting. Dose escalation is currently ongoing in the fourth multi-dose cohort of 900 million cells per dose.

    At the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting held in June, the Company highlighted positive interim clinical data for 11 patients treated in the second and third multi-dose cohorts of 90 million cells per dose (n=4) and 300 million cells per dose (n=7). Patients had received a median of three prior lines of therapy and a median of two prior lines containing CD20-targeted therapy. Of the eleven patients, eight patients had aggressive B-cell lymphoma, five patients were refractory to their most recent prior therapy, and four patients were previously treated with autologous CD19 CAR-T cell therapy. No dose-limiting toxicities, and no FT516-related serious adverse events or FT516-related Grade 3 or greater adverse events, were observed. The FT516 treatment regimen was well tolerated, and no TEAEs of any grade of CRS, ICANS, or GVHD were reported.

    Ongoing Response Assessment

    Of the 11 patients treated in the second and third multi-dose cohorts, eight patients (73%) achieved an objective response, including six patients (55%) who achieved CR, as assessed by PET-CT scan per Lugano 2014 criteria on Day 29 following the second FT516 treatment cycle. Notably, two of four patients (50%) previously treated with autologous CD19 CAR-T cell therapy achieved CR. At three months following first infusion, all eight responders maintained their response without further therapeutic intervention (3-Month Rate of 73% OR and 55% CR). As of the data cutoff date of July 7, 2021:

    • Five patients (45%) maintained their response without further therapeutic intervention, including four patients that remained in CR (4.6-9.5 months) and one patient that remained in partial response (6.1 months);
    • Two patients that had achieved CR experienced disease progression (4.2 and 5.1 months); and
    • One patient that had achieved partial response was treated with additional anti-cancer therapy (4.1 months).

    FT516 Patient Case Study

    The ASCO presentation featured a case study of a 36-year old male with triple-hit, high-grade B-cell lymphoma with rearrangements of MYC, BCL2, and BCL6 genes. The patient was refractory to all prior lines of therapy with the exception of autologous CD19 CAR T-cell therapy, for which a complete response of two months' duration was achieved. The patient was most recently refractory to an investigational CD20-targeted T-cell engager and presented with bulky lymphadenopathy with the largest lesion measuring approximately 10 centimeters. The first FT516 treatment cycle resulted in a complete response with resolution of all metabolically active disease and 85% reduction in the size of target lesions. The patient received a second FT516 treatment cycle, after which the response assessment continued to show complete response. As of the data cutoff date of July 7, 2021, the patient's most recent assessment at 4.9 months showed MRD negativity, confirming a profound CR.

    Today's Webcast

    The Company will host a live audio webcast today, Thursday, August 19, 2021 at 4:30 p.m. ET to review interim clinical data for the Company's FT516 and FT596 off-the-shelf, iPSC-derived NK cell programs. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com. The archived webcast will be available on the Company's website beginning approximately two hours after the event.

    About Fate Therapeutics' iPSC Product Platform

    The Company's proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company's first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company's platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics' iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

    About FT516

    FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in a multi-dose Phase 1 clinical trial as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of advanced B-cell lymphoma (NCT04023071). Additionally, FT516 is being investigated in a multi-dose Phase 1 clinical trial in combination with avelumab for the treatment of advanced solid tumor resistant to anti-PDL1 checkpoint inhibitor therapy (NCT04551885).

    About FT596

    FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and hnCD16 targeting receptors enhances cytotoxic activity, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a humanized mouse model of lymphoma, FT596 in combination with the anti-CD20 monoclonal antibody rituximab showed enhanced killing of tumor cells in vivo as compared to rituximab alone. FT596 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell lymphoma as a monotherapy and in combination with rituximab, and for the treatment of relapsed / refractory chronic lymphocytic leukemia (CLL) as a monotherapy and in combination with obinutuzumab (NCT04245722).

    About Fate Therapeutics, Inc.

    Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the safety and therapeutic potential of the Company's iPSC-derived NK cell product candidates, including FT516 and FT596, the Company's plans and timelines for its ongoing and planned clinical studies, and the expected clinical development plans for FT516 and FT596. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results observed in studies of its product candidates, including interim results and results from earlier studies, may not be predictive of final results or results observed in ongoing or future studies involving these product candidates, the risk of a delay in the initiation of, or in the enrollment or evaluation of subjects in, any clinical studies, the risk that the Company may cease or delay clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, the amount and type of data to be generated, or otherwise to support regulatory approval, difficulties or delays in subject enrollment and continuation in current and planned clinical trials, difficulties in manufacturing or supplying the Company's product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission, including but not limited to the Company's most recently filed periodic report, and from time to time in the Company's press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

    Contact:

    Christina Tartaglia

    Stern Investor Relations, Inc.

    212.362.1200

    christina@sternir.com

     



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  4. First Patient Treated for Relapsed / Refractory ALL in Landmark Phase 1 Clinical Trial of FT819, the First-ever iPSC-derived CAR T-cell Therapy; Off-the-Shelf Product Candidate Derived from Clonal Master iPSC Line with Novel CD19-specific 1XX CAR Integrated into TRAC Locus

    FT516 Interim Phase 1 Data for Relapsed / Refractory Lymphoma Featured at ASCO; 8 of 11 Patients in Dose Cohorts 2 and 3 Achieved Objective Response, including 6 Patients with Complete Response

    Interim Phase 1 Data from FT516 and FT538 Programs for Relapsed / Refractory AML Highlighted at May Investor Event; 5 of 12 Patients Achieved Objective Response with Complete Clearance of Bone Marrow Leukemic Blasts

    New Phase 1 Clinical Data from FT516 and FT596

    First Patient Treated for Relapsed / Refractory ALL in Landmark Phase 1 Clinical Trial of FT819, the First-ever iPSC-derived CAR T-cell Therapy; Off-the-Shelf Product Candidate Derived from Clonal Master iPSC Line with Novel CD19-specific 1XX CAR Integrated into TRAC Locus

    FT516 Interim Phase 1 Data for Relapsed / Refractory Lymphoma Featured at ASCO; 8 of 11 Patients in Dose Cohorts 2 and 3 Achieved Objective Response, including 6 Patients with Complete Response

    Interim Phase 1 Data from FT516 and FT538 Programs for Relapsed / Refractory AML Highlighted at May Investor Event; 5 of 12 Patients Achieved Objective Response with Complete Clearance of Bone Marrow Leukemic Blasts

    New Phase 1 Clinical Data from FT516 and FT596 Programs in Relapsed / Refractory Lymphoma to be Featured at Investor Event on August 19

    SAN DIEGO, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today reported business highlights and financial results for the second quarter ended June 30, 2021.

    "We are very pleased with the early clinical safety and activity we have observed with our off-the-shelf, iPSC-derived NK cell programs in relapsed / refractory lymphoma and acute myeloid leukemia, where interim Phase 1 data indicate FT516 and FT538 are well tolerated and can deliver complete responses for patients. We look forward to sharing additional clinical data from our FT516 and FT596 programs in B-cell lymphoma at our upcoming investor event," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Additionally, treatment of the first patient with FT819, the first-ever iPSC-derived T-cell therapy to undergo clinical investigation, is a landmark achievement and further demonstrates the Company's leadership in off-the-shelf, iPSC-derived cell therapy and the versatility of its proprietary iPSC Product Platform."

