INAB IN8bio Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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INB-100
Allogeneic hematopoietic stem cell transplantation (HSCT)
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Phase 1
Phase 1
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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INB-200
Glioblastoma
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Phase 1
Phase 1
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Phase 1 preliminary data presented at ASCO June 4, 2021. INB-200 was generally well tolerated with no observed infusion reactions. Phase 1 data reported that all four patients exceeded their expected progression-free survival (PFS) interval. Enrollment in cohort 2 to be complete in 2022, noted January 6, 2022.
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Latest News
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NEW YORK, Jan. 10, 2022 (GLOBE NEWSWIRE) -- IN8bio, Inc. (NASDAQ:INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, today announced that William Ho, Chief Executive Officer and co-founder of IN8bio, will present at four upcoming virtual investor conferences in January.
Event: H.C. Wainwright & Co. BioConnect Conference Presentation: On-demand virtual presentation Date: January 10-13, 2022 Link: https://investors.in8bio.com/news-events/events-presentations Event: Solebury Trout Virtual 2022 1x1 Management Access Event Presentation: 1x1's Date: January 10-13 and January 18-20, 2022 Link: https://bit.ly/trout2022 Event: Biotech Showcase 2022 Presentation: Panel Discussion: Outsmarting Cancer: Next Generation Therapies Date: January 10, 2022, at 11:00 a.m.-12:00 p.m. EST Link: https://bit.ly/3F5ZKXH Presentation: On-demand virtual presentation Date: January 10-12, January 17-19, 2022 Link: https://partneringone.informaconnect.com/event/716/company/358 Event: B. Riley Virtual Oncology Investor Conference Presentation: Fireside Chat and 1x1's Date: January 27, 2022, at 11:00 a.m. EST Link: https://www.webcaster4.com/Webcast/Page/2828/44085 About IN8bio
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue.The proprietary IN8bio DeltEx platform is designed to overcome many of the challenges associated with the expansion, genetic engineering, and scalable manufacturing of gamma-delta T cells. The DeltEx platform employs allogeneic, autologous, and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells. This approach allows us to expand the cells ex vivo to administer a potentially therapeutic dose to patients, harnessing the unique properties of gamma-delta T cells, including their ability to broadly recognize cellular stress signals on tumor cells. We have used the DeltEx platform to create our deep pipeline of innovative allogeneic, autologous and/or genetically modified product candidates designed to effectively target and potentially eradicate disease and improve patient outcomes.
IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types.
For more information about IN8bio and its programs, please visit www.IN8bio.com.
Company Contact:
IN8bio, Inc.
Charles Butler
+1 646.600.6GDT (6438)
[email protected]Investors:
Solebury Trout
David Buck
+ 1 646.378.2927
[email protected]Media:
Burns McClellan, Inc.
Robert Flamm, Ph.D. / Katie Larch
[email protected] / [email protected]
-
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- INB-200 is the first-ever genetically modified gamma-delta T cell therapy in clinical trials and is currently in a repeated-dose escalation cohort
- Cohort 1 dosing is complete with three patients who received a single dose of INB-200 with no dose limiting toxicities (DLTs), cytokine release syndrome (CRS), or neurotoxicity, and a manageable safety profile
- Cohort 2 is enrolling with one patient having received all three doses of INB-200, the first-ever repeat dosing of genetically modified gamma-delta T cells
- Of the four patients treated to date, all have exceeded their expected progression-free survival (PFS) interval, with an encouraging trend in OS1-3
NEW YORK, Jan. 06, 2022 (GLOBE NEWSWIRE) -- IN8bio, Inc. (NASDAQ:INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, provided an update today from the ongoing Phase 1 clinical trial of INB-200, an autologous DeltEx drug resistant immunotherapy (DRI). DeltEx DRI consists of gamma-delta T cells that have been genetically engineered to be chemotherapy resistant, allowing them to be administered concurrently with alkylating chemotherapeutic agents, including temozolomide (TMZ). This clinical trial, conducted in patients newly diagnosed with glioblastoma multiforme (GBM), is the first and most clinically advanced trial to use genetically modified gamma-delta T cells and includes a multi-dose escalation regimen.
Cohort 1 accrual and treatment is complete with three patients having received a single dose of DeltEx DRI via intracranial infusion concurrent with maintenance TMZ administration. Cohort 2 is currently recruiting and treating patients, with one patient having completed all three doses administered intracranially at 28-day intervals concurrent with maintenance TMZ. The Phase 1 clinical trial of INB-200 (NCT04165941) and the progress reported here constitute the first single- and multiple-dosed patients with genetically modified gamma-delta T cells in any indication.
