HCW Biologics (Nasdaq: HCWB), based in Miramar, Florida, reported that its fusion immunotherapeutic HCW11-040 prevented bronchopulmonary dysplasia in a preclinical animal model during IND-enabling studies conducted with collaborators at Queen's University in Kingston, Ontario. According to the company, a single subcutaneous dose of HCW11-040 effectively prevented BPD development in what it described as a clinically relevant and highly stringent animal model, with an IND filing targeted after completion of enabling studies in the second half of 2027.
In the animal model, HCW11-040 was administered as a single subcutaneous dose and was reported to prevent BPD development, according to the company's announcement. The model involved high-oxygen-induced conditions consistent with the hyperoxic injury that underlies BPD in premature infants, and the company attributed the observed effect in part to elimination of senescent cells generated under those conditions. No quantitative efficacy data, group sizes, histopathological measurements, biomarker readouts, or statistical analyses were disclosed in the press release, and no safety or tolerability data from the BPD model were reported.
HCW did not disclose the animal species, strain, sample sizes, dose level, duration of observation, or comparator arms used in the BPD experiment. The plan is to complete IND-enabling studies in the second half of 2027 and intends to file an IND application to evaluate HCW11-040 in patients at high risk of developing BPD.