IN8bio's Phase 1 Clinical Trial Of INB-100 Offers Hope To Leukemia Patients With Promising Data

IN8bio 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 ACET and Century Therapeutics 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.

Featured photo by National Cancer Institute on Unsplash.

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