INB-200 has had a manageable safety profile in all four patients treated to date, with no DLTs, CRS, immune effector cell-associated neurotoxicity syndrome (ICANS) or treatment-related serious adverse events (SAEs). The data to-date indicate promising PFS and OS, which will continue to be assessed on an on-going basis, with additional data anticipated at medical meetings later this year along with comprehensive biological correlative data.
"Patients with GBM have poor prognoses with a median survival of 14.6 to 16.6 months and PFS of approximately 4 to 6.9 months. The data reported today suggest that INB-200 may have the potential to extend both progression-free and overall survival compared with standard-of-care in the front-line setting," said Trishna Goswami, MD, Chief Medical Officer at IN8bio. "We believe that the combination of our DRI technology and the potential to administer multiple doses of INB-200 could lead to improved efficacy results by making our gamma-delta T cells resistant to chemotherapy induced cell death, potentially permitting prolonged and more efficient tumor killing. This approach may overcome the limited efficacy observed in clinical trials of other cellular therapies in patients with solid tumors."
"We are pleased to see that INB-200 has continued to be well-tolerated in both the single and multiple-dose treated patients to-date," said principal investigator, L. Burt Nabors, MD at the O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB). "GBM is one of the most difficult cancers to treat, with an urgent need for new therapies. One of the significant hurdles to the use of cellular therapies in solid tumors is the impact of chemotherapies on immune cells, which has been uniquely addressed in the engineering of the DeltEx DRI cells."
Four patients have been treated to-date. In cohort 1, all have exceeded their expected PFS interval, with an encouraging trend in OS based on standard-of-care for their respective age and methylguanine-DNA methyltransferase (MGMT) status1-3. One of these patients remains alive at 17 months post-treatment, having exceeded their expected PFS and OS. As previously reported, a second patient survived for 15.6 months, with a PFS of 8.3 months, and died from an unrelated medical event without further progression. The third patient in cohort 1 exceeded predicted PFS and died at 9.6 months due to progression. In cohort 2, the first patient to complete all three doses has stable disease at 6.9 months and remains in follow-up. An earlier patient enrolled in cohort 2 completed two doses of INB-200 but died due to an acute cardio-pulmonary event without further disease progression. This was reviewed by the data safety monitoring board (DSMB) and the FDA who deemed the event unlikely to be related to therapy, and the study was allowed to continue uninterrupted. Neither patient dosed in cohort 2 experienced any infusion reactions, CRS, DLTs, or ICANS. Patient recruitment and treatment are ongoing with anticipated completion of enrollment in 2022.
INB-200 is an investigator initiated, open-label Phase 1 clinical trial evaluating IN8bio's DeltEx DRI therapy in newly diagnosed GBM patients. Patients in cohort 1 received a single dose of INB-200, while patients in cohort 2 receive three doses at 28-day intervals and patients in cohort 3 are planned to receive six doses at 28-day intervals. All doses are given concurrently with maintenance TMZ and are intended to eliminate residual cancer during the vulnerable period of chemotherapy-induced tumor injury, when immune stress ligand expression is upregulated. The primary endpoints of this Phase 1 trial are safety and tolerability, with secondary endpoints based on biologic response, progression free and overall survival.
References
1 NEJM 2005;352:987-996. DOI: 10.1056/NEJMoa043330
2 NEJM 2005;352997-1003. DOI: 10.1056/NEJMoa043331
3 NEJM 2017;376:1027-1037 DOI: 10.1056/NEJMoa1611977About IN8bio
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue.The proprietary IN8bio DeltEx platform is designed to overcome many of the challenges associated with the expansion, genetic engineering, and scalable manufacturing of gamma-delta T cells. The DeltEx platform employs allogeneic, autologous, and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells. This approach allows us to expand the cells ex vivo to administer a potentially therapeutic dose to patients, harnessing the unique properties of gamma-delta T cells, including their ability to broadly recognize cellular stress signals on tumor cells. We have used the DeltEx platform to create our deep pipeline of innovative allogeneic, autologous and/or genetically modified product candidates designed to effectively target and potentially eradicate disease and improve patient outcomes.
IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types.
For more information about IN8bio and its programs, please visit www.IN8bio.com.
