8-K: IN8bio Announces Positive Phase 1 Trial Results for INB-100 in Leukemia Patients, Showing 100% Complete Remission in AML Patients

IN8bio reports updated data from its Phase 1 trial of INB-100, showing 100% complete remission in acute myeloid leukemia (AML) patients with a median follow-up of 20.1 months.

Summary

• IN8bio, Inc. announced positive updated data from its Phase 1 trial of INB-100, an allogeneic gamma-delta T cell therapy for patients with complex leukemias.
• The trial results showed that 100% of acute myeloid leukemia (AML) patients in both the original and expansion cohorts remained in complete remission (CR) with a median follow-up of 20.1 months.
• AML patients treated with INB-100 demonstrated one-year progression-free survival (PFS) and overall survival (OS) exceeding real-world control groups.
• The company will host a conference call to discuss the results.
• The data will be presented at the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR in Honolulu, HI.

Sentiment

Score: 9

Explanation: The document presents highly positive clinical trial results, with strong efficacy and a favorable safety profile, suggesting a promising future for INB-100 and IN8bio. The management's optimistic comments further contribute to the positive sentiment.

Positives

• INB-100 shows potential to support durable relapse-free remissions in high-risk leukemia patients.
• The therapy is helping patients avoid relapse and preserve their quality of life.
• The manageable toxicity profile suggests it could become an attractive cellular therapy.
• Gamma-delta T cells are showing they can fight residual cancer cells without significant side effects like CRS or neurotoxicity.

Risks

• The forward-looking statements are subject to various risks and uncertainties, including those related to clinical trial commencement, patient enrollment, and regulatory approvals.
• IN8bio's ability to raise additional capital and continue as a going concern are also risks.
• Reliance on third parties and the uncertainty of regulatory approvals are potential risks.

Future Outlook

IN8bio is working to lay the groundwork for a potential registrational trial and aims to provide further updates later this year as they build momentum toward this goal.

Management Comments

• Dr. Joseph P. McGuirk stated 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.
• William Ho, CEO of IN8bio, expressed pleasure with the consistent, long-term remission results with INB-100 and its potential to change the standard-of-care.

Industry Context

The announcement highlights the potential of gamma-delta T cell therapies in the treatment of complex leukemias, offering a novel approach compared to traditional treatments and CAR-T therapies, particularly in patients with high-risk disease and those who have failed prior therapies.

Comparison to Industry Standards

• The INB-100 trial demonstrated significantly higher survival rates compared to historical controls from the Center for International Blood and Marrow Transplant Research (CIBMTR) and Kansas University Cancer Center (KUCC).
• The 100% PFS and OS at one year for AML patients treated with INB-100 is a notable improvement over the CIBMTR's 67.8% PFS and 74.7% OS, and KUCC's 57.4% PFS and 66.7% OS at one year.
• This suggests that INB-100 may offer a superior outcome compared to standard treatments in this patient population.

Stakeholder Impact

• Shareholders may react positively to the promising clinical trial results.
• Patients with complex leukemias may benefit from the potential of INB-100.
• The company's employees may be motivated by the positive progress of the clinical trial.

Next Steps

• IN8bio will continue to enroll patients and expand the trial network.
• The company is working diligently to lay the groundwork for the future regulatory pathway towards a potential registrational trial.
• IN8bio plans to provide further updates later this year.

Key Dates

Keywords

IN8bio, INB-100, AML, Leukemia, Gamma-delta T cell therapy, Clinical trial, Complete remission, PFS, OS, HSCT, Cellular therapy