8-K: IN8bio Announces Positive Clinical Data and FDA Guidance for Gamma-Delta T Cell Therapies

IN8bio reports 100% complete remission in AML patients treated with INB-100 and receives FDA guidance for a registrational trial, while also showing promising results in glioblastoma with INB-200.

Summary

• IN8bio has announced positive updated clinical data from its Phase 1 investigator-sponsored trials for INB-100 in acute myeloid leukemia (AML) and INB-200 in glioblastoma (GBM).
• The company has received FDA guidance on the registrational path for INB-100 in AML, with an Investigational New Drug (IND) submission anticipated in Q1 2025.
• All AML patients treated with INB-100 remain in complete remission (CR), and patients in both AML and GBM trials have exceeded expected progression-free survival (PFS).
• IN8bio is the first company to report improvements in relapse-free survival in both solid and hematological cancers using allogeneic or autologous gamma-delta T cells.
• The safety profile of the gamma-delta T cell therapies has been manageable and well-tolerated across both indications, with no significant cell therapy-related toxicities reported.
• For INB-100 in AML, 100% of patients have achieved one-year relapse-free survival, compared to a typical relapse rate of 25% within 100 days and up to 50% by one year for high-risk patients.
• The expansion cohort for INB-100 is ongoing, with full enrollment of 10 patients expected by the end of 2024 and long-term follow-up results anticipated in 2025.
• For INB-200 in GBM, patients in higher repeat dose cohorts have exceeded the overall survival expected with standard-of-care alone, with one patient in remission for over a year.
• Updated clinical data for INB-200 is expected to be presented in Q4 2024.
• IN8bio's INB-400 is in a Phase 2 trial for front-line GBM treatment.

Sentiment

Score: 9

Explanation: The document presents very positive clinical data, FDA guidance, and a clear path forward for the company's lead programs. The results are significantly better than expected, and the company is positioning itself as a leader in the field. The only minor negative is the relapse of some patients with other leukemic diagnoses, but this is mitigated by the focus on AML in the Phase 2 trial.

Positives

• The company has achieved 100% complete remission in AML patients treated with INB-100.
• INB-100 has shown 100% one-year relapse-free survival in AML patients, which is significantly better than the expected relapse rate for high-risk patients.
• INB-200 has demonstrated prolonged remission in GBM patients, with some exceeding expected overall survival.
• The gamma-delta T cell therapies have shown a manageable and well-tolerated safety profile.
• The company has received FDA guidance for the registrational path of INB-100, which is a positive step towards commercialization.
• The persistence and expansion of gamma-delta T cells up to day 365 post-infusion is a significant finding.
• The company is advancing multiple programs in both hematological and solid tumors.

Negatives

• Some patients with other leukemic diagnoses (ALL and MDS/MPN overlap with concurrent TP53 mutations) who relapsed are still alive, but the proposed Phase 2 registrational trial will only include patients with AML.
• All patients in the first cohort of the INB-200 trial eventually relapsed.

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 relies on third parties, including licensors and clinical research organizations.
• There is a risk that trials and studies may be delayed and may not have satisfactory outcomes.
• Potential adverse effects may arise from the testing or use of IN8bio's product candidates.
• The company's ability to meet anticipated deadlines and milestones is subject to various factors, including public health crises and regulatory developments.

Future Outlook

IN8bio plans to submit an IND application to the FDA in Q1 2025 for INB-100 and potentially initiate a registrational trial in 2025. The company also anticipates presenting updated clinical data for INB-200 in Q4 2024 and long-term follow up results for INB-100 in 2025.

Management Comments

• William Ho, CEO and co-founder of IN8bio, stated that their gamma-delta T cell therapies continue to demonstrate their potential to eliminate residual cancer cells and revolutionize cancer treatment.
• Mr. Ho also commented that the therapies take advantage of the gamma-delta T cells natural ability to target the heterogeneity of cancers, prevent immune escape and disease relapse.

Industry Context

This announcement positions IN8bio as a leader in the development of gamma-delta T cell therapies for cancer, particularly in difficult-to-treat cancers like AML and GBM. The positive results and FDA guidance could accelerate the development and adoption of this novel approach in the oncology field.

Comparison to Industry Standards

• The 100% complete remission rate in AML patients treated with INB-100 is significantly higher than the typical outcomes for high-risk AML patients, where relapse rates can be as high as 50% within one year post-transplant.
• The prolonged relapse-free survival observed in both AML and GBM trials exceeds the historical data for standard-of-care treatments, suggesting a potential improvement in patient outcomes.
• The persistence and expansion of gamma-delta T cells up to day 365 post-infusion is a novel finding, as most cellular therapies do not demonstrate such long-term activity.
• Companies like Adaptimmune and Kite Pharma are also developing cell therapies for cancer, but IN8bio's focus on gamma-delta T cells and its early clinical results differentiate it from these competitors.

Stakeholder Impact

• Shareholders are likely to react positively to the strong clinical results and FDA guidance.
• Patients with AML and GBM may benefit from these novel therapies.
• Employees of IN8bio may be motivated by the positive progress of the company's programs.
• The company's success could attract further investment and partnerships.

Next Steps

• IN8bio plans to submit an IND application to the FDA in Q1 2025 for INB-100.
• The company could initiate a registrational trial for AML in 2025.
• Full enrollment of the 10-patient expansion cohort for INB-100 is expected by the end of 2024.
• Long-term follow-up results for INB-100 are anticipated in 2025.
• Updated clinical data from the INB-200 trial is expected to be presented in Q4 2024.

Key Dates

Keywords

Gamma-delta T cell therapy, AML, Glioblastoma, INB-100, INB-200, Relapse-free survival, Complete remission, FDA guidance, Immunotherapy, Oncology