Orizuru Therapeutics, Inc. (OZTx), a Japanese biotechnology company focusing on the research and development of iPSC-derived regenerative medicine, and PeptiGrowth Inc. (PeptiGrowth), a Japanese biotechnology company specializing in the development of synthetic peptide based growth factors, are pleased to announce the successful completion of the joint development project (first announced on August 23, 2023) for chemically synthesized peptide as an alternative to specific recombinant growth factors used in the manufacturing of regenerative medicine products developed by OZTx. The developed peptide was confirmed to bind to cellular receptors in a manner similar to the respective recombinant growth factor, inducing phosphorylation and signaling within the cells, thereby triggering differentiation and proliferation of iPSCs. [Read more…]
Eterna Therapeutics Releases Positive Preclinical Results for ERNA-101, an Allogenic iMSC Therapeutic
ERNA-101 is a cell therapy that utilizes iPSCs to create induced allogenic mesenchymal stem cells (iMSCs) that secrete interleukins IL-7 and IL-15.
Proof-of-concept study provides roadmap for treatment of ovarian cancer.
CAMBRIDGE, Mass., Jan. 14, 2025 — Eterna Therapeutics (Nasdaq: ERNA), a leader in cell therapies for the treatment of advanced solid tumors, announced positive results from a preclinical study on the company’s lead cell therapy product, ERNA-101, which is designed to activate and regulate the immune system’s response to recognize and attack ovarian cancer cells. This successful proof-of-concept study demonstrated massive T cell infiltration after only one dose of ERNA-101, reduced tumor burden, and extended survival in mice with ovarian cancer. [Read more…]
IPS HEART’s Secures Orphan Drug Designation for iPSC-Derived Mesenchymal Progenitor Cell (MPC) Therapy, GIVI-MPC
In a groundbreaking development for the treatment of muscular dystrophies, IPS HEART received Orphan Drug Designation (ODD) from the U.S. FDA on January 13th, 2025, for its innovative stem cell therapy, GIVI-MPCs. GIVI-MPCs are mesenchymal progenitor cells derived from induced pluripotent stem cells (iPSCs) that have the potential to treat Becker Muscular Dystrophy (BMD). This milestone recognizes the therapy’s unprecedented ability to generate new skeletal muscle containing full-length dystrophin—a crucial protein missing or defective in individuals with BMD. [Read more…]
CHU Toulouse receives CTA Approval to initiate ALLOFIST, a Phase 1/2 Trial based on Cell-Easy’s proprietary adipose-derived MSC in Patients suffering from Crohn Disease.
Toulouse, France, January 16, 2025 – The long-term partnership between Cell-Easy and Toulouse University Hospital (CHU Toulouse) continues to bear fruits, bringing innovative MSC-based therapies to local patient cohorts. This time, it’s in the field of Crohn’s disease that the pair is experimenting with the allogeneic cell therapy approach. By tackling all CMC, regulatory and medico-economic concerns, the Cell-Easy CDMO has succeeded in developing a cell therapy drug from scratch in just 2 years. The principal investigator Dr Etienne Buscail, a colo-rectal surgeon and proctologist at Toulouse University Hospital, recently submitted a request for authorization of CTA to the European Agency EMA, which was rapidly accepted. An initial cohort of patients suffering from Crohn’s disease will be able to benefit from this experimental innovant treatment starting in 2025 Q1. [Read more…]
China’s NMPA Approves Country’s First MSC-Based Cell Therapy, Ruibosheng
On January 2, 2025, China’s National Medical Products Administration (NMPA) granted conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001), marking a significant milestone in the country’s medical and biotechnological advancements. The product is being marketing under the brand name Ruibosheng. This approval designates it as China’s first human umbilical cord-derived mesenchymal stem cell (hUC-MSC) therapy, offering a promising treatment option for steroid-refractory acute graft-versus-host disease (GVHD), a serious and often fatal complication following stem cell transplants. [Read more…]
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