    B-cell Malignancy Disease Franchise

    • Positive Interim Phase 1 Clinical Data of FT516 Presented at ASCO. At the 2021 American Society of Clinical Oncology Annual Meeting (ASCO) held in June, the Company highlighted interim clinical data from its dose-escalating Phase 1 study of FT516 in combination with rituximab for the treatment of relapsed / refractory B-cell lymphoma (BCL). As of the data cutoff date of March 11, 2021, eight of eleven patients (73%) in Dose Cohorts 2 and 3 (n=4 at 90 million cells / dose and n=7 at 300 million cells / dose, respectively) achieved an objective response, including six patients (55%) who achieved a complete response. Notably, two of four patients previously treated with autologous CD19 CAR-T cell therapy achieved a complete response. The FT516 treatment regimen was well tolerated, and no treatment-emergent adverse events of any grade of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GVHD) were reported. Dose escalation is ongoing with enrollment in Dose Cohort 4 (900 million cells / dose).
    • FT596 Phase 1 Clinical Trial Enrolling in Dose Cohort 4. The dose-escalating Phase 1 study of FT596 for patients with relapsed / refractory BCL has successfully cleared dose-limiting toxicity in Dose Cohort 3 (single dose of 300 million cells) as monotherapy and in combination with rituximab. Dose escalation of the single-dose treatment schedule is ongoing in both regimens with enrollment in Dose Cohort 4 (900 million cells). The Company is also preparing to initiate enrollment of a multi-dose treatment schedule in both regimens, with FT596 administered on Day 1 and Day 15 at 300 million cells / dose with the potential to dose escalate to 900 million cells / dose.
    • First Patient Treated in Landmark Phase 1 Study of iPSC-derived T-cell Therapy. In July, the first patient was treated in the Company's landmark Phase 1 clinical trial of FT819, the first-ever T-cell therapy derived from a clonal master induced pluripotent stem cell (iPSC) line to undergo clinical investigation. FT819 is an off-the-shelf, allogeneic CAR T-cell therapy targeting CD19, and is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy including a novel 1XX CAR signaling domain (1XX-CAR19) that extends T-cell effector function without eliciting exhaustion; integration of the CAR transgene directly into the T-cell receptor alpha constant (TRAC) locus, which promotes uniform CAR expression and enhances T-cell potency; and complete bi-allelic disruption of T-cell receptor expression to prevent GVHD. The first patient received a single FT819 dose of 90 million cells for the treatment of relapsed / refractory acute lymphoblastic leukemia (ALL).

    AML Disease Franchise

    • Interim Phase 1 Clinical Data of FT516 Demonstrate Anti-leukemic Activity. At a virtual investor event in May, the Company highlighted interim clinical data from its dose-escalating Phase 1 study of FT516 as monotherapy for the treatment of relapsed / refractory acute myeloid leukemia (AML). As of the data cutoff date of April 16, 2021, of the nine patients treated in Dose Cohorts 1 and 2 (n=3 at 90 million cells / dose and n=6 at 300 million cells / dose, respectively), six patients showed anti-leukemic activity as evidenced by on-treatment reduction in bone marrow blasts, with four patients (44%) achieving an objective response with complete clearance of leukemic blasts in the bone marrow. Three of these four responders achieved a best overall response of complete remission with incomplete hematopoietic recovery (CRi) based on 2017 ELN response criteria, including two patients in Dose Cohort 2 with ongoing remission without further therapeutic intervention at six months' follow-up. The FT516 treatment regimen was well tolerated, and no treatment-emergent adverse events of any grade of CRS, ICANS, or GVHD were reported. Dose escalation is ongoing with enrollment in Dose Cohort 3 (900 million cells / dose).
    • Anti-leukemic Activity Observed in Dose Cohort 1 of FT538 Phase 1 Study. The Company also highlighted initial clinical data from its dose-escalating Phase 1 Study of FT538 as monotherapy for the treatment of relapsed / refractory AML. As of the data cutoff date of May 6, 2021, two patients in Dose Cohort 1 (100 million cells / dose) were evaluable for safety and anti-leukemic activity, both of whom showed anti-leukemic activity as evidenced by on-treatment reduction in bone marrow blasts. One patient, who was refractory to their two most recent prior therapies, achieved a CRi based on 2017 ELN response criteria at the end of the first treatment cycle. The FT538 treatment regimen was well tolerated, and no treatment-emergent adverse events of any grade of CRS, ICANS, or GVHD were reported. No dose-limiting toxicities have been observed, and dose escalation is ongoing with enrollment in Dose Cohort 1. Upon clearance of Dose Cohort 1, enrollment is set to commence in an investigator-initiated Phase 1 clinical trial of FT538 in combination with the CD38-targeted monoclonal antibody daratumumab in patients with relapsed / refractory AML, a therapeutic strategy designed to exploit the product candidate's proprietary high-affinity, non-cleavable (hnCD16) receptor and CD38 knock-out (CD38KO) to target and eliminate CD38+ leukemic blasts.
    • Adaptive Phenotype and Functionality of FT538 Featured at ASGCT Symposium. At the 24th Annual American Society of Gene & Cell Therapy Meeting (ASGCT) held virtually in May, Dr. Jeffrey S. Miller, Professor of Medicine, University of Minnesota and Deputy Director of the Masonic Cancer Center, presented preclinical data demonstrating that the metabolic, transcriptional and functional properties of FT538 are substantially similar to those of adaptive NK cells, a discrete subset of memory-like NK cells with superior effector function. The deletion of the CD38 gene (CD38KO) was shown to enhance metabolic fitness, resistance to oxidative stress, serial innate cytotoxicity, and antibody-dependent cellular cytotoxicity compared to peripheral blood NK cells.

