US biologics contract manufacturer Omnia Biologics has announced a master services agreement to provide drug development company Intradigm with process development and current good manufacturing practice (cGMP) services for cancer therapeutics delivered with a synthetic nanoparticle system.
Intradigm is using its TargeTran technology, based on a self-assembling, layered nanoparticle, to deliver siRNA particles systemically for the inhibition of angiogenesis, and is enlisting Omnia's services to accelerate its clinical development programmes.
The Maryland-based companies believe that the use of novel biological inhibitors to block the function of the pro-angiogenic factors for cancer treatment has proven that targeting tumor-associated vascularisation and angiogenesis is an effective approach.
"The application of Intradigm's expertise to siRNA is a huge step forward for making nanotechnology practical in medicine,", said Omnia CEO Dale VanderPutten.
"Intradigm's technology has begun to transcend traditional notions of small molecules versus biologics by incorporating aspects of each, so the advantages of this technology over current therapeutic regimes are enormous and we are overjoyed that Intradigm chose Omnia to assist them in this important work."
Intradigm's lead siRNA cancer therapeutic candidate, ICS-283, is in late pre-clinical development for solid tumors, so Intradigm was picked because it specialises in preclinical and Phase I clinical programs for therapeutics that do not have effective or known manufacturing protocols.
Although a number of new therapeutics have been developed to intervene with and control angiogenesis, they are not fully effective, so improved agents will generate very large markets not just in cancer, but also in blinding eye disease from diabetes and arthritic diseases of the joints.
By using siRNA to inhibit expression of target proteins, each siRNA effectively reduces the activity of many protein molecules, as compared to a conventional inhibitor, that binds and blocks only a single protein molecule, so Inradigm hopes its product will revolutionalise the market.
"Omnia provides unique services for bridging pre-clinical and clinical manufacture," said Martin Woodle, Intradigm's chief scientific officer.
"The breadth of their services is particularly important to small companies and those developing novel pharmaceuticals at pilot scale, so we are very pleased to have their development assistance as we move toward the clinic."
The TargeTran synthetic vector is a nanoparticle about one-tenth the size of a red blood cell, enhancing intracellular uptake with its ligand-mediated binding.
Upon internalisation, the siRNA is released into the cytoplasm where it inhibits expression of the selected gene.
The actual nanoparticle consists of an siRNA core, surrounded by a layered protective polymer shell stabilised in the blood stream.
Thus, when inert in the blood, the external polymer shell blocks non-specific binding to cells and tissues while en route to the diseased tissue, where ligands are then exposed on the surface of the shell that bind to the target cells.
The vector is cationic, has low toxicity and its steric polymers can be biodegradable.