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A patient with MG is also the first evaluated to reach 1 year of follow-up and has a continued durable immunomodulator-free response.

BRG01 is the first cell therapy to move into a phase 2 clinical trial for relapsed/metastatic EBV-positive nasopharyngeal carcinoma in both the US and China.

For the 5 patients in long-term follow-up who have been evaluated, the average PFS is 4.8 months (range, 2-8 months).

The president and chief executive officer of Passage Bio discussed feedback from a recent Type C meeting with the FDA.

In light of the FDA’s decision, 4DMT plans to continue enrolling patients in INGLAXA before the end of 2024.

Janice Chen, PhD, the cofounder and chief technology officer of Mammoth Biosciences, discussed the importance of diverse approaches to gene editing to address a variety of indications.

TRX103 is also being evaluated for the prevention of graft versus host disease (GvHD) in patients undergoing HLA-mismatched HSCT.

The head of therapeutics at Epic Bio discussed EPI-321, an investigational treatment for facioscapulohumeral muscular dystrophy.

Going forward, the company is mainly focused on distributing the gene therapy in the United States, Germany, and Italy.

The chief medical officer at Creyon Bio discussed future applications for the company’s AI-guided discovery platform.

Lucas Harrington, PhD, the cofounder and chief scientific officer of Mammoth Biosciences, discussed the company’s mouse model research on treating hypertriglyceridemia.

NGN-401 is being evaluated in an early phase clinical trial which has been selected for the FDA’s START Pilot Program.

Elderly patients were at higher risk of infections and subsequent malignant neoplasms.

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.