US Patent Issued to HCW Biologics for Foundational Platform Technology

HCW Biologics Inc. was granted US Patent No. 11,401,324, which contains claims for immunotherapeutic compounds comprised of a single-chain chimeric polypeptide with two target-binding domains on a scaffold made of an extracellular domain of human tissue factor.

This patent provides intellectual property protection for the lead drug candidate, HCW9302, a single-chain, IL-2-based fusion protein designed to activate and expand regulatory T (T_reg) cells to suppress the activity of inflammasome-bearing cells and the inflammatory factors which they secrete. Preclinical studies in mouse models have demonstrated the ability of HCW9302 to activate T_reg cells and reduce inflammation-related disease pathologies, supporting the potential of HCW9302 to treat a wide variety of autoimmune and proinflammatory diseases. HCW9302 is currently completing IND-enabling activities for an IND application for a clinical trial in an autoimmune disorder.

HCW Biologics has created an extensive patent portfolio with multiple families of patent applications that are directed to its internally developed TOBI discovery platform technology for creation of novel single-chain and multi-chain chimeric polypeptides as well as methods of use of these polypeptides alone and in combination.

Hing C. Wong, PhD, Founder and CEO of HCW Biologics, expressed his excitement upon reaching this milestone by stating “We are thrilled to announce the issuance of a patent that has allowed such broad claims. The issuance of our first patent marks an important step in the evolution of our patent portfolio. This news, along with our progress in the prosecution of our other patent applications, reinforces our belief that our novel single-chain and multi-chain immunotherapeutics, as well as the proprietary approach used to create them with our TOBI discovery platform, are novel, valuable assets. We are pleased that this patent has been granted by the US Patent and Trademark Office, providing vital recognition and protection of the intellectual property on which we based one of our lead product candidates, HCW9302.”

HCW Biologics is represented by the leading global intellectual property law firm, Fish & Richardson P.C. “From the beginning, we have worked with HCW Biologics to build a portfolio of foundational patents which will protect the Company’s technology, inventions and improvements that are commercially important to the foundation of its business,” said Tiffany A. Reiter, PhD, Principal in the Boston office of Fish & Richardson P.C.

HCW Biologics is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation, and age-related diseases, such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases, and autoimmune diseases. The company has combined deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI (Tissue factOr-Based fusIon) discovery platform. The company uses its TOBI discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties. The invention of HCW Biologics’ two lead molecules, HCW9218 and HCW9302, was made via the TOBI discovery platform. The Masonic Cancer Center, University of Minnesota, has initiated a Phase 1 clinical trial to evaluate HCW9218 in solid tumors that have progressed after prior chemotherapies. The FDA has also cleared HCW Biologics to initiate a Phase 1b clinical trial for HCW9218 in patients with advanced pancreatic cancer. HCW9302 is currently undergoing IND-enabling studies for an autoimmune indication.