Merus N.V. (MRUS) Reports Strategic Collaboration with Betta Pharmaceuticals to Develop & Commercialize MCLA-129 in China
January 2, 2019 8:02 AM
Merus N.V. (NASDAQ: MRUS) today announced that it has agreed to grant Betta Pharmaceuticals Co Ltd (300558) an exclusive license to develop and commercialize Merus Biclonics® MCLA-129 in China. Merus will retain all rights outside of China.
Under the terms of the agreement, Betta Pharmaceuticals has agreed to be responsible for clinical development and commercialization of MCLA-129 in China. As a key strategic component of the collaboration, Betta will retain a contract manufacturing organization with experience in filing Initial New Drug (IND) applications with U.S. and European regulatory authorities in order to produce clinical trial materials for the Chinese market and rest of world. Betta will facilitate regulatory filings and early stage clinical trial materials supply for potential use by Merus for development of MCLA-129 outside of China.
“This latest collaboration is representative of our long term strategy to unlock Biclonics® platform value beyond our core programs,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “Betta Pharma is a market leader in EGFR inhibitors in China and we anticipate will be a strong partner for Merus in MCLA-129 development.”
MCLA-129 is a Biclonics® binding to EGFR and cMET for the treatment of solid tumors. EGFR is an important oncogenic driver in many cancers; the upregulation of c-MET signaling has been associated with resistance to EGFR inhibition.
MCLA-129 has two distinct mechanisms of action. First, Merus’ Dock & Block® mechanism of action blocks the signaling of EGFR as well as c-MET, with the potential to inhibit tumor growth and survival. Second, MCLA-129 utilizes GlymaxX® antibody-dependent cell-mediated cytotoxicity (ADCC)-enhancement technology designed for greater cell-killing potential. Because the Dock & Block and ADCC mechanism of action is based on the co-expression of EGFR and c-MET, it is expected to have less toxicity compared to agents targeting EGFR alone.
In preclinical studies, MCLA-129 showed a significant reduction in tumor volume for EGFR inhibitor resistant lung cancer models lacking immune cells. Additionally, in cell lines that co-express both EGFR and c-MET, MCLA-129 effectively induced tumor cell lysis at low antibody concentrations.
In addition to receiving an upfront payment, Merus will be eligible to receive payments contingent upon Betta Pharmaceuticals achieving certain specified development and commercial goals in China. Merus will also be eligible to receive tiered royalty payments on sales in China from Betta Pharmaceuticals. Betta Pharmaceuticals will be eligible to receive payments contingent upon Merus achieving certain specified development and commercial goals, and will be eligible to receive tiered royalty payments on sales outside of China from Merus.
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