TIL Instil Bio Inc.

12.7
-0.03  0%
Previous Close 12.73
Open 12.48
52 Week Low 12.27
52 Week High 29.49
Market Cap $1,637,370,081
Shares 128,926,778
Float 16,530,607
Enterprise Value $1,122,012,080
Volume 359,197
Av. Daily Volume 629,682
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Upcoming Catalysts

Drug Stage Catalyst Date
ITIL-168 (DELTA-1)
Melanoma
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
ITIL-168 (DELTA-2)
Non-small cell lung cancer (NSCLC)
Phase 1
Phase 1
Phase 1 trial to be initiated 1H 2022.

Latest News

  1. DALLAS, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today announced poster presentations demonstrating pre-clinical data of the CoStimulatory Antigen Receptor (CoStAR) platform at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2021), held from November 10-14, 2021. Instil also presented a Trials-in-Progress poster detailing DELTA-1, the ongoing Phase 2 study of ITIL-168 in advanced melanoma.

    Pre-clinical data of the anti-FOLR1 CoStAR construct utilized in ITIL-306, Instil's first genetically-engineered CoStAR-TIL product candidate…

    DALLAS, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today announced poster presentations demonstrating pre-clinical data of the CoStimulatory Antigen Receptor (CoStAR) platform at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2021), held from November 10-14, 2021. Instil also presented a Trials-in-Progress poster detailing DELTA-1, the ongoing Phase 2 study of ITIL-168 in advanced melanoma.

    Pre-clinical data of the anti-FOLR1 CoStAR construct utilized in ITIL-306, Instil's first genetically-engineered CoStAR-TIL product candidate, was shown in Poster 198. The results demonstrated that CoStAR broadly enhances effector function of T cells including cytolytic activity, cytokine secretion and proliferation of T cells. CoStAR did not stimulate T cells on its own, but only increased T-cell function in the presence of signals activating both the tumor-reactive TCR and the CoStAR molecule. Additionally, data were presented that showed CoStAR was transduced at high efficiency (greater than 40%) into primary ovarian cancer TILs and effector function of CoStAR-TIL was increased over untransduced TILs when cocultured with autologous tumor cells.

    The proprietary CoStAR platform utilizes intracellular CD28 and CD40 domains to deliver novel synergistic costimulatory activity to T cells. Poster 199 showcased enhanced activity of T cells engineered with dual CD28/CD40-containing CoStARs, with greater proliferation, enhanced effector function, and a superior cytokine secretion profile compared to a CD28-only CoStAR. Importantly, CoStAR-expressing T cells proliferated exponentially after exposure to tumor antigen, even in the absence of exogenous interleukin (IL)-2, a key required growth factor for T cells in vitro.

    "These data further support our excitement for the CoStAR platform, which addresses a major challenge for solid tumor cell therapy: the lack of effective costimulation within the tumor microenvironment," said Mark Dudley, Ph.D., Head of Research at Instil. "The optimized intracellular signaling domains of our CoStAR platform include CD28 and CD40, which demonstrate superior performance over CoStARs containing only CD28."

    "With the encouraging preclinical data presented at SITC, we are optimistic that CoStAR may be able to enhance the activity of TILs in patients with cancer and may eliminate the need for high doses of post-infusion IL-2, which is a frequent cause of toxicity in unmodified TIL therapy," said Zachary Roberts, M.D. Ph.D., Chief Medical Officer of Instil Bio. "We continue to look forward to the upcoming Phase 1 first-in-human study of ITIL-306 which we expect to initiate in the first half of 2022."

    The company also presented a trial-in-progress poster for DELTA-1, the ongoing Phase 2 study of ITIL-168 in advanced melanoma (Poster 544).

    Details of the poster presentations are as follows:

    Title: Costimulatory antigen receptor (CoStAR): a novel platform that enhances the activity of TILs

    Authors: Sukumaran S, et al.

    Poster/Abstract Number: 198 / DOI: 10.1136/jitc-2021-SITC2021.198

    Title: Potent T cell costimulation mediated by a novel costimulatory antigen receptor (CoStAR) with dual CD28/CD40 signaling domains to improve adoptive cell therapies

    Authors: Sykorova M, et al.

    Poster/Abstract Number: 199 / DOI: 10.1136/jitc-2021-SITC2021.199

    Title: A global, multicenter phase 2 study of ITIL-168, an unrestricted autologous TIL cell therapy, in adult patients with advanced cutaneous melanoma

    Authors: Gastman B, et al.

