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.
Cstone Pharmaceuticals Co. Ltd. released positive data from the phase III trial, Gemstone-302, of sugemalimab plus chemotherapy for the first-line treatment of patients with stage IV squamous and non-squamous non-small cell lung cancer.
Autumn's arrival in the Northern Hemisphere on Sept. 22 swept in significant news of progress for the global fight against COVID-19. A protein-based COVID-19 vaccine candidate from Clover Biopharmaceuticals Ltd. and Dynavax Technologies Corp. appeared wholly effective in preventing severe disease and hospitalization, sending Dynavax shares (NASDAQ:DVAX) climbing 26.5% to close at $18.79 on Sept. 22. In another study of Gilead Sciences Inc.'s Veklury (remdesivir), the drug significantly reduced hospitalization in high-risk patients with COVID-19. Meanwhile, governments and companies continued to expand efforts to supply new vaccines and therapeutics against the disease even as efforts continued far and wide to evaluate the efficacy of new and emerging candidates in both categories.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Clearside, Demerx, Hightide, Hoth, Hutchmed, J&J, Lyra, Moderna, Poxel, PTC, Rhovac, Small Pharma, Stoke, Vigeo, Zenith.
Fresh data from Johnson & Johnson show COVID-19 protection dramatically increased with a booster shot of its single-dose vaccine, adding momentum to the U.S. drive for boosters.
Sanofi SA’s high-profile phase III blow-up Sept. 9 with the oral BTK inhibitor rilzabrutinib in pemphigus brought fresh attention to the group of rare diseases – which cause blisters on the skin and mucous membranes throughout the body – and to players pushing for a new treatment.
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