IN8bio Gets FDA Guidance for Registrational Trial of INB-100

 

• FDA Guidance on Registrational Program: Following a Type B meeting with the FDA earlier this summer, IN8bio received regulatory guidance on advancing INB-100 for the treatment of AML as a post-transplant maintenance therapy, with relapse-free survival as the primary endpoint. To date, 100% of AML patients treated with INB-100 are in long-term CR, providing a promising path for the registrational trial. IN8bio plans to submit an Investigational New Drug (IND) application to the FDA in Q1 2025. Pending clearance, the Company could initiate a registrational trial for AML in 2025.
• https://www.biospace.com/in8bio-solidifies-position-as-a-clinical-leader-of-gamma-delta-t-cell-therapy-in-oncology-with-100-of-treated-aml-patients-in-complete-remission-and-receives-fda-guidance-for-registrational-trial-of-inb-100