    Poster/Abstract Number: 544 / DOI: 10.1136/jitc-2021-SITC2021.544

    The posters are available on the publications section of the Instil Bio website: www.instilbio.com/publications.

    About CoStAR

    CoStAR (Co-Stimulatory Antigen Receptor) is a novel platform technology used to create a new class of genetically engineered TIL therapies. These modified TILs rely on their native, patient-specific T cell receptors, or TCRs, for detection of tumor-specific antigens, with significantly enhanced effector function when the CoStAR molecule is simultaneously bound to its target in the tumor microenvironment. Submission of the IND for ITIL-306, Instil's lead CoStAR-TIL product candidate which binds FOLR1 (Folate Receptor Alpha), is anticipated for the first half of 2022.

    About ITIL-168

    ITIL-168 is an investigational, autologous cell therapy made from tumor infiltrating lymphocytes, or TILs. Made from each patient's digested and cryopreserved tumor, ITIL-168 is a TIL cell therapy manufactured to offer an unrestricted T cell receptor (TCR) repertoire. Instil's proprietary, optimized, and scalable manufacturing process has been designed to capture and preserve the maximum diversity of each patient's TILs. By collecting the patient's tumor and immediately processing and then cryopreserving it, our process offers significant scheduling flexibility for patients and physicians at the time of both tumor resection and TIL treatment. In addition to DELTA-1, Instil plans to investigate ITIL-168 in additional solid tumor indications in Phase 1 clinical trials beginning in 2022.

    About DELTA-1

    DELTA-1 is a global, multicenter Phase 2 clinical trial of ITIL-168 in adult patients with advanced melanoma. Using an open-label, single-arm design, the main study cohort will evaluate the efficacy and safety of ITIL-168, when administered after a 5-day course of lymphodepleting chemotherapy and followed by up to 8 doses of high-dose interleukin-2 (IL-2), in patients whose cancer has progressed following a PD-1 inhibitor and, if positive for a BRAF-activating mutation, a BRAF inhibitor. Approximately 80 subjects are planned for enrollment and treatment in Cohort 1. Cohort 2 is anticipated to enroll approximately 25 subjects and is designed to evaluate the efficacy and safety of the regimen in patients who required discontinuation of PD-1 inhibitor(s) due to unacceptable toxicity, regardless of best overall disease response. Cohort 3 is also anticipated to enroll approximately 25 subjects and will evaluate efficacy and safety in patients whose best ongoing response to PD-1 inhibitor(s) is stable disease. Patients in Cohorts 2 and 3 whose cancer expresses a BRAF-activating mutation will be required to have experienced disease progression following BRAF inhibitor therapy. The primary endpoint of DELTA-1 is the objective response rate (ORR) according to RECIST v1.1 as assessed by independent central review. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety.

    About Instil Bio

    Instil Bio, Inc. (NASDAQ:TIL) is a clinical-stage biopharmaceutical company focused on developing TIL therapies for the treatment of patients with cancer and as an innovation platform for next generation therapies. The Company has assembled an accomplished management team with a successful track record in the development, manufacture, and commercialization of cell therapies. Using the Company's proprietary, optimized, and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors as well as ITIL-306, a next-generation, genetically engineered TIL therapy for multiple solid tumors. For more information visit www.instilbio.com and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the timing of our ongoing and potential future clinical trials and the availability of data therefrom, the potential for our product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, whether, if approved, these product candidates will be successfully distributed and marketed, our plans to expand clinical manufacturing capabilities, and the potential benefits of orphan drug designation to ITIL-168, the adequacy of our cash resources, and other statements that are not historical fact. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our prospectus dated March 18, 2021, as filed with the SEC on March 22, 2021, pursuant to Rule 424(b) under the Securities Act of 1933, as amended, and the section titled "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law. 

    Contacts:

    Brendan Payne

    Stern Investor Relations

    1-212-362-1200

    Media Contact:

    1-833-446-7845 Ext. 1009



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    • Patients enrolled and recruitment ongoing in Phase 2 trial of ITIL-168 in melanoma (DELTA-1)
    • Fast Track Designation granted by FDA for ITIL-168 in metastatic melanoma
    • CoStAR mechanism of action data presented at SITC 2021
    • Successful pre-IND meeting for ITIL-306

    DALLAS, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or (TIL), therapies for the treatment of patients with cancer, today reported its third quarter 2021 financial results and provided a corporate update.

