Cell Therapy Archives | Page 56 of 62

Novartis Receives Health Canada Approval of its CAR-T cell therapy, Kymriah™

September 6, 2018 By Cade Hildreth, Founder & President Leave a Comment

Kymriah, the first chimeric antigen receptor T cell (CAR-T) therapy approved in Canada, is manufactured individually for each patient
Novartis is working with qualified treatment centres to prepare for the delivery of this treatment for relapsed/refractory (r/r) pediatric and young adult B-cell ALL and adult r/r DLBCL indications

DORVAL, QC, Sept. 6, 2018 – Novartis is pleased to announce that following a Priority Review, Health Canada has approved Kymriah™ (tisagenlecleucel/ CTL019) the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in Canada.

Kymriah, a CD19-directed genetically modified autologous T-cell immunocellular therapy, is approved to treat two life-threatening cancers that have limited treatment options and historically poor outcomes, demonstrating the critical need for new therapies for these patients. [Read more…]

Gradalis® Announces Initiation of Phase 3 Study of Vigil(TM) in Ewing’s sarcoma

August 28, 2018 By Cade Hildreth, Founder & President Leave a Comment

– The open-label trial will measure progression free survival of participants from date of randomization until first disease progression in the study –
– The trial will use product produced from Gradalis’ recently-upgraded cGMP Carrollton facility –

DALLAS, August 28, 2018 — Gradalis, Inc., a clinical-stage immunotherapy company developing investigational treatments for individuals suffering from multiple cancer indications, today announced the initiation of its Phase 3 clinical trial of Vigil for individuals with Ewing’s sarcoma using product produced from Gradalis’ recently upgraded current Good Manufacturing Practice (cGMP) Carrollton facility. [Read more…]

Irvine Scientific Introduces Chemically-Defined Natural Killer Cell Expansion Medium for Immunotherapy & Translational Research Applications

July 24, 2018 By Cade Hildreth, Founder & President Leave a Comment

The first chemically-defined, animal component-free cell culture medium for natural killer (NK) cells

July 2018, Santa Ana, Calif. — Irvine Scientific, an industry leader in the development and manufacture of cell culture media, announced the introduction of PRIME-XV^® NK Cell CDM— the first commercially available chemically-defined (CDM), animal component-free (ACF) medium for the ex vivo expansion of NK cells. The advanced medium delivers natural killer (NK) cell expansion while preserving NK cell potency and functionality. [Read more…]

CAR-T Manufacturing | Novartis Selects French CDMO CELLforCURE

July 17, 2018 By Cade Hildreth, Founder & President Leave a Comment

CELLforCURE is a French pharmaceutical group that is authorized to do CAR-T manufacturing at its bioproduction site in Les Ulis (Essonne). CELLforCURE holds two Good Manufacturing Practice (GMP) certificates that allows it to manufacture experimental and commercial cell and gene therapies.

On July 10, 2018, CELLforCURE signed an agreement to manufacture CAR-T products for Novartis. Under the terms of the agreement, CELLforCURE will produce cancer CAR-T therapies (“chimeric antigen receptor T-cells”).

Production is scheduled to begin in 2019 following transfer of Novartis’ CAR-T manufacturing technology to CELLforCURE. [Read more…]

Cellerant Therapeutics Awarded 20th RMAT in U.S.

July 7, 2018 By Cade Hildreth, Founder & President Leave a Comment

On July 2nd, 2018, Cellerant Therapeutics was awarded a Regenerative Medicine Advanced Therapy (RMAT) designation for romyelocel-L (human myeloid progenitor cells) by the U.S. FDA. The treatment is used for the “prevention of serious bacterial and fungal infections in patients with de novo acute myeloid leukemia (AML) undergoing induction chemotherapy.”

Cellerant RMAT Designation

Romyelocel- is a universal, off-the-shelf cell therapy, because it does not require HLA matching between patient and donor. Neutropenia is a major side effect of myelosuppressive chemotherapies, including induction therapy. This can endanger patients by placing them at risk for life-threatening infections.

According to Ram Mandalam, President and CEO of Cellerant, “Receiving RMAT designation for romyelocel-L is an important milestone and recognition by the FDA of the potential of romyelocel-L to serve this unmet medical need.” [Read more…]