October 11, 2020 - Alphamab Oncology (stock code: 9966.HK) announced that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Jiangsu Alphamab”), a wholly-owned subsidiary of the company, hosted an Investigator Meeting in Beijing about “A Phase II Study to Evaluation of the efficacy, safety and tolerability of KN026 (a recombinant humanized anti-HER2 bispecific antibody) in combination with KN046 (a recombinant humanized PD-L1/CTLA-4 bispecific antibody) for HER2-positive solid tumors” (clinical trial No.: SEARCH-01/KN026-203). Over 100 investigators, clinical and pathology researchers from more than 30 research institutions across the country participated in the meeting along with Alphamab Oncology team, partners and other related parties.
KN026 and KN046 are innovative bispecific antibody biologics independently developed by Alphamab Oncology. Both biologics have shown favorable safety, tolerability and anti-tumor efficacy in respective monotherapy clinical trials. The phase I clinical trial of the combination therapy initiated in 2019 has shown preliminary promising efficacy results in heavily pre-treated patients including patients who failed HER2-targeted therapy and immune therapy. Patients tolerated well to the combination. The latest clinical data will be announced in the 35th Anniversary Annual Meeting of the Society for Immunotherapy of Cancer’s (SITC) in 2020. SEARCH-01 trial is an open label, multi-center, phase II platform clinical study, with indications including but not limited to HER2-positive breast cancer, gastric and gastroesophageal junction cancer, esophageal cancer, colorectal cancer, pancreatic cancer, biliary tract cancer, ovarian cancer, endometrial cancer, urothelial cancer and lung cancer, etc. The study is led by the Primary Investigator Professor Lin Shen from Beijing Cancer Hospital.
Professor Lin Shen from Beijing Cancer Hospital commented “I am very pleased to see that Alphamab Oncology has developed KN026 and KN046 and other internationally leading innovative drugs with its determination to forge ahead as an outstanding innovative biopharmaceutical company in the field of immune oncology in China. The exploratory study of the combination therapy of KN026 and KN046 is an internationally advanced clinical study of multiple tumors, which reflects the unique charm of multidisciplinary cooperation and model breakthroughs. We believed that this new treatment will lead the clinical research direction of HER2-positive tumors globally, demonstrate the original research capabilities of Chinese pharmaceutical companies, and the innovation of the multidisciplinary clinical research collaboration model of the Chinese medical team.
Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology, commented, “Based on the unique molecular design and synergistic mechanism of KN026 and KN046, we initiated the clinical trial of the combination therapy last year and achieved exciting preliminary efficacy results. We look forward to making a breakthrough in the treatment of HER2-positive solid tumors worldwide and providing patients with an effective and safe treatment with the combination therapy of these two innovative antibodies.”
Ms. Yang Liu, Executive Director and Vice President of Corporate Operations of Alphamab Oncology commented, “I want to thank Professor Lin Shen and experts for your participation and support. The goal of SEARCH-01 is to set a new standard for the treatment of HER2-positive solid tumors through the global registration of novel-novel combination of KN026 and KN046. We look forward to the successful completion of this study with the collective efforts of everyone, obtaining accelerated approval for marketing in China and the United States, and laying a solid foundation to further clinical development in the first-line and neoadjuvant therapy.
About KN026
KN026 is an anti-HER2 bispecific antibody developed 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. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab and Pertuzumab alone or in combination, 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 excellent safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.
About KN046
KN046 is the world's first recombinant humanized PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a proprietary CTLA-4 domain antibody with a significantly improved safety profile; a bispecific antibody fused with PD-L1 antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg clearing function. The preclinical and clinical trial results of KN046 have shown promising efficacy and significantly reduced toxicity to human peripheral system, with the potential to become a breakthrough cancer immunotherapy.
There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, TNBC, ESCC, HCC and pancreatic cancer in Australia and China. The results of these clinical trials have shown a preliminary profile of good safety and promising efficacy. Alphamab has received FDA clearance to enter phase Ⅱ trial of KN046 based on the clinical results in China and Australia. The phase Ⅲ clinical trials to evaluate efficacy and safety of combination therapy of KN046 and platinum-based chemotherapy in patients with stage IV squamous non-small cell lung cancer have started in China.
About Alphamab Oncology
Alphamab Oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. On December 12, 2019, the Company was listed in the mainboard of Hong Kong 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 eight tumor monoclonal antibodies and bispecific antibodies and a Covid-19 multifunctional antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, and Japan.
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 an 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.com for more information.
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