On November 6, 2026, Chimigen Bio announced that its independently developed PAP-targeting recombinant protein cancer vaccine, KMV002, for metastatic castration-resistant prostate cancer (mCRPC), achieved first-in-human (FIH) administration at West China Hospital of Sichuan University. The first-dose cohort completed its dose-limiting toxicity (DLT) observation period with no DLTs observed within 14 days. Dose escalation and immunogenicity evaluation will proceed as planned.

Driven by the proprietary SynNeogen® platform, KMV002 utilizes AI-assisted engineering to achieve efficient FcR-mediated dendritic cell (DC) targeted delivery, thereby activating cross-antigen presentation and specific CD8+ T cell immune responses. It is designed to induce anti-tumor immunity and enhance the efficacy of immune checkpoint inhibitors (ICIs), androgen receptor-targeted agents, and other therapies. KMV002 has also received U.S. FDA IND clearance and Fast Track Designation, with early-stage clinical development progressing in Australia.

We are delighted to witness this encouraging progress from Chimigen Bio and sincerely congratulate the team on achieving this important milestone. As the CRDMO partner for this program, we’re proud to support the advancement of this promising therapy through our proprietary Bac/Sf9 platform for large-scale, GMP-grade production of recombinant proteins. We look forward to supporting its continued development and future clinical progress. 

With a proven track record of success in supporting 30+ drug development projects and multiple China/U.S. IIT and IND submissions, Genevoyager has advanced recombinant protein vaccines and AAV gene therapies targeting hepatitis B, cancer, Parkinson’s disease, and refractory epilepsy, with selected programs cleared by the FDA for Phase I/II trials. We are committed to providing the academic, pharmaceutical, and biotech communities worldwide with high-quality recombinant protein products featuring high safety, efficient expression, strong stability, and consistent batch-to-batch performance.

Source:
https://www.chimivac.com/