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In Brief This Week: Anixa Biosciences, Rocket Pharmaceuticals, RadioMedix, Kinea Bio, PanTera

NEW YORK – Anixa Biosciences this week treated the first patient in the second cohort of an ongoing Phase I trial of its follicle stimulating hormone receptor-mediated CAR T-cell therapy. The patient has received triple the dose of CAR T cells compared with the three patients in the first cohort. Anixa CEO Amit Kumar said the researchers observed no safety issues in the first cohort. The trial, which began in August 2022, will enroll up to 48 ovarian cancer patients. 

Rocket Pharmaceuticals this week said the US Food and Drug Administration has extended the priority review period for the company's biologics license application for a gene therapy for severe leukocyte adhesion deficiency-I, Kresladi (marnetegragene autotemcel). The agency now expects to issue a decision on Kresladi by June 30, a three-month extension designed to allow additional time for the agency to review chemistry, manufacturing, and controls information that Rocket submitted in response to a request from the FDA. 

The US Food and Drug Administration this week granted breakthrough therapy designation to RadioMedix and Orano Med's radiopharmaceutical, AlphaMedix (212Pb-DOTAMTATE) as treatment for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients who have not received prior peptide receptor radionuclide therapies. The designation — which is meant to expedite development and review for particularly promising drugs in difficult-to-treat diseases — is based on encouraging data from a Phase I clinical trial and ongoing Phase II clinical trial of AlphaMedix in GEP-NET patients who had never received treatment with Novartis' Lutathera (lutetium Lu 177 dotatate). 

Parent Project Muscular Dystrophy this week announced $500,000 in funding to Kinea Bio through the nonprofit's venture philanthropy program. Kinea will use the funding to complete preclinical studies of its adeno-associated virus vector-based gene replacement therapy, a treatment it's developing for Duchenne muscular dystrophy, a condition caused by mutations in the DMD, or dystrophin, gene. The gene therapy is designed to deliver a "midi-dystrophin" transgene developed by the company to muscle cells. 

PanTera said this week that it has inked a deal with Bayer to supply the radioisotope actinium-225 to Bayer to support its radiopharmaceutical development. PanTera is developing a large-scale production facility as part of its goal to become a major EU actinium-225 supplier. The deal supports Bayer in developing targeted alpha therapies that use actinium-225. The deal will begin during the second half of 2024. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.