Catalent has signed an agreement with Zumutor Biologics to manufacture Zumutor’s lead candidate, ZM008, for the treatment of solid tumors. Zumutor develops novel immuno-oncotherapeutics to drive transformational improvements in cancer treatment.

ZM008 is a first-in-class monoclonal antibody targeting tumor cell receptors that block natural killer (NK) cell inhibitory signals and enables NK cell activation to generate a potent immune response. ZM008 targets solid tumor cells for diseases such as prostate cancer.

Catalent Biologics will provide process optimization and drug substance manufacturing services from its site in Madison, WI. The site is currently undergoing a significant expansion, with the build-out of two new suites, each with a 2 x 2,000-liter single-use bioreactor system, providing additional clinical and commercial production. The expansion is scheduled to be completed by mid-2021 and will more than double Catalent Biologics’ commercial biomanufacturing capacity.

“We were able to fast track the development of ZM008 by leveraging INABLR, our proprietary antibody discovery platform,” said Kavitha Iyer, Founder & CEO of Zumutor Biologics. “Robust preclinical data for ZM008 demonstrates tumor cell death, immune cell infiltration, and tumor growth inhibition. In vivo studies demonstrate anti-tumor efficacy as a monotherapy or in combination with immune checkpoint inhibitors. Development is on track for investigational new drug filing by the end of 2020, and we have placed our trust in Catalent to deliver on-time and with the highest quality in true partnership.”

“Catalent values the long-standing partnership and technical relationship that we have developed with Zumutor over the years,” said Mike Riley, Region President, Catalent Biologics, North America. “We are excited to work on this innovative lead candidate as the company prepares to take it into the clinic and beyond and look forward to working closely with Zumutor to support its clinical development and commercialization needs.”