Suzhou, February 21 2022 - Alphamab Oncology (stock code: 9966.HK) announced the IND application to conduct a Phase II Clinical Trial (KN046-209) of its proprietary PD-L1/CTLA-4 bispecific antibody KN046 combined with Pfizer's axitinib was approved by the Center for Drug Evaluation (CDE) of NMPA.
KN046-209 is a multicenter, open-label Phase II clinical study to evaluate the efficacy, safety and tolerability of KN046 combined with axitinib in the treatment of advanced NSCLC. Systemic treatment-naïve patients with advanced or metastatic NSCLC who are PD-L1 positive (TPS ≥ 1%) will be enrolled.
KN046 is a tetravalent bispecific antibody that simultaneously recognizes PD-L1 and CTLA-4. It can more effectively prime and activate T cells. Data from the phase II clinical study of KN046 combined with platinum doublet chemotherapy for the 1st line treatment of patients with advanced NSCLC were published at ASCO 2021: the objective response rate (ORR) was 50.6%, the disease control rate (DCR) was 87.7%. and the OS rate at 12 and 15 months were both 74.9%; similar OS curves have been observed in PD-L1 ≥1% and PD-L1<1% patients; the median PFS was 10.8 months for PD-L1 ≥1% squamous NSCLC patients.
Axitinib is a novel kinase inhibitor that is designed to inhibit tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2 and VEGFR-3); these receptors can influence tumor growth, vascular angiogenesis and progression of cancer.
Lung cancer is the most fatal malignant tumor both in China and worldwide. According to GLOBOCAN 2020, lung cancer accounts for over 18% of all cancer-related deaths worldwide, more than any other cancer type. In China, there are 820,000 new cases and 710,000 deaths each year, both rates ranked first in all tumor types. Immunotherapy combined with chemotherapy have become the first line standard of care in advanced NSCLC. However, more than 70% of patients progressed on first-line anti-PD-(L)1 treatment. There is no effective option for PD-(L)1 refractory NSCLC patients, thus there is a large unmet medical need. Many clinical trials showed an improved anti-cancer efficacy and prolonged survival following the addition of anti-angiogenic agents to ICIs. We hope this innovative combo therapy will afford a new option to address this unmet need.
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 includes fifteen anticancer monoclonal antibodies and bispecific antibodies and a Covid-19 bispecific antibody. 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.
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