8-K: IN8bio Reports Promising Phase 1 Trial Results for Leukemia Treatment

IN8bio's INB-100 therapy shows continued progression-free survival in leukemia patients, with durable remissions and no relapses observed in AML patients after a median follow-up of 19.7 months.

Summary

• IN8bio announced updated data from its Phase 1 trial of INB-100, an allogeneic gamma-delta T cell therapy for leukemia patients.
• The data shows continued progression-free survival in patients, with no relapses observed in acute myeloid leukemia (AML) patients after a median follow-up of 19.7 months.
• The therapy demonstrates durable complete remissions (CR) in AML patients, including those with high-risk disease.
• INB-100 exhibits long-term impact, with durable in vivo expansion and persistence of allogeneic gamma-delta T cells 365 days after a single administration.
• Historically, approximately 25% of AML patients undergoing HSCT would be expected to have a leukemic relapse within the first 100 days post-transplant, with up to nearly 50% experiencing relapse by one-year.
• As of September 30, 2024, the median CR was at 16.4 months following a median of 19.2 months of follow-up.
• All ten patients in the trial remained alive, progression-free, and in durable CR through one year.
• 100% of AML patients remain in CR after a median 19.7 months of follow-up, with some high-risk patients remaining in remission for over three years.
• The trial has been expanded to enroll additional patients at Dose Level 2, the recommended Phase 2 dose.

Sentiment

Score: 8

Explanation: The document presents very positive clinical trial results with strong efficacy and safety data, indicating a promising outlook for the therapy. The lack of relapses and the durable persistence of the cells are particularly encouraging. However, there are still risks associated with clinical trials and the need for further data.

Positives

• The INB-100 therapy shows a strong safety profile with no cytokine release syndrome (CRS) or neurotoxicity (ICANS) observed.
• The therapy demonstrates a long-term impact with durable in vivo expansion and persistence of allogeneic gamma-delta T cells.
• The results show a significant improvement compared to historical relapse rates in AML patients undergoing HSCT.
• The persistence of gamma-delta T cells suggests continued surveillance against leukemic relapse.
• The trial expansion indicates confidence in the therapy's potential.

Negatives

• 60% of patients experienced low grade (1-2) acute graft versus host disease (GvHD), though it was steroid responsive.
• Treatment-related serious adverse events included Grade 2 rash (60%) and Grade 3 nausea (20%).
• One patient death was previously reported due to idiopathic pulmonary syndrome likely related to the underlying HSCT at 15.5 months, without disease progression.

Risks

• The company faces risks related to site initiation, clinical trial commencement, patient enrollment, and follow-up.
• There are uncertainties inherent in the initiation and completion of preclinical studies and clinical trials.
• The company may be unable to raise additional capital, potentially forcing delays or reductions in development programs.
• There is a risk that the company may not realize the intended benefits of its DeltEx platform.
• The outcomes of preclinical studies may not be predictive of clinical trial results.
• There is a risk of potential adverse effects arising from the testing or use of the company's product candidates.
• The company relies on third parties, including licensors and clinical research organizations.

Future Outlook

The company expects to report new clinical data, including results from the INB-100 expansion cohort and control data, in the first half of 2025. The company also plans to continue enrolling additional patients into the expansion cohort.

Management Comments

• Dr. Joseph P. McGuirk stated that the data demonstrates the potential of allogeneic INB-100 gamma-delta T cells to provide durable relapse-free remissions in high-risk or relapsed AML patients undergoing HSCT.
• Management noted that the observed long-term durable remissions using allogeneic gamma-delta T cells are very encouraging.

Industry Context

This announcement is significant in the context of the broader industry trend towards developing novel immunotherapies for cancer. The use of allogeneic gamma-delta T cells represents a promising approach to treating hematologic malignancies, particularly in high-risk patients who have limited treatment options. The results are particularly relevant given the high relapse rates associated with traditional treatments for AML.

Comparison to Industry Standards

• Historically, approximately 25% of AML patients undergoing HSCT would be expected to have a leukemic relapse within the first 100 days post-transplant, with up to nearly 50% of such patients experiencing relapse by one-year.
• The INB-100 trial results show 100% of patients remaining in CR after a median 19.7 months of follow-up, which is a significant improvement compared to historical benchmarks.
• The durable persistence of the allogeneic gamma-delta T cells at 365 days is a novel finding, as other cellular therapies often struggle with long-term persistence.
• Companies like Kite Pharma and Novartis have made progress in CAR T-cell therapies, but these are often autologous and have different safety and efficacy profiles. IN8bio's allogeneic approach could offer advantages in terms of scalability and accessibility.

Stakeholder Impact

• Shareholders will likely view the positive clinical trial results favorably.
• Patients with AML and other hematologic malignancies may benefit from this new treatment option.
• Employees of IN8bio may be encouraged by the progress of the company's lead program.
• The results may attract potential partners and investors.

Next Steps

• The company will continue to enroll additional patients into the expansion cohort at Dose Level 2.
• Updated data from the INB-100 expansion cohort and control data are expected to be reported in the first half of 2025.

Key Dates

Keywords

INB-100, gamma-delta T cells, leukemia, AML, hematologic malignancies, immunotherapy, allogeneic, HSCT, clinical trial, remission, cancer therapy