Patent news and news that DCVax-direct is already treating multiple patients
his next generation system has already been cleared by FDA for use in the manufacturing for NW Bio's clinical trials. These systems are now in use producing the vaccines which already have been injected into the tumors of DCVax-Direct patients.
This next generation process automates certain crucial stages of the manufacturing process within a self-contained system. Automating some or all of the production process within such a system can eliminate the need for today's extremely expensive "GMP" clean rooms (with, for example, special air handling to maintain sterile air in an entire building). Eliminating the special costs for such clean rooms will further enhance product economics, allowing wider margins and pricing flexibility.
At the heart of this next generation manufacturing advance are Tangential Flow Filtration machines, or TFF for short. These machines and associated disposable sets provide an automated, closed system for the crucial stages of the manufacturing process isolating the particular immune cells that become the dendritic cells in the Company's DCVax products.
Most significantly, the dendritic cells produced through this next generation system, are manufactured using procedures which are more closely related to what one finds in nature. The result is increased potency of the dendritic cells (which are the active agent in the DCVax products).
As such, full implementation of the TFF can be another major step forward in advancing immune therapies, and help to position the manufacturing of DCVax products for potential commercial scale-up when the time comes.
"Ongoing development of our technologies for cost reduction and simultaneous enhancements in quality continues to strengthen our competitive position," commented Linda Powers, CEO of NW Bio. "The TFF system provides major advantages in this regard, and the issuance of this latest patent is a significant addition to our portfolio of over 180 issued and pending patents worldwide."
"This next generation process automates certain crucial stages of the manufacturing process within a self-contained system. Automating some or all of the production process within such a system can eliminate the need for today's extremely expensive "GMP" clean rooms (with, for example, special air handling to maintain sterile air in an entire building). Eliminating the special costs for such clean rooms will further enhance product economics, allowing WIDER MARGINS (I like that!) and pricing flexibility."
Dr. Marnix Bosch, one of the inventors on this line of patents, says: "We have approached the issues of dendritic cell manufacturing from a process-improvement perspective, and the material covered in these issued patents takes advantage of the natural biology of dendritic cells and their precursors, thereby allowing us to produce more potent dendritic cells in a more efficient and automated system."
NW Bio holds numerous related international patents in Australia, Japan, New Zealand, Russia, China, South Korea, Mexico and other countries.
IT SEEMS THAT MD ANDERSON CONTINUES WORKING WITH DCVAX-DIRECT MEANING THAT AT LEAST SOME PATIENTS DO REACT WELL. OTHERWISE MD ANDERSON ALREADY STOPPED THE TRIAL AT THEIR LOCATION, TO PRESERVE THEIR EXCELLENT CANCER TREATMENT STATUS.
... i dont want to see some bad news in this news. but an other interpretation could alo be: "trials are not running as expected. we think we could get better results with the next generation system". Just my two cents.