The 2020 ASCO annual meeting will be held online May 29-31. KLUS Pharma will present the latest progress of two clinical trials, A166 (HER2-ADC) and SKB264 (TROP2-ADC), including the following abstracts:
A first in-human study of A166 in patients with locally advanced/metastatic solid tumors that are HER2-positive or HER2-amplified, who did not respond or stopped responding to approved therapies. Abstract # 1049
A Phase I study on the safety and pharmacokinetics of A166, a novel selective inhibitor of human epidermal growth factor receptor-2 (HER2), in Chinese patients with advanced solid tumors. Abstract # e13007
A first in-human study of SKB264 in patients with locally advanced unresectable/metastatic solid tumors who are refractory to available standard therapies. Abstract # TPS3659
A166 is the first HER2 antibody linked to a highly active toxin via quantitative and site-specific conjugation to lysine residues. The target indications include breast cancer, gastric cancer, and other metastatic cancers with HER2 (human epidermal growth factor receptor 2) gene amplification or overexpression. Non-clinical studies showed good results in safety, efficacy, and manufacturing. Compared to similar products on the market, A166 showed higher efficacy in animal models with various expression levels of HER2 and tolerance to trastuzumab. The high stability in circulation and specificity to tumor cells allow A166 to achieve a high drug payload while maintaining safety and tolerability. Quantitative and site-specific conjugation is performed under mild conditions. Antibody engineering, modification, or reduction is not required for drug conjugation, which lowers the risk of immunogenicity. The manufacturing process has been optimized to maintain homogeneity and stability of the ADC in large-scale production. In May 2018, the product received IND/CTA clearance from the FDA and NMPA to begin Phase 1 clinical trials in the US and China. Evaluation of the tolerability, safety, and efficacy of A166 was based on the interim data of these ongoing studies.
SKB264 is an antibody-drug conjugate (ADC) targeting trophoblast cell surface antigen 2 (TROP2). Our proprietary conjugation chemistry and novel cytotoxic payload enables a high DAR (drug-to-antibody ratio) to be achieved. Non-clinical studies showed significant anti-tumor activity in animal models of breast cancer, gastric cancer, lung cancer, and colorectal cancer with overexpression of TROP2. The product was well tolerated with a good safety profile. The manufacturing process showed high stability, controllability, scalability, and batch-to-batch consistency. SKB264 received IND/CTA clearance from the FDA and NMPA to begin Phase 1 clinical trials in the US and China, and we are currently recruiting patients for the Phase 1 study.
KLUS Pharma Inc.
Cranbury, New Jersey, US