A phase 3 trial of Biokin’s bispecific antibody-drug conjugate (ADC) has hit at least one primary endpoint, boosting the prospects of a candidate that Bristol Myers Squibb licensed outside of China for $800 million upfront.
BMS paid the upfront sum, part of a deal worth up to $8.4 billion, in 2023 to secure ex-China rights to izalontamab brengitecan (iza-bren). The candidate is designed to engage EGFR and HER3, receptors involved in the survival and proliferation of epithelial tumors, and deliver a cytotoxic payload to cells that express the proteins.
On Wednesday, Biokin reported (PDF) positive topline results from a phase 3 trial of the ADC. The study enrolled patients with recurrent or metastatic nasopharyngeal carcinoma who had received at least two lines of chemotherapy after trying a PD-1/L1 antibody.
The study met at least one primary endpoint. Biokin is yet to share data from the trial. The study was designed to compare the effect of iza-bren to the physician’s choice of chemotherapy.
Biokin’s Baili Pharmaceutical, the trial’s sponsor, selected objective response rate and overall survival as the primary endpoints for the study.
BMS has made triple-negative breast cancer its lead indication for the asset, with a phase 2/3 trial scheduled to start this month, but its Chinese partner’s program could generate evidence to support use in a range of other tumor types. Baili is running studies in indications including cancers of the biliary tract, kidneys, liver, lung and ovaries.
Meanwhile, other EGFRxHER3 ADCs are in development. Duality Biotherapeutics and Avenzo Therapeutics secured FDA clearance to start a phase 1/2 trial in May. Biocytogen published preclinical data on a candidate last year. And CStone Pharmaceuticals shared preclinical data on its contender in May.