Manufacturing contract for world-first cancer vaccine
year, Dendreon has awarded Diosynth Biotechnology with a long-term
contract to supply the recombinant protein antigen component of its
novel vaccine for prostate cancer - the third most common cancer in
the world.
If approved, Dendreon's Provenge (sipuleucel-T) will be the first cancer vaccine ever to reach the market.
The product is currently in late-stage clinical development and is also now undergoing a biologics license application (BLA) with the FDA.
Diosynth already produces the recombinant protein antigen component of the product on a small scale to supply clinical trials from its plant in North Carolina, US and plans to upscale manufacturing capacity at this facility once demand for Provenge increases.
The company also has the option to shift production to its large-scale cell culture facility in the Netherlands if required to meet demand.
"We expect to receive FDA approval in time to begin making Provenge for commercial purposes beginning 2007," Richard Basile, vice president, global marketing & sales of Diosynth Biotechnology, told In-PharmaTechnologist.com.
"This contract demonstrates the strength of our recombinant biotech manufacturing facilities and capabilities which position us as one of the world leaders in innovative process development and biopharmaceutical manufacturing," said Frank Tielens, president of Diosynth.
No further terms of the agreement were disclosed by the company.
Once approved, Dendreon will use the recombinant protein antigen supplied by Diosynth to manufacture Provenge for market launch and commercial sale in its facility in New Jersey.
Provenge may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system.
It is delivered via Dendreon's proprietary antigen delivery cassette technology, which uses a recombinant form of an antigen found in approximately 95 per cent of prostate cancers, prostatic acid phosphatase (PAP), to stimulate the patient's immune system to attack the cancer cells.
Although both Phase III clinical trials of Provenge have so far missed their primary endpoint of slowing tumor progression, after following patients for a longer period of time, Provenge did appear to extend survival and a third trial is now underway.
The commercial launch of the drug will therefore depend largely on whether any established survival benefit is significant enough for the FDA to accept the data and give the green light for production.
