News

The dosing of additional patients in a double-blind, placebo-controlled design will help support a BLA submission for TSHA-120.

Mesoblast is resubmitting its BLA with new CMC, survival, and mechanism of action data on the therapy and phase 3 trial.

AB-101 is also being investigated with the innate cell engager AFM13 for CD30 lymphomas.

Olga Uspenskaya, MD, PhD, vice president, clinical development, Prevail Therapeutics, discussed the PROCEED trial of PR001.

Positive preclinical data related to SENTI-202 and SENTI-401 were presented at conferences last year.

MCO-010 is in phase 2 clinical trials for treating retinitis pigmentosa and Stargardt disease.

The professor of pediatrics at Stanford Cancer Institute discussed recent data from clinical trials of the lentiviral gene therapy RP-L102.

There were no deaths or safety signals identified by the DSMB for the 3 treated patients in cohort 1.

Sana Biotechnology also plans to submit another IND for the same indications for a CD22-targeted CAR T later in 2022.

The phase 1 portion of the trial assessing CNA3103 will start enrollment in Australia in the first half of 2023; the phase 2 portion will expand to the US.

Cilta-cel demonstrated a significant improvement in progression-free survival over standards of care.

Review top news and interview highlights from the week ending January 27, 2023.

The chief executive officer and president of Eterna Therapeutics discussed the company’s new collaboration with the University of Texas MD Anderson Cancer Center.

No dose-limiting toxicities were observed at 28 days of follow-up.

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.

No patients treated with Tevogen Bio’s TVGN 489 showed progression of their COVID-19 infections.

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.