Suzhou, February 10 2022- Alphamab Oncology (stock code: 9966.HK) announced the first patient has been dosed in the phase III registration clinical study (KN046-303, ENREACH-PANCREATIC-01) of PD-L1/CTLA-4 bispecific antibody KN046 plus nab-paclitaxel/gemcitabine for the first line treatment of advanced pancreatic ductal adenocarcinoma (PDAC).
The incidence and mortality of pancreatic cancer are increasing worldwide in recent years. According to GLOBOCAN 2020, there were an estimated 125,000 new cases and 122,000 deaths as a result of pancreatic cancer in China in 2020,ranking 8th and 6th respectively in all tumor types. Around 80% pancreatic cancer, when diagnosed, are in late stage. Locally advanced or metastatic stage pancreatic cancer has very poor prognosis, with 5-year survival rate of 3-5%, Currently, there are very limited options for those non operable patients, Immunotherapies, as represented by PD-1 antibodies, failed to show significant therapeutics efficacy. Therefore, there are urgent needs for more effective medicines.
ENREACH-PANCREATIC-01 is a randomized, double-blind, multicenter phase III study in systemic treatment-naïve patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). 408 patients will be randomized 1:1 and receive KN046 (or placebo) plus nab-paclitaxel/gemcitabine. The primary endpoint is overall survival (OS).
Professor Gang Jin from the First Affiliated Hospital of Naval Military Medical University (Changhai Hospital of Shanghai), the leading PI of the study, commented: "Pancreatic cancer is one of the most aggressive cancers, which is difficult to diagnose or treat. Very few effective therapies are available for these patients and the prognosis is extremely poor. KN046，a novel PD-L1/CTLA-4 bispecific antibody, showed promising efficacy in phase II study with 50% ORR and 95.5% DCR respectively. We hope this phase 3 study will make a success in China.”
“Pancreatic cancer is one of the most difficult solid tumors to treat, and many patients lack access to treatment for a variety of reasons, including locally advanced, post-surgical metastases, and metastases at the time of detection, etc. KN046 combined with nab-paclitaxel plus gemcitabine (AG) achieved an encouraging ORR than the historical ORR report of AG regimen in phase 2 study. We look forward to bringing this innovative therapy to more PDAC patients through this Phase III study." Said professor Jianming Xu from the First Medical Center of PLA General Hospital, the co-leading PI.
Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, commented,“Immunotherapy, as represented by PD-1 antibodies, has become an established pillar of cancer treatment. However, it failed to show significant therapeutics efficacy in advanced pancreatic cancer. Thanks to its unique mechanisms of action, KN046 has demonstrated excellent efficacy in early clinical trials. With the initiation of ENREACH-PANCREATIC-01, we look forward to confirming the efficacy and safety of KN046 in advanced pancreatic cancer, bringing better treatment options to patients and improving the long-term survival. With the support from Prof. Jin, Prof. Xu and other PIs participated in this trial, we will continue to identify the full potential of KN046 in pancreatic cancer such as new adjuvant, adjuvant and conversion therapy, making pancreatic cancer manageable and curable in the future.”
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, 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 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. In November 2021, 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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