News

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.

The European Commission granted conditional marketing authorization under the name Beqvez to the European Union.

The chief scientific officer of Tome Biosciences discussed the company’s technologies in the context of integrative gene therapy and cell therapy.

There were no serious adverse events related to the cell therapy and no evidence of ARIA.

Steve Kanner, PhD, the chief scientific officer of Caribou Biosciences, discussed results from preclinical research evaluating the gene editing approach.

Omar Nadeem, MD, clinical director, Myeloma Cellular Therapies, Dana-Farber Cancer Institute, discussed GPRC5D-targeted CAR-T, BMS-986393.

The company acquired the program, along with Spark Therapeutics’ pipeline, in December 2019.

Review top news and interview highlights from the week ending July 26, 2024.

The principal investigator at Seattle Children’s Research Institute discussed her lab’s work on using ultrasound mediated gene delivery to target hemophilia A.

The clearance is based on the agency’s acceptance of clinical trial protocols and a chemistry, manufacturing, and controls clinical development plan for the program.

Cell and gene therapies can transform the paradigm of care for patients with chronic, complex conditions, but these therapies come at an up-front cost of several million dollars per treatment, complicating the pipeline of access to them.

IASO also received IND clearance for a trial in myasthenia gravis in April 2024.

The Don and Marilyn Anderson Professor of Oncology at University of Wisconsin – Madison discussed the state of cell and gene therapy development.

It was noted that the patient, who is 1 of 6 treated in the study so far, may be showing clinical activity in response to their first dose with the CER-T.