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BioWorld - Friday, March 5, 2021
Home » Topics » Clinical

Clinical
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ASCO GU: Janssen and Exelixis post positive data ahead of conference

Feb. 9, 2021
By Lee Landenberger
No Comments
Janssen Pharmaceutica NV and Exelixis Inc. are among the many companies releasing new data ahead of the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), which runs Feb. 11-13.
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Interna closes $22M series B round as it enters the clinic

Feb. 9, 2021
By Cormac Sheridan
No Comments
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.
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Heat Biologics shares sizzle as new phase II NSCLC data put it on path to possible pivotal trial

Feb. 9, 2021
By Michael Fitzhugh
No Comments
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.
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Swollen face

Kalvista’s angle of HAE attack firms up oral argument in phase II

Feb. 9, 2021
By Randy Osborne
No Comments
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.
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In the clinic for Feb. 9, 2021

Feb. 9, 2021
No Comments
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Amicus, BMS, Brooklyn Immunotherapeutics, Cardior, Curis, Cyclo, Evolve, Exelixis, Heat, Innate, Innovent, Ipsen, Janssen, Kalvista, Medigene, Melt, Neurorx, Opiant, Orchard, Paxmedica, Regenxbio, Sumitomo, Taiga, Trefoil, Turn.
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Avrobio reports new advances with upgraded gene therapy platform

Feb. 8, 2021
By Michael Fitzhugh
No Comments
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.
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(Micro)tubular bells chime for Veru with phase II pill against COVID-19 demon

Feb. 8, 2021
By Randy Osborne
No Comments
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.
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South African flag and syringe

South Africa shifts vaccination plan on SARS-CoV-2 variant data

Feb. 8, 2021
By Nuala Moran
No Comments
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.
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In the clinic for Feb. 8, 2021

Feb. 8, 2021
No Comments
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.
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Astrazeneca-COVID-19-vaccine-vials

Positive news: Astrazeneca vaccine still effective in B.1.1.7 SARS-CoV-2 variant

Feb. 5, 2021
By Nuala Moran
No Comments
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.
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