Zumutor Biologics, a developer of immuno-oncotherapeutics, prepares to file an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for its lead candidate treatment, ZM008, by the end of 2020.
The agreement will see Catalent’s biologics arm provide process optimization and drug substance manufacturing services from its US site in Madison, Wisconsin, which is undergoing a significant expansion, expected to be completed by mid-2021 and to double the company’s biomanufacturing capacity.
ZM008 is a 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.
NK cells are a type of cytotoxic lymphocyte (white blood cell) and a critical component in the innate human immune system, which ZM008 can utilize to target solid tumor cells for diseases such as prostate cancer, explained Zumutor.
To date, the candidate has presented ‘robust’ preclinical data including tumor cell death, immune cell infiltration, and tumor growth inhibition, according to the company's CEO, Kavitha Iyer.
For the manufacture of the potential treatment, Iyer stated that Catalent was selected as a trusted partner to deliver the product on-time and with the highest quality.