On June 13, 2024 Zumutor Biologics Inc. "Zumutor", a Boston-based clinical stage Oncology Company developing first-in-class monoclonal antibody molecules targeting innate immunological pathways, reported that the first patient was dosed in its Phase 1 clinical trial, with ZM008 (Press release, Zumutor Biologics, JUN 12, 2024, View Source [SID1234644293]). The dose escalation trial is evaluating ZM008 in patients with advanced solid tumors, as a single agent and in combination with pembrolizumab.
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ZM008 is a novel fully human IgG1 monoclonal antibody against LLT1 (CLEC2D), which disrupts the interaction of LLT1-CD161 between NK cells and tumor cells. ZM008-mediated NK cell activation and subsequent T cell activation will modify the immune infiltrate in the tumor microenvironment driving eventual antitumor effects. The mode of action of ZM008 is to convert the ‘cold’ or less immune responsive cancers (TME) into ‘hot’ or highly immune responsive tumors. This approach could provide significant benefits to patients resistant to available immunotherapy treatments.
"While immunotherapy has made a significant and positive impact on patient outcomes, there remains a significant unmet need. ZM008 is a first-in-class antibody that could help patients, both as a single agent as well as in combination with anti-PD-1 directed therapy. We are pleased to participate in the study and are optimistic that early clinical activity may be observed in this heavily pre-treated patient population based on clinical evaluation and translational data," commented Dr. Ildefonso Ismael Rodriguez, MD, Principal Investigator at NEXT Oncology.
Understanding the Trial Design
The ZM008-001 trial is an open-label, first-in-human, multicenter, Phase 1 dose escalation trial of ZM008 administered alone or combined with Pembrolizumab. The trial will assess the safety, pharmacokinetics, establish the maximum tolerated dose, pharmacodynamic biomarkers, and initial antitumour activity of ZM008. The study will recommend the Phase 2 dose.
In stage 1A, increasing doses of ZM008 will be administered to patients with solid tumors, without standard therapeutic options. This will be followed by stage 1B, where ZM008 will be given in combination with the anti PD1 drug, Pembrolizumab. Multiple solid cancer indications will be enrolled: 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. Clinical responses and detailed translational studies will be performed, to evaluate the activation of the immune system, safety and patient benefits, after ZM008 monotherapy and combination therapy.
Knowing the Criteria
The ZM008-001 clinical trial is for adults, aged 18 or older, with advanced metastatic solid tumors. Patient must have adequate hematologic, renal and hepatic functions. Patients with a history of auto-immune reactions and toxicities with previous anti-cancer therapies (irAEs) are not eligible. ZM008 will be administered intravenously once every three weeks. This trial requires multiple visits to NEXT Oncology sites for lab tests, safety evaluations, and other follow-up appointments each month.
"Advancing our first novel drug ZM008 into clinical development is an important inflection point for Zumutor and underscores the power of our Antibody discovery engine, INABLR, supporting the immuno-oncology pipeline," said Maloy Ghosh, PhD, Chief Scientific Officer at Zumutor Biologics. "We are excited to enroll patients in this first-in-human Phase 1 study, focused on advanced solid tumor patients. Activation of immune pathways, by targeting this novel mechanism with ZM008, will be a viable option for patients to fight advanced solid cancers."
"We are looking forward to see safety and efficacy data from the ZM008-001 clinical trial," said Kavitha Iyer Rodrigues, Founder/CEO of Zumutor. "There is such a tremendous unmet need for patients suffering from multiple solid cancers. 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."
"ZM008 is a very exciting molecule. The preclinical work, including the ex-vivo studies, have shown remarkable activity both as 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," said Dr. Debasish Roychowdhury, MD, Medical Oncologist.
Additional information on this clinical trial will be updated on www.clinicaltrials.gov (NCT06451497).
For questions or to enroll in this study, the patient’s treating physician can contact Jordan Georg. Phone: 210-580-9521