Zumutor Biologics Receives the US FDA’s IND Clearance of ZM008 for Multiple Solid Cancers
Shots:
- The US FDA has cleared an IND application to initiate the P-I trial of ZM008 (IgG1 mAb against LLT1). The study is expected to be initiated in Q4’23
- The P-I study will evaluate the safety, tolerability, PK, PD & preliminary efficacy of monotx. treatments & RP2D of ZM008 who are not benefited from existing SoC. To help a broader range of patients whose immune response might be increased with ZM008 followed by pembrolizumab therapy to generate favorable disease responses, the US FDA allowed the "safety first" staggered parallel trial design of the ZM008 + pembrolizumab
- Elegant assays using a humanized mice xenograft model & an ex vivo platform with patient biopsies from bladder & lung cancer in the presence of autologous PBMC showed that ZM008 had anticancer effects
Ref: Prnewswire | Image: Zumutor
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