FDA also accepted the "safety first" staggered parallel clinical design of ZM008 combination arm with Pembrolizumab to benefit a wider range of patients whose immune response could be boosted with ZM008 followed by Pembrolizumab treatment to obtain favourable disease responses.

"The U.S. 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 INABLRä 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," said Dr Maloy Ghosh, PhD, Chief Scientific Officer, Zumutor Biologics. "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. 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".

"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," said Kavitha Iyer Rodrigues, Founder/ CEO of Zumutor

ZM008 Phase 1 study design will provide important information about the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary efficacy of monotherapy treatments as well as Recommended Phase 2 Dose (RP2D) of this novel drug in patients with solid cancers who are not benefited from existing 'standard of care'.