Presented positive data showing continued durable complete remissions (CR) achieved in 100% of evaluable leukemia patients in Phase 1 investigator-sponsored trial of INB-100 at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition
Presented new data at Society for Neuro-Oncology (SNO) 28th Annual Meeting highlighting the potential of INB-200 and INB-400 to treat patients with newly diagnosed glioblastoma multiforme (GBM), with all patients treated with mandated doses of INB-200 exceeding a progression-free survival of seven months
Closed private placement in December 2023 with initial gross proceeds of $14.4 million giving a current cash runway into 2025 with potential total of $46.9 million in capital at increasing valuations
NEW YORK, Jan. 04, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (NASDAQ: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today highlighted recent business updates and provided pipeline goals for 2024.
"2023 was a year marked by strong execution for IN8bio. We delivered on several clinical milestones, reporting positive data updates across our pipeline of innovative gamma-delta T cell therapies at many prestigious medical meetings, and secured the financing to extend our runway into 2025," said William Ho, CEO and co-founder of IN8bio. "We continue to be excited by the data from the Phase 1 trial of INB-100, which showed that all evaluable patients remained in durable complete remission, with six patients remaining relapse free beyond one year. Importantly, we are excited that we are seeing in vivo expansion and persistence of allogeneic gamma-delta T cells, now out to 365 days. This persistence clearly differentiates our results from the data presented on other allogeneic cellular therapies to date and we believe this data underscores the far-reaching potential of gamma-delta T cells to help provide durable relapse-free periods in patients with hematologic malignancies undergoing haploidentical stem cell transplantation. We believe we are well positioned to execute on our clinical programs and are poised for many exciting updates in 2024."
Recent Company Updates
Announced positive clinical update demonstrating continued durable complete remissions in 100% of evaluable patients (n=10) in the Phase 1 trial of INB-100 in leukemia patients undergoing haploidentical stem cell transplantation. The data was presented at the ASH Annual Meeting in December.
Presented data demonstrating INB-200's extended progression-free survival in glioblastoma multiforme (GBM) patients and potential for INB-400 to treat GBM at the SNO Annual Meeting.
Initiated enrollment for the Phase 2 trial of INB-400 in GBM (NCT05664243).
Announced a private placement totaling up to $46.9 million in gross proceeds. The initial closing of $14.4 million is expected to support operational execution and extended the Company's cash runway into 2025 with the potential for up to $32.5 million in additional capital at increasing valuations.
INB-100: Enroll an additional 10 patients in an expansion cohort at the recommended Phase 2 dose (RP2D) and report Phase 1 long-term follow-up results at multiple medical meetings throughout 2024; potentially submit IND for Phase 3 randomized control trial in 2024.
INB-200: Report Phase 1 long-term follow up results at multiple medical meetings in 2024.
INB-300: Present additional preclinical data demonstrating proof-of-concept for the nsCAR platform targeting CD33 and CD123 at American Association for Cancer Research (AACR) 2024.
INB-400: Dose first patient and treat up to 15 patients at multiple sites across the United States in the Phase 2 trial in newly diagnosed GBM; potentially submit IND for allogeneic Phase 1b in relapsed GBM in 2024.
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 allogenic, autologous, iPSC and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.
IN8bio has initiated a Phase 2 trial of INB-400 in GBM at multiple centers across the United States and has two ongoing Phase 1 trials in solid and hematologic tumors, including INB-200 for GBM and INB-100 for patients with hematologic malignancies undergoing transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other hematological and solid tumor cancers. 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 extending IN8bio's cash runway into 2025; IN8bio's ability to extend runway upon receipt of additional capital from the December 2023 private placement; IN8bio's ability to raise additional capital from the December 2023 private placement; IN8bio's ability to advance its work in other solid tumor indications; the potential for INB-400 to treat GBM; the timing of initiation, progress and scope of clinical trials for IN8bio's product candidates, including INB-100, INB-200, INB-300 and INB-400; and IN8bio's ability to achieve anticipated milestones, including expected data readouts from its trials, enrollment of additional patients in its clinical trials and advancement of clinical development plans. 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 public health crises 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 November 9, 2023, 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.
Company Contact: IN8bio, Inc. Patrick McCall +1 646.600.6GDT (6438) info@IN8bio.com
