First Patient Dosed in Phase II Study of KN046 Combined with Axitinib for the First Line Treatment of Advanced Non-Small Cell Lung Cancer

SUZHOU,China,Aug. 9,2022 -- Alphamab Oncology (stock code: 9966.HK) announced the first patient has been dosed in the phase II clinical study (KN046-209) of PD-L1/CTLA-4 bispecific antibody KN046 plus Axitinib for the first line treatment of advanced Non-Small Cell Lung Cancer (NSCLC).

KN046-209 is an open-label,multi-center,Phase 2 study in subjects with treatment-naïve locally advanced (unresectable and unable to receive radical chemoradiotherapy) or metastatic PD-L1-positive non-small cell lung cancer (NSCLC) who have never received systemic therapy. Evaluation of the efficacy,safety and tolerabilityof KN046 in combination with Axitinib. The study targets to enroll 54 patients,with objective response rate (ORR) as the primary endpoint.

Professor Zhang Li from Sun Yat-Sen University Cancer Hospital,the leading PI of the study,commented: "Lung cancer is the most threatening malignant tumor to the health and life of the population,although immunotherapy combined chemotherapy have made progress in the treatment of advanced non-small cell lung cancer. However,there is still huge unmet medical needs for patients who cannot be intolerant of chemotherapy. Investigating novel combination therapies for advanced NSCLC has significant implications. KN046 is a novel PD-L1 /CTLA-4 bispecific antibody developed by Jiangsu Alphamab. In a Phase II clinical study of KN046 combined with platinum doublet chemotherapy as the first-line treatment of NSCLC,the confirmed Objective Response Rate (ORR) was 50.6% and the Disease Control Rate (DCR) was 87.7%. OS rate at 12 and 15 months were both 74.9%.The median PFS of patients(sq NSCLC) with PD-L1≥1% reached 10.8 months. We believe that KN046 combined with the anti-angiogenic drug Axitinib also has well-acceptable safety and anti-tumor potential,bringing a new first-line 'chemotherapy-free' treatment strategy to advanced NSCLC patients."

About KN046

KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism - CTLA-4 fused with 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,the US and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab Oncology has received FDA clearance to enter phase II trial 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,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.

Visit http://www.alphamabonc.comfor more information.