Immutep Ltd.’s lead immunotherapy candidate eftilagimod (IMP-321, efti) met the primary endpoint in its phase II trial evaluating the combination of efti and Merck & Co. Inc.’s Keytruda (pembrolizumab) as first-line treatment of non-small-cell lung cancer (NSCLC), reporting final data that show an overall response rate of 40.4%.
GSK plc said it will restrict the second-line maintenance indication for ovarian cancer drug Zejula (niraparib) to only patients with deleterious or suspected germline BRCA mutations, at the request of the FDA, in a sign that U.S. regulators aren’t going to relax scrutiny on PARP inhibitors any time soon.
In August, Pact Pharma Inc. suspended its phase I trial after 16 patients had been treated with its autologous CRISPR-edited T cells “for business reasons,” the company announced at the time. Scientifically, though, the trial broke enough new ground to be concurrently presented in a late-breaking oral session at the 2022 annual meeting of the Society for the Immunotherapy of Cancer (SITC) and published as an accelerated article preview in Nature on Nov. 10, 2022.
New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer Annual Meeting including: Apexigen, Aulos, CG, Crispr, Cue, Curevac, Domain, Enterome, Immutep, Invios, Iovance, Medikine, Neoimmunetech.
The U.S. FDA hit a Phoenix-based Abraxis Biosciences LLC facility with a warning letter citing out-of-control aseptic manufacturing processes for Abraxane (paclitaxel), a key chemotherapy drug. The letter, posted Nov. 8, noted that multiple media fill failures occurred last year during simulated aseptic processing operations on the Abraxane filling line.
A new method for controlling naturally magnetized bacteria has improved the prospects of applying them as vehicles for intratumoral delivery of cancer drugs and in hyperthermia therapy.
Shares in Clovis Oncology Inc. (NASDAQ:CLVS) tumbled more than 71% after it warned it is facing bankruptcy with barely enough cash left to last until the end of 2022, debts of more than $3 billion, and dwindling revenues from its only approved cancer drug, Rubraca (rucaparib).
New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer Annual Meeting including: Affimed, Compugen, Genenta, Geneos, Hummingbird, Iovance, Nextcure, Nouscom, Oncolytics.
Biocytogen Pharmaceuticals Co. Ltd.’s subsidiary Eucure Biopharma Co. Ltd. has granted Isu Abxis Co. Ltd. rights to use its humanized agonistic anti-CD40 antibody YH-003 to develop cancer drugs.
Radiopharmaceutical company Telix Pharmaceuticals Ltd’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data.
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