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BioLife Solutions Customer Kite Pharma Receives FDA Approval for Yescarta™ CAR T-Cell Therapy

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Each Yescarta Dose is Frozen in Proprietary CryoStor® Freeze Media to Maintain CAR T-Cell Viability and Enable Worldwide Distribution

BOTHELL, Washington — October 19, 2017 —BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media (“BioLife” or the “Company”), today announced that its customer Kite Pharma, Inc., a wholly-owned subsidiary of Gilead Sciences, has received US FDA approval for Yescarta, the first CAR T-cell therapy for treatment of adult patients with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy. [Read more…]

Be The Match BioTherapies Launches New Technology Platform for Cell Therapy Supply Chain Management

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Software to improve the end-to-end supply chain management of autologous cell therapies leverages parent company’s 30-year experience managing stem cell transplants worldwide

MINNEAPOLIS, October 4, 2017 – Be The Match BioTherapies®, an organization offering solutions for delivering autologous and allogeneic cellular therapies, today announced the launch of a new, implementation-ready technology platform for cell and gene therapies in clinical development or poised for commercialization. MatchSourceSM is an ordering, tracking and delivery software for cell and gene therapies that was custom designed based on the software used by Be The Match BioTherapies’ parent company, the National Marrow Donor Program®(NMDP)/Be The Match®. NMDP/Be The Match has 30 years of experience managing more than 80,000 stem cell transplants around the world through an extensive network of U.S. and international partners, including more than 145 U.S. transplant centers and more than 80 U.S. apheresis centers.

NMDP/Be The Match began developing technology platforms to manage the collection and delivery of life-saving allogeneic stem cells to patients at transplant centers more than 20 years ago, and has continually enhanced its software with new innovations that incorporate customer feedback. Today, the company’s software platforms support approximately 6,200 stem cell transplants and 22,000 cell and blood shipments annually.  [Read more…]

$7.9M Granted to nTRACK Collaborative Project to Study Pluristem’s PLX-PAD Cells

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  • Grant from European Union’s Horizon 2020 program to nTRACK project designed to study nanoparticle effects on PLX-PAD cell viability and functionality
  • Grant brings total to approximately $25 Million (€21.8 million) in funding from Horizon 2020 program to cover clinical and research activity for PLX-PAD

HAIFA, Israel, Oct. 02, 2017 — Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that a $7.9 million (€6.8 million) non-dilutive grant from the European Union’s Horizon 2020 program has been awarded to nTRACK, a collaborative project carried out by an international consortium led by LEITAT. [Read more…]

BioLife Solutions CryoStor® Cell Freeze Media Embedded in Cellular Biomedicine Group Clinical Trial of AlloJoin™

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Off the Shelf Allogeneic Stem Cell Therapy for Knee Osteoarthritis

BOTHELL, Wash., Sept. 19, 2017  — BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media (“BioLife”), announced that Cellular Biomedicine Group (NASDAQ: CBMG), a leading clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases (“CBMG”), has validated BioLife’s proprietary CryoStor freeze media for use in CBMG’s planned US Phase I clinical trial of AlloJoin, an off the shelf allogeneic stem cell therapy for knee osteoarthritis.

AlloJoin - Quote by Mike Rice, Biolife President & CEOMike Rice, BioLife President & CEO, commented, “We are very pleased to support CBMG in their development and potential commercialization of AlloJoin. CBMG is the leading regenerative medicine company in China, with a robust clinical pipeline and high-quality, scalable manufacturing facilities.”

In addition to this product adoption by CBMG, CryoStor and HypoThermosol®, BioLife’s companion cell storage and shipping media, have been used in at least 250 regenerative medicine applications, including several late-stage clinical trials. BioLife’s customer base has grown to over 2,000 companies, universities and clinical centers in the regenerative medicine, drug discovery and biobanking markets. [Read more…]

U.S. FDA Grants Fast Track Designation to Pluristem’s PLX-PAD for the Treatment of CLI

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  • Pluristem’s Ongoing Phase III CLI trial has been selected for accelerated approval pathways in both the U.S. and Europe

  • Fast Track Designation allows for expedited review of drugs to treat serious conditions with unmet medical need

HAIFA, Israel, Sept. 18, 2017 (GLOBE NEWSWIRE) — Pluristem Therapeutics, Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s ongoing Phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization. The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With Fast Track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.

Zami Aberman, Pluristem Therapeutics - FDA Fast Track Designation“We are extremely pleased with the FDA’s decision to grant Fast Track Designation to PLX-PAD in the treatment of CLI. Up to 40% of patients with CLI are ineligible for revascularization and are at high risk of amputation and death within the first year of diagnosis. This disease takes a heavy toll on patients and their families, while the cost of treating CLI in the U.S. alone is estimated at over $25 billion per year. We are working tirelessly to provide a cell therapy that will address this severe unmet medical need,” said Zami Aberman, Chairman and Co-CEO of Pluristem.

“Regulators in some of the largest healthcare markets in the world are now in alignment regarding the need for accelerated approval pathways for our cell therapy product in the treatment of CLI. Programs like the Fast Track Designation offer real hope for patients battling this disease and we look forward to accelerating the path to market for PLX-PAD,” stated Pluristem President and Co-CEO, Yaky Yanay. [Read more…]

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