Zumutor Biologics Begins Dosing First Patient with ZM008 Anti-LLT1 Antibody

Zumutor Biologics Inc., a Boston-based clinical-stage oncology firm, has announced the commencement of its Phase 1 clinical trial for its novel monoclonal antibody, ZM008. This first-in-human trial aims to evaluate the safety and efficacy of ZM008 in patients with advanced solid tumors, both as a standalone treatment and in combination with pembrolizumab.

ZM008 is a fully human IgG1 monoclonal antibody targeting LLT1 (CLEC2D), crucial for interfering with the LLT1-CD161 interaction between NK cells and tumor cells. By mediating NK cell and subsequent T cell activation, ZM008 aims to modify the tumor microenvironment, potentially transforming 'cold' or less immune-responsive tumors into 'hot' or highly immune-responsive ones. This mechanism could particularly benefit patients who have shown resistance to existing immunotherapies.

The clinical trial, designated ZM008-001, is an open-label, first-in-human, multicenter, Phase 1 dose escalation trial. The study is structured to assess the safety, pharmacokinetics, and pharmacodynamic biomarkers of ZM008, along with establishing its maximum tolerated dose. The trial will also evaluate the initial antitumor activity of ZM008, aiming to recommend a dose for Phase 2.

In Stage 1A of the trial, increasing doses of ZM008 will be administered to patients with advanced solid tumors who have no standard therapeutic options left. Stage 1B will see ZM008 combined with pembrolizumab. The trial is set to enroll patients across multiple solid cancer indications, such as non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), prostate cancer, colorectal cancer (CRC), and high-grade serous ovarian cancer (HGSOC). In-depth translational studies will be conducted to assess the immune system's activation, safety, and patient benefits from both monotherapy and combination therapy.

The trial is open to adults aged 18 and older with advanced metastatic solid tumors. Eligibility criteria include adequate hematologic, renal, and hepatic functions. Patients with a history of autoimmune reactions or toxicities from previous anti-cancer therapies are not eligible. ZM008 will be administered intravenously every three weeks, requiring multiple visits to NEXT Oncology sites for lab tests, safety evaluations, and other follow-up appointments.

Dr. Ildefonso Ismael Rodriguez, Principal Investigator at NEXT Oncology, expressed optimism about the study, highlighting the unmet need in immunotherapy. He emphasized that ZM008 could offer significant benefits as a single agent and in combination with anti-PD-1 directed therapy.

Maloy Ghosh, Chief Scientific Officer at Zumutor Biologics, described the advancement of ZM008 into clinical development as a pivotal moment for the company. He noted the potential of Zumutor's INABLR® antibody discovery engine in supporting their immuno-oncology pipeline.

Zumutor Biologics was founded in 2015 and has since raised $28 million from investors, including Accel Partners, Bharat Innovation Fund, and Siana Capital. The company's focus is on harnessing NK cells to modulate the tumor microenvironment, and its pipeline includes additional assets targeting NK cell activation pathways.

Kavitha Iyer Rodrigues, Founder and CEO of Zumutor, remarked on the significant unmet need for patients suffering from multiple solid cancers. She expressed eagerness to see ZM008 advance through clinical trials and ultimately benefit patients in need.

Dr. Debasish Roychowdhury, a Medical Oncologist, highlighted the promising preclinical work of ZM008, noting its remarkable activity as a single agent and in combination with pembrolizumab. He thanked the trial sites for their participation in developing ZM008.

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