Suzhou, April 28, 2022 - Alphamab Oncology (stock code: 9966.HK) announced posters to highlight a phase III pivotal clinical study of KN046 (PD-L1/CTLA-4 bispecific antibody) combined with nab-paclitaxel and gemcitabine in patients with advanced pancreatic cancer, and a phase II clinical study of KN026 (anti-HER2 bispecific antibody) in advanced GC/GEJ patients with HER2 expression, will be presented at the 2022 American Society of Clinical Oncology Annual Meeting (2022 ASCO) to be held from June 3th to June 7th.
Title: A Multicenter, Randomized, Double-Blind Phase III Clinical Study to Evaluate the Efficacy and Safety of KN046 Combined with Nab-Paclitaxel and Gemcitabine Versus Placebo Combined with Nab-Paclitaxel and Gemcitabine in Patients with Advanced Pancreatic Cancer (ENREACH-PDAC-01)
Abstract Number: TPS4189
Presentation Format: Poster
First author: Professor Gang Jin, Changhai Hospital of Shanghai
Poster released time: June 4, 2022, at 8:00-11:00 AM CDT
KN046 is a PD-L1/ CTLA-4 bispecific antibody developed by Alphamab Oncology. In an investigator-initiated Phase II clinical study, KN046 combined nab-paclitaxel and gemcitabine as the first-line treatment of PDAC achieved more than doubled ORR than historical AG regimen. the IND application of a phase 3 registration study (ENREACH-PDAC-01) of KN046 plus nab-paclitaxel/gemcitabine for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) was approved by the Center for Drug Evaluation (CDE) of the NMPA In November 2021. The first patient was dosed in February 2022.
Title: A phase II study evaluating KN026 monotherapy in patients with previously treated, advanced HER2-expressing gastric or gastroesophageal junction cancers
Abstract Number: 4040
Presentation Format: Poster
First author: Professor Jianming Xu, Fifth Medical Center of PLA General Hospital
Poster released time: June 4, 2022, at 8:00-11:00 AM CDT
KN026 is a HER2 bispecific antibody invented by Alphamab Oncology, and codeveloped with CSPC in the indications of breast cancer and GC/GEJ in mainland China. Data from the Phase II clinical study of KN026, published at ASCO in 2021, demonstrated favorable safety and promising efficacy in Chinese HER2 overexpressing GC/GEJ patients, pretreated either with or without anti HER2 treatments.
KN026-202 is a single-arm, open-label, multi-center, phase II clinical study, led by Professor Xu Jianming from the Chinese People's Liberation Army General Hospital, to evaluate the safety and efficacy of KN026 as the late-line treatment of HER2-expressing GC/GEJ.
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 KN026
KN026 is an anti-HER2 bispecific antibody invented by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. KN026 has demonstrated potentially equivalent efficacy compared with Trastuzumab and Pertuzumab in combination, and was superior to either single agent, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines.
KN026 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has good safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.
In August 2021, the company entered an agreement with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China. According to the terms of the agreement, JMT-Bio will obtain the exclusive license rights of KN026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (GC/GEJ) in Mainland China (excluding Hong Kong, Macau and Taiwan).
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.
Alphamab Oncology Forward-Looking Statements
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