- Data support the potential of INB-100 to induce long-term durable responses in patients with high-risk or relapsed acute myeloid leukemia (AML).
- Clinical activity observed includes continuing robust durability of relapse-free survival; all three patients in Cohort 1 remain alive and progression-free; ongoing durations of response exceed 12 months and extend beyond 25 months.
- To date, INB-100 continues to demonstrate a manageable safety profile with no dose-limiting toxicities.
NEW YORK, Nov. 03, 2022 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell therapies that utilize its DeltEx platform, today announced positive early data from the ongoing Phase 1 trial evaluating INB-100, an allogeneic gamma-delta T cell therapy, in patients with high-risk acute myeloid leukemia (AML) undergoing haploidentical hematopoietic stem cell transplant (HSCT) have been selected for a poster presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 10-13, 2022.
“The patients with high-risk AML undergoing HSCT in Cohort 1 continue to demonstrate encouraging signs of long-term durable responses after a single dose with INB-100. These early signs of long-term durability and progression-free survival demonstrate the potential of INB-100 as a new treatment option in this patient population. Importantly, the safety profile on INB-100 continues to be manageable, and we have not seen dose-limiting toxicities (DLTs) to date, which is encouraging,” said Trishna Goswami, M.D., Chief Medical Officer of IN8bio. “These data suggest that treatment with a one-time allogeneic gamma-delta T cell therapy has the potential to disrupt the treatment paradigm for AML. We look forward to sharing updated data at ASH and additional data at future peer-reviewed conferences.”
The abstract highlights data from Cohort 1 of the ongoing Phase 1 clinical trial of INB-100 in patients with high-risk AML undergoing HSCT. Three patients have at least 12 months of follow-up, and all remain in morphological complete remission (CR); two patients have remained progression-free for more than two years (26.5 months and 24.2 months) and a third for more than one year (12.5 months) post-transplant at the time of abstract submission. Immune system reconstitution through the first 100 days post-treatment demonstrates continued normal function, including observed elevations in T cells, B cells, and gamma-delta T cells. No DLTs or greater than grade 3 events of acute or chronic graft versus host disease (GvHD), cytokine release syndrome (CRS), or immune effector cell neurotoxicity syndrome (ICANS) have been observed. The most common adverse events (AEs) were constipation, cytomegalovirus (CMV) reactivation, emesis, fatigue, and hypomagnesaemia, the majority of which were Grade 1/2.
Additional updated data will be presented during the poster session at ASH.
Details for the ASH 2022 presentation are as follows:
Title: Relapse Prophylaxis Post-Haploidentical Bone Marrow Transplantation and Cyclophosphamide (Haplo/Cy) By Infusion of Donor-Derived Expanded/Activated Gd T Cells: A Phase I Trial
Presenter: Joseph McGuirk, DO, The University of Kansas Cancer Center
Abstract #: 3323
Date and time: Sunday, December 11, 2022, 6:00 pm - 8:00 pm CDT
Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
About the INB-100 Phase 1 Trial
The Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic derived, gamma-delta T cells from matched related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following haploidentical HSCT. 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. IN8bio’s DeltEx platform employs allogeneic, autologous, iPSC 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 potential of INB-100 to disrupt the treatment paradigm for AML; the timing of initiation, progress and scope of clinical trials for IN8bio’s product candidates; and IN8bio’s ability to achieve planned milestones. 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 as well as rising inflation and regulatory developments; 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 August 12, 2022, 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.
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