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.
“I think elections are like pregnancy. … Everyone puts all of the energy into D-day – the birth. We’ve had the gender reveal, but what really, really matters is what happens now and the path ahead.” That was the instant response of Emma Walmsley, CEO of GSK plc, reacting to breaking news from the U.S. that Donald Trump has won a second term in office.
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.
Beijing Normal University presented data on fibroblast activation protein (FAP)-targeting agents containing a nitroimidazole moiety, [68Ga]/[177Lu]AAZTA-NI-FAPI-04, being developed for the potential imaging and treatment of cancer.
Scientists from the University of Wisconsin-Madison have reported the discovery of novel carbonic anhydrase IX (CAIX) radioligands for molecular imaging in clear cell renal cell carcinoma (ccRCC).
Researchers from Eli Lilly & Co. presented the discovery and preclinical characterization of a novel protein tyrosine kinase 7 (PTK7)-targeting antibody-drug conjugate (ADC), LY-4175408, being developed for the treatment of cancer.
Iksuda Therapeutics Ltd. disclosed the design of a novel, effective and safe antibody-drug conjugate (ADC), IKS-012, for the potential treatment of folate receptor α (FRα)-positive cancers.
Avacta Life Sciences (Avacta Group plc) presented preclinical data on AVA-6103, a second-generation Precision peptide-drug conjugate, being developed for the potential treatment of cancer. AVA-6103 was developed using the company’s proprietary Precision technology incorporating a dipeptide specifically cleaved by fibroblast activation protein α (FAPα) leading to tumor-specific delivery of exatecan directly into the tumor cells.
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.
RSS
