
Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team.
Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team.
Participants are being dosed with OCU400 in the ongoing phase 3 liMeliGhT trial.
Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.
The cofounder and chief science officer of Longeveron discussed working to show potential benefits in a follow-up phase 3 trial.
The trial evaluating the safety and tolerability of IDP-023 will be led by Stanford and UCSF.
The chief scientific officer of Tome Biosciences also discussed the company’s pipeline for its new technology.
A recent study also recommended a shorter, more flexible monitoring period post-CAR–T therapy.
The chief medical officer at Creyon Bio discussed findings from a treated patient with a TNP02 missense mutation.
The open-label, multicenter phase 1/2 STARLIGHT-1 study takes the form of a dose escalation trial with a 3+3 design.
BriaCell initiated the pivotal phase 3 BRIA-ABC trial in October 2023.
Paul Y. Song, MD, the chairman and chief executive officer of NKGen, discussed discussed the new clinical study design for evaluating cell therapy SNK01 in PD.
At the selected phase 2 dose, 76% of patients were injection free, with maintained visual acuity and fluid control.
The president and chief executive officer of Passage Bio discussed feedback from a recent Type C meeting with the FDA.
BioNTech is evaluating BNT111 in a phase 2 trial, primary analysis data from which will be presented in a future medical conference.
The company has filed a protocol amendment with the EMA and anticipates resuming recruitment imminently.
Review top news and interview highlights from the week ending August 2, 2024.
It is the first engineered T-cell therapy to be approved by the FDA for a solid tumor indication.
OBX-115 recently demonstrated a 50% ORR at doses over 30 × 109 cells at 29.5 weeks after infusion.
The chief technology officer at GenSight Biologics discussed using Verdot’s FlexiPro system to produce Lumevoq gene therapy.
There were no new cases of CRS past 2 weeks after infusion and non-relapse mortality was driven by infection in follow-up.
The trial will be open to patients with relapsed/refractory large-B-cell lymphoma and chronic lymphocytic leukemia.
The chief executive officer of Tessera Therapeutics discussed ongoing research into developing its platform for sickle cell disease, CAR T-cell therapy, and more.
CT-0525 is being evaluated in a phase 1 clinical trial currently enrolling participants.
Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.
Paul Y. Song, MD, the chairman and chief executive officer of NKGen, discussed the mechanism behind the company’s NK cell therapy SNK01 and promising early results in patients with PD.
The chief medical officer and head of translational research at Ring Therapeutics discussed research presented at ASGCT 2024.
The program’s cancellation follows a previous announcement that its phase 3 trial had missed its primary end point.
Ractigen is also evaluating saRNA therapies for ALS and SMA.
The cofounder and chief science officer of Longeveron discussed updated data from the phase 2a CLEAR MIND study.
Pending positive outcomes, Actinium plans to later evaluate Iomab-ACT as a conditioning agent for SCD gene therapies.