HCW Biologics discovers drug candidate prevents lung disease in infants

HCW Biologics Inc. (NASDAQ: HCWB) announced that its drug candidate HCW11-040 prevented bronchopulmonary dysplasia in animal studies conducted with collaborators at Queen's University at Kingston, Ontario.

The company reported that a single subcutaneous dose of HCW11-040 effectively prevented the development of bronchopulmonary dysplasia in what it described as a clinically relevant animal model. HCW11-040 is a pembrolizumab-based fusion immunotherapeutic designed to activate immune cells and eliminate senescent cells caused by high oxygen exposure.

Bronchopulmonary dysplasia is a lung condition affecting premature infants that can cause long-term respiratory problems and neurodevelopmental delays. The disease affects approximately 10,000 to 15,000 cases annually in the United States and currently has no cure.

HCW Biologics expects to complete IND-enabling studies in the second half of 2027 and plans to file an investigational new drug application to evaluate HCW11-040 in patients at high risk of developing the condition.

The company believes the indication could qualify for the rare pediatric disease priority review voucher program, which was reauthorized through September 2029 under the Mikaela Naylon Give Kids a Chance Act signed in February 2026.

"We created HCW11-040 with a generic form of Keytruda, the clear leader in immune checkpoint inhibitors," said Dr. Hing C. Wong, the company's founder and chief executive officer. "We consider our immunotherapeutic as second generation, since in our preclinical studies, it outperformed pembrolizumab as a monotherapy."

The Miramar, Florida-based biopharmaceutical company focuses on developing fusion immunotherapeutics for autoimmune diseases, cancer, and senescence-associated conditions. The information was provided in a company press release.

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