    Multiple Myeloma Franchise

    • Multiple Clinical Sites Activated for Phase 1 Study of FT538 in Combination with Daratumumab. The Phase 1 clinical trial is designed to assess three once-weekly doses of FT538 in combination with the CD38-targeted monoclonal antibody, daratumumab, for patients with relapsed / refractory multiple myeloma (NCT04614636). Multiple clinical sites have now been activated for study conduct, and the Company will initiate enrollment at 100 million cells per dose upon clearance of the first dose cohort in its Phase 1 study of FT538 in relapsed / refractory AML.
    • Initiated GMP Production of FT576 for Phase 1 Study. FT576 is derived from a clonal master iPSC line engineered with four functional components (CAR-BCMA + hnCD16 + IL-15RF + CD38KO) designed to enable multi-antigen targeting of myeloma cells, augment antibody-dependent cellular cytotoxicity (ADCC), promote NK cell activation without exogenous cytokine support, enhance NK cell persistence and prevent anti-CD38 monoclonal antibody-induced fratricide. GMP manufacture of FT576 is ongoing, and the Company is preparing to initiate a multi-center Phase 1 clinical trial to assess single-dose and multi-dose treatment regimens of FT576 as monotherapy and in combination with CD38-targeted monoclonal antibody therapy for the treatment of relapsed / refractory multiple myeloma.

    Solid Tumor Franchise

    • Completed Qualification of FT536 Clonal Master Engineered iPSC Bank. The master cell bank, which was created from a single iPSC clone engineered with four functional elements including a novel CAR targeting the alpha-3 domain of the pan-tumor associated stress antigens MICA and MICB, has successfully been released for initiation of FT536 GMP manufacture. Pilot manufacturing runs in support of the Investigational New Drug (IND) application for FT536 are ongoing. The Company plans to submit an IND application to the U.S. Food and Drug Administration (FDA) in the second half of 2021 to initiate a Phase 1 clinical trial of FT536 for the treatment of solid tumors. In preclinical studies, FT536 has demonstrated superior recognition and killing against a broad array of cancer cell lines compared to expanded primary NK cells as well as anti-NKG2D CAR T cells.
    • Preclinical Milestone Reached for First Product Candidate under Janssen Collaboration. In June, the Company and Janssen elected to initiate IND-enabling activities for an iPSC-derived CAR NK cell product candidate incorporating a Janssen proprietary antigen binding domain that targets an antigen expressed on certain solid tumors, triggering the payment of a milestone fee to the Company from Janssen under the collaboration. Janssen maintains an option to develop and commercialize the iPSC-derived CAR NK cell product candidate in all territories of the world, with the Company retaining the option to co-commercialize the product candidate in the United States.

    Other Corporate Highlights

    • Appointed Dr. Mark Plavsic as Chief Technical Officer. Dr. Plavsic brings to the Company over 20 years of broad technical excellence in global biopharmaceutical operations, having led teams in the commercial-scale cGMP manufacture and distribution, as well as the clinical-stage process, assay, and formulation development, of complex biologics. Mark will oversee the Company's manufacturing, technical, and supply chain operations.
    • Appointed Dr. Yuan Xu to its Board of Directors. Dr. Xu has over 25 years of discovery, development, manufacturing, and commercial experience in the global biopharmaceuticals business, most recently serving as the Chief Executive Officer and Board Member of Legend Biotech Corporation, where she led the company's efforts in advancing ciltacabtagene autoleucel (cilta-cel) from proof-of-concept in 2018 to BLA preparation in 2020.

