Coherus Launches Phase 1 Study of ZM008 with Toripalimab in Up to 45 Patients
CHRS•Coherus Oncology and Zumutor Biologics have dosed the first patient in a Phase 1 trial (NCT06451497) evaluating ZM008, an anti-LLT1 mAb, combined with toripalimab-tpzi in up to 45 patients across colorectal, head and neck, NSCLC, renal cell and urothelial cancers. The study will assess safety, tolerability and recommended Phase 2 dose.
1. Clinical Collaboration Launch
Coherus Oncology and Zumutor Biologics have entered a clinical collaboration and supply agreement to initiate a Phase 1 trial (NCT06451497) evaluating the combination of ZM008, a novel anti-LLT1 monoclonal antibody, with LOQTORZI (toripalimab-tpzi), a next-generation PD-1 inhibitor. Under the agreement, Coherus will supply LOQTORZI and Zumutor will sponsor the study.
2. Trial Design and Patient Enrollment
The open-label, dose-escalation and expansion study plans to enroll up to 45 patients with colorectal, head and neck, non-small cell lung, clear cell renal cell and urothelial cancers across multiple US sites. Primary objectives include safety, tolerability and determination of recommended Phase 2 dose for the combination regimen.
3. ZM008 Preclinical and Early Data
ZM008 was discovered via Zumutor’s INABLR® fully human antibody library and has shown a favorable safety profile with no dose-limiting toxicities or anti-drug antibodies in monotherapy studies, alongside early signals of clinical benefit in metastatic patients previously treated with immune checkpoint inhibitors. Combining ZM008’s NK checkpoint blockade with toripalimab-tpzi’s PD-1 inhibition aims to target both innate and adaptive immune pathways, particularly in hard-to-treat “cold” tumors.
4. Strategic Rationale and Rights
The collaboration aligns with Coherus’s strategy to broaden LOQTORZI indications beyond nasopharyngeal carcinoma and enhance its US clinical data package through cost-effective supply partnerships. Both companies retain commercial rights to their agents, positioning them for potential co-development or independent monotherapy commercialization.