    "We have achieved key milestones in our continued development of ITIL-168 with clearance of our IND for the DELTA-1 study, Fast Track Designation approval…



    • Patients enrolled and recruitment ongoing in Phase 2 trial of ITIL-168 in melanoma (DELTA-1)
    • Fast Track Designation granted by FDA for ITIL-168 in metastatic melanoma
    • CoStAR mechanism of action data presented at SITC 2021
    • Successful pre-IND meeting for ITIL-306

    DALLAS, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or (TIL), therapies for the treatment of patients with cancer, today reported its third quarter 2021 financial results and provided a corporate update.

    "We have achieved key milestones in our continued development of ITIL-168 with clearance of our IND for the DELTA-1 study, Fast Track Designation approval and initiation of enrollment in DELTA-1," said Bronson Crouch, Chief Executive Officer of Instil. "Our progress in establishing a platform for cell therapy continues with the expansion of our UK clinical manufacturing capabilities which are on track to reach an annual capacity of over 200 lots by year end 2021 as well as with US clinical manufacturing coming online next year. With this added capacity, we expect to initiate additional trials in the months ahead as we progress both ITIL-168 and ITIL-306, our first genetically-engineered CoStAR-TIL."

    Third Quarter 2021 Highlights and Recent Corporate Updates:

    Clinical Development:

    • Received IND Clearance from the FDA to Initiate DELTA-1, a Phase 2 Clinical Trial for Patients with Advanced Melanoma: On September 13, 2021, Instil reported clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to initiate DELTA-1, a global Phase 2 clinical trial of ITIL-168 with registrational intent in patients with advanced melanoma. The DELTA-1 trial was expanded during the IND review process in consultation with FDA to include additional populations of patients with advanced melanoma, including patients who discontinued PD-1 inhibitor therapy due to intolerable toxicity and patients who had an unsatisfactory response to prior PD-1 inhibitor.



    • Initiated enrollment in DELTA-1: Instil reported that patients have been enrolled and recruitment is ongoing into the pivotal study. Enrollment for Cohort 1 is expected to be completed within 12 months, with Cohorts 2 and 3 finishing enrollment thereafter. Instil expects top-line data and BLA filing submission in 2023 and a European Medicines Agency (EMA) marketing authorization application (MAA) filing in 2024.



    • ITIL-168 in Advanced Melanoma Granted FDA Fast Track Designation: Instil was recently granted Fast Track Designation from the U.S. FDA for ITIL-168 in advanced melanoma. Fast Track designation confers certain benefits on the development process, including more frequent communications with the FDA and potential eligibility for accelerated approval and priority review.



    • Readiness to Initiate DELTA-2 in H1 2022: Preparations are on track to initiate enrollment in DELTA-2, a Phase 1 study of ITIL-168 in non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cervical cancer, and cutaneous squamous cell carcinoma (CSCC). Enrollment in DELTA-2 is planned to initiate in H1 2022.



    • Presented Clinical Data in Advanced Cutaneous Melanoma at ESMO: Instil presented a subset analysis of treatment outcomes with TILs in 12 patients with checkpoint inhibitor-refractory advanced cutaneous melanoma, demonstrating a 58% objective response rates and median overall survival of 21.3 months; all patients in the subset analysis had experienced disease progression following treatment with a PD-1 inhibitor and CTLA-4 inhibition with ipilimumab.

    Manufacturing and Technical Operations:

    • Clinical Manufacturing Readiness: U.K. manufacturing capacity remains on track for regulatory approval of the additional IMPACT manufacturing suite in Q4 2021, which will approximately triple the current U.K. manufacturing capacity. U.S. clinical manufacturing in Tarzana, CA remains on track for launch of clinical manufacturing in H1 2022, with qualification ongoing.

