Tidewave Bio Completes FDA INTERACT Meeting for TBC-1, a Universal Cell Therapy Platform in Solid Tumors

By: Tidewave Biotech Inc via GlobeNewswire

August 28, 2025 at 08:00 AM EDT

LOS ANGELES, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Tidewave Bio, a biotechnology company developing a universal, off-the-shelf, gene-enhanced antigen-presenting cell therapy platform, today announced the successful completion of its FDA INTERACT meeting. This milestone provides critical regulatory feedback as the company advances its lead program, TBC-1, toward IND-enabling studies.

Tidewave Bio’s platform is designed to address one of the greatest challenges in oncology: effective and accessible treatment for solid tumors. Unlike current therapies that target limited antigens or require patient-specific manufacturing, Tidewave’s universal cell therapy is tumor type–agnostic, cost-reducing, and available in real time. By delivering a broad repertoire of tumor antigens, the platform is designed to activate robust and durable immune responses across a wide range of 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.

About Tidewave Bio

Tidewave Bio’s mission is to expand access to life-saving therapies for all solid tumor patients regardless of tumor type, treatment setting, or resource availability. The company is developing a universal, off-the-shelf immunotherapy platform that is converted into a patient-specific precision medicine in real time using a tumor biopsy. This single, allogeneic product is designed to treat a broad range of solid tumors without the manufacturing delays or logistical burdens of autologous cell therapies. Tidewave’s platform offers enhanced potency through broad antigen targeting, superior cost-effectiveness, and fast availability shortly after diagnosis, bringing next generation cancer immunotherapy closer to patients when and where they need it most. Currently in preclinical development, the company is pursuing accelerated regulatory pathways to address urgent, unmet needs in oncology.

Media Contact:

Francois Binette

Founder & CEO, Tidewave Bio

email@tidewavebio.com

https://www.tidewavebio.com

www.linkedin.com/company/tidewave-bio/