Avrobio Inc. said Feb. 8 that the first person dosed with AVR-RD-01, an investigational ex vivo lentiviral gene therapy from its upgraded manufacturing platform, Plato, experienced a complete clearance of the toxic substrate lyso-Gb3 in a kidney biopsy.
CEO Mitchell Steiner said Veru Inc. at first downplayed the prospects of oncology candidate VERU-111 in COVID-19 treatment but now, with positive phase II data in hand, the company has a moral obligation to push onward to late-stage research.
LONDON – South Africa has decided against using the 1 million doses of Astrazeneca plc’s COVID-19 vaccine already in the country to start the rollout of its national vaccination program, in favor of opening a phase IIIb study of Johnson & Johnson’s single shot product. “Over the next few days, we expect to announce a plan to expedite vaccination using [J&J’s] investigational vaccine in health care professionals in South Africa,” said Glenda Gray, CEO of the South African Medical Research Council and chair of the country’s research committee on COVID-19.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Avrobio, Cassava, Covaxx, Cue, Dong-A, Eiger, Erytech, Freeline, Jasper, Magenta, Sinovac, Uniqure, Veru.
LONDON – A follow-up study of participants in the phase II/III U.K. trial of Astrazeneca plc’s COVID-19 vaccine has shown it remains effective against the new B.1.1.7 variant of SARS-CoV-2.
In the wake of Study 045’s failure with Translarna (ataluren) in nonsense mutation Duchenne muscular dystrophy, PTC Therapeutics Inc. is “trying to thread the needle between the notion of getting Study 041 completed in the third quarter of 2022 vs. getting accelerated approval now,” CEO Stuart Peltz said.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achilles, Astrazeneca, Covaxx, GSK, I-Mab, PTC, Sanofi, Spark, Spero.
Probably no one was surprised by the FDA’s recent nod for the combination of Alameda, Calif.-based Exelixis Inc.’s tyrosine kinase inhibitor, Cabometyx (cabozantinib), which targets MET, AXL and VEGF, and PD-1 drug Opdivo (nivolumab) from Bristol Myers Squibb Co. as a first-line treatment for advanced renal cell carcinoma (RCC), but investors may feel less confident about the odds for the pairing in a competitive space.
LONDON – The U.K has started the world’s first trial alternating an adenoviral vectored COVID-19 vaccine with one that delivers the virus spike protein instructions encoded in messenger RNA. The heterologous prime boost trial will recruit 820 participants into an eight-arm study comparing different combinations of the Astrazeneca plc/Oxford University and Pfizer Inc./Biontech SE vaccines, administered in a different order and at different intervals.
PERTH, Australia – Synthetic cannabinoid company Botanix Pharmaceuticals Ltd. announced top-line data from a phase IIa study showing that two different formulations of BTX-1801, a synthetic cannabidiol, eradicated Staphylococcus aureus (staph) in the nose, meeting study endpoints for safety and efficacy.
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