    Research:

    • Appointed Mark Dudley, Ph.D. as Head of Research: Instil has appointed Mark Dudley, Ph.D. as Head of Research. Prior to Instil, Dr. Dudley led early development of T cell therapies at Adaptimmune Therapeutics plc, and before that was on the technical R&D leadership team at Novartis. Before Novartis, Dr. Dudley spent nearly two decades at the Surgery Branch of the National Cancer Institute, where he contributed to a diverse portfolio of experimental T cell therapies, including TIL, TCR-T, and CAR-T products. Dr. Dudley is a recognized pioneer in adoptive cell therapy, having published seminal studies in TIL therapy for refractory melanoma patients, and the first studies of CD19 CAR-T in humans, IL-2 and IL-12 genetically engineered T cells in clinical trials, and TCR-T cells in clinical trials.



    • Successful Pre-IND Meeting with FDA on First-in-Human Study of ITIL-306: Instil Bio recently completed a pre-IND meeting with the FDA for the proposed first-in-human Phase 1 study of ITIL-306, a TIL product genetically engineered to express a Costimulatory Antigen Receptor (CoStAR) molecule, to gain alignment on nonclinical, manufacturing, and clinical aspects of the program. The company expects initiate a Phase 1 study of ITIL-306 in multiple cancer indications in H1 2022.



    • Presented Pre-clinical Data on the CoStAR Platform at SITC: Instil presented posters highlighting pre-clinical data from the CoStAR platform which demonstrated that CoStAR expression by T cells led to marked enhancement of effector function and proliferation of T cells and TILs. The novel design of CoStAR, which includes two intracellular costimulatory domains derived from CD28 and CD40, showed significantly improved activity compared to a CoStAR that contained only a CD28 domain, demonstrating the superiority of CD40-containing CoStAR molecules and important synergies of CD40 and CD28 signaling. Further details can be found in the poster publications available here.

    Third Quarter 2021 Financial and Operating Results:

    As of September 30, 2021, we had $20.4 million in cash and cash equivalents and $495.0 million in marketable securities, compared to $241.7 million in cash and cash equivalents and no investments in marketable securities as of December 31, 2020. The Company expects that its cash, cash equivalents and marketable securities as of September 30, 2021 will enable it to fund its operating plan into 2023.

    Research and development expenses were $29.1 million and $64.7 million for the three and nine months ended September 30, 2021, compared to $4.9 million and $9.2 million for the three and nine months ended September 30, 2020.

    General and administrative expenses were $14.0 million and $37.1 million for the three and nine months ended September 30, 2021, compared to $2.9 million and $7.2 million for the three and nine months ended September 30, 2020.



    INSTIL BIO, INC.

    SELECTED FINANCIAL DATA

    (Unaudited; in thousands, except share and per share amounts)

    Statements of Operations

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
     2021 2020 2021 2020
    Revenue$  $52  $  $138 
    Operating expenses:       
    Research and development29,064  4,908  64,674  9,152 
    General and administrative13,960  2,855  37,134  7,153 
    Total operating expenses43,024  7,763  101,808  16,305 
    Loss from operations(43,024) (7,711) (101,808) (16,167)
    Interest and other (expense) income, net(639) 449  (657) (4,386)
    Loss before income tax benefit$(43,663) $(7,262) $(102,465) $(20,553)
    Income tax benefit658    1,021   
    Net loss$(43,005) $(7,262) $(101,444) $(20,553)
    Net loss per share, basic and diluted$(0.33) $(0.43) $(1.03) $(1.32)
    Weighted-average shares used in computing net loss per share, basic and diluted 128,794,142   16,928,831   98,256,027   15,616,389 



    Selected Balance Sheet Data

     September 30,

    2021
     December 31,

    2020
    Cash, cash equivalents and marketable securities$515,358  $241,714 
    Total assets647,397  319,012 
    Total liabilities45,977  26,645 
    Convertible preferred stock and stockholders' equity (deficit)601,420  292,367 



    About Instil Bio

    Instil Bio, Inc. (NASDAQ:TIL) is a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or (TIL), therapies for the treatment of patients with cancer. The Company has assembled an accomplished management team with a successful track record in the development, manufacture, and commercialization of cell therapies. Using the Company's proprietary, optimized, and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors as well as ITIL-306, a next-generation, genetically engineered TIL therapy for multiple solid tumors. For more information visit www.instilbio.com and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the timing of our ongoing and potential future clinical trials and the availability of data therefrom, the potential for our product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, whether, if approved, these product candidates will be successfully distributed and marketed, our plans to expand clinical manufacturing capabilities, and the potential benefits of orphan drug designation to ITIL-168, the adequacy of our cash resources, and other statements that are not historical fact. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our prospectus dated March 18, 2021, as filed with the SEC on March 22, 2021, pursuant to Rule 424(b) under the Securities Act of 1933, as amended, and the section titled "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021 available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

