HCW Biologics’ single-dose HCW11-040 prevents BPD in preclinical model
HCW Biologics showed that one subcutaneous dose of HCW11-040 prevented bronchopulmonary dysplasia in a stringent animal model during IND-enabling studies. It plans to complete IND-enabling by H2 2027 and pursue a Rare Pediatric Disease priority review voucher under the program extended through September 2029.
1. Preclinical Discovery of HCW11-040
In IND-enabling studies with academic collaborators, HCW Biologics found that a single subcutaneous dose of HCW11-040 prevented bronchopulmonary dysplasia in a stringent animal model, showcasing efficacy beyond its checkpoint inhibitor design.
2. Bronchopulmonary Dysplasia Disease Burden
BPD affects 10,000–15,000 underweight premature infants annually in the United States, causing chronic lung damage, asthma-like symptoms, neurodevelopmental delays and long-term health complications with no approved treatments.
3. Rare Pediatric Disease Priority Review Voucher Alignment
The Rare Pediatric Disease PRV program was extended through September 2029, allowing BPD designations to earn priority review vouchers, which can be sold or used to expedite other drug applications.
4. IND-Enabling Timeline and Next Steps
HCW Biologics expects to complete IND-enabling studies by the second half of 2027 and plans to file an IND application immediately to evaluate HCW11-040 in high-risk neonates.