Anti-PD-L1 candidate collaboration aimed at Hepatitis B

Ascletis and Alphamab announce strategic collaboration and licensing agreement for anti-PD-L1 to treat Hepatitis B and other viral diseases

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HANGZHOU, SHAOXING and SUZHOU, China—Ascletis Pharma Inc. and Suzhou Alphamab Co., Ltd. announced today that Ascletis’ subsidiary and Alphamab have entered into a strategic collaboration and exclusive licensing agreement for anti-PD-L1 KN035 to treat hepatitis B and other viral diseases in Greater China.
“There is a lack of new innovative drugs that can lead to effective clinical cures for chronic Hepatitis B. As T cell exhaustion in 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 a clinical cure for chronic Hepatitis B,” said Professor Guiqiang Wang, MD, 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.
“PD-L1 antibody KN035 has been investigated in several global clinical trials in cancer patients, including pivotal cancer trials in China. These clinical trials provided invaluable human safety data for KN035. The subcutaneous route of administration for PD-L1 antibody ASC22 (KN035) provides a differentiated approach, which can increase patient compliance in clinical practice. I am very pleased that innovative Chinese biotechs are taking the lead in clinical studies of PD-L1 antibody for chronic Hepatitis B. Immunotherapy with PD-L1 antibody approach may lead to a significant breakthrough towards a clinical cure for chronic Hepatitis B.”
KN035, as a PD-L1 single domain antibody Fc fusion, 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. To date, KN035 has been studied in multiple clinical trials, with more than 500 patients exposed in U.S, China and Japan. KN035 has entered into two pivotal trials and demonstrated good safety profile and encouraging preliminary efficacy.
Jinzi J. Wu, PhD, Founder, Chairman and CEO at Ascletis noted, “Alphamab is a leading biopharmaceutical company and we’re excited to partner with them. Hepatitis B remains a highly unmet medical need in China and globally. Through the strategic collaboration with Alphamab, we have the opportunity to develop ASC22 (KN035) as a potential first-in-class HBV immunotherapy and offer a clinical cure for Hepatitis B patients. Following the recent collaboration with Roche on Pegasys, this collaboration marks another major step forward for Ascletis to expand its pipeline and platform with biological drugs and to fulfill its commitment to developing innovative Hepatitis B therapies.”
Under the terms of the agreement, Ascletis has an exclusive license from Alphamab to develop and commercialize ASC22 (KN035) for viral diseases, including hepatitis B in Greater China. Ascletis will pay Alphamab a upfront cash payment, and Alphamab will be eligible to receive payments in development and commercial milestones, as well as tiered royalties from the mid-teens to around twenty percent on future sales of ASC22. Alphamab will manufacture ASC22 for clinical trials and commercialization of viral indications in Greater China for Ascletis. For ASC22 in viral indications worldwide outside Greater China, Ascletis will be eligible to share certain economics such as upfront, milestone payments and royalties, depending on the development and regulatory status of ASC22 inside Greater China.
“We are pleased to enter this strategic collaboration with Ascletis, a pioneer in innovative antiviral drug development,” mentioned Dr. Ting Xu, Chairman of Alphamab. “Alphamab has been working on HBV for several years, we are excited to see KN035 to move into clinical development for Hepatitis B. With Ascletis’ demonstrated clinical development expertise in liver infectious diseases, we are confident that KN035 immunotherapy may lead to an effective clinical cure for Hepatitis B. With KN035 collaboration as a good starting point, Alphamab is looking forward to a much broader and long-term partnership with Ascletis in viral and liver diseases.”

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