Catalent signs agreement for first-in-class oncological therapy


Zumutor Biologics has chosen Catalent to provide process optimisation and drug substance manufacturing services

Image as seen on company website

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

ZM008 is a first-in-class monoclonal antibody targeting tumour cell receptors that block natural killer (NK) cell inhibitory signals and enables NK cell activation to generate a potent immune response.

NK cells are a type of cytotoxic lymphocyte (white blood cell) and are a critical component in the innate human immune system, which ZM008 can utilise to target solid tumor cells for diseases such as prostate cancer.

“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. Adding that development is on track for investigational new drug filing by the end of 2020.

Iyer explained: “Robust preclinical data for ZM008 demonstrates tumour cell death, immune cell infiltration, and tumour growth inhibition. In vivo studies demonstrate anti-tumour efficacy as a monotherapy or in combination with immune checkpoint inhibitors.”

CDMO services

Under the terms of the agreement, Catalent Biologics will provide process optimisation and drug substance manufacturing services from its site in Madison, Wisconsin.

The Madison site is currently undergoing a significant expansion, with the build-out of two new suites, each with a 2 x 2,000 litre 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.

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“Catalent values the long-standing partnership and technical relationship that we have developed with Zumutor over the years,” said Mike Riley, Region President for Catalent Biologics, North America.