Ascletis Pharma Inc, an innovative R&D driven biotech, announces that phase IIa data demonstrated that ASC22 (Envafolimab) is safe and well tolerated in chronic hepatitis B (CHB) patients and phase IIb clinical test has been initiated. ASC22 (Envafolimab) may be a first-in-class, subcutaneously administered PD-L1 antibody.
In August this year, the corporate started dosing of first HBV patient in phase IIa single dose escalation clinical test to explore the security and tolerability of ASC22 (Envafolimab) within the CHB patients. the info from phase IIa study indicated that ASC22 (Envafolimab) is safe and well tolerated within the CHB patients receiving nucleos(t)ides because the background therapy.
All adverse effects were grade 1 and no grade 2 or above adverse effects were observed so far .
“I am impressed with the security and tolerability data from the phase IIa study,” said Dr. Guiqiang Wang, “It is exciting that ASC22 (Envafolimab) is entering the phase IIb study because the first PD-L1/PD-1 antibody for CHB indication. i’m looking forward to developing this first-in-class drug candidate with a completely unique mechanism of action as an immunotherapy, which has the potential to clinically cure CHB and offers convenient subcutaneous injections for patients.”
“We are excited about initiation of this phase IIb trial in CHB patients,” said Dr. Jinzi J. Wu, founder, chairman and CEO of Ascletis. “As a first-in-class immunotherapy to clinically cure CHB, ASC22 (Envafolimab) has potential to be a cornerstone therapy in various treatment regimens, including combinations with our in-house developed drug candidates and potentially with drug candidates from other industrial leaders.”
“Therapeutic activity has been demonstrated for Envafolimab (KN035) in multiple oncology indication along side strong safety profile emerging from quite 1000 patient exposure. Although tremendous progress in HBV treatment has been made recently, we are still in uphill battle to cure this disease,” said Dr. Ting Xu, chairman of Alphamab. “Because of its superior safety, convenience and compliance, we are confident that KN035, as a primary SubQ PD-L1 antibody, will offer a viable option for CHB patients.”
As T cell exhaustion in chronic HBV infections is a crucial think about immune tolerance, blocking the PD-1/PD-L1 pathway might be an efficient immunotherapy approach to enhance specific T cell function and cause an efficient clinical cure for CHB. There are 257 million people worldwide, including 70 million people in China, infected by HBV.
ASC22, also referred to as KN035 or Envafolimab, exclusively licensed from Alphamab by Ascletis for all viral indications, may be a PD-L1 single domain antibody Fc fusion and has the benefits of injection and good stability at temperature . These would be of great value to enhance patients’ compliance and quality of life. Ascletis and Suzhou Alphamab Co., Ltd. announced on January 14, 2019 the strategic collaboration and contract for anti-PD-L1 to treat hepatitis B and other viral diseases.
Envafolimab has been enrolled in additional than 1,000 patients and has shown good safety and efficacy in multiple tumor indications. Alphamab has submitted a replacement drug application for MSI-H solid tumors.