The US Food and Drug Administration (FDA) has granted clearance to Zumutor Biologics’ investigational new drug (IND) application for initiating a Phase I trial of monoclonal antibody drug ZM008 against multiple solid cancers.
The first-in-human study will evaluate the tolerability, safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the drug as monotherapy in patients with solid cancers who did not respond to existing therapies.
It will also determine the recommended Phase II dose that can used for initiating further studies.
Zumutor Biologics chief scientific officer Dr Maloy Ghosh said: “The US Food and Drug Administration’s approval of ZM008 IND application is an important milestone for Zumutor and a clear recognition of the intriguing preclinical data supporting novel/non overlapping mode of actions, generated thus far.
“Our work to translate the promise of Zumutor’s INABLRa platform into improved and more potent human antibody products for patients in need will delve further into unique immune pathways involving NK cells and other innate immune compartments.
“We are now focusing on clinical execution of ZM008, closely working with oncologists for Phase I trial at NEXT Oncology, San Antonio and other sites in US, targeting first patient recruitment soon.”
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Based on FDA’s approval, Zumutor is also parallelly evaluating ZM008 along with Pembrolizumab to boost immune response in patients and obtain favourable disease responses.
Zumutor Biologics founder and CEO Kavitha Iyer Rodrigues said: “We believe that newer therapies like ZM008 will usher in options for patients and translate to better clinical outcomes.
“We anticipate start of Phase I studies in Q4 2023.”
ZM008 disrupts the interaction of LLT1-CD161 between immune and tumour cells thereby leading to reversal from less to highly immune responsive tumour microenvironment.