SUZHOU, China, June 14, 2022 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that the first patient was dosed in a Phase I clinical study (KN052-CHN-001) of KN052, its proprietary PD-L1/OX40 bispecific antibody, in patients with advanced solid tumors in China.
With the development of immunotherapy and further understanding of tumor pathogenesis, cancer therapy has entered a new era, among which PD-(L)1 inhibitors have become a star product. However, PD-1/PD-L1 inhibitors did not bring satisfied response rate when used as monotherapy, and innovative treatment regimens are expected. KN052 is the world's first PD-L1/OX40 bispecific antibody entering first-in-human clinical study. It can effectively reverse tumor induced immune inhibition by blocking the PD-L1/PD-1 pathway and promote the immune response by activating OX40. In preclinical studies, KN052 showed significantly stronger activity than either single antibody or in combination.
KN052-CHN-001 is a Phase I clinical study in Chinese patients with advanced solid tumors to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN052, and to determine the recommended dose for further development.
Professor Zhengbo Song from Zhejiang Cancer Hospital, the principal investigator, commented, "OX40 is a member of the TNF receptor superfamily. The mechanism of action of OX40 agonism can result in conditions favorable to immune responses, where activated T cells increase in number, while the induction of Tregs is suppressed in the periphery. The combination of OX40 and an immune checkpoint inhibitor is expected to enhance the efficacy. We look forward to exploring the safety and preliminary efficacy of KN052 in this clinical study."
About KN052
KN052 is a PD-L1/OX40 bispecific antibody developed in house by Alphamab Oncology. It can simultaneously bind PD-L1 and OX40, effectively blocking the PD-L1/PD-1 pathway and activating OX40. In February 2022, the IND for KN052 was approved by the National Medical Products Administration (NMPA) to initiate Phase I clinical trials in China.
About Alphamab Oncology
Alphamab Oncology is focusing on innovation, including discovery, development, production and commercialization of anti-tumor drugs. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.
Alphamab has a fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Five products have advanced into phase I-III clinical trials in China, the United States, Japan and Australia and in November 2021, one of these products, the unique PD-L1 antibody for subcutaneous administration, Envafolimab, received marketing authorization from the Chinese National Medical Products Administration (NMPA) for the treatment of previously treated MSI-H/dMMR advanced solid tumors.
The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA's cGMP standards and a complete quality system which has passed the on-site inspection of a European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.
