amcure and Hinova Pharmaceuticals enter into an exclusive license agreement for the development, manufacturing and commercialization of AMC303 in oncology in the Greater China region
- Category: Proteins and Peptides
- Published on Thursday, 12 November 2020 14:22
- Hits: 673
EGGENSTEIN-LEOPOLDSHAFEN, Germany and CHENGDU, China I November 12, 2020 I amcure GmbH, a biopharmaceutical company developing first-in-class cancer therapeutics, and Hinova Pharmaceuticals Inc. (Chengdu, China), one of the fastest growing start-up drug discovery and development companies in China, entered into an exclusive license agreement for AMC303 to further develop, manufacture and commercialize the peptide inhibitor in the Greater China region (Mainland China, Hong Kong SAR, Macau SAR, and Taiwan).
Under the terms of the agreement, Hinova will develop, manufacture and commercialize AMC303 for the Greater China market with an initial focus on esophageal metastatic squamous cancer. China is projected to be the largest market globally for esophageal squamous cancer treatments. Additional cancer indications and combination therapies will be jointly evaluated by the companies. amcure retains all rights to AMC303 outside of the Greater China region. As part of the agreement, amcure will receive an upfront payment, plus development and commercial milestone payments as well as royalties on net sales.
The first-in-class drug candidate AMC303 targets CD44v6, a splice variant of the CD44 family of transmembrane glycoproteins that is involved in many processes relevant for tumor progression, including EMT, cell migration and invasion. By binding CD44v6, AMC303 blocks signaling via the three tyrosine kinases VEGFR-2, c-MET and RON and thus, strongly inhibits tumor growth and metastasis in squamous tumors. In animal models, AMC303 has shown synergistic effects with other anti-tumor agents. This novel mode of action has been proven in preclinical and clinical studies. In the first completed Phase I/Ib study in Europe, AMC303 was shown to be safe and well tolerated with a manageable adverse event profile and indicated single-agent anti-tumor activity. These results together with the unique mode of action suggest AMC303 to be a good candidate for combination treatments in squamous cancer.
"This agreement between amcure and Hinova represents an important milestone for the development of our lead candidate AMC303 and is a strong validation from an innovative China-based biotech company with management experience from renowned international pharmaceutical companies," said Dr. Klaus Dembowsky, CEO 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, make them the ideal partner for us."
"We are pleased to partner with amcure to bring AMC303 to the Greater China region for the benefit of patients with esophageal squamous cancer," noted Yuanwei Chen, President and CEO of Hinova Pharmaceuticals. "amcure is a specialist in development of macrocyclic peptides. The collaboration will enrich Hinova's oncology pipeline and provide more treatment options for the unmet clinical needs in the Chinese market."
amcure GmbH is a spin-off from the Karlsruhe Institute of Technology established in 2012. The company develops peptide-based compounds for the treatment of highly metastatic forms of cancer. amcure’s most advanced development candidate, AMC303, has entered clinical development and has demonstrated through in vivo animal proof-of-concept studies, a high efficacy against different types of epithelial cancers.
Hinova Pharmaceuticals Inc., founded in 2013, is a biopharmaceutical company dedicated to the discovery, development and commercialization of novel and targeted therapeutic agents. Using its proprietary platform technologies, Hinova has developed a portfolio and pipeline addressing unmet medical needs such as cancers and metabolic disorders. The company is advancing HC-1119, an innovative androgen receptor (AR) antagonist, a potential global best-in-class product, in registration trials for metastatic castration resistant prostate cancer (mCRPC) in China and globally. The company is also developing HP501, a novel drug for the treatment of hyperuricemia and gout. HP501 is undergoing Phase II clinical studies in China. Hinova has branch offices in the USA and Australia.