Los Angeles, CA — August 28, 2025 — Leads & Copy — Tidewave Bio, a biotechnology company focused on developing a universal, off-the-shelf, gene-enhanced antigen-presenting cell therapy platform, has announced the successful completion of its FDA INTERACT meeting. This milestone offers critical regulatory feedback as the company moves its lead program, TBC-1, toward IND-enabling studies.
Tidewave Bio’s platform is designed to address challenges in oncology, namely effective and accessible treatment for solid tumors. The universal cell therapy aims to be tumor type–agnostic, cost-reducing, and available in real time, delivering a range of tumor antigens to activate robust and durable immune responses across cancers.
“We are proactively engaging with the FDA as an external validation of our risk-mitigation strategy during product development,” said Francois Binette, PhD, Chief Executive Officer and Co-Founder. “The feedback from our INTERACT meeting provides clarity and confidence as we progress toward IND-enabling activities… Our mission is to expand access to advanced therapies for all solid tumor patients, and today we are one step closer to that goal.”
Tidewave Bio will integrate FDA feedback into its development program and pursue a pre-IND meeting to further shape its regulatory strategy. The company intends to work closely with regulatory agencies in the U.S. and abroad throughout product development to progressively de-risk its innovative program toward successful IND/CTA submissions.
Francois Binette, Founder & CEO, Tidewave Bio, email@tidewavebio.com
Source: Tidewave Bio
