Stem Cell News

BioInformant's coverage of stem cell news includes iPS cells, mesenchymal stem cells, hematopoietic stem cells, neural stem cells and more.

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Orchard Therapeutics Receives RMAT for OTL-103 for Treatment of Wiskott-Aldrich Syndrome

July 30, 2019 By Cade Hildreth, Founder & President Leave a Comment

Three-Year Registrational Data Set to be Presented by Year End 2019

Regulatory Submissions Planned in the U.S. and Europe for 2021

BOSTON and LONDON, July 29, 2019 — Orchard Therapeutics (Nasdaq: ORTX), a leading commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, today announced that it has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for OTL-103, Orchard’s ex vivo autologous hematopoietic stem cell (HSC)-based gene therapy for the treatment of Wiskott-Aldrich Syndrome (WAS) developed at the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy. [Read more…]

First iPSC-Derived CAR-T Therapy by CiRA and Takeda Nears Clinical Testing

July 23, 2019 By Cade Hildreth, Founder & President Leave a Comment

− iCART Program Advances the Potential for a Highly Scalable, Lower Cost, Off-the-Shelf CAR T-Cell Therapy to Treat Cancer

KYOTO and OSAKA, Japan I July 16,2019 – The Center for iPS Cell Research and Application (CiRA) at Kyoto University and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that a novel induced pluripotent stem (iPS) cell-derived chimeric antigen receptor (CAR) T-cell therapy (iCART) has been transferred from their T-CiRA research collaboration to Takeda as the program begins process development toward clinical testing. Under the terms of the T-CiRA agreement, Takeda has the global rights to develop and commercialize the iCART product and CiRA will receive development and approval milestones. The teams will continue to collaborate as they prepare the iCART program for a clinical trial in 2021. [Read more…]

Qrons Appoints Veteran U.S. Based Biotech Executive Dr. John N. Bonfiglio to Lead IND and Capital Markets Related Activities

June 27, 2019 By Cade Hildreth, Founder & President Leave a Comment

New York, NY, June 27, 2019 — Qrons Inc. (OTC: QRON), an emerging biotechnology company developing advanced stem cell-synthetic hydrogel-based solutions for the treatment of traumatic brain injuries (“TBIs”), including concussions and penetrating injuries, announced today the appointment of John N. Bonfiglio, PhD, MBA as its Chief Operating Officer. Qrons Inc. (OTC: QRON)

Dr. Bonfiglio’s primary responsibility will be to oversee all investigational new drug (“IND”) activities in the United States in coordination with Qrons’ Israeli-based scientific team. [Read more…]

Mesoblast’s Mesenchymal Precursor Cell (MPC) Therapy Receives Orphan Drug Designation

June 24, 2019 By Cade Hildreth, Founder & President Leave a Comment

Mesoblast (ASX:MSB; Nasdaq: MESO) announced that the U.S. FDA granted the company’s product candidate, Revascor, Orphan Drug Designation for prevention of gastrointestinal bleeding in patients with left ventricular assist devices.

Revascor, Mesenchymal Precursor Cells

Revascor is Mesoblast’s investigational cell therapy composed of 150 million allogeneic mesenchymal precursor cells (MPCs). [Read more…]

ElevateBio to Operate at a Hybrid CDMO and Investment Holding Group

June 17, 2019 By Cade Hildreth, Founder & President Leave a Comment

ElevateBio, a newcomer to the cell and gene therapy sector, is taking a different approach than the competition. Founded only months ago in early 2019, the company plans to aggregate a portfolio of cell and gene therapy companies that will develop, manufacture and commercialize life-transforming medicines.

It has launched with an unusual business model, which is to be a hybrid CDMO for cell and gene therapy companies, as well as an investment holding company. It will accomplish this feat by offering “R&D and cGMP manufacturing facilities to be shared across several portfolio companies, each with a different disease focus.”

Key to ElevateBio’s plan is the construction of an R&D and cGMP manufacturing facility in Cambridge, MA, that it calls BaseCamp. The complex will act as a centralized research and manufacturing group to support a portfolio of promising cell and gene therapy companies, each which will have a different disease focus.

[Read more…]