september 26, 2020 - alphamab oncology (stock code: 9966 hk) announced that jiangsu alphamab biopharmaceuticals co., ltd. (“jiangsu alphamab”), a wholly-owned subsidiary of the company, has achieved the first patient dosing in enreach-lung-01, a pivotal phase ⅲ clinical trial of kn046, a recombinant humanized pd-l1/ctla-4 bispecific antibody invented and developed by alphamab (study code: enreach-lung-01).
enreach-lung-01 is a multi-center, randomized, double-blind, placebo-controlled phase ⅲ clinical trial to evaluate the efficacy and safety of kn046 in combination with the platinum-based chemotherapy in patients with advanced unresectable or metastatic squamous non-small cell lung cancer. it is being conducted at about 60 clinical sites and planning to enroll about 500 patients. the primary endpoint is the progression-free survival (pfs) evaluated by irc according to the recist 1.1 criteria and secondary endpoints include overall survival and pfs2. enreach-lung-01 is based on the results of a phase ⅱ clinical study of kn046 in combination with chemotherapy for the treatment of non-small cell lung cancer. the detailed data of the study will be published at an academic conference in 2021.
lung cancer has the highest incidence rate and is the most common cause of cancer related death in the world . approximately 750,000 new lung cancer cases were diagnosed in china each year. non-small cell lung cancer (nsclc) accounts for about 85% of all lung cancers, 30% of which are squamous-cell carcinoma, and about half of patients are already in the advanced stage of the disease at the initial diagnosis. immunotherapy-based combination is a breakthrough in the treatment of lung cancer in recent years. the long-term survival benefits of dual immune checkpoint blockades have obvious tailing effects. patients whose tumors have low pd-l1 expression also experience favorable efficacy, but the toxicity to some extent limits the clinical application of dual immune checkpoint blockades in addition to other standard of care therapies. therefore, to further improve patients’ survival outcome, it is an unmet clinical need to develop bispecific immunotherapy antibody with a more tolerable safety profile in combination with other standard of care therapies.
professor zhou caicun, director of oncology department from shanghai pulmonary hospital commented, “lung cancer is a high-incidence tumor that poses a major threat to global public health. although multiple treatment options have been available in recent years, patients at advanced disease stages urgently need better treatment options. considering the good progression-free survival data of kn046 in the early phase clinical trial in squamous nsclc, we expect that kn046, an innovative bispecific antibody invented and developed by the domestic company, will significantly benefit patients with advanced lung cancer. i hope that all participating units will work together to promote the implementation of this phase ⅲ study.”
dr. ting xu, the founder and chairman/ceo of alphamab oncology, commented,” kn046 has shown great safety and efficacy in multiple tumor indications among more than 500 patients in the early clinical studies. these clinical results confirmed the unique mechanism and advantages of kn046. we hope that we can establish kn046's leading position in the new generation of cancer immunotherapy in the highly competitive battleground of squamous non-small cell lung cancer with enreach-lung-01, and bring long-term survival benefits to patients. we want to thank professor zhou caicun and participating units for their support. we hope this phase ⅲ trial will establish a new standard of care for the first-line treatment of lung cancer, and lay a solid foundation for the marketing and global registration of kn046, as well as subsequent development and commercialization.”
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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