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Anticancer stem cell therapeutics
BASEL, Switzerland—Lonza, a prominent manufacturer of biologics, and OncoMed Pharmaceuticals Inc., a clinical-stage biopharmaceutical company dedicated to improving cancer treatment, have inked an agreement for the development and manufacture of OncoMed's pipeline of anticancer stem cell therapeutics.
Under the agreement, Lonza will produce material at its mammalian manufacturing facility in Slough, United Kingdom. The multiproduct license provides OncoMed with access to Lonza's GS Gene Expression System and Version 8 manufacturing platform.
Lonza's proprietary GS Gene Expression System uses a robust viral promoter and selection via glutamine metabolism to provide rapid development of high-yielding and stable mammalian cell lines. Lonza claims that the system is used by more than 100 global pharmaceutical and biotechnology companies and is "familiar to all authorities."
Ten products have been approved that use the GS System, including Zenapax (Roche), Synagis (Medimmune) and Solaris (Alexion). Lonza has itself created hundreds of cell lines using the GS System, many of which have been grown at large-scale and produced product for use in clinical trials and in-market supply.
Other GS System users have accumulated experience with a diverse range of products where high yields have been achieved, the company says. Many investigators use the GS System, not only to develop a manufacturing process, but as a tool to create recombinant proteins for biological studies.
"We are pleased to continue to deepen our relationship with Lonza," says Michael Mulkerrin, vice president of process development at OncoMed. "Over the years, Lonza's expertise has been invaluable in helping us rapidly advance our growing anticancer stem cell pipeline."
OncoMed's pipeline is focused on the development of novel monoclonal antibodies that target cancer stem cells (CSCs), which are the subpopulation of cells in a tumor responsible for driving growth and metastasis of the tumor. CSCs, also known as tumor-initiating cells, exhibit certain properties which include the capacity to divide and give rise to new CSCs, as well as the capacity to differentiate or change into the other cells that form the bulk of the tumor. Common cancer drugs target bulk tumor cells but have limited impact on CSCs, thereby providing a path for recurrence of the tumor.
OncoMed's product candidates target CSCs by blocking self-renewal and driving differentiation of CSCs toward a non-tumorigenic state, and also impact bulk tumor cells. OncoMed believes that its product candidates are distinct from the current generations of chemotherapies and targeted therapies, and have the potential to significantly impact cancer treatment and the clinical outcome of patients with cancer.
Privately held OncoMed has advanced five anticancer therapeutics into clinical development—anti-DLL4 (demcizumab, OMP-21M18), anti-Notch2/3 (OMP 59R5), anti-Fzd7 (OMP-18R5), anti-Notch1 (OMP-52M51) and Fzd8-Fc (OMP-54F28)—which target key cancer stem cell signaling pathways Notch and Wnt. In addition, OncoMed's pipeline includes several novel preclinical product candidates targeting multiple validated cancer stem cell pathways, including the RSPO-LGR pathway. OncoMed has formed additional strategic alliances with Bayer Pharma AG and GlaxoSmithKline PLC.
The process development and manufacturing collaboration with Lonza includes, but is not limited to, the first four of the therapeutics named above, plus anti-DLL4/VEGF bi-specific, which is currently in preclinical testing.
"OncoMed's pipeline is a great example of how emerging biotech companies are successfully innovating in the oncology field," says Dr. Stephan Kutzer, chief operating officer of 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."