Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.

In a pipeline shakeup, Tango Therapeutics Inc. has halted enrollment in a phase I/II study in order to push two other brain cancer drugs into development. TNG-908 had success in treating non-CNS solid tumors such as non-small-cell lung cancer and pancreatic cancer but missed the minimum pharmacokinetic exposure in clinical efficacy for treating glioblastoma.

Celltrion Inc. posted preclinical study results of two new antibody-drug conjugate (ADC) candidates – CT-P70 and CT-P71 – at the World ADC 2024 conference in San Diego Nov. 6, with plans to move the assets into clinical trials. Poster presentations of both ADC candidates “drew significant attention from the attendees” at the oncology meeting, Incheon, South Korea-based Celltrion said, while highlighting its efforts to transition from a biosimilar maker to a novel therapy developer.

Data from two Alzheimer’s tests being developed by Roche Holding AG showed high accuracy in detecting the disease in patients being tested for the condition. The tests measure biomarkers in the blood linked to Alzheimer’s and will help provide desperately needed information by letting patients know whether they have the disease or not, Margherita Carboni, Neurology Indication Lead at Roche Diagnostics told BioWorld.

Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York. The agency is trying to set up cell and gene companies for success and that’s a very different agency than what it was years ago, said Paul Bresge, CEO of Ray Therapeutics Inc.

Alongside the release of abstracts related to the American Society of Hematology meeting next month in San Diego, and as part of the firm’s third-quarter update, Beam Therapeutics Inc. disclosed that one patient died in the phase I/II trial testing BEAM-101 in sickle cell disease (SCD).

OSE Therapeutics SA has reported positive data for lusvertikimab in a phase II trial in ulcerative colitis, boosting the monoclonal antibody’s prospects of becoming the first anti-interleukin-7 therapy to reach the market.

A year out from Leqembi’s approval for Alzheimer’s disease (AD), ongoing research coupled with artificial intelligence is advancing both radiopharmaceuticals and small-molecule drugs for AD diagnostics and treatment, speakers at the 2024 KoNECT-MOHW-MFDS conference said.

Equillium Inc. plans to continue on its own with itolizumab – now the top pipeline priority – as Ono Pharmaceutical Co. Ltd. Is letting expire the option for rights to the monoclonal antibody, designed to target the CD6-ALCAM signaling pathway.