Zumutor’s cancer drug trial cleared by FDA
On 11 August 2023, the biopharmaceutical company Zumutor Biologics announced that the trial of its ZM008 drug for cancer had been granted clearance by the US Food and Drug Administration (FDA). ZM008 is a novel monoclonal antibody drug that helps to eliminate tumor cells in cancer patients.
The FDA granted the Boston-based company’s investigational new drug (IND) application for the drug to establish a phase 1 first-in-human clinical study for the treatment of solid cancers.
Dr Maloy Ghosh, chief scientific officer at Zumutor Biologics, said: “We are now focusing on clinical execution of ZM008, closely working with oncologists for phase 1 trial at NEXT Oncology, San Antonio and other sites in US, targeting first patient recruitment soon. We strongly believe this unique product will influence immune pathways involving both NK cell and T-cell compartments with amazing potential for combination with Anti PD1 antibody like pembrolizumab to benefit patients with advanced solid tumors.”
In order to benefit patients on a larger scale, the FDA accepted the “safety first” clinical design of ZM008 combined with pembrolizumab; this would enable their immune system to be boosted to obtain disease responses. The phase 1 study design will provide an understanding of the safety, tolerability and pharmacodynamics of the treatment, as well as the recommended phase 2 dose.
Kavitha Iyer Rodrigues, founder and CEO of Zumutor stated: “We believe that newer therapies like ZM008 will usher in options for patients and translate to better clinical outcomes. We anticipate start of phase 1 studies in Q4 2023.”
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