News

The DGX-A01 study met its primary safety and efficacy endpoints in its highest dose cohort of IDCT.

Nearly half of participants were able to engage in normal physical activity without angina at 6 months post-treatment.

Breyanzi is currently approved for the second-line or later treatment of large B-cell lymphomas.

Patients continued to show statistically significant upper limb performance improvements.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

The CD19/CD20 dual-targeted CAR is currently under investigation in an investigator-initiated study in UCLA.

The dosing of the first patient took place in December 2022 and no adverse events related to the therapy have been reported.

The FAD has granted primary IND clearance to the company’s T-Plex program and 2 initial TCR-T therapies.

NGN-401 is Neurogene’s second investigational gene therapy to enter clinical trials.

With confidence building, numerous cell and gene therapies will likely go before the FDA and other global regulatory agencies this year, in addition to key data readouts.

REGENXBIO has also initiated recruitment for AFFINITY BEYOND, an observational study assessing the prevalence of AAV8 antibodies in male patients with DMD.

Simeone discussed the progress and challenges seen so far in the BASECAMP-1 observational study.

The overall response rate was 44% among 16 patients with synovial sarcoma.

The associate professor of medicine at University of Pennsylvania discussed new data from the BENEGENE-2 study of fidanacogene elaparvovec.

Review top news and interview highlights from the week ending January 20, 2023.

The FDA has lifted a clinical hold placed in the summer of 2022 due to a mild but medically significant case of peripheral sensory neuropathy.

Simeone discussed the design of BASECAMP-1, an observational study for patients previously treated for solid tumors who are at a high risk of relapse.

The company is reprioritizing to focus on its clinical stage programs, which ran into a number of setbacks in 2022.

Investigators analyzed data from 3 phase 3 studies and a long-term follow-up study.

Steven Pipe, MD, CS Mott Children’s Hospital, discussed the latest follow-up data from the HOPE-B study of the approved therapy, Hemgenix.

The chief executive officer of Cartherics discussed the company’s development of NK cell, T-cell, and macrophage cell therapies for various solid tumor indications.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

It was previously announced that CT103A received FDA clearance of its investigational new drug application for the treatment of relapsed/refractory (r/r) multiple myeloma.

A phase 1 clinical trial of EXG102-031 is expected to initiate in the first quarter of 2023.

The assistant member of the bone marrow transplant department at St. Jude Children’s Research Hospital discussed advantages of OTQ923 in treating SCD.

Forge Biologics’ FBX-101 previously demonstrated promising safety and efficacy in early data from the phase 1/2 RESKUE clinical trial.

Of the 20 mice treated with the experimental approach, 19 achieved clearance of residual tumor cells.

The director of clinical research at Sierra Eye Associates discussed data from the phase 1/2 PRISM study.