8-K: IN8bio Announces Positive Phase 1 Trial Results for INB-100, Demonstrating 100% Durable Complete Remission at One Year

IN8bio reports that 100% of evaluable leukemia patients in a Phase 1 trial of INB-100 achieved durable complete remission at one year, showcasing the potential of their gamma-delta T cell therapy.

Summary

• IN8bio announced positive results from its Phase 1 trial of INB-100, a gamma-delta T cell therapy, at the European Hematology Association 2024 Hybrid Congress.
• The trial showed that 100% of evaluable leukemia patients (10 out of 10) achieved a durable complete remission (CR) at one year.
• This includes patients with high-risk and relapsed acute myeloid leukemia (AML) who had previously failed multiple lines of therapy, including CAR-T.
• The therapy demonstrated long-term in vivo expansion and persistence of allogeneic gamma-delta T cells for 365 days after a single administration.
• Two patients have remained alive and relapse-free for over three and a half years, and a third is nearing three years.
• The trial also showed a favorable safety profile with no dose-limiting toxicities, cytokine release syndrome, neurotoxicity, or serious infections.
• One patient died from idiopathic pulmonary fibrosis, a known transplant toxicity, without evidence of disease progression.
• The trial has been expanded to enroll an additional ten patients at Dose Level 2, with updated data expected in late 2024 and 2025.
• IN8bio plans to discuss a potential registrational trial with the FDA this summer.

Sentiment

Score: 9

Explanation: The document presents highly positive clinical trial results with a 100% complete remission rate and long-term persistence of the therapy, indicating a strong potential for the treatment. The safety profile is also encouraging, and the company is moving forward with trial expansion and regulatory discussions. The only negative is one death due to a known transplant toxicity and two relapses, but the overall sentiment is very positive.

Positives

• The INB-100 therapy demonstrated a 100% durable complete remission rate at one year in evaluable patients.
• The therapy showed long-term persistence of gamma-delta T cells, indicating a durable effect.
• The safety profile of INB-100 was favorable, with no significant toxicities observed.
• The results are particularly encouraging given that the patients had high-risk or relapsed AML and had failed previous treatments.
• The trial expansion to enroll more patients at the recommended Phase 2 dose suggests confidence in the therapy's potential.

Negatives

• One patient died from idiopathic pulmonary fibrosis, a known transplant toxicity, although without evidence of disease progression.
• Two patients with TP53 mutations relapsed, although they remain alive.

Risks

• The risk of relapse remains a concern, as evidenced by the two patients who relapsed despite the treatment.
• The trial is still in Phase 1, and further studies are needed to confirm the efficacy and safety of INB-100.
• The company's plans for a registrational trial are still subject to discussion with the FDA.
• The company relies on third parties for clinical trials and may face delays or challenges in the future.
• The company may not achieve the plans, intentions, or expectations disclosed in forward-looking statements.

Future Outlook

IN8bio expects to discuss plans for a potential registrational trial for INB-100 with the FDA this summer and anticipates updated data from the expanded Phase 1 trial in late 2024 and 2025.

Management Comments

• Trishna Goswami, MD, Chief Medical Officer of IN8bio, stated that the data demonstrate the potential of allogeneic INB-100 gamma-delta T cells to provide durable relapse-free periods for patients with high-risk or relapsed AML and other hematologic malignancies undergoing HSCT.
• Dr. Joseph P. McGuirk, from The University of Kansas Cancer Center, noted that the emerging safety, efficacy, and durability profile of the therapy supports its potential to improve relapse-free survival for patients with blood cancers following allogeneic stem cell transplantation.

Industry Context

The results are significant in the context of hematologic malignancies, where relapse rates after stem cell transplants are high. The 100% complete remission rate at one year and the long-term persistence of the therapy are notable improvements over existing treatments, including CAR-T therapy, which some of these patients had previously failed.

Comparison to Industry Standards

• Historically, up to 50% of patients with hematologic malignancies undergoing HSCT with reduced intensity conditioning relapse by one year, and often succumb to the disease shortly thereafter, making IN8bio's 100% remission rate at one year a significant improvement.
• The long-term persistence of the gamma-delta T cells is a novel finding, as other cellular therapies often have limited persistence.
• The results are particularly impressive when compared to CAR-T therapies, which have shown efficacy but also have limitations, including toxicity and relapse rates.
• Companies like Kite Pharma and Novartis have developed CAR-T therapies, but IN8bio's approach with gamma-delta T cells offers a different mechanism of action and may address some of the limitations of CAR-T.

Stakeholder Impact

• Shareholders are likely to react positively to the strong clinical trial results.
• Patients with hematologic malignancies may benefit from this novel therapy.
• Employees of IN8bio may be motivated by the positive results and the potential for the therapy to reach the market.
• The company's suppliers and partners may see increased business opportunities.

Next Steps

• IN8bio will enroll an additional ten patients at Dose Level 2 in the Phase 1 trial.
• The company expects updated data from the trial in late 2024 and 2025.
• IN8bio plans to discuss a potential registrational trial with the FDA this summer.

Key Dates

Keywords

IN8bio, INB-100, Gamma-delta T cells, Leukemia, Acute Myeloid Leukemia, AML, Complete Remission, Cell Therapy, Hematologic Malignancies, Clinical Trial, Allogeneic, HSCT, FDA