IN8bio Reports Promising Phase 1 Trial of INB-100 in Leukemia Patients Data

February 11, 2025

DENVER, Colo., Feb 11, 2025 (247marketnews.com)- IN8bio (NASDAQ:INAB) reported promising clinical data from the ongoing Phase 1 investigator-sponsored trial of INB-100, an allogeneic gamma-delta T cell therapy, is a significant milestone for the company and could have major implications for the treatment of complex leukemias, including acute myeloid leukemia (AML). The data reveals promising outcomes, particularly in terms of remission rates, survival improvements, and tolerability.

The most striking data from the trial is that 100% of AML patients treated with INB-100 remain relapse-free through January 17, 2025. This is an outstanding result, particularly given the typically poor prognosis of AML patients, especially those with high-risk disease or those who have already undergone prior treatments.

The original cohort of AML patients reached a median complete remission (CR) of 23.3 months, with some patients in remission for over three years. The median duration across all treated AML patients is 20.1 months, which is quite significant, considering the aggressive nature of AML.

These findings suggest that INB-100 has the potential to achieve durable long-term remissions and could lead to improved survival for AML patients, which is especially valuable for those who have failed prior treatments.

The one-year progression-free survival (PFS) and overall survival (OS) rates for INB-100 are dramatically higher than those seen in historical controls from major transplant centers.

INB-100: 90.9% PFS and 100% OS at one year for all patients; 100% PFS and 100% OS at one year for AML patients.

Historical Controls: Data from CIBMTR and Kansas University Cancer Center show PFS of 67.8% and OS of 74.7% at one year, and PFS of 57.4% and OS of 66.7% at one year, respectively.

These comparisons suggest that INB-100 may offer significant improvements in both survival and disease progression compared to current standard-of-care treatments. This could make INB-100 a potential game-changer for AML patients, particularly those with poor prognoses.

Dr. Joseph P. McGuirk, stated, “These data suggest that the addition of allogeneic INB-100 gamma-delta T cells appears to have the potential to support durable relapse-free remissions in high-risk leukemia patients, with 100% of treated AML patients remaining in remission after a median follow-up of almost two years post-transplant. Typically, patients receiving reduced-intensity conditioning face substantial risks of relapse within a year, and those who relapse are often left with very few treatment options. INB-100 is not only helping patients avoid this common relapse timeline but is doing so while helping to preserve their quality of life. These results are truly exciting. We are seeing something we rarely encounter in high-risk leukemia patients: sustained, durable remissions with minimal side effects to date. These continued results of INB-100, with the manageable toxicity profile, suggest it could become an attractive cellular therapy with the potential to extend survival in this difficult-to-treat patient population.”

The trial results are particularly noteworthy because they show efficacy in older, high-risk patients who typically have poor outcomes with traditional treatments. The median age of patients in the study is 68, and many of them had complex, high-risk disease or had failed multiple prior therapies, including CAR-T treatments.

INB-100’s ability to achieve durable remission in these older, high-risk patients is a significant achievement, as they are often excluded from clinical trials for other therapies due to their age or comorbidities.

William Ho, CEO and co-founder of IN8bio, commented, “We’re incredibly pleased with our efforts to continue to deliver consistent, long-term remission results with INB-100. It’s rare to see 100% relapse-free survival in high-risk AML patients, especially over a prolonged period. For patients who may not have had a clear path forward in the past, INB-100 is providing hope, extending survival, and demonstrating the potential to change the standard-of-care. What makes this even more exciting is the safety profile we’ve observed. Gamma-delta T cells are showing that they can do the job of fighting residual cancer cells without causing significant side effects like CRS or neurotoxicity—issues that often plague other cell therapies. As we continue to enroll patients and expand the trial network, we are working diligently to lay the groundwork for the future regulatory pathway towards a potential registrational trial. The IN8bio team is working hard to de-risk the future path to approval and to bring this innovative therapy towards broader patient access. We are committed to providing further updates later this year as we build momentum toward this goal.”

The trial shows that INB-100 may be able to address a critical unmet need for therapies that are both effective and safe for elderly and complex patients, who represent a substantial portion of the AML population.

One of the key takeaways from the data is that INB-100 appears to be well-tolerated with minimal side effects. There were no cases of cytokine release syndrome (CRS) or neurotoxicity, which are often seen with other immune-based therapies like CAR-T cells.  The graft-versus-host disease (GvHD) observed in the trial was tolerable and in line with historical data, managed with steroids. Limited mild infections were reported, which is common in patients undergoing hematopoietic stem cell transplantation (HSCT) and immunotherapy. The favorable safety profile and the absence of severe side effects such as CRS and neurotoxicity could make INB-100 a highly attractive treatment for AML patients, who are often vulnerable to the toxicities of existing therapies.

IN8bio plans to present the full clinical data at the 2025 Tandem Meetings in Honolulu, HI, hosted by ASTCT and CIBMTR. This presentation is likely to garner attention from the broader medical community and could lead to further collaborations, investments, and partnerships.

The data suggests that INB-100 could become a key player in the AML treatment space, and its future development will be closely watched by investors, regulatory bodies, and clinicians.

If the promising results from this Phase 1 trial are confirmed in subsequent studies, INB-100 could position IN8bio (NASDAQ:INAB) as a leader in the treatment of AML and potentially other hematologic malignancies.

The positive survival outcomes and the potential for long-term remission could differentiate INB-100 from other emerging AML treatments, including CAR-T therapies and other immunotherapies, which often come with severe side effects or limited efficacy. INB-100’s focus on improving survival in high-risk patient populations, such as older patients or those who have failed prior treatments, makes it highly relevant in addressing unmet medical needs in the oncology market.

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