    Contacts:

    Brendan Payne

    Stern Investor Relations

    1-212-362-1200

    Media Contact:

    1-833-446-7845 Ext. 1009



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  2. DALLAS, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today announced that company management will participate in two upcoming investor conferences in November:

    Cowen 5th Annual IO Next Summit
    Monday, November 15, 2021
    Session Time: 4:45 PM – 5:05 PM ET
    Live Session Link: https://wsw.com/admin/link/presenter.aspx?418616172

    Jefferies Global Healthcare Conference (London)
    Thursday, November 18, 2021
    Session Time: 3:00 AM ET
    Session Link: https://wsw.com/webcast/jeff201/til/1696446/.
    An archived replay of the webcast will be available on the Company's website for…

    DALLAS, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today announced that company management will participate in two upcoming investor conferences in November:

    Cowen 5th Annual IO Next Summit

    Monday, November 15, 2021

    Session Time: 4:45 PM – 5:05 PM ET

    Live Session Link: https://wsw.com/admin/link/presenter.aspx?418616172

    Jefferies Global Healthcare Conference (London)

    Thursday, November 18, 2021

    Session Time: 3:00 AM ET

    Session Link: https://wsw.com/webcast/jeff201/til/1696446/.

    An archived replay of the webcast will be available on the Company's website for approximately 90 days following the presentation.

    Both sessions can also be accessed by visiting the News & Events section of the Instil Bio website at www.instilbio.com.

    About Instil Bio

    Instil Bio, Inc. (NASDAQ:TIL) is a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer. The Company has assembled an accomplished management team with a successful track record in the development, manufacture, and commercialization of cell therapies. Using the Company's proprietary, optimized, and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors as well as ITIL-306, a next-generation, genetically engineered TIL therapy for multiple solid tumors. For more information visit www.instilbio.com and LinkedIn.

    Contacts:

    Investor Relations

    1-972-499-3350



    www.instilbio.com



    Brendan Payne

    Stern Investor Relations

    1-212-362-1200

     



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  3. DALLAS, Sept. 16, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, announced today that a subset analysis of treatment outcomes with unselected autologous tumor infiltrating lymphocytes (TILs) in patients with checkpoint inhibitor-refractory advanced cutaneous melanoma was presented today at the 2021 European Society for Medical Oncology (ESMO) Congress, taking place virtually from September 16-21, 2021.

    Among the 12 patients featured in this subset analysis who had disease progression following treatment with a PD-1 inhibitor, all were also resistant to CTLA-4 inhibition…

    DALLAS, Sept. 16, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, announced today that a subset analysis of treatment outcomes with unselected autologous tumor infiltrating lymphocytes (TILs) in patients with checkpoint inhibitor-refractory advanced cutaneous melanoma was presented today at the 2021 European Society for Medical Oncology (ESMO) Congress, taking place virtually from September 16-21, 2021.

    Among the 12 patients featured in this subset analysis who had disease progression following treatment with a PD-1 inhibitor, all were also resistant to CTLA-4 inhibition with ipilimumab. Seven (58%) patients achieved an objective response, with 1 (8%) achieving a complete response. With a median duration of follow-up of 45.5 months, the median overall survival was 21.3 months with nearly half of patients experiencing long term survival. Side effects of treatment were largely transient, manageable with supportive care, and generally attributable to the lymphodepleting chemotherapy regimen and post-TIL high-dose IL-2 treatment. Outcomes in this highly treatment-refractory subgroup were similar to those observed in all 21 treated patients, with high response rates and an expected safety profile.

    "The results of this analysis of a difficult-to-treat subgroup of patients further demonstrate that TIL therapy may offer benefit to patients with advanced melanoma once standard treatments have failed," said Zachary Roberts, M.D., Ph.D., Chief Medical Officer of Instil Bio. "We eagerly anticipate building on these results in DELTA-1, our Phase 2 study of ITIL-168 in patients with advanced melanoma."

