IN8bio’s Phase 1 Clinical Trial Of INB-100 Offers Hope To Leukemia Patients With Promising Data
Detroit, Michigan
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January 23, 2024 09:00 AM Eastern Standard Time
By Faith Ashmore, Benzinga
IN8bio (NASDAQ: INAB) is a biotechnology company that specializes in developing novel therapies based on gamma-delta T cells. Its innovative technology focuses on harnessing the potential of these cells to effectively target and eliminate cancer cells in both solid and hematological tumors. IN8bio's pipeline consists of a range of preclinical and clinical investigational therapies that aim to address various types of cancer with large unmet needs.
Leukemia, with a specific focus on Acute Myeloid Leukemia (AML) and potentially Myelodysplastic Syndrome (MDS), is an area of interest for IN8bio. The AML market is projected to to grow from $3.5 billion in 2022 to $6.1 billion in 2028 – representing a CAGR of 10%, while the MDS market which was worth $ 3.3 billion in 2022 is expected to exhibit a CAGR of 9.3% over 2023-2030. IN8bio's INB-100 is an allogeneic-derived, gamma-delta T-cell product candidate aimed at addressing the unmet need in these areas.
The latest clinical data from the INB-100 trial presented in December 2023 at the 65th American Society of Hematology (ASH) Annual Meeting shows that patients who received this treatment experienced a significant increase and persistence of allogeneic gamma-delta T cells in the first year following treatment. Previously published data demonstrate that leukemia patients with high levels of gamma-delta T cells have better survival outcomes. Compared with patients who underwent haploidentical hematopoietic stem cell transplantation (HSCT) without INB-100 therapy, those who received INB-100 at Dose Level (DL) 2 had gamma-delta T cell levels that were, on average, 49 times higher at 60 days. Additionally, the levels were 8 times higher than those achieved at DL 1, showing a dose-response relationship. At 365 days, the levels were 2.7 times higher than those in DL 1, which is considered beneficial for survival outcomes.
“With more patients and a longer observation period, we are excited to report that 100% of evaluable dosed patients continue to remain in morphological complete remission, with six patients remaining alive and relapse-free beyond one year,” shared Trishna Goswami, MD, Chief Medical Officer at IN8bio. “Leukemic relapse is the leading cause of death in patients undergoing HSCT and prevention of relapse remains a high unmet need. In this trial, the first three patients were high-risk or relapsed AML patients with complex cytogenetics. We are happy to report two of the patients remain alive and relapse-free for over three years, and the third is now past two years. Furthermore, INB-100 has demonstrated for the first time, the in-vivo expansion and persistence of an allogeneic, or donor-derived, cellular therapy at 365 days with blood levels of gamma-delta T cells surpassing levels previously observed to be associated with greater survival.”
Other positive observations include increases in CD4+, CD8+ T cells, NK cells and B cells, indicating a favorable response and stable immune system reconstruction after the transplant. Cytokine data also showed increased pro-inflammatory cytokines in the blood shortly after gamma-delta T cell infusion, demonstrating overall immune activation.
Updated safety data through November 3, 2023, includes three more patients. 60% of the treated patients experienced low-grade acute graft versus host disease (GvHD), but all cases responded well to steroid treatment. Three patients experienced chronic GvHD and no dose-limiting toxicities were observed. Across DL 1 and DL 2, all patients in the study remained alive and in complete remission, with two patients now remaining progression-free for more than three years.
While there are other companies, such as Adicet Bio (NASDAQ: ACET) and Century Therapeutics (NASDAQ: IPSC), that are also studying gamma-delta T cells, IN8bio's DeltEx platform and clinical results set the company apart from competitors in the field of cancer therapy. The company seems to have a focused vision for the path forward, and it recently announced that it has entered into a securities purchase agreement with healthcare-focused institutional investors to raise up to $46.9 million at increasing valuations. The deal includes initial gross proceeds of $14.4 million and extends the company’s runway into 2025.
IN8bio’s expertise, proprietary techniques and scalable manufacturing process potentially position it as a leader in harnessing the potential of gamma-delta T cells for the development of innovative and effective cancer treatments, and the company may be one to watch for those interested in this growing market.
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