The Israel-based placenta-derived cell therapy developer told us about its partnering plan this week, just days after securing IP protection for its 3D culturing methods in Japan.
Spokeswoman Karine Kleinhaus said: “Japan is a very important market for regenerative medicine. It is the only country in the world that I am aware of that has a specific, dedicated rapid regulatory pathway for regenerative medicine.”
In addition to the tech patents, Pluristem also recently had a protocol for a Phase II trial of its cell based therapy for critical limb ischemia approved via Japan’s accelerated regulatory pathway. Kleinhaus cited this a significant development.
“Our acceptance into this pathway could clearly shorten time to market for our PLX-PAD cell therapy product in this indication by several years, and also could be expected to save millions of dollars in development costs.
Acceptance of the protocol “also supports us as we work to secure a partnership deal with a large pharmaceutical company in Japan” according to Kleinhaus, who did not name the company involved.
Phase II supplies
Pluristem makes therapies from cells derived from donated placentas. The products which work by secreting therapeutic proteins targeting different indications which stimulate the body to use its own repair systems to treat damaged tissues.
All therapies are produced at the firm’s facility in Haifa, which has also been approved by Japanese regulators.
Kleinhaus old us “Japan’s PMDA has cleared our production process for PLX-PAD and the manufacturing facility in Israel to make cells from placentas donated in Israel for use in Japanese patients for the trial.
She added that: “If we reach the market and commercial demand were to grow, we would consider construction of additional manufacturing facilities, but have no concrete plans at this time because our existing facility can manufacture 150,000 doses a year.
The Japanese patent is only the latest Pluristem has received for its 3D culturing process – which uses a proprietary bioreactor in which cells grow in three dimensions on a scaffold. Pluristem claims that growing cells in this way is 70 time more efficient than other methods and 5% the cost.
At present Pluristem’s IP efforts are designed to protect its technology according to Kleinhaus, who told us “We have no immediate plans to license out the IP for the 3D cell expansion technology. Our current plan is to keep IP and manufacturing.”