Lonza and OncoMed Pharmaceuticals signed a process development and manufacturing collaboration for the latter’s anticancer monoclonal antibody candidates, and a multiproduct licensing deal that will give OncoMed a license to Lonza’s GS Gene Expression System™, and Version 8 media and feeds manufacturing platform.
Under terms of the contract Lonza will carry out process development and production of OncoMed’s cancer stem cell-targeting monoclonal antibody portfolio. This currently includes the early clinical-stage candidates demcizumab (an anti-DLL4 mAb designated OMP-21M18), anti-Notch 2/3 (OMP-59R5), anti-Fzd7 (OMP-18R5), Anti-Notch1 (OMP-52M51), and a preclinical-stage anti-DLL4/VEBF Bi-specific antibody. “OncoMed’s pipeline is a great example of how emerging biotech companies are successfully innovating in the oncology field,” comments Stephan Kutzer, Ph.D., COO at Lonza custom manufacturing. “This multiproduct contract and GS license agreement demonstrate Lonza’s ability to offer world-class expression platforms in combination with secure manufacturing capabilities for the complete product lifecycle.”
OncoMed’s anti-Notch 2/3 candidate OMP-59R5 started in a Phase Ib/II clinical trial earlier this month, in combination with gemcitabine as first-line therapy for advanced pancreatic cancer. Also this month FDA granted IND approval for the firm to start clinical trials with the anti-Notch1 antibody OMP-52M51. OncoMed plans to initiate the first trial in hematologic cancers, and will file an additional IND application later this year to start trials with the antibody in solid tumors.
The clinical milestones triggered an $8 million payment from GlaxoSmithKline, OncoMed’s partner for the Notch pathway program. Under terms of the alliance, originally signed back in 2007, GSK retains an option through the end of certain Phase II clinical trials to obtain an exclusive license to OMP-59R5, and an option through the end of certain Phase I or certain Phase II clinical trials to obtain an exclusive license to OMP-52M51.