Birmingham-based IN8bio is advancing its lead solid tumor drug program into Phase 2 clinical trials.
The company recently said it received FDA clearance of its Investigational New Drug application. The trial is expected to commence in 2023 with the enrollment of newly diagnosed glioblastoma patients. Glioblastoma is an aggressive type of cancer.
The news comes as the company is advancing therapeutic research toward treating aggressive brain cancers. IN8bio was launched from technology developed at University of Alabama at Birmingham and intellectual property licensed from the Bill L. Harbert Institute for Innovation and Entrepreneurship and two other institutions.
The trial will involve a genetically modified autologous gamma-delta T cell therapy, or INB-400, targeting newly diagnosed glioblastoma. The study will assess the safety, efficacy and tolerability of genetically modified DeltEx drug-resistant immunotherapy cells at leading medical centers across the U.S.
“Obtaining clearance to begin the INB-400 Phase 2 clinical trial is an important milestone for IN8bio as it is our first company-sponsored IND," said William Ho, CEO and co-founder of IN8bio. "This milestone demonstrates the clinical, regulatory and CMC capabilities of the IN8bio team in continuing to advance novel gamma-delta T cell therapies to cancer patients. ... We believe the insights we unlock in (glioblastoma) will be essential as we apply our DeltEx platform across multiple solid tumor cancers."
IN8bio hosted a conference call and webcast on Dec. 12 to review recent clinical updates, including updated data from the Phase 1 clinical trial of INB-100 being presented at ASH.
The company is also currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types.