    Poster Presentation Details

    Title: Treatment outcomes with unselected autologous tumor infiltrating lymphocytes (TILs) in patients (pts) with checkpoint inhibition–refractory advanced cutaneous melanoma

    Poster Session: ePoster Display

    Poster Number: 1058P

    About ITIL-168

    ITIL-168 is an investigational, autologous cell therapy made from tumor infiltrating lymphocytes, or TILs. Made from each patient's digested and cryopreserved tumor, ITIL-168 is a TIL cell therapy manufactured to offer an unrestricted T cell receptor (TCR) repertoire. Instil's proprietary, optimized, and scalable manufacturing process has been designed to capture and preserve the maximum diversity of each patient's TILs. By collecting the patient's tumor and immediately processing and then cryopreserving it, our process offers significant scheduling flexibility for patients and physicians at the time of both tumor resection and TIL treatment. In addition to DELTA-1, Instil plans to investigate ITIL-168 in additional solid tumor indications in Phase 1 clinical trials beginning in 2022.

    About DELTA-1

    DELTA-1 is a global, multicenter Phase 2 clinical trial of ITIL-168 in adult patients with advanced melanoma. Using an open-label, single-arm design, the main study cohort will evaluate the efficacy and safety of ITIL-168, when administered after a 5-day course of lymphodepleting chemotherapy and followed by up to 8 doses of high-dose interleukin-2 (IL-2), in patients whose cancer has progressed following a PD-1 inhibitor and, if positive for a BRAF-activating mutation, a BRAF inhibitor. Approximately 80 subjects are planned for enrollment and treatment in Cohort 1. Cohort 2 is anticipated to enroll approximately 25 subjects and is designed to evaluate the efficacy and safety of the regimen in patients who required discontinuation of PD-1 inhibitor(s) due to unacceptable toxicity, regardless of best overall disease response. Cohort 3 is also anticipated to enroll approximately 25 subjects and will evaluate efficacy and safety in patients whose best ongoing response to PD-1 inhibitor(s) is stable disease. Patients in Cohorts 2 and 3 whose cancer expresses a BRAF-activating mutation will be required to have experienced disease progression following BRAF inhibitor therapy. The primary endpoint of DELTA-1 is the objective response rate (ORR) according to RECIST v1.1 as assessed by independent central review. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety.

    About Instil Bio

    Instil Bio, Inc. (NASDAQ:TIL) is a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer. The Company has assembled an accomplished management team with a successful track record in the development, manufacture, and commercialization of cell therapies. Using the Company's proprietary, optimized, and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors as well as ITIL-306, a next-generation, genetically engineered TIL therapy for multiple solid tumors. For more information visit www.instilbio.com and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, including the design and enrollment of the DELTA-1 clinical trial, the timing of initiating clinical trials, the timing of reporting of data and the timing of regulatory submissions, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, whether, if approved, these product candidates will be successfully distributed and marketed, and our clinical manufacturing capabilities. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, as filed with the SEC on August 12, 2021, which is available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

    Contacts:

    Brendan Payne

    Stern Investor Relations

    1-212-362-1200

        

    Media Contact:

    1-833-446-7845 Ext. 1009

     



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  4. Main Study Cohort: Phase 2 clinical trial with registrational intent for patients with advanced melanoma

    Additional Cohorts: ITIL-168 clinical trial expanded during IND review process with two additional cohorts, broadening the study target population

    DALLAS, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today reported clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate DELTA-1, a global Phase 2 clinical trial of ITIL-168 in patients with advanced melanoma whose disease has relapsed after…

    Main Study Cohort: Phase 2 clinical trial with registrational intent for patients with advanced melanoma

    Additional Cohorts: ITIL-168 clinical trial expanded during IND review process with two additional cohorts, broadening the study target population

    DALLAS, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (NASDAQ:TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today reported clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate DELTA-1, a global Phase 2 clinical trial of ITIL-168 in patients with advanced melanoma whose disease has relapsed after a PD-1 inhibitor and, if positive for a BRAF-activating mutation, a BRAF inhibitor.

    The DELTA-1 trial was expanded during the IND review process, in consultation with FDA, to include additional populations of patients with advanced melanoma. Cohorts 2 and 3 will enroll patients who discontinued PD-1 inhibitor therapy due to intolerable toxicity and patients who had an unsatisfactory response to prior PD-1 inhibitor but have not yet experienced disease progression, respectively. Topline safety and efficacy results are expected in 2023 and, if positive, are anticipated to support the submission of a biologics license application (BLA) to the FDA in 2023 and a Marketing Authorization Application (MAA) to the European Medicines Agency in 2024.

