Suzhou Alphamab Co., Ltd (“Suzhou Alphamab”) is exploring safety and tolerability of KN035 (Envafolimab) in chronic hepatitis B (CHB) patients, by co-development with Ascletis Pharma Inc. Phase IIa data demonstrated that Envafolimab is safe and well tolerated in CHB patients and Phase IIb clinical trial has been initiated. (ClinicalTrials.gov Identifier: NCT04465890).
In August this year, first dosing of HBV patient in Phase IIa single dose escalation clinical trial is started to explore the safety and tolerability of Envafolimab in the CHB patients. The data from Phase IIa study indicated that Envafolimab is safe and well tolerated in the CHB patients receiving nucleos(t)ides as the background therapy. All adverse effects were grade 1 and no grade 2 or above adverse effects were observed to date. Based on such data, the multi-dose phase IIb study initiation meeting of Envafolimab was held and chaired by Professor Guiqiang Wang, MD, Principal Investigator of the Study and 11th President of Infectious Diseases Society of China, Vice-President of Chinese Society of Physicians for Infectious Diseases and Director of Centre for Liver Diseases at Peking University First Hospital.
“I am impressed with the safety and tolerability data from the Phase IIa study,” said Dr. Guiqiang Wang, “It is exciting that Envafolimab is entering the Phase IIb study as the first PD-L1/PD-1 antibody for CHB indication. I am looking forward to developing this first-in-class drug candidate with a novel mechanism of action as an immunotherapy, which has the potential to clinically cure CHB and offers convenient subcutaneous injections for patients.”
As T cell exhaustion in chronic HBV infections is an important factor in immune tolerance, blocking the PD-1/PD-L1 pathway could be an effective immunotherapy approach to improve specific T cell function and lead to an effective clinical cure for CHB. There are 257 million people worldwide, including 70 million people in China, infected by HBV.
About KN035 (Envafolimab)
Envafolimab, known as KN035 is a PD-L1 single domain antibody Fc fusion and has the advantages of subcutaneous injection and good stability at room temperature. These would be of great value to improve patients' compliance and quality of life. Envafolimab has been enrolled in more than 1,000 patients and has shown good safety and efficacy in multiple tumor indications. Alphamab has submitted a new drug application for MSI-H solid tumors.