Drug

Indication

Discovery

Development

Pre-IND

Phase 1

Phase2

Phase 3

 Immuno-Oncology

Nasopharyngeal carcinoma ( NPC) and other cancers

Solid tumors

Solid tumors

A337

Solid tumors

A348

Solid tumors

 Oncology Programs

Colorectal cancer

Solid tumors

Solid tumors

Solid tumors

A315

Gastric cancer

 Life-Threatening Diseases

A157

Thrombocytopenia

A336

Anti-coagulation

A167, anti-PD-L1 mAb

A167 is a monoclonal antibody targeting PD-L1. It is currently being tested in a Phase 2 clinical trial in US and China. 

KL-293, anti-TIM-3 mAb 

KL-293 is a monoclonal antibody targeting TIM-3. It is currently being tested in a Phase 1 clinical trial in China since 2019. The preclinical data demonstrated promising efficacy in lung and colorectal cancer in mouse models as a single agent and in combination with anti-PD-1 mAbs. Safety studies showed an MTD of 600 mg/kg (single intravenous injection) and NOAEL of 200 mg/kg. 

KL-A289, anti-LAG3 mAb 

A289 is a monoclonal antibody targeting LAG3. The IND application was recently approved in Q2 2020 in China. Preclinical studies in mouse models showed promising efficacy and a good safety profile in combination with anti-PD-1 mAbs.

A140, Cetuximab Biosimilar

A140 is a monoclonal antibody targeting epidermal growth factor receptor (EGFR) currently being tested in a Phase 3 clinical trial in China. Global rights of development and commercialization are available for licensing or partnership. 

A166, anti-HER2 ADC 

A166 is an antibody-drug conjugate (ADC) targeting HER2, developed with cleavable Val-Cit linker and Auristatin-based payload. Phase 1 clinical trials conducted in US and China showed that it was well tolerated at 4.8 mg/kg. The Disease Control Rate (DCR) reached 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.

SKB264, anti-TROP2 ADC 

SKB264 is a third-generation antibody-drug conjugate (ADC) targeting TROP2. The Phase 1 clinical trial is currently recruiting patients in both the US and China, open to populations with locally advanced /metastatic solid tumors who are refractory to available standard therapies. The investigational product combines the high potency of a topoisomerase I inhibitor, site-specific conjugation, and highly stable chemical linkers. Preclinical in vivo studies of SKB264 showed comparable or better results in the efficacy and safety window compared to sacituzumab govitecan.

A168, Ramucirumab Biosimilar

A140 is a monoclonal antibody targeting VEGFR2 currently being tested in a Phase 1 clinical trial in China. Global rights of development and commercialization are available for licensing or partnership. 

 
 
 
 
 
 
 

©2020 by KLUS Pharma Inc.