On August 28, 2025 Tidewave Bio, a biotechnology company developing a universal, off-the-shelf, gene-enhanced antigen-presenting cell therapy platform, reported the successful completion of its FDA INTERACT meeting (Press release, Tidewave Bio, AUG 28, 2025, https://www.globenewswire.com/news-release/2025/08/28/3140757/0/en/Tidewave-Bio-Completes-FDA-INTERACT-Meeting-for-TBC-1-a-Universal-Cell-Therapy-Platform-in-Solid-Tumors.html?utm_source=chatgpt.com [SID1234656369]). This milestone provides critical regulatory feedback as the company advances its lead program, TBC-1, toward IND-enabling studies.
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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.