December 20, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Pluristem Therapeutics , located in Haifa, Israel, and Tokyo’s Corporate Venture Capital, a subsidiary of Sosei Group Corporation, inked a binding term sheet to create a Japanese corporation, NewCo, to develop and commercialize Pluristem’s PLX-PAD cell therapy product in Japan.
Pluristem will own 35 percent of NewCo in exchange for a perpetual license to commercialize PLX-PAD for critical limb ischemia (CLI) in Japan. All proprietary rights related to the compound will be the exclusive property of Pluristem. Sosei CVC’s investment fund, Sosei RMF1, along with more Japanese investors, plan to raise about $11 million, and will own 65 percent of the new company.
Pluristem’s placental expanded (PLX) cells are derived from the placenta, and are given to patients without tissue or genetic matching. They then release molecules such as soluble cytokines, chemokines, and growth factors. These molecules stimulate the body’s own mechanism of regeneration to improve healing. PLX-PAD cells are being developed for ischemic conditions, including critical limb ischemia (CLI).
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved a 75-patient trial of PLX-PAD in CLI under an accelerated regulatory pathway. The study has the potential to lead to early conditional marketing approval. The definitive agreement is expected to be finalized no later than March 31, 2017.
In November 2016, The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) also approved a 250-patient Phase III trial of PLX-PAD for the treatment of CLI in the U.S. and UK. It may provide enough data for conditional marketing approval in Europe under the European Medicines Agency’s (EMA) Adaptive Pathways pilot project.
“We are pleased to partner with Sosei CVC to commercialize PLX-PAD in Japan,” said Zami Aberman, Pluristem’s chairman and chief executive officer, in a statement. “The development of our CLI program through the accelerated regulatory pathway could allow a more rapid entrance into the sizeable Japanese market, as has been our strategy. Our cooperation with Sosei CVC also creates the potential to develop additional indications in this market, by drawing on our robust portfolio of cell therapy product candidates in development.”
Pluristem utilizes a proprietary 3D bioreactor system to manufacture cell products in large quantities. It also has another PLX cell therapy product, PLX-R18, in development to treat hematologic disorders, as well as incomplete engraftment of transplanted hematopoietic cells, and acute radiation syndrome (ARS).
At the beginning of this month, Pluristem announced that the U.S. National Institutes of Health (NIH)’s National Institute of Allergy And Infectious Diseases (NIAID) had begun the final phase of animal dosing in an animal study to determine the treatment dose prior to submitting a Biologics License Application (BLA) under the U.S. Food and Drug Administration (FDA)’s Animal Rule regulatory pathway. NIAID has already finished two small animal studies of PLX-R18 as a possible treatment for hematologic disorders associated with ARS.
“We are eager to begin the joint development of PLX-PAD in critical limb ischemia with the goal of commercialization, and believe that our cooperation could lead to an efficient and successful entry into Japan’s substantial market,” said Toshimi Miyoshi, director of Sosei CVC, in a statement. “The NewCo is expected to be a meaningful investment by Sosei RMF1 into the regenerative medicine space, and will support our goal to stimulate the biotechnology industry in Japan.”
