BEIJING – CAR T-cell therapeutics developer Carsgen Therapeutics Co. Ltd., of Shanghai, won IND clearance from the FDA for its first-in-class CT-041 for advanced gastric and pancreatic cancers. The company said it is the first claudin18.2 (CLDN18.2)-targeted CAR T-cell therapy cleared for clinical trials in the world.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Antisense, Apollomics, Arvelle, Entera Bio, Galapagos, Gilead, Kadmon, Poseida, Tonix.
Saying it’s too early to gauge the potential economic benefit of a marketed COVID-19 therapy for his firm, Aldeyra Therapeutics Inc. CEO Todd Brady cited “a strong feeling of altruism” among researchers addressing the crisis, as they turn over discoveries likely to be helpful beyond it.
LONDON – MGB Biopharma Ltd. is looking for new investors or a commercialization partner to take its lead program, MGB-BP-3, through to market, after reporting 100% initial and sustained cure of Clostridium difficile infections in a phase IIa dose-ranging study.
DUBLIN – Kancera AB is the latest contender to reposition a clinical-stage small molecule with an immunomodulatory mechanism as a drug candidate for COVID-19.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkermes, Arch, Astex, Beyond Air, Cidara, Cyclo, Diffusion, Forma, KBP, Roche, Santhera.
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors.
LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Amplyx, Arbutus, Biogen, Covis, Hepion, Lidds, Mezzion, MGB Biopharma.
Balt USA LLC, of Irvine, Calif., has received a thumbs up from the FDA to begin an IDE trial of its Squid liquid embolic device for the treatment of chronic subdural hematoma (cSDH). The nonadhesive agent offers a minimally invasive option for a disabling neurological condition that often requires brain surgery to correct.
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