    Second Quarter 2021 Financial Results

    • Cash & Investment Position: Cash, cash equivalents and investments as of June 30, 2021 were $845.1 million.
    • Total Revenue: Revenue was $13.4 million for the second quarter of 2021, which was derived from the Company's collaborations with Janssen and Ono Pharmaceutical.
    • R&D Expenses: Research and development expenses were $48.0 million for the second quarter of 2021, which includes $8.6 million of non-cash stock-based compensation expense.
    • G&A Expenses: General and administrative expenses were $12.2 million for the second quarter of 2021, which includes $4.6 million of non-cash stock-based compensation expense.
    • Shares Outstanding: Common shares outstanding were 94.3 million, and preferred shares outstanding were 2.8 million, as of June 30, 2021. Each preferred share is convertible into five common shares.

    Today's Conference Call and Webcast

    The Company will conduct a conference call today, Wednesday, August 4, 2021 at 5:00 p.m. ET to review financial and operating results for the quarter ended June 30, 2021. In order to participate in the conference call, please dial please dial 800-773-2954 (toll free) or 847-413-3731 (toll) and refer to conference ID 50196101. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.fatetherapeutics.com. The archived webcast will be available on the Company's website beginning approximately two hours after the event.

    About Fate Therapeutics' iPSC Product Platform

    The Company's proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company's first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company's platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics' iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

    About FT516

    FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in a multi-dose Phase 1 clinical trial as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of advanced B-cell lymphoma (NCT04023071). Additionally, FT516 is being investigated in a multi-dose Phase 1 clinical trial in combination with avelumab for the treatment of advanced solid tumor resistant to anti-PDL1 checkpoint inhibitor therapy (NCT04551885).

    About FT596

    FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and hnCD16 targeting receptors enhances cytotoxic activity, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a humanized mouse model of lymphoma, FT596 in combination with the anti-CD20 monoclonal antibody rituximab showed enhanced killing of tumor cells in vivo as compared to rituximab alone. FT596 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell lymphoma as a monotherapy and in combination with rituximab, and for the treatment of relapsed / refractory chronic lymphocytic leukemia (CLL) as a monotherapy and in combination with obinutuzumab (NCT04245722).

    About FT538

    FT538 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components: a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; an IL-15 receptor fusion (IL-15RF) that augments NK cell activity; and the deletion of the CD38 gene (CD38KO), which promotes persistence and function in high oxidative stress environments. FT538 is designed to enhance innate immunity in cancer patients, where endogenous NK cells are typically diminished in both number and function due to prior treatment regimens and tumor suppressive mechanisms. In preclinical studies, FT538 has shown superior NK cell effector function, as compared to peripheral blood NK cells, with the potential to confer significant anti-tumor activity to patients through multiple mechanisms of action. FT538 is being investigated in a multi-dose Phase 1 clinical trial for the treatment of acute myeloid leukemia (AML) and in combination with daratumumab, a CD38-targeted monoclonal antibody therapy, for the treatment of multiple myeloma (NCT04614636).

    About FT819

    FT819 is an investigational, universal, off-the-shelf, T-cell receptor (TCR)-less CD19 chimeric antigen receptor (CAR) T-cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line, which is engineered with the following features designed to improve the safety and efficacy of CAR19 T-cell therapy: a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion; integration of the CAR19 transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR19 expression and enhanced T-cell potency; and complete bi-allelic disruption of TCR expression for the prevention of graft-versus-host disease (GvHD). FT819 demonstrated antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of primary CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia (Valamehr et al. 2020). FT819 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell malignancies, including B-cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia (NCT04629729).

    About Fate Therapeutics, Inc.

    Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company's results of operations, financial condition and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and plans related to its product candidates, clinical studies and preclinical research and development programs, the Company's progress, plans and timelines for the manufacture and clinical investigation of its product candidates, the timing for the Company's receipt of data from its clinical trials and preclinical studies, the initiation of additional clinical trials and additional dose cohorts in ongoing clinical trials of the Company's product candidates and the submission of IND applications for additional programs, the Company's development and regulatory strategy, the therapeutic and market potential of the Company's product candidates, and the parties' rights and obligations under the Company's collaboration agreements. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company's product candidates may not demonstrate the requisite safety or efficacy to achieve regulatory approval or to warrant further development, the risk that results observed in prior studies of the Company's product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company's product candidates or in the initiation of, or enrollment of patients in, any clinical studies, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, the amount and type of data to be generated, or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company's ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company's product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), risks related to the impact of the COVID-19 pandemic on various aspects of the Company's business and operations, including its ability to initiate, conduct and complete its clinical trials, and the risk that the Company's expenditures may exceed current expectations for a variety of reasons. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission, including but not limited to the Company's most recently filed periodic report, and from time to time in the Company's press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

    Availability of Other Information about Fate Therapeutics, Inc.

    Investors and others should note that the Company routinely communicates with investors and the public using its website (www.fatetherapeutics.com) and its investor relations website (ir.fatetherapeutics.com) including, without limitation, through the posting of investor presentations, SEC filings, press releases, public conference calls and webcasts on these websites. The information posted on these websites could be deemed to be material information. As a result, investors, the media, and others interested in Fate Therapeutics are encouraged to review this information on a regular basis. The contents of the Company's website, or any other website that may be accessed from the Company's website, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share data)

    (unaudited)

     Three Months Ended  Six Months Ended 
     June 30,  June 30, 
     2021  2020  2021  2020 
          
    Collaboration revenue$13,412  $5,465  $24,552  $7,980 
    Operating expenses:               
    Research and development 48,023   26,669   92,873   55,947 
    General and administrative 12,168   7,503   24,668   15,232 
    Total operating expenses 60,191   34,172   117,541   71,179 
    Loss from operations (46,779)  (28,707)  (92,989)  (63,199)
    Other income (expense):               
    Interest income 346   635   723   1,607 
    Change in fair value of stock price appreciation milestones (8,700)  -   (7,956)  - 
    Total other income (expense), net (8,354)  635   (7,233)  1,607 
    Net loss$(55,133) $(28,072) $(100,222) $(61,592)
    Other comprehensive income (loss):               
    Unrealized gain (loss) on available-for sale securities, net 174   481   (156)  601 
    Comprehensive loss$(54,959) $(27,591) $(100,378) $(60,991)
    Net loss per common share, basic and diluted$(0.58) $(0.35) $(1.07) $(0.79)
    Weighted–average common shares used to compute basic and diluted net loss per share 94,326,648   79,304,627   93,881,734   77,595,795 
                    

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

     June 30,  December 31, 
     2021  2020 
            
    Assets       
    Current assets:       
    Cash and cash equivalents$76,654  $167,347 
    Accounts receivable 10,303   5,515 
    Short-term investments and related maturity receivables 618,942   315,569 
    Prepaid expenses and other current assets 7,369   5,892 
    Total current assets 713,268   494,323 
    Long-term investments 149,501    
    Operating lease right-of-use assets 66,184   67,084 
    Other long-term assets 86,713   61,050 
    Total assets$1,015,666  $622,457 
            
    Liabilities and stockholders' equity       
    Current liabilities:       
    Accounts payable and accrued expenses$31,507  $21,847 
    Deferred revenue, current portion 23,032   21,144 
    CIRM award liability, current portion 3,200   3,200 
    Operating lease liabilities, current portion 5,068   3,355 
    Stock price appreciation milestones, current portion 42,793   36,018 
    Total current liabilities 105,600   85,564 
    Deferred revenue, net of current portion 38,925   46,021 
    CIRM award liability, net of current portion 800   800 
    Operating lease liabilities, net of current portion 105,405   93,943 
    Stock price appreciation milestones, net of current portion 12,865   11,684 
    Stockholders' equity 752,071   384,445 
    Total liabilities and stockholders' equity$1,015,666  $622,457 
            

    Contact:

    Christina Tartaglia

    Stern Investor Relations, Inc.

