EGGENSTEIN-LEOPOLDSHAFEN, Germany & CHENGDU, China—amcure GmbH and Hinova Pharmaceuticals Inc. report that the companies have entered into an exclusive license agreement for amcure’s AMC303. The agreement will further develop, manufacture and commercialize AMC303 in the Greater China region, which includes mainland China, Hong Kong SAR, Macau SAR and Taiwan.
Under the agreement terms, Hinova will develop, manufacture and commercialize AMC303 for Greater China, with an initial focus on esophageal metastatic squamous cancer. Additional cancer indications and combination therapies will be jointly evaluated by the companies, as well. amcure retains all rights to AMC303 outside of the Greater China region, and will receive an upfront payment, plus development and commercial milestone payments, as well as royalties on net sales.
“This agreement between amcure and Hinova represents an important milestone for the development of our lead candidate AMC303,” stated Dr. Klaus Dembowsky, chief executive officer of amcure. “Hinova’s proven expertise in developing novel oncology treatments, their development capabilities and knowledge of the Chinese market, plus their promising pipeline of research projects, makes them the ideal partner for us.”
The drug candidate AMC303 targets CD44v6, a splice variant of the CD44 family of transmembrane glycoproteins that is involved in many processes relevant to tumor progression, including EMT, cell migration and invasion. By binding CD44v6, AMC303 blocks signaling via three tyrosine kinases — VEGFR-2, c-MET and RON — and strongly inhibits tumor growth and metastasis in squamous tumors.
AMC303 has shown synergistic effects with other anti-tumor agents in animal models, and its novel mode of action has been proven in preclinical and clinical studies. In the first completed Phase 1/1b study in Europe, AMC303 was shown to be safe and well tolerated, with a manageable adverse event profile. It also indicated single-agent anti-tumor activity. These results, together with the unique mode of action, suggest that AMC303 will be a good candidate for combination treatments in squamous cancer.
“We are pleased to partner with amcure to bring AMC303 to the Greater China region for the benefit of patients with esophageal squamous cancer. amcure is a specialist in development of macrocyclic peptides,” pointed out Yuanwei Chen, president and chief executive officer of Hinova Pharmaceuticals. “The collaboration will enrich Hinova’s oncology pipeline and provide more treatment options for the unmet clinical needs in the Chinese market.”