    "The IND clearance for the DELTA-1 Phase 2 clinical trial is a testament to the talent, experience and devotion of the Instil Bio team," said Bronson Crouch, Chief Executive Officer of Instil. "Motivated by patients in need, our organization will develop ITIL-168 commercially as we expand our clinical programs with current and next-generation therapies."

    "This achievement reflects the depth of cell therapy experience, scientific talent and focused execution of our organizations in both the U.S. and U.K.," said Vijay Chiruvolu, Ph.D., Chief Technical Officer of Instil. "Additionally, the development of the product release plan, encompassing the innovative potency assay as part of QC release as well as the comprehensive characterization strategy, was built on expertise from our broad, cross-functional team including research, process development, analytical sciences and translational medicine."

    Zachary Roberts, M.D. Ph.D., Chief Medical Officer of Instil added, "We are pleased to begin this clinical trial of ITIL-168 in an area of marked unmet medical need. Furthermore, the inclusion of additional cohorts of patients who have not been systematically studied with TIL therapy provides us with the opportunity to learn about the potential role of ITIL-168 in other populations who lack effective therapies."

    About ITIL-168

    ITIL-168 is an investigational, autologous cell therapy made from tumor infiltrating lymphocytes, or TILs. Made from each patient's digested and cryopreserved tumor, ITIL-168 is a TIL cell therapy manufactured to offer an unrestricted T cell receptor (TCR) repertoire. Instil's proprietary, optimized, and scalable manufacturing process has been designed to capture and preserve the maximum diversity of each patient's TILs. By collecting the patient's tumor and immediately processing and then cryopreserving it, our process offers significant scheduling flexibility for patients and physicians at the time of both tumor resection and TIL treatment. In addition to DELTA-1, Instil plans to investigate ITIL-168 in additional solid tumor indications in Phase 1 clinical trials beginning in 2022.

    About DELTA-1

    DELTA-1 is a global, multicenter Phase 2 clinical trial of ITIL-168 in adult patients with advanced melanoma. Using an open-label, single-arm design, the main study cohort will evaluate the efficacy and safety of ITIL-168, when administered after a 5-day course of lymphodepleting chemotherapy and followed by up to 8 doses of high-dose interleukin-2 (IL-2), in patients whose cancer has progressed following a PD-1 inhibitor and, if positive for a BRAF-activating mutation, a BRAF inhibitor. Approximately 80 subjects are planned for enrollment and treatment in Cohort 1. Cohort 2 is anticipated to enroll approximately 25 subjects and is designed to evaluate the efficacy and safety of the regimen in patients who required discontinuation of PD-1 inhibitor(s) due to unacceptable toxicity, regardless of best overall disease response. Cohort 3 is also anticipated to enroll approximately 25 subjects and will evaluate efficacy and safety in patients whose best ongoing response to PD-1 inhibitor(s) is stable disease. Patients in Cohorts 2 and 3 whose cancer expresses a BRAF-activating mutation will be required to have experienced disease progression following BRAF inhibitor therapy. The primary endpoint of DELTA-1 is the objective response rate (ORR) according to RECIST v1.1 as assessed by independent central review. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety.

    About Instil Bio

    Instil Bio, Inc. (NASDAQ:TIL) is a clinical-stage biopharmaceutical company focused on developing TIL therapies for the treatment of patients with cancer and as an innovation platform for next generation therapies. The Company has assembled an accomplished management team with a successful track record in the development, manufacture, and commercialization of cell therapies. Using the Company's proprietary, optimized, and scalable manufacturing processes at its in-house manufacturing facilities, Instil is advancing its lead TIL product candidate, ITIL-168, for the treatment of advanced melanoma and other solid tumors as well as ITIL-306, a next-generation, genetically engineered TIL therapy for multiple solid tumors. For more information visit www.instilbio.com and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, including the design and enrollment of the DELTA-1 clinical trial, the timing of initiating clinical trials, the timing of reporting of data and the timing of regulatory submissions, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, whether, if approved, these product candidates will be successfully distributed and marketed, and our clinical manufacturing capabilities. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, as filed with the SEC on August 12, 2021, which is available on the SEC's website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

    Contacts:

    Brendan Payne

    Stern Investor Relations

    1-212-362-1200

        

    Media Contact:

    1-833-446-7845 Ext. 1009

     



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