    212.362.1200

    christina@sternir.com



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  5. SAN DIEGO, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, today announced the appointment of Yuan Xu, Ph.D., to its Board of Directors as an independent director. Dr. Xu brings to Fate Therapeutics over 25 years of discovery, development, manufacturing, and commercial experience in the global biopharmaceuticals business, most recently serving as the Chief Executive Officer and Board Member of Legend Biotech Corporation where she led the company's efforts in advancing ciltacabtagene autoleucel (cilta-cel) from proof-of-concept in 2018 to BLA preparation in 2020.

    "Yuan is an accomplished leader…

    SAN DIEGO, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, today announced the appointment of Yuan Xu, Ph.D., to its Board of Directors as an independent director. Dr. Xu brings to Fate Therapeutics over 25 years of discovery, development, manufacturing, and commercial experience in the global biopharmaceuticals business, most recently serving as the Chief Executive Officer and Board Member of Legend Biotech Corporation where she led the company's efforts in advancing ciltacabtagene autoleucel (cilta-cel) from proof-of-concept in 2018 to BLA preparation in 2020.

    "Yuan is an accomplished leader and innovator with extensive experience in guiding development and scaling manufacture of novel therapies, including CAR T-cell therapies such as cilta-cel," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We are excited to work with Yuan, and we look forward to benefiting from her deep domain expertise as the Company advances its off-the-shelf, iPSC-derived NK and T-cell product candidates further into clinical development, transitions to large-scale manufacture, and establishes technical operations to support commercial approval."

    Dr. Xu joined Legend Biotech Corporation in March 2018 as chief executive officer and as a director, playing a leading role in the company's IPO, clinical development of the autologous CAR T-cell therapy cilta-cel, and partnership with Janssen until her resignation in August 2020. Prior to Legend, Dr. Xu was Senior Vice President at Merck from August 2015 to August 2017, where she led discovery, preclinical and technical development, and manufacture of the Biologics & Vaccines subdivision. Dr. Xu was Vice President at Gilead from March 2014 to August 2015, where she led biologics and vaccines development and oversaw all operational aspects of the company's Oceanside manufacturing facility as Site Head, and was Vice President at Novartis from 2008 to 2014, where she led several functions in the U.S. and Europe including the biotherapeutics development unit focusing on innovative medicines such as engineered cell therapies, gene therapies, and antibody drug conjugates. Dr. Xu currently serves as an independent director on the board of directors of Akero Therapeutics, Inc. (NASDAQ:AKRO).

    "Fate Therapeutics has pioneered the field of iPSC-derived cell therapy, and has established a clear leadership position in the development of off-the-shelf NK and T-cell cancer immunotherapy with its robust clinical pipeline, novel iPSC product platform, and high-value strategic collaborations," said Dr. Xu. "I look forward to working closely with the Company's board and management team as we move into late-stage clinical development, scale manufacture, and seek to make these innovative cancer medicines more broadly accessible to patients."

    Early in her career, Dr. Xu held positions at Amgen, Chiron, GlaxoSmithKline and Genentech. Dr. Xu received a B.S. in biochemistry from Nanjing University and a Ph.D. in biochemistry from the University of Maryland, and she completed her post-doctoral training in virology and gene therapy at the University of California, San Diego.

    About Fate Therapeutics' iPSC Product Platform

    The Company's proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company's first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company's platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics' iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

    About Fate Therapeutics, Inc.

    Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of, plans related to, and the therapeutic potential of the Company's product candidates, the Company's clinical development and manufacturing strategies, and the Company's plans for the clinical investigation and manufacture of its product candidates. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results observed in studies of its product candidates, including preclinical studies and clinical trials of any of its product candidates, will not be observed in ongoing or future studies involving these product candidates, the risk that the Company may cease or delay clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, the amount and type of data to be generated, or otherwise to support regulatory approval, difficulties or delays in subject enrollment and continuation in current and planned clinical trials, difficulties in manufacturing or supplying the Company's product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission, including but not limited to the Company's most recently filed periodic report, and from time to time in the Company's press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

    Contact:

    Christina Tartaglia

    Stern Investor Relations, Inc.

    212.362.1200

    christina@sternir.com



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