Now that Pfizer Inc.-Biontech SE has submitted initial phase II/III study data to the FDA bolstering the case for an emergency use authorization (EUA) for its COVID-19 vaccine to children ages 5 through 11 years, the competition, including Moderna Inc., Novavax Inc. and Sanofi SA, falls further behind.
What one analyst characterized as “a little bit of an exotic or at least unusual statistical analysis on the phase II primary endpoint” may have dampened enthusiasm somewhat for Evelo Biosciences Inc.’s results in mild and moderate psoriasis with EDP-1815, but the firm is advancing the compound to registration studies.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astex, Astrazeneca, Capricor, Glycomimetics, Innovent, Kyowa Kirin, Novavax, PTC, Reven, Roche, SAB, Sarepta, Scholar Rock, TG, Vtv.
Paul Peter Tak means business. In one very active year, the entrepreneurial president and CEO of Candel Therapeutics Inc., an oncolytic viral immunotherapy company he said was long run as cost-efficient "semi-academic lab,” has hired on a new chief business officer and CFO, recruited a new research advisory board, and led the company to completion of a $79.1 million IPO. Now, ahead of a weekend presentation of data on one of the company's lead candidates for fast-growing brain tumors, shares (NASDAQ:CADL) that dipped post-IPO are again climbing as the company works to develop a slow-growing class of new medicines.
Capricor Therapeutics Inc. CEO Linda Marban said the company’s CAP-1002 for Duchenne muscular dystrophy (DMD) should serve as “adjunctive to any of the therapies out there” – a handful are approved – and bring bonus favorable effects on cardiac function that one analyst called “a one-two punch” against the disease.
Imugene Ltd.’s recent win with a patent granted in Japan with its HER-Vaxx immunotherapy, in development for HER2-positive gastric cancer, represented a smallish but significant win in the HER2/neu space, where plenty of other players are busy, with Greenwich Life Sciences Inc. a strong emerging name.
Astrazeneca plc and Merck & Co. Inc. have data for a new indication for their blockbuster PARP inhibitor class drug Lynparza (olaparib) in advanced prostate cancer in combination with standard abiraterone therapy. The companies said the Propel phase III study testing Lynparza in combination with abiraterone showed a statistically significant and clinically meaningful improvement in radiographic progression-free survival in first-line metastatic castration-resistant prostate cancer vs. standard abiraterone care.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Appili, Ascendis, Ayala, Bellus, Cytovation, Daré, Horizon, Immunocore, Nicox, Novan, Point, TFF, Valneva.
When an independent data monitoring committee told Immunocore Ltd. plc’s David Berman in November that tebentafusp had met a phase III study’s pre-defined boundaries for statistical significance in overall survival (OS) after its first pre-planned interim analysis, the head of R&D was shocked.
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