IN8bio Secures FDA Guidance on Bringing Gamma-Delta T-cell Therapy INB-100 to Pivotal AML Trial
According to the company, the regulatory guidance came after a Type B meeting with the agency and pertains specifically to INB-100 for the treatment of AML.
IN8bio has received guidance from the FDA regarding the path for bringing INB-100, an allogeneic gamma-delta T-cell therapy intended for use as a maintenance therapy after receiving haploidentical stem cell transplant (HSCT), to a registrational phase 2 clinical trial for acute myeloid leukemia (AML).1
According to the company, the regulatory guidance came after a Type B meeting with the agency and pertains specifically to INB-100, which has been evaluated in multiple hematological malignancies, for the treatment of AML. With the guidance in mind, IN8bio intends to submit an investigational new drug (IND) application to the FDA in the first quarter of next year for a phase 2 trial that will utilize relapse-free survival as the primary end point. The company expects that it may be able to begin conducting the trial within the same year, pending clearance of the IND.
INB-100 is currently being evaluated in a phase 1 investigator-sponsored clinical trial (NCT03533816) for hematologic malignancies including AML, acute lymphoblastic leukemia, myelodysplastic/myeloproliferative neoplasms, and chronic myeloid leukemia. Alongside the announcement of the FDA’s guidance, IN8bio also reported newly updated results from the phase 1 trial that have a data cutoff of August 1, 2024. The company pointed out that all of the patients with AML treated in the trial (100%) remain in relapse-free survival. Furthermore, patients with other types of hematologic malignancies who were previously reported to have relapsed after treatment with INB-100 in a prior data update were noted to remain alive. IN8bio additionally stated that a 10-patient expansion cohort for the trial is currently enrolling participants and that it is expected to complete enrollment this year. Among the patients who have been treated in the expansion cohort so far, all remain in complete remission (CR), with some having reached 90 days of posttransplant follow-up and 1 patient having reached almost 7 months of posttransplant follow-up.
“Our gamma-delta T cell therapies, engineered with our industry-leading manufacturing technology, continue to demonstrate their potential to eliminate residual cancer cells and to revolutionize cancer treatment,” William Ho, MBA, the chief executive officer and cofounder of IN8bio, said in a statement with reference to the phase 1 clinical trial for INB-100 and a separate phase 1 clinical trial evaluating INB-200, another of the company’s gamma-delta T-cell products, for glioblastoma.1 “The safety profile of gamma-delta T cells has been manageable and well-tolerated across both indications with no significant cell therapy-related toxicities reported to date in any patients across these Phase 1 trials.”
Data from the phase 1 trial for INB-100 were previously presented at the European Hematology Association (EHA) 2024 Congress, held June 13 to 16, both virtually and in Madrid, Spain.2 Among 10 patients who had been treated with INB-100 in the trial as of the data cutoff, all 10 (100%) maintained their state of CR at 12 months or more posttreatment, with a median follow-up time of 17.4 months. It was additionally noted that 3 patients who have high-risk disease have remained free of relapse for more than 35 months.
“In this trial, the first 3 patients were high-risk or relapsed AML patients with complex cytogenetics, including trisomy of chromosome 8 and deletion of chromosome 7,” Trishna Goswami, MD, the chief medical officer of IN8bio, said in a June 2024 statement.3 “All 3 patients remain alive and progression free with one lost-to-follow-up at 42.4 months after they relocated away from the study site. Achieving these outcomes despite giving patients a reduced intensity conditioning regimen, which carries a higher risk of relapse, in an older population with a median age of 68 is very encouraging. We look forward to advancing our novel gamma-delta T cell therapy for patients who need additional options.”
