Alphamab Oncology Announces First Patient Dosed in the Pivotal Clinical Study of KN046 for the Treatment of PD-(L)1 Refractory Advanced NSCLC

Alphamab Oncology (stock code: 9966.HK) announced, a pivotal clinical study of PD-L1/CTLA-4 bispecific antibody KN046 in China (ENREACH-LUNG-02) recently completed the first drug administration.

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.

About Alphamab Oncology

Alphamab Oncology is focusing on innovation, production and commercialization of anti-tumor drugs. On December 12, 2019, the Company was listed in the mainboard of Hong Kong, S.A.R., China Stock Exchange with stock code 9966.

Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a Covid-19 bispecific antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, Japan and Australia. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA).

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.

Source: Alphamab Oncology