DUBLIN – After a COVID-19-induced delay that set it back most of last year, Interna Technologies BV has moved its first microRNA-based drug development program into the clinic and has also unveiled €18.5 million (US$22.4 million) in a series B funding round, which it completed in two stages.
New interim phase II data in advanced non-small-cell lung cancer (NSCLC) has shown that a combination of Heat Biologics Inc.'s cell therapy candidate, HS-110 (viagenpumatucel-L), and Bristol Myers Squibb Co.'s Opdivo (nivolumab) helped extend overall survival for both checkpoint inhibitor-naïve patients and those who had been treated with a checkpoint inhibitor but whose disease had later progressed.
Kalvista Pharmaceuticals Inc.’s chief development officer, Christopher Yea, said the across-the-board positive phase II top-line data with KVD-900 for on-demand use against hereditary angioedema (HAE) attacks will open “a very flexible discussion with regulators” regarding the design and endpoints of the phase III study to come with the oral kallikrein inhibitor. Shares of the Cambridge, Mass.-based firm (NASDAQ:KALV) closed at $33.50, up $17.89, or 115%, after reaching a high of $45, as Wall Street digested the findings.
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.
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