Century Therapeutics

Cellino and Karis Bio Partner to Develop First Autologous iPSC Therapy for Cardiovascular Disease

a month ago

• Cellino and Karis Bio have formed a strategic partnership to industrialize the world's first clinical-stage autologous iPSC-derived cell therapy for peripheral and coronary artery diseases. • The collaboration leverages Cellino's Nebula platform for scalable iPSC production and Karis Bio's vessel regeneration technology to offer patients an alternative to invasive procedures while eliminating immune rejection risks. • This partnership marks Cellino's expansion into the Asia-Pacific region, with initial focus on manufacturing optimization before advancing to Phase 2 trials through Karis Bio's U.S. operations.

Century Therapeutics' CNTY-101 to be Evaluated in Autoimmune Diseases in Investigator-Initiated Trial

4 months ago

• Century Therapeutics' CNTY-101, an iPSC-derived CD19 CAR-iNK cell therapy, will be assessed in a Phase 1/2 trial for B-cell mediated autoimmune diseases. • The CARAMEL trial, led by Professors Schett and Mackensen, will evaluate CNTY-101's safety and efficacy in systemic lupus erythematosus, lupus nephritis, and other conditions. • CNTY-101 is engineered with six gene edits to target and eliminate B cells, which are crucial in autoantibody production and lupus disease activity. • The trial, sponsored by Friedrich-Alexander University Erlangen-Nürnberg, is set to commence in mid-2025, pending clinical trial application approval.

Krystal Biotech and CRISPR Therapeutics Announce Key Updates in Gene Therapy Programs

4 months ago

• Krystal Biotech reported a 473% increase in full-year revenue, driven by VYJUVEK sales, and anticipates European and Japanese regulatory decisions in 2025. • Krystal Biotech's KB407 for cystic fibrosis received full sanctioning for its Phase 1 CORAL-1 study, with interim molecular data expected mid-2025. • CRISPR Therapeutics reported positive momentum in the CASGEVY launch, with over 50 activated treatment centers and patients initiating cell collection globally. • CRISPR Therapeutics expects key clinical data updates in 2025 for CTX112 in oncology and autoimmune diseases, and for CTX310 and CTX320 in cardiovascular programs.

Gameto's Fertilo Receives FDA Clearance for Phase 3 iPSC Fertility Trial

5 months ago

• Gameto's Fertilo, an iPSC-based therapy, has received FDA IND clearance for a Phase III trial, marking a significant advancement in reproductive medicine. • The Fertilo technology uses engineered ovarian support cells to mature eggs outside the body, reducing hormone injections by 80% and shortening treatment cycles. • The Phase III trial will assess the safety and efficacy of Fertilo, focusing on embryo development, pregnancy rates, and maternal health across 15 US sites. • Fertilo achieved the world's first live birth using its technology in December 2024 and has secured regulatory clearance in multiple countries.