HCW Biologics has requested a Type B pre-Investigational New Drug meeting with the U.S. Food and Drug Administration to discuss development and regulatory strategy for HCW11-018b, a tetravalent T-cell engager built on the company’s TRBC platform.
According to the company, HCW11-018b is designed for subcutaneous administration to treat solid tumors that overexpress tissue factor, including gynecologic and pancreatic cancers, and preclinical studies showed targeted engagement of tissue factor-expressing cancer cells, activation of CD3-positive effector T cells and reduction of immunosuppression in the tumor microenvironment.
The company claims extensive in vitro and in vivo assessments, pharmacokinetics and nonhuman primate toxicity testing indicate a favorable therapeutic window and the potential to address limitations of earlier-generation T-cell engagers; the company also reports the candidate did not trigger cytokine release syndrome within its therapeutic dose range in preclinical work.
HCW Biologics says it has developed a streamlined manufacturing process based on high-producing recombinant CHO cell lines and a proprietary monoclonal antibody manufactured under GMP by a contract development and manufacturing organization to produce cGMP material at lower cost.
Regulators have approved eight T-cell engagers for 12 indications and approved therapies in this class generate multi-billion-dollar annual sales.
