Morphotek has signed a deal with Danish contract manufacturer CMC Biopharmaceuticals for the development, clinical supply and regulatory documentation support of its new therapeutic antibody for advanced melanoma and other cancers. The drug - MORAb-028 - is a human IgM monoclonal antibody that specifically recognises a cell surface antigen over-expressed on a significant fraction of metastatic melanoma, brain cancers and non-small cell lung carcinoma.
Historically, IgM monoclonal antibodies have been underrepresented in human therapeutic development due to production difficulties and other manufacturing constraints, said Morphotek. MORAb-028 is being prepared to enter clinical triasl in 2008 and represents a growing list of therapeutic monoclonal antibodies being developed by US-based Morphotek for the treatment of cancer.
Also in the contract biomanufacturing arena, Cobra Biomanufacturing has announced that a project it is leading has just received a £1.1m (€814,000) grant from the UK government. The scheme - which aims at evaluating the application of its proprietary vaccine technology - includes researchers from the University of Cambridge and the Royal Holloway, University of London.
The firm said the funds awarded will be largely used to support preclinical experimentation in its collaborators laboratories. Cobra's ORT-VAC vaccine delivery system exploits the use of innocuous bacteria to deliver vaccines orally. Avoiding the need for needles in vaccination, increases the ease of vaccine distribution and administration and simplifies production technology, the company claims.
Cobra CEO David Thatcher said the project targets the development of oral vaccines for bird influenza and AIDS. In other news, Fraunhofer USA Center for Molecular Biotechnology has inked a $2.6m (€1.9m) contract with the US government to further develop and validate a new system that speeds the manufacture of biopharmaceuticals.
Delaware-based Fraunhofer said that if all phases of the programme are completed, the total value of the deal could be $8.5m. Under the first phase of the contract - signed through the Defense Advanced Research Projects Agency (DARPA) - Fraunhofer USA CMB will validate its unique plant-based technology platform for the rapid, cost-effective production of vaccines and monoclonal antibodies.
The firm claims its platform can significantly reduce the time required, from the identification of infectious agents to the manufacture of millions of doses of medical countermeasures. The technology employs a proprietary vector system and non-genetically modified plants to produce vaccines, antibodies and therapeutic proteins.
"This contract from DARPA will significantly accelerate our development of this much-needed technology that addresses some of the concerns affecting current biopharmaceutical manufacturing," said Dr Vidadi Yusibov, executive director of Fraunhofer USA CMB. Fraunhofer said it was awarded this contract under DARPA's Accelerated Manufacture of Pharmaceutics Programme - a multiphase project aimed at creating new biological systems that quickly produce medical countermeasures for today's naturally-occurring, intentionally-released and pandemic biological threat agents.
The goal of the initiative is to generate 3m doses of vaccine or immune-therapeutic within 12 week of an outbreak, and to do so at extremely low cost using highly resilient, rigorously controlled, GMP-quality production platforms.