Patricia F. Fitzpatrick Dimond Ph.D. Technical Editor of Clinical OMICs President of BioInsight Communications
A few pioneering contract manufacturing organizations are testing the drug development waters.
In what seems a logical business move but perhaps not a good trust-engendering move, a handful of biologics contract manufacturers are applying what they have learned making other companies’ biopharma products to developing their own proprietary pipelines.
Some CMOs, it turns out, have been using their manufacturing capacity not only to produce revenues but also to accumulate and polish the know-how to develop their own proprietary drugs.
One example is Biovest International, which is developing Biovax ID, an autologous therapeutic cancer vaccine for non-Hodgkin lymphoma. Biovest, a contract manufacturer, was selected in the early 90s by the NCI to develop the vaccine under a CRADA.
To date, Biovest and the NCI have completed three clinical trials including a Phase III study establishing the therapeutic vaccine’s safety and efficacy for the treatment of indolent follicular non-Hodgkin lymphoma.
On June 20 of this year, Biovest announced that it had submitted notification to the European Medicines Agency informing the agency of its intent to file a Marketing Authorization Application (MAA) seeking approval in the European Union for BiovaxID. Upon approval, BiovaxID would be the first cancer vaccine available in Europe for lymphoma patients.
According to Douglas W. Calder, vp, strategic planning & capital markets, “Biovest’s founding core competency is in providing GMP cell culture biomanufacturing solutions for virtually every kind of protein product including therapeutics and diagnostics.”
“With over three decades of experience in contract manufacturing, we’ve managed every aspect of the life cycle for protein drug production for thousands of clients, and this business unit has provided Biovest with not only a source of revenues to help support our own proprietary cancer vaccine development, but more importantly with what we believe are the most innovative cell culture instruments and production techniques for the manufacture of vaccines and cell-based products, including autologous personalized medicines.”
Another innovative CMO is South Korea’s Celltrion, which currently has several biosimilars in development, including a CD-PO6 anti-her2 neu antibody, a CT-P13 (Infliximab) that neutralizes TNDF-α, and its anti-CD20 antibody, CT-P10.
But besides the development and manufacturing of these biosimilars, Celltrion is advancing its own biopharmaceutical development using, it says, accumulated R&D capabilities and technologies gained through co-development agreements with pharmaceutical and biotechnology companies.
Celltrion is focused on developing several of its own drugs, including CT-P27, an antiviral intended to act against pandemic and seasonal influenza infections. The company says the product, which contains two mAbs, CT-P22 and CT-P23, has shown antiviral activity against major influenza viruses including H1N1, H3N2, and H5N1.
Also under development are the company’s CT-P19, a therapeutic monoclonal antibody that is being co-developed with the U.S. Department of Health and Human Services, and its CT-PO4, a preclinical development-stage anti-GP88 mAb intended to treat breast cancer being co-developed with A&G Pharmaceuticals.
The agreement provides Celltrion exclusive commercialization rights in Asia, including Japan, to anti-GP88 oncology therapies. In return, A&G will receive clinical materials and milestones worth up to $6.4 million as well as royalties on any future anti-GP88 cancer therapeutic product sales by Celltrion in Asia. A&G retains all commercialization rights to its anti-GP88 monoclonal antibody in North America, Europe, and the rest of the world.
It will be interesting to see, in the long run, if any new biopharmaceutical companies will morph from CMOs implementing a business model in which manufacturing revenues drive the development of their own drugs.
Patricia F. Dimond, Ph.D. ([email protected]), is a principal at BioInsight Consulting.