On October 29, 2021 Alphamab Oncology (stock code: 9966.HK) reported, a pivotal clinical study of PD-L1/CTLA-4 bispecific antibody KN046 in China (ENREACH-LUNG-02) recently completed the first drug administration (Press release, Alphamab, OCT 29, 2021, View Source [SID1234592178]).
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ENREACH-LUNG-02 is a multi-center, open-label, randomized-controlled phase II/III clinical study. Phase III study is planned to be carried out in about 50 research centers, recruiting about 486 patients, with OS and PFS as co-primary endpoints. To evaluate the efficacy of KN046 combined with lenvatinib versus docetaxel in patients with advanced NSCLC who have progressed on anti-PD-(L)1 treatment.
The principal investigator Professor Caicun Zhou, Director of the Department of Oncology from Shanghai Pulmonary Hospital Affiliated to Tongji University, commented, "In recent years, major progress has been made in lung cancer treatment, especially immunotherapies have brought significant clinical benefits to patients. However, there is still no effective option for PD-(L)1 refractory NSCLC patients. Through ENREACH-LUNG-02 study, we look forward to bringing new treatment options to these patients with huge unmet needs."
About KN046
KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism CTLA-4 domain fused with a PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg（suppress tumor immunity） clearing function.
There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, thymic cancer, pancreatic cancer, HCC, ESCC and TNBC in Australia and China. The results of these clinical trials have shown promising data in terms of survival for patients. Alphamab Oncology has received FDA clearance to enter later stage trials of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA’s orphan drug designation for thymic epithelial tumor in September 2020. Four pivotal clinical trials are currently being conducted.