Tidewave Bio Reaches Key Regulatory Milestone with FDA INTERACT Meeting Scheduled for August 2025

Company advances development of first-in-class solid tumor immunotherapy platform

LOS ANGELES, Aug. 07, 2025 (GLOBE NEWSWIRE) — Tidewave Bio, a biotechnology company developing a novel immune activation platform for solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has accepted its request for an INTERACT meeting, scheduled for August 2025. This regulatory milestone marks a critical step in Tidewave’s effort to advance its lead immunotherapy candidate toward clinical development.

“Our platform is designed to unlock a broader and more potent immune response to cancer by targeting a diverse antigen repertoire through a point-of-care-enabled system, not achievable with existing approaches,” said Francois Binette, PhD, Co-founder and CEO of Tidewave Bio. “This upcoming engagement with the FDA represents an important validation of our approach and supports our goal of moving rapidly toward IND-enabling activities.”

In preparation for an IND submission targeted in Q2 2026, Tidewave Bio is focused on completing key preclinical studies, advancing toward cGMP manufacturing, and finalizing its regulatory documentation. Supporting this next phase, Tidewave co-founder Michael Montgomery has committed an initial $100,000 investment—underscoring the founding team’s strong belief in the scientific foundation and clinical potential of the platform.

Tidewave’s proprietary technology is designed to amplify the natural process of antigen presentation and trafficking, eliciting a robust anti-tumor immune response and helping to overcome the immunosuppressive environment characteristic of solid tumors. The company’s approach enables timely, personalized treatment delivery through real-time biopsy processing, with potential applicability across multiple tumor types.

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 immediate availability at the time of 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.

CONTACT: Media Contact

Francois Binette

Founder & CEO, Tidewave Bio

email@tidewavebio.com
https://www.tidewavebio.com
www.linkedin.com/company/tidewave-bio/