Zumutor Biologics Inc., based in Boston and specializing in clinical-stage oncology, has commenced a Phase 1 clinical trial with ZM008. This trial will evaluate ZM008 both as a monotherapy and in conjunction with pembrolizumab for treating patients with advanced solid tumors.

ZM008 is a novel fully human IgG1 monoclonal antibody targeting LLT1 (CLEC2D), aiming to interrupt the interaction between LLT1 and CD161 on NK cells and tumor cells. This interaction disruption seeks to activate NK and T cells, potentially converting 'cold' tumors—those with poor immune response—into 'hot' tumors that might respond better to immunotherapy. This approach could offer new treatment options for patients who haven't benefited from existing therapies.

"While immunotherapy has significantly improved outcomes for many patients, substantial unmet needs remain," said Dr. Ildefonso Ismael Rodriguez, MD, Principal Investigator at NEXT Oncology. "ZM008 is a pioneering therapy that shows promise both on its own and when combined with anti-PD-1 therapy. We are optimistic about seeing initial clinical responses in this heavily pre-treated group."

The ZM008-001 study is an open-label, first-in-human, multicenter Phase 1 dose escalation trial designed to assess the safety, pharmacokinetics, maximum tolerated dose, and pharmacodynamic biomarkers of ZM008, along with its initial antitumor effectiveness. The study will also establish the recommended dose for subsequent Phase 2 trials.

In the first stage (1A), escalating doses of ZM008 will be administered to patients with advanced solid tumors who have exhausted standard treatment options. Stage 1B will assess the combination of ZM008 with pembrolizumab. The trial will include patients with various cancers 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), among others. The trial will monitor clinical responses, immune system activation, safety, and therapeutic benefits from both monotherapy and combination therapy.

Participants in the ZM008-001 trial must be adults aged 18 or older with advanced metastatic solid tumors and must show adequate levels of hematologic, renal, and hepatic function. Patients with a history of autoimmune disorders or severe side effects from previous cancer treatments are excluded. ZM008 will be administered intravenously every three weeks, requiring frequent visits to NEXT Oncology centers for lab tests, safety checks, and follow-up evaluations.

"Advancing ZM008 into clinical development is a crucial milestone for Zumutor and showcases the effectiveness of our Antibody discovery platform, INABLR®, in supporting our immuno-oncology initiatives," stated Maloy Ghosh, PhD, Chief Scientific Officer at Zumutor Biologics. "We are excited about the potential of ZM008 to activate immune pathways in treating advanced solid tumors."

"We are keen to see the outcomes regarding the safety and efficacy from the ZM008-001 clinical trial," said Kavitha Iyer Rodrigues, Founder/CEO of Zumutor. "This novel monoclonal antibody could provide a significant new option for patients with multiple solid tumors, addressing a critical unmet need."

"ZM008 has demonstrated remarkable activity in preclinical studies, both independently and in combination with pembrolizumab," commented Dr. Debasish Roychowdhury, MD, Medical Oncologist. "We hope these preclinical successes will translate into meaningful benefits for patients, and we are thankful to the trial sites for their collaboration in developing ZM008."

 

Source: prnewswire.com

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