Pfizer Inc. said that, in children aged 5 through 11, the COVID-19 vaccine it co-developed with Biontech SE showed 90.7% efficacy against all variants of concern following two doses. The data were included in briefing documents filed ahead of a full discussion at the FDA’s Vaccines and Related Biological Products advisory committee meeting set for Oct. 26.
Sio Gene Therapies Inc. CEO Pavan Cheruvu said the company sees no “significant rate limiters to moving forward” with FDA fast-tracked AXO-AAV-GM1 for the treatment of GM1 gangliosidosis. Shares of the New York-based firm (NASDAQ:SIOX) closed at $2.36, up 21 cents, as Wall Street welcomed positive interim data from the ongoing phase I/II study with the adeno-associated viral vector 9-based gene therapy for GM1 gangliosidosis.
Stealth Biotherapeutics Corp.’s refusal to file (RTF) letter from the FDA regarding the NDA for elamipretide, a candidate that targets mitochondria in the treatment of Barth syndrome, hardly knocked the stock, as investors likely saw the bad news coming.
The Menarini Group and Radius Health Inc.’s phase III Emerald study of oral elacestrant as a monotherapy vs. standard of care in treating estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer hit its two primary endpoints. The study’s top-line data, according to the companies, showed statistically significant progression-free survival in both the overall population and in patients with tumors harboring estrogen receptor 1 mutations.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Atea, Avadel, Avrobio, Cour, Dicerna, Edesa, Eli Lilly, Entasis, Galera, Harbour, Immune, Immunitybio, Inhibikase, Iterion, Noxxon, Ono, Opthea, Paratek, Pharnext, Seal Rock, Sifi, Small, Statera, Ultragenyx, Vyne.
Natera Inc. added its Prospera assessment for lung transplant patients to its portfolio, joining the company’s tests for rejection of kidney and heart transplants. The test uses donor-derived cell-free DNA (dd-cfDNA) to detect acute rejection as well as chronic rejection and infection in stable patients. Results of the VALID study presented at CHEST 2021 demonstrated that the Prospera Lung test had a negative predictive value of 97.33%, sensitivity of 89.06% and area under the curve of 0.91.
LONDON – Inivata Ltd. is extending efforts to bring its liquid biopsies into routine use, in two new clinical trials in lung cancer. The first will attempt to show increased speed in getting advanced non-small-cell lung cancer (NSCLC) patients on to the most appropriate therapies. The second study aims to demonstrate that detecting circulating tumor DNA (ctDNA) will single out those early-stage lung cancer patients who have residual or recurring disease after surgery and need further treatment with chemo- or immuno-therapies.
Based on positive phase IIb data from 2020 for avasopasem manganese (GC-4419) in treating severe oral mucositis (SOM) in patients with locally advanced head and neck cancer, Galera Therapeutics Inc. had been confident about phase III data for the selective small-molecule dismutase. However, the phase III Roman trial failed to hit its primary endpoint of reduction in the incidence of SOM. Mel Sorensen, Galera’s CEO, expressed his surprise at the results and said the company is evaluating the next steps for the program.
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