Announcing Manufacturing Partnership with Genezen

Today, we’re thrilled to share a major milestone for Humane Genomics: we’ve partnered with Genezen to begin process transfer and cGMP (Current Good Manufacturing Practice) manufacturing of our lead oncolytic virus candidate for hepatoblastoma. This marks a big step forward in our mission to bring precision-engineered viral therapies to patients with cancer.

Genezen is a leading viral vector CDMO with state-of-the-art facilities in Indianapolis and Lexington. Their deep expertise in viral vector process development and cGMP production makes them an ideal partner as we transition our platform from the research stage into manufacturing.

We began discussions with Genezen earlier this year and were immediately struck by the depth of their technical knowledge and the enthusiasm of their team. During our site visits, we saw first-hand their immaculate facilities. Next to this, we witnessed their commitment to scientific rigor and quality.

Our lead candidate for hepatoblastoma has undergone rigorous testing, the latest results of which we proudly presented at AACR 2025. These studies have built a strong foundation for the next stage: manufacturing a cGMP-grade batch suitable for toxicology studies and ultimately, First-in-Human (FIH) trials, pending regulatory approval.

Transitioning to cGMP production is a critical milestone in any therapeutic development program. It ensures that every step — from cell banking to viral purification — adheres to strict quality standards required for clinical testing. With Genezen’s expertise we’re confident this collaboration will yield a product that meets the highest standards of safety, reproducibility, and performance.

Over the coming months, our teams will complete tech transfer and then the first proof of concept run will be done. These efforts will set the stage for producing our first full cGMP batch.Together, we’re taking another significant step toward realizing our vision: developing synthetic oncolytic viruses that safely and selectively destroy cancer cells — starting with pediatric liver cancers like hepatoblastoma.

Stay tuned for updates as we move closer to the clinic.