Forward Looking Statements
Certain statements herein concerning the Company's future expectations, plans and prospects, including without limitation, the Company's current expectations regarding the advancement of its product candidates through preclinical studies and clinical trials and the prospects for such candidates and underlying technology, including the ability of INB-200 to treat GBM, constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," the negative of these and other similar expressions are intended to identify such forward looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond the Company's control. Consequently, actual future results may differ materially from the anticipated results expressed in such statements. Specific risks which could cause actual results to differ materially from the Company's current expectations include: scientific, regulatory, technical and clinical developments; failure to demonstrate safety, tolerability and efficacy; final and quality controlled verification of data and the related analyses; expense and uncertainty of obtaining regulatory approval, including from the U.S. Food and Drug Administration; the impact of the ongoing COVID-19 pandemic on the Company's clinical trials; and the Company's reliance on third parties, including licensors and clinical research organizations. Do not place undue reliance on any forward-looking statements included herein, which speak only as of the date hereof and which the Company is under no obligation to update or revise as a result of any event, circumstances or otherwise, unless required by applicable law.Contacts
IN8bio, Inc.
Charles Butler
+1 646.600.6GDT (6438)
[email protected]Investors:
Solebury Trout
David Buck
+ 1 646.378.2927
[email protected]Media:
Burns McClellan, Inc.
Robert Flamm, Ph.D. / Katie Larch
[email protected] / [email protected]
-
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- The ongoing Phase 1 trial of INB-100 is the first and most clinically advanced program administering large systemic doses of allogeneic gamma-delta T cells to patients
- 3 patients have been treated to date, all of whom remain in remission with the first two patients at ~20 months and ~18 months post treatment, respectively, and the most recent at ~6 months
- Of the 3 patients that were dosed with INB-100, all have achieved and remain in remission to date, durable responses of >1.5 years were observed in two patients
- INB-100 continues to demonstrate a manageable safety profile to-date, with no dose-limiting toxicities, no treatment-related grade 3 or greater adverse events, and no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS)
NEW YORK, Dec. 16, 2021 (GLOBE NEWSWIRE) -- IN8bio, Inc. (NASDAQ:INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, today provided an update from the ongoing Phase 1 clinical trial of INB-100, a donor-derived gamma-delta T cell therapeutic in development for patients with leukemia undergoing haploidentical hematopoietic stem cell transplant (HSCT). The three patients with relapsed acute myeloid leukemia (AML) treated to date demonstrate that allogeneic gamma-delta T cell therapy has a manageable toxicity profile with the potential for durable responses in high-risk patients. Haploidentical HSCT patients have high relapse rates of up to 50% at one-year post-treatment. All three of the INB-100 treated patients remain in remission with two patients in remission at 18 and 20 months, respectively. No treatment-related grade 3 or greater adverse events, infusion reactions or dose-limiting toxicities were observed. The trial continues to track these patients and enroll additional patients.
"We believe that the encouraging early data from the first patients dosed in this clinical trial suggest the potential of gamma-delta T cells to offer a novel treatment option for patients with aggressive hematologic malignancies," said Trishna Goswami, M.D., Chief Medical Officer at IN8bio. "Multiple complete responses with durability greater than 1.5 years is especially promising for patients with high-risk leukemias, who have high rates of post-HSCT relapse. The absence of grade 3 or greater graft versus host disease (GvHD) 100 days post gamma-delta T cell infusion is also encouraging for an allogeneic therapy. We continue to enroll patients in this Phase 1 clinical trial and look forward to reporting additional data from this program in 2022."
This Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic, or donor-derived, gamma-delta T cells that have been expanded and activated ex vivo and administered systemically to patients with leukemia following haploidentical HSCT. Three high-risk AML patients with complex cytogenetics have been treated to-date, including patients with trisomy 8, del7 mutations. The single-institution clinical trial is currently being conducted at The University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue.The proprietary IN8bio DeltEx platform is designed to overcome many of the challenges associated with the expansion, genetic engineering and scalable manufacturing of gamma-delta T cells. The DeltEx platform employs allogeneic, autologous and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells. This approach allows us to expand the cells ex vivo to administer a potentially therapeutic dose to patients, harnessing the unique properties of gamma-delta T cells, including their ability to broadly recognize cellular stress signals on tumor cells. We have used the DeltEx platform to create our deep pipeline of innovative allogeneic, autologous and/or genetically modified product candidates designed to effectively target and potentially eradicate disease and improve patient outcomes.
IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types.
For more information about IN8bio and its programs, please visit www.IN8bio.com.
