China-bound for Merus and Promega

UTRECHT, Netherlands & MADISON, Wis.—Jan. 2 saw Dutch pharma Merus N.V., a clinical-stage immuno-oncology company developing Biclonics—innovative full-length human bispecific antibody therapeutics—announce that it had agreed to grant Betta Pharmaceuticals Co. Ltd. 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 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 Dr. Ton Logtenberg, CEO 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.

Bioclonics bispecific antibody therapeutics are based on the full-length format of immunoglobulin G antibodies and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity.

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 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.

In other China-related news, U.S. company Promega Corp.’s latest microsatellite instability (MSI) technology has been granted an “innovation designation” by the Chinese National Medical Products Administration (NMPA). With this status, the path to become classified as an in-vitro diagnostic will gain “elevated efficiency,” the company says, by having a program coordinator assigned from NMPA and priority status for multiple processes.

“We are excited and honored with this decision from NMPA,” says Frank Fan, senior director of research and China operations at Promega. “Our Promega China team appreciated the emerging and important role our MSI technology can play in healthcare because of its sensitivity and prominent use around the world.”

This version of the Promega MSI platform, trademarked as ProDx in China, is the latest version (MSI 2.0) of the Promega MSI platform. The technology is a PCR-based method for detecting MSI, a form of genomic instability caused by the insertion or deletion of repeating bases called microsatellites during DNA replication and the failure of the mismatch repair system to correct these errors. MSI status is a measure of mismatch-repair deficiency commonly found in solid tumors, providing oncologists, pathologists and patients more information to determine the best treatment path. This new MSI technology is currently being accessed globally in investigator-initiated trials to determine its application in solid tumors beyond colon cancer.