Press Releases Archives | Page 35 of 119

FUJIFILM Cellular Dynamics and Opsis Therapeutics Announce License with BlueRock Therapeutics for iPSC-derived Retinal Cell Therapy Candidate

January 26, 2024 By Cade Hildreth, Founder & President Leave a Comment

MADISON, WI, January 23, 2024 — FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human induced pluripotent stem cells (iPSC), and Opsis Therapeutics, LLC, a joint venture of FUJIFILM Cellular Dynamics and co-founder David Gamm, M.D., Ph.D., focusing on developing cell therapies for patients with ocular diseases, today announced an agreement granting BlueRock Therapeutics (Cambridge, Mass.) an exclusive, worldwide license to develop and commercialize an iPSC-derived cell therapy candidate for the treatment of human retinal diseases. BlueRock Therapeutics, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, exercised its option to exclusively license OpCT-001, an iPSC-derived photoreceptor cell therapy for human retinal diseases. [Read more…]

Bio-Techne Files Drug Master File For ExCellerate GMP iPSC Expansion Medium to Support Manufacture of Stem Cell Therapies

January 24, 2024 By Cade Hildreth, Founder & President Leave a Comment

MINNEAPOLIS, MN, December 20, 2023 — Bio-Techne Corporation (NASDAQ: TECH) has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ExCellerate™ GMP iPSC Expansion Medium, Animal Free (CCM0036-GMP), supporting the development and manufacture of regenerative medicine and stem cell therapies. [Read more…]

BioCentriq® Strengthens Cell Therapy CDMO Services with $29.2M in Capital Investment

January 7, 2024 By Cade Hildreth, Founder & President Leave a Comment

NEWARK, N.J., — BioCentriq®, a global cell-based therapy Contract Development and Manufacturing Organization (CDMO), proudly announces the successful completion of its latest round of fundraising, securing $29.2M in capital investment. The funding round marks a significant milestone in BioCentriq’s mission to accelerate delivery of innovative cell therapies by translating, optimizing, and scaling processes for GMP manufacture. [Read more…]

MESOBLAST Achieves First Ever U.S. FDA Approval of an MSC Therapy (RYONCIL®)

January 1, 2024 By Cade Hildreth, Founder & President Leave a Comment

RYONCIL (remestemcel-L) is the first MSC product approved by FDA for any indication.
In a single-arm, multi-center, Phase 3 trial of children with steroids-refractory (SR) acute GvHD, 70% achieved an overall response by Day 28 of treatment with RYONCIL, a measure that predicts survival.
RYONCIL’S immunomodulatory effects, including inhibition of T cell activation and secretion of pro-inflammatory cytokines, position the therapy for potential other indications in diseases with excessive inflammation.

[Read more…]

IN8bio Presents Positive Data Update from iPSC Platform at SITC 38th Annual Meeting

December 24, 2023 By Cade Hildreth, Founder & President Leave a Comment

This data represents a step forward in developing next-generation ‘off-the-shelf’ iPSC derived gamma-delta T cells. Our proprietary expansion methods are serum and feeder-free and have the potential to produce billions of iVδ1 T cells.
IN8bio’s iVd1+ subtype cells have an expression profile linked to a low risk of cytokine release syndrome (CRS) and have shown strong cancer-killing abilities against various solid and liquid cancers.
Showcases the capability to manufacture specific gamma-delta T cell sub-types using a process that can be scaled for GMP- manufacturing as a potentially ‘off-the-shelf’ platform for allogeneic cell therapy.

[Read more…]

RYONCIL (remestemcel-L) is the first MSC product approved by FDA for any indication.

In a single-arm, multi-center, Phase 3 trial of children with steroids-refractory (SR) acute GvHD, 70% achieved an overall response by Day 28 of treatment with RYONCIL, a measure that predicts survival.

RYONCIL’S immunomodulatory effects, including inhibition of T cell activation and secretion of pro-inflammatory cytokines, position the therapy for potential other indications in diseases with excessive inflammation.

This data represents a step forward in developing next-generation ‘off-the-shelf’ iPSC derived gamma-delta T cells. Our proprietary expansion methods are serum and feeder-free and have the potential to produce billions of iVδ1 T cells.

IN8bio’s iVd1+ subtype cells have an expression profile linked to a low risk of cytokine release syndrome (CRS) and have shown strong cancer-killing abilities against various solid and liquid cancers.

Showcases the capability to manufacture specific gamma-delta T cell sub-types using a process that can be scaled for GMP- manufacturing as a potentially ‘off-the-shelf’ platform for allogeneic cell therapy.