Forward Looking Statements
Certain statements herein concerning the Company's future expectations, plans and prospects, including without limitation, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for the Company's product candidates; and the prospects for such candidates and underlying technology, constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," the negative of these and other similar expressions are intended to identify such forward looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond the Company's control. Consequently, actual future results may differ materially from the anticipated results expressed in such statements. Specific risks which could cause actual results to differ materially from the Company's current expectations include: scientific, regulatory and technical developments; failure to demonstrate safety, tolerability and efficacy; potential for interim, top-line and preliminary data to change as audit and verification procedures are completed; difficulties enrolling patients; expense and uncertainty of obtaining regulatory approval, including from the U.S. Food and Drug Administration; and the Company's reliance on third parties, including licensors and clinical research organizations. Do not place undue reliance on any forward-looking statements included herein, which speak only as of the date hereof and which the Company is under no obligation to update or revise as a result of any event, circumstances or otherwise, unless required by applicable law.Contacts
IN8bio, Inc.
Charles Butler
+1 646.600.6GDT (6438)
[email protected]Investors:
Solebury Trout
David Buck
+ 1 646.378.2927
[email protected]Media:
Burns McClellan, Inc.
Robert Flamm, Ph.D.
+1 212.213.0006 - ext. 364
[email protected]
- The ongoing Phase 1 trial of INB-100 is the first and most clinically advanced program administering large systemic doses of allogeneic gamma-delta T cells to patients
-
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NEW YORK, Dec. 09, 2021 (GLOBE NEWSWIRE) -- IN8bio, Inc. (NASDAQ:INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its proprietary DeltEx platform, today announced the promotion of Kate Rochlin, Ph.D. to Chief Operating Officer (COO). Dr. Rochlin previously served as Vice President, Operations and Innovation.
Dr. Rochlin will be responsible for multiple functional areas, including chemistry, manufacturing and controls (CMC), technical operations, laboratory operations as well as collaborative development of our preclinical pipeline and clinical translational programs. Dr. Rochlin will also continue to work with our early innovation programs and partners.
"Since joining IN8bio in August 2020, Kate has been a major contributor to operations across the Company, helping to aggressively drive our growth and the advancement of our pipeline," said William Ho, Chief Executive Officer of IN8bio. "She has a track record of success and has been an instrumental part of our management team. We are delighted to promote Kate to her new position as COO and look forward to her leadership in the advancement of our operations."
At IN8bio, Dr. Rochlin has led several areas of operations and corporate development, including key contributions to our successful initial public offering (IPO) in August 2021. Dr. Rochlin has also been responsible for the development of analytical, quality and manufacturing teams and spearheading the buildout of the Company's planned 10,000 sq. ft. research laboratory in Birmingham, AL. Prior to joining IN8bio, Dr. Rochlin gained extensive expertise in company development at Curadigm, where she served as Chief Business Officer, Nanobiotix, Filament Biosolutions and Immunovent, the latter of which she co-founded and served as Chief Scientific Officer. At these companies she conducted scientific research, managed intellectual property strategy, oversaw business development and managed company operations, including corporate strategy, partnering and team development. Dr. Rochlin was recognized in 2019 as one of the top women in tech by Crain's New York Business. Dr. Rochlin earned a Ph.D. in Molecular Biology and Genetics from Weill Cornell Medical College and conducted research at the Memorial Sloan Kettering Cancer Center. She earned a B.A. in Biology from the University of Pennsylvania.
"I joined IN8bio because of its novel and innovative approach to gamma-delta T-cell therapies for cancer," said Dr. Rochlin. "The DeltEx platform's groundbreaking approach has the potential to be applicable across multiple solid and liquid tumors. It may also be the first immuno-oncology therapeutic to use engineered chemotherapy resistance in gamma-delta T-cells to drive cell therapy response and efficacy. I am thrilled to be recognized for my organizational contributions to date and excited to advance our platform for the benefit of patients."
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bio's DeltEx platform employs allogeneic, autologous and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types.
For more information about IN8bio and its programs, please visit www.IN8bio.com.
Forward Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the impact of Dr. Rochlin's promotion on its operations; the timing of initiation, progress and scope of clinical and preclinical trials for IN8bio's product candidates; and the potential of IN8nio's DeltEx platform to discover and develop innovative product candidates. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio's ability to meet anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio's product candidates; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio's product candidates; expectations for regulatory approvals to conduct trials or to market products; IN8bio's reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 10, 2021, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.Contacts
IN8bio, Inc.
Charles Butler
+1 646.600.6GDT (6438)
[email protected]Investors:
Solebury Trout
David Buck
+ 1 646.378.2927
[email protected]Media:
Burns McClellan, Inc.
Robert Flamm, Ph.D.
