ProBioGen AG and Merus N.V. jointly announced that Merus has signed a commercial multi-product license agreement for ProBioGen’s GlymaxX® ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) enhancement technology. Under the terms of the agreement, Merus has obtained non-exclusive use of GlymaxX® technology for Merus’ Biclonics® pipeline of bispecific cancer antibodies to enhance their ADCC activity. Financial details of the license agreement were not disclosed.
MCLA-158 is the first GlymaxX®-modified ADCC-enhanced bispecific antibody being developed under this commercial license. MCLA-158 is being developed as a potential treatment for colorectal cancer and other types of solid tumors. The compound is designed to bind to cancer stem cells that express EGFRs (epidermal growth factor receptors) and Lgr5 (leucine-rich repeat-containing G protein-coupled receptor 5).
Merus had previously utilized the GlymaxX® Technology for its lead candidate, MCLA-128, which is designed to bind to HER2 and HER3-expressing solid tumors. Merus reported interim clinical data from an ongoing phase 1/2 clinical trial for MCLA-128 in April 2016. These data included a favorable safety profile and early signs of anti-tumor activity in patients with advanced solid tumors.
“We are pleased that Merus is again collaborating with ProBioGen for development of their promising antibody cancer therapy, MCLA-158,” said Dr. Wieland Wolf, CEO of ProBioGen. “Merus’ Biclonics® platform represents an encouraging approach to the killing of cancer cells, and we believe that Biclonics® utilizing our enhanced ADCC technology hold great promise in potentially transforming the cancer treatment paradigm.”
“ProBioGen’s GlymaxX® technology is proven to increase an antibody’s ability to bind to cellular targets, resulting in greater cell-killing proficiency,” said Ton Logtenberg, PhD, Chief Executive Officer of Merus. “We are eager to advance development of MCLA-158 utilizing this exciting technology, and we plan to file an IND with the FDA by the end of next year. At the same time, we are continuing to advance our other GlymaxX®-enabled candidate, MCLA-128 for HER-expressing solid tumors, and we expect to report topline results from our ongoing Phase 1/2 trial in the second half of 2017.”
ProBioGen’s GlymaxX
® technology is based on the heterologous, cytosolic expression of a bacterial enzyme that redirects the de-novo fucose synthesis pathway towards a sugar-nucleotide that cannot be metabolized by the cell. The enzyme mediates the secretion of antibodies with minimized fucose content. The resulting modification of the glycostructure of IgG1 antibodies enhances their binding to natural killer, or NK, cells and thus the ADCC response in potency assays. Consequently, the potency of the modified antibodies, directed against tumor or infected cells, is substantially increased.