A167 is a monoclonal antibody targeting PD-L1. It is currently being tested in pivotal Phase 2 clinical trials in the US and China. This program is being developed in collaboration with an external partner.
KL-A289 is a monoclonal antibody targeting LAG-3. An IND was recently approved by the NMPA in August 2020 to conduct a Phase 1 clinical trial in China. Preclinical studies showed that the drug was well tolerated and demonstrated efficacy as monotherapy and in combination with anti-PD-1 mAbs. Development and commercial rights are available for licensing or partnership.
A337 is an IgG-like bispecific antibody targeting PD-L1 and CTLA-4. To ensure a good safety profile, the affinity was tuned separately for PD-L1 and CLTA-4, resulting in an MTD as high as 500 mg/kg in cynomolgus. The bsAb was designed for higher efficacy by blocking interactions between PD1/PD-L1, CTLA-4/CD80, and CTLA-4/CD86. Product has been validated in 200 L batch with productivity up to 4 g/L. A337 is currently under GLP toxicology studies.
A140 is a monoclonal antibody targeting epidermal growth factor receptor (EGFR) and developed as a cetuximab biosimilar. A Phase 3 study is planned to begin in the near future. Development and commercial rights are available for licensing or partnership.
A166 is an antibody-drug conjugate (ADC) that is composed of anti-HER2 antibody conjugated to a highly potent auristatin-based payload, via site-specific conjugation and cleavable Val-Cit linker. Phase 1 clinical trials conducted in the US and China showed that the drug was well tolerated at 4.8 mg/kg. Furthermore, the drug was able to achieve a Disease Control Rate (DCR) of 100% in breast cancer patients. Based on these promising results, a Phase 2 clinical trial is expected to be initiated by the end of 2020. Development and commercial rights are available for licensing or partnership.
SKB264 is a third-generation antibody-drug conjugate (ADC) that is composed of anti-TROP2 antibody conjugated to a highly potent topoisomerase I inhibitor, via site-specific conjugation and highly stable linkers. The Phase 1 clinical trial is currently recruiting patients in both the US and China, open to populations with locally advanced and/or metastatic solid tumors who are refractory to available standard therapies. In preclinical studies, SKB264 demonstrated comparable or superior safety and efficacy when compared to sacituzumab govitecan. Development and commercial rights are available for licensing or partnership.
A168 is a monoclonal antibody targeting VEGFR2 and developed as a ramucirumab biosimilar. It is currently being tested in a Phase 1 clinical trial in China. Development and commercial rights are available for licensing or partnership.
SKB315 is a third-generation antibody-drug conjugate (ADC) targeting Claudin 18.2. The novel antibody was developed with a high affinity to Claudin 18.2, a protein that is specifically expressed on gastric and pancreatic cancer cells. Equipped with our proprietary linker and payload molecules, A315 showed a promising efficacy and safety profile in pre-clinical studies, and is expected to be a first-in-class ADC product. The IND application is scheduled for Q1 2021.
A336 is a novel humanized antibody targeting Factor XI. The antibody inhibits activation of Factor XI, and subsequently blocks the intrinsic coagulation pathway with no impact on the extrinsic pathway. Therefore, the antibody is highly efficient in prevention of thromboembolism without associated hemorrhagic risks. A336 has been formulated for both intravenous and subcutaneous administration with demonstrated stability at up to 150 mg/mL. We expect to finish IND-enabling studies by Q1 2021 and to file IND application in Q2 2021.