+1 212.213.0006 - ext. 364
[email protected]
-
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NEW YORK, Nov. 16, 2021 (GLOBE NEWSWIRE) -- IN8bio, Inc. (NASDAQ:INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, today announced the appointment of Trishna Goswami, M.D. as Chief Medical Officer.
"Trishna's experience and skills as a leader in immuno-oncology drug development aligns perfectly with our goals to advance multiple gamma-delta T cell therapeutic candidates through clinical development and approval," said William Ho, Chief Executive Officer of IN8bio. "Her successful track record at leading companies such as Gilead, Immunomedics, Stemline Therapeutics and AstraZeneca/MedImmune makes her a highly valuable addition to our Company. I, along with my colleagues and the Board of Directors, welcome Trishna to IN8bio and look forward to her contributions."
Dr. Goswami has extensive experience managing the clinical development and regulatory approval of oncology product candidates, including those for both solid and hematologic tumors. She is a triple board-certified hematologist oncologist who brings more than a decade of industry experience in drug development across small molecule and biological assets including antibody-drug conjugates, monoclonal antibodies and immune therapies.
"Gamma-delta T cells have increased in prominence as a cellular therapy that has the potential to revolutionize cancer therapy," said Dr. Goswami. "This T cell subtype has both innate and adaptive characteristics and can be engineered and employed as cancer therapeutics that bridge the benefits of both arms of the immune system. IN8bio's DeltEx platform leverages genetic engineering and advanced manufacturing to generate gamma-delta T cells with attributes such as chemotherapy resistance, which have the potential to improve treatments for cancers. I look forward to working with the team to advance their current clinical candidates and move future pipeline projects for new indications into clinical development. I look forward to working with the team to advance their current clinical candidates and move future pipeline projects for new indications into clinical development."
Dr Goswami most recently served as Vice President, Clinical Development at Gilead Sciences, Inc. (via its $21 billion acquisition of Immunomedics in 2020) where she led a team that secured accelerated approval of Trodelvy® in bladder cancer and was a key contributor to securing full FDA approval in triple-negative breast cancer. Prior to Gilead/Immunomedics, she served as a Senior Medical Director at Stemline Therapeutics, Inc. where she oversaw the development of multiple hematologic assets and helped secure approval of ELZONRIS® (tagraxofusp) in blastic plasmacytoid dendritic cell neoplasm, a rare leukemia. Dr. Goswami was previously at MedImmune, then AstraZeneca/MedImmune post-acquisition, where she managed biologics development for hematologic indications, launching the first phase 3 trial in an oncology indication at MedImmune. At AstraZeneca, Dr. Goswami also participated in the development of IMFINZI® (durvalumab) and tremelimumab. Before her career in industry, Dr. Goswami served as Assistant Professor, Department of Medicine, Division of Hematology/Oncology at the University of Maryland. She is an author of multiple publications during her tenure in academia and industry. Dr. Goswami earned her M.D. from Drexel University College of Medicine, completed her postgraduate training in internal medicine and hematology/oncology at Georgetown University Hospital and completed her MBA from Smith School of Business at the University of Maryland.
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bio's DeltEx platform employs allogeneic, autologous and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types.
For more information about IN8bio and its programs, please visit www.IN8bio.com.
Forward Looking Statements
Certain statements herein concerning the Company's future expectations, plans and prospects, including without limitation, the Company's current expectations regarding the advancement of its product candidates through preclinical studies and clinical trials and the prospects for such candidates and underlying technology, constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," the negative of these and other similar expressions are intended to identify such forward looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond the Company's control. Consequently, actual future results may differ materially from the anticipated results expressed in such statements. Specific risks which could cause actual results to differ materially from the Company's current expectations include: scientific, regulatory and technical developments; failure to demonstrate safety, tolerability and efficacy; final and quality controlled verification of data and the related analyses; expense and uncertainty of obtaining regulatory approval, including from the U.S. Food and Drug Administration; and the Company's reliance on third parties, including licensors and clinical research organizations. Do not place undue reliance on any forward-looking statements included herein, which speak only as of the date hereof and which the Company is under no obligation to update or revise as a result of any event, circumstances or otherwise, unless required by applicable law.Contacts
IN8bio, Inc.
Charles Butler
+1 646.600.6GDT (6438)
[email protected]Investors:
Solebury Trout
David Buck
+ 1 646.378.2927
[email protected]Media:
Burns McClellan, Inc.
Robert Flamm, Ph.D. / Harrison Wong
+1 212.213.0006 - ext. 364 / 316
[email protected] / [email protected]
