Coherus and Zumutor Launch Phase 1 Trial of NK Checkpoint Antibody ZM008 Combined with PD-1 Inhibitor LOQTORZI in Solid Tumors
核心洞察
Coherus Oncology (搜索) and Zumutor Biologics (搜索) announced a clinical collaboration to evaluate ZM008, a novel anti-LLT1 (搜索) monoclonal antibody, in combination with the PD-1 (搜索) inhibitor LOQTORZI (toripalimab-tpzi) in a Phase 1 trial.
The trial (NCT06451497) will enroll up to 45 patients across dose-escalation and expansion cohorts, targeting colorectal, head and neck, non-small cell lung cancer (搜索), clear cell renal cell carcinoma (搜索), and urothelial cancers.
ZM008 has demonstrated a favorable safety profile with no dose-limiting toxicities in monotherapy and has shown clinical benefit in metastatic patients previously treated with immune checkpoint inhibitors.
Coherus Oncology (搜索), Inc. (Nasdaq: CHRS) and Zumutor Biologics (搜索) Inc. announced on June 23, 2026, a clinical collaboration and supply agreement to conduct a Phase 1 trial evaluating ZM008, a novel NK checkpoint anti-LLT1 (搜索) monoclonal antibody, in combination with LOQTORZI (toripalimab-tpzi), a next-generation PD-1 (搜索) inhibitor. The trial, identified as NCT06451497, will enroll patients across multiple solid tumor types, including colorectal, head and neck, non-small cell lung cancer (搜索) (NSCLC), clear cell renal cell carcinoma (搜索), and urothelial cancers.
Theresa LaVallee, Ph.D., Chief Scientific and Development Officer at Coherus Oncology (搜索), stated: "We are excited to partner with Zumutor Biologics (搜索) on the development of LOQTORZI with ZM0008 as a novel combination treatment for cancer patients in this Phase 1 study." She added that the collaboration exemplifies Coherus's strategy to "expand potential LOQTORZI indications beyond NPC and strengthen the clinical data package in the US through cost-efficient drug supply agreements, evaluating LOQTORZI with novel mechanisms in prioritized tumor types such as NSCLC, HNSCC, and others."
ZM008: A Novel NK Checkpoint Targeting LLT1 (搜索)
ZM008 was discovered using Zumutor's proprietary fully human monoclonal antibody library, INABLR®, which combines high-diversity human antibody libraries with yeast and phage display technologies. In an ongoing monotherapy study, ZM008 has demonstrated a favorable safety profile, with no dose-limiting toxicities or anti-drug antibodies observed. Notably, the antibody has shown clinical benefit in metastatic patients who were previously treated with immune checkpoint inhibitors.
The scientific rationale behind the combination rests on targeting complementary adaptive and innate immune pathways. By simultaneously engaging the PD-1 (搜索) axis through LOQTORZI and the NK cell checkpoint LLT1 (搜索) through ZM008, the partners aim to unlock meaningful clinical benefit, particularly in hard-to-treat "cold tumors" that remain less responsive to current immunotherapies.
Trial Design and Objectives
The Phase 1 study will evaluate safety, tolerability, and the recommended dose of ZM008 when administered in combination with LOQTORZI. The trial will enroll up to 45 patients across dose-escalation and expansion cohorts in the United States. Zumutor will serve as the sponsor of the Phase 1 clinical combination trial.
Maloy Ghosh, Ph.D., Chief Scientific Officer of Zumutor, explained: "This Phase 1 study will evaluate ZM008 in combination with LOQTORZI and will generate key insights into response mechanisms, identify predictive biomarkers, and refine patient selection strategies to accelerate personalized therapies."
Strategic Significance
Kavitha Iyer Rodrigues, CEO of Zumutor Biologics (搜索) Inc., described the initiation of combination studies as "a pivotal milestone for our lead program," adding: "Building on encouraging early clinical data, this advancement strengthens our conviction in ZM008's potential to deliver a differentiated and meaningful immunotherapy option for patients with difficult-to-treat cancers and underscores our commitment to accelerating its clinical development."
Under the terms of the clinical trial collaboration and supply agreement, Coherus Oncology (搜索) will provide LOQTORZI to Zumutor. Both companies retain all commercial rights to their respective compounds, whether as monotherapies or combination therapies.
Zumutor Biologics (搜索), headquartered in Boston with R&D operations in Bangalore, is a clinical-stage biotechnology company founded in 2015 that has raised approximately $33 million from a global investor syndicate. Coherus Oncology (搜索) is a fully integrated commercial-stage oncology company with an approved PD-1 (搜索) inhibitor, LOQTORZI, currently indicated for relapsed/metastatic nasopharyngeal carcinoma (搜索), and a pipeline that includes two mid-stage clinical candidates: tagmokitug, an anti-CCR8 antibody in Phase 1b/2a studies, and casdozokitug, an IL-27 antagonistic antibody in a Phase 2 study for first-line hepatocellular carcinoma.