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.
Despite Beyondspring Pharmaceuticals Inc.’s phase III study meeting its primary and key secondary endpoints of a plinabulin/docetaxel combination in treating non-small-cell lung cancer (NSCLC), the company stock (NADAQ:BYSI) took a pounding. Shares sunk 32.9% on Sept. 20 to close at $15.36 each.
Pfizer Inc. and Biontech SE have announced new data that could pave the way for childhood COVID-19 vaccine programs, with findings of a trial showing their shot is safe and effective in children of 5 to 12 years of age.
Shares of Protagonist Therapeutics Inc. (NASDAQ:PTGX) fell 62% to $17.53 on Sept. 17 after it reported finding malignant skin tumors in a mouse model test of its most advanced candidate, rusfertide for blood disorders. After the company notified the FDA, the regulator put the program on a clinical hold, leading dosing of patients in all ongoing trials of rusfertide to be halted for now. The development could impact Protagonist's ability to start phase III testing of the candidate in polycythemia vera (PV) early in 2022, as well as efforts to expand its development to a third indication beyond PV and hereditary hemochromatosis (HH) by the end of this year, as it has planned.
Nearly 18% of clinical data reported in August were focused on the COVID-19 pandemic, representing the highest percentage for any single month this year. During the month, as the Delta variant took hold throughout the U.S., news of COVID-19 efforts spiked, doubling the amounts seen in both June and July, in which about 9% of the news was pandemic-related, and up significantly from 10% in May.
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