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Astellas and Universal Cells Collaborate to Utilize Universal Donor Cell Technology

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Oct. 19, 2017 — Astellas Pharma Inc. and Universal Cells, Inc. announced that Astellas Institute for Regenerative Medicine (“AIRM”) and Universal Cells have entered into an exclusive worldwide license agreement to research, develop and commercialize a novel cell therapy for an undisclosed indication. The collaboration will utilize Universal Cells’ Universal Donor Cell technology to create cell therapy products that can be administered to any recipient without the need for Human Leukocyte Antigen (HLA) matching.

Astellas collaboration with Universal Cells“I am pleased to enter into this collaboration with Universal Cells for a novel cell therapy using their proprietary Universal Donor Cell technology based on gene editing by rAAV (recombinant Adeno-Associated Virus) and cell engineering of pluripotent stem cells,” said Yoshitsugu Shitaka, Ph.D., president of AIRM. “This is definitely an important step forward in developing a potential new option as an innovative cell therapy to treat devastating diseases with high unmet medical needs.”

While the research will be conducted jointly by AIRM and Universal Cells, Astellas will lead and fully fund the development program and will obtain worldwide rights for commercialization. In consideration for the collaboration and grant of rights, under the terms of the agreement, Universal Cells is eligible to receive up to $9 million in a combination of an upfront payment and research milestones. Universal Cells is also eligible to receive research funding and further clinical development and regulatory milestone payments of up to $115 million, as well as royalties.
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RoosterBio Launches New cGMP Stem Cell Product Portfolio

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RoosterBio Launches New cGMP Stem Cell Product Portfolio, Maintaining Unwavering Commitment to Driving the Explosive Regenerative Medicine Industry

Next Generation Products are Harbinger of Paradigm Shift in the Adult Stem Cell Industry

RoosterBioFrederick, MD, USA. September 14, 2017 – RoosterBio Inc, today, proudly announces the launch of its CliniControl™ (CC) product portfolio, clinically-relevant starting and ancillary materials that generate unprecedented efficiencies in adult stem cell manufacturing, accelerating clinical translation of human Mesenchymal Stem/Stromal Cell (hMSC)-based therapies.  The CliniControl product portfolio will radically simplify major steps in product development and clinical translation, improving the likelihood of commercial success for RoosterBio customers.

The first in the CliniControl line of products, RoosterNourish™-MSC-CC bioprocess medium sets the new standard of industry-leading performance.  RoosterNourish-MSC-CC is a first-in-class, standardized, xeno-free (XF) bioprocess medium engineered to support not only 2D (plastic adherent), but also 3D suspension culture of hMSCs in allogeneic and autologous therapeutic manufacturing.  Formulated specifically for clinical research process and product developers, RoosterNourish-MSC-CC yields superior media productivity, leading to drastically reduced cost of goods as compared to other hMSC culture media.   The highly productive RoosterNourish medium is designed for batch 2D and fed-batch 3D cultures and seamlessly translates between culture platforms enabling scalable hMSC culture,  delivering robust, reproducible and standardized results at a commercially-viable cost of goods.  [Read more…]

Celltex Therapeutics | Interview with CEO David Eller

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David Eller CelltexCelltex Therapeutics is a regenerative medicine company that specializes in banking autologous mesenchymal stem cells (MSCs) for therapeutic use. In the Celltex procedure, a small fat sample is taken, from which MSCs are extracted, isolated, multiplied and stored for future use. Patients can then use these autologous (“self-derived”) stem cells for regenerative purposes through infusions or injections performed by a licensed physician.

In this article: 

An Expert’s Perspective on Accelerated Pathways for Cell Therapy Approvals

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Yaron Ramati, Director of Regulatory Affairs at Pluristem Therapeutics
Yaron Ramati, Director of Regulatory Affairs at Pluristem Therapeutics

Over the past few years, the regulatory landscape for cell therapy development has grown increasingly complex. There are now accelerated pathways for advanced therapy medicinal products (ATMPs) in several countries worldwide, including the U.S., Japan, and South Korea. While the possibility for accelerated commercialization has resulted from these changes, substantial complexity has also been introduced, making it a more elaborate process to move cell therapy products from “bench to bedside.”

In the interview with Yaron Ramati, Director of Regulatory Affairs at Pluristem Therapeutics, we get an expert’s perspective on how the regulatory environment has changed and new opportunities that exist for bringing cell therapy products through the clinical trial process and into the global marketplace. [Read more…]

U.S. DOD to Conduct Studies of Pluristem’s PLX-R18 in a New ARS Project for Use Before Radiation Exposure

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• The DOD studies seek to test the effectiveness of PLX-R18 as a novel medical countermeasure for Acute Radiation Syndrome (ARS) prior to and within 24 hours of exposure to high levels of radiation
• The DOD studies will be conducted in parallel with the ongoing ARS project with the NIH

Pluristem TherapeuticsHAIFA, ISRAEL, August 16, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that a pilot study of the company’s PLX-R18 cell therapy will be initiated by the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI), part of the Uniformed Services University of Health Sciences (USU). The study will examine the effectiveness of PLX-R18 as a treatment for Acute Radiation Syndrome (ARS) prior to, and within the first 24 hours of exposure to radiation.  [Read more…]

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