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Through the agreement, Catalent will offer process optimization and drug substance manufacturing services for the drug candidate at its Madison, WI site.
Catalent announced on Feb. 11, 2020 that it has signed an agreement with Cambridge, MA-based therapeutics company, Zumutor Biologics, to manufacture Zumutor’s lead candidate, ZM008, a monoclonal antibody for the treatment of solid tumors.
Through the agreement, Catalent will offer process optimization and drug substance manufacturing services for the drug candidate at its Madison, WI site, according to a Catalent press release. The site is currently being expanded and is scheduled to be completed in mid-2020.
ZM008 works to target tumor cell receptors that block natural-killer-cell inhibitory signals and allows for natural killer cell activation to create an effective immune response, the release said. Natural killer cells (white blood cell type) play a crucial role in the innate human immune system, and ZM008 can use them to work against solid tumor cells.
“We were able to fast-track the development of ZM008 by leveraging INABLR, our proprietary antibody discovery platform,” stated Kavitha Iyer, founder and CEO of Zumutor Biologics, in the press release. “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,” added Mike Riley, region president, Catalent Biologics, in the press release. “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.”