Zumutor Biologics Announces Dosing of First Patient with ZM008, a First-in-Class Anti LLT1 Antibody USA - English India - English

BOSTON, June 12, 2024 ~ Boston-based Oncology Company Zumutor Biologics Inc., also known as "Zumutor", has announced the dosing of the first patient in its Phase 1 clinical trial for ZM008. The trial is evaluating the novel monoclonal antibody in patients with advanced solid tumors, both as a single agent and in combination with pembrolizumab.

ZM008 is a fully human IgG1 monoclonal antibody that targets LLT1 (CLEC2D), disrupting the interaction between NK cells and tumor cells. This activation of NK cells and subsequent T cell activation has the potential to modify the immune infiltrate in the tumor microenvironment, making it more responsive to treatment. This approach could be particularly beneficial for patients who have not responded to current immunotherapy treatments.

Dr. Ildefonso Ismael Rodriguez, MD, Principal Investigator at NEXT Oncology, expressed optimism about the potential of ZM008. "While immunotherapy has made a significant impact on patient outcomes, there is still a significant unmet need," he said. "ZM008 is a first-in-class antibody that could help patients, both as a single agent and in combination with anti-PD-1 directed therapy."

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The ZM008-001 trial is an open-label, multicenter Phase 1 dose escalation trial that will assess the safety, pharmacokinetics, maximum tolerated dose, pharmacodynamic biomarkers, and initial antitumor activity of ZM008. The study will also recommend the Phase 2 dose.

In stage 1A of the trial, increasing doses of ZM008 will be given to patients with solid tumors who do not have standard therapeutic options. This will be followed by stage 1B where ZM008 will be combined with pembrolizumab. Multiple types of solid cancer indications will be enrolled in this trial including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), prostate cancer, colorectal cancer (CRC), high-grade serous ovarian cancer (HGSOC), and others. Detailed translational studies will also be conducted to evaluate the activation of the immune system, safety, and patient benefits after ZM008 monotherapy and combination therapy.

To be eligible for the trial, patients must be 18 years or older with advanced metastatic solid tumors and have adequate hematologic, renal, and hepatic functions. Patients with a history of auto-immune reactions and toxicities from previous anti-cancer therapies are not eligible. ZM008 will be administered intravenously once every three weeks, requiring multiple visits to NEXT Oncology sites for lab tests, safety evaluations, and other follow-up appointments each month.

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Chief Scientific Officer at Zumutor Biologics, Maloy Ghosh, PhD, stated that advancing ZM008 into clinical development is a significant milestone for the company. "We are excited to enroll patients in this first-in-human Phase 1 study focused on advanced solid tumor patients," he said. "Targeting this novel mechanism with ZM008 has the potential to activate immune pathways and provide a viable option for patients fighting advanced solid cancers."

Founder/CEO of Zumutor Biologics Kavitha Iyer Rodrigues also expressed enthusiasm for the potential of ZM008. "There is such a tremendous unmet need for patients suffering from multiple solid cancers," she said. "We are eager to see this novel monoclonal antibody advance through clinical trials and hope it will one day be available for these patients in need."

Dr. Debasish Roychowdhury, MD, Medical Oncologist added that ZM008 has shown remarkable activity in preclinical studies as both a single agent and in combination with pembrolizumab. "We are hoping this will translate to beneficial activity in patients and are thankful to the trial sites for joining us in developing ZM008," he said.

For more information on this clinical trial, visit www.clinicaltrials.gov (NCT06451497). Patients interested in enrolling can contact Jordan Georg at 210-580-9521.
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