CMC Biologics and OncoSynergy have announced that the two companies entered into an agreement for cell-line development, process development, analytical development and manufacturing of non-GMP material to enable early toxicology testing and cGMP material for IND enabling toxicology studies and Phase I clinical trials.
This work will advance OncoSynergy’s OS2966 monoclonal antibody program based on its “Targeted Synergy” approach - a transformative strategy allowing broad inhibition of multiple
fundamental cancer growth mechanisms with a single drug.
“We look forward to helping advance OncoSynergy’s OS2966 drug platform targeting cancers resistant to currently available therapies,” said Gustavo Mahler, Global Chief Operations Officer
of CMC Biologics. “This contract highlights CMC Biologics’ proven and trusted platform for monoclonal antibody development and manufacturing.”
The project will be executed by CMC Biologics at its Copenhagen development and manufacturing facility. OncoSynergy EU SAS in France will lead the project.
"We are impressed with CMC Biologics’ experience and technical competency in biopharmaceutical development and cGMP manufacturing," said OncoSynergy Co-Founder and CEO, Shawn Carbonell, MD, PhD.
Carbonell continued, “Choosing a partner who can provide a complete solution - from expression of the sequence of interest, to providing material suitable for clinical trials - was a critical decision as we advance our lead candidate. They have also shown flexibility to accommodate our unique program needs as a virtual startup company.”