The U.S. FDA has approved the country’s first-ever respiratory syncytial virus (RSV) vaccine, Arexvy, from GSK plc. The adjuvanted vaccine is also the first for older adults anywhere on the planet. GSK now has a head start to vaccinate the U.S. market, but other big companies, such as Sanofi SA and especially Pfizer Inc., are in late-stage development and will pose strong challenges in the coming year. Pfizer’s PF-0692831/RSVpreF, an RSV vaccine for treating lower respiratory tract disease caused by RSV, has a priority BLA with a May 31 PDUFA date.
A precancerous condition caused by the human papillomavirus (HPV) affects up to 300,000 American women who are diagnosed each year, and yet there are no treatments, just preventive vaccines introduced in 2006 – targeted to younger generations prior to the first sexual encounter. That leaves a large proportion of the female population stuck with a “wait-and-see” approach that involves continuous monitoring of their HPV infection through pap smears to detect cellular changes that could lead to cervical cancer. South San Francisco-based Antiva Biosciences Inc. is seeking to find a better response to this condition known as high-grade cervical intraepithelial neoplasia (CIN2,3) with its lead topical therapeutic, ABI-2280, a prodrug of an acyclic nucleoside phosphonate that is currently in phase I trials.
Rnaimmune Inc., a nonwholly owned subsidiary of Sirnaomics Ltd., has received clearance from the FDA for its IND application to conduct a phase I trial for RV-1730, a SARS-CoV-2 vaccine booster candidate.
The supply chain for Seres Therapeutics Inc.’s oral microbiome therapeutic Vowst, formerly known as SER-109, to prevent recurrent Clostridium difficile infection (rCDI) is “well-established,” said David Arkowitz, the firm’s chief financial officer and head of business development. “It’s the same supply chain that we used for phase III [trials], and we’ve been manufacturing product for launch for some time.” Arkowitz spoke during a conference call with investors April 27, regarding the previous day’s U.S. FDA go-ahead for Vowst, cleared for adults with rCDI, including first recurrence following antibacterial therapy.
As expected, Seres Therapeutics Inc. gained U.S. FDA approval of the BLA for the oral microbiome therapeutic Vowst, formerly known as SER-109, for prevention of recurrent Clostridium difficile infection (rCDI), accepted for priority review in October of 2022 without an advisory committee meeting.
A Blacksmith Medicines Inc. patent describes the development of prodrugs of UDP-3-O-(R-3-hydroxymyristoyl)-N-acetylglucosamine deacetylase (LpxC) (bacterial) inhibitors reported to be useful for the treatment of complicated urinary tract infections (UTIs).
Turbinmicin analogues reported to be useful for the treatment of fungal infections have been described in a recent Wisconsin Alumni Research Foundation (WARF) patent.
A unique characteristic of Helicobacter pylori could serve to end infections of this gastric bacterium. A group of scientists from the University of Munich have found that this pathogen has a strategic point in its mitochondrial respiratory complex I that could be targeted with inhibitors. “We did not look for respiration inhibitors in the first place,” co-senior author Wolfgang Fischer told BioWorld. “We screened libraries with a reporter assay, looking for something different, a particular protein secretion, the secretion system type (T4SS). Then, we found that a lot of compounds inhibit this process. From these compounds, we came to the point that they are actually respiration inhibitors,” he explained.
Researchers at NYU Langone Health and Janssen Biotech Inc. have reported on mAbtyrins, bioengineered molecules composed of human monoclonal antibodies and centyrins that are a new way to fight Staphylococcus aureus infection on all fronts.In their experiments, which were published in Cell Host & Microbe on April 24, 2023, the team described mAbtyrin, as “a protein-based therapeutic that targets 10 disease-causing mechanisms employed by S. aureus,” senior author Victor Torres told BioWorld.
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