CGTLive

4 days ago | cgtlive.com | Noah Stansfield

The FDA will no longer require an advisory committee (AdComm) meeting regarding the biologics license application (BLA) for Capricor Therapeutics’ Deramiocel (also known as CAP-1002), an investigational allogeneic cardiosphere-derived cell therapy under review for the treatment of Duchenne muscular dystrophy (DMD) cardiomyopathy.1 The Prescription Drug User Fee Act (PDUFA) action date for the BLA continues to be set for August 31, 2025, and an in-person late-cycle review meeting for the...

5 days ago | cgtlive.com | Noah Stansfield

Zhengzhou Revo-Gene Technology is currently evaluating a tumor polypeptide pool induced dendritic cell-cytotoxic T-lymphocyte (DC-CTL) cell injection for the treatment of various solid tumor types in a real-world exploratory clinical study (NCT06524024).1 For this installment of Clinical Trials in Progress, CGTLive® has decided to take a closer look at this active study.

5 days ago | cgtlive.com | Peter Cook |Noah Stansfield

Seattle Children’s Research Institute is currently conducating preclinical research on the potential use of BCMA-directed dimerizing agent-regulated immune-receptor complex (DARIC) T-cells for the clearance of plasma cells, which could have applications in autoimmune disease.

6 days ago | cgtlive.com | Brian Kim |Noah Stansfield

This is the second part of an interview with Brian Kim, MBA. For the first part, click here. Mission Bio is seeking to overcome limitations of bulk sequencing and standard single cell sequencing methods with Tapestri, its platform that is intended to offer a multiomic single cell sequencing solution. The company recently presented data related to this platform at the American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting, held May 13 to 17, 2024, in New Orleans, LA.

1 week ago | cgtlive.com | Noah Stansfield

Vertex Pharmaceuticals’ VX-880, an investigational allogeneic insulin-producing islet cell therapy, has restored endogenous insulin secretion in patients with type 1 diabetes (T1D) treated in the phase 1/2 FORWARD clinical trial (NCT04786262).1 The data were announced in an oral presentation at the 85th Scientific Sessions of the American Diabetes Association® (ADA) , held June 20 to 23, in Chicago, IL, and simultaneously reported in the New England Journal of Medicine.