Vir Biotechnology presents new data on VIR-2482 in prevention of Influenza A

The two abstracts accepted for poster presentation include:

Preliminary, blinded pharmacokinetic and safety data from the first-in-human, randomized, placebo-controlled Phase 1 study, which demonstrate that intramuscular dosing of -2482 was well tolerated among healthy volunteers at doses up to 1,800mg (Abstract #631). The preliminary pharmacokinetic profile also shows a prolonged half-life, which could enable once-per-season dosing.

Preclinical data, which show that -2482 has broad binding and neutralizing potential against all major strains of influenza A, including pandemic strains, from the last 100 years (Abstract #1231). Additionally, -2482 administered prophylactically 24 hours prior to lethal doses of influenza significantly reduced morbidity and prevented mortality in mouse models.

The data presented at IDWeek quantify the magnitude of the urgent need for a universal influenza A-neutralizing monoclonal antibody with high efficacy. The data also suggest that -2482, because of its broad influenza A strain coverage, potency and prolonged half-life, has the potential to be the first neutralizing monoclonal antibody to address this large unmet need.

Vir and Alnylam identify RNAi therapeutic development candidate for the treatment of the-virus

Vir Biotechnology, Inc. () and Alnylam Pharmaceuticals, Inc. () today announced the selection of a development candidate for the potential treatment and/or prevention of redacted. […]
The companies plan to soon meet with the U.S. Food and Drug Administration (FDA) and other regulatory authorities to discuss a potential accelerated path for filing an Investigational New Drug (IND) or IND equivalent application at or around year-end 2020, less than a year since program initiation. The companies plan to advance -2703 (also referred to as ALN-COV), an investigational RNAi therapeutic targeting the redacted genome, as an inhalational formulation for the potential treatment and/or prevention of redacted.

In its discovery efforts, Alnylam synthesized over 350 small interfering RNAs (siRNAs) – the molecules that mediate RNAi – targeting highly conserved regions of the redacted genome, which were then analyzed bioinformatically and assessed in in vitro potency assays. Multiple highly potent siRNAs were identified that demonstrated a 3-log reduction of viral replication in an in vitro redacted live virus model conducted by Vir. In dose-response assays, -2703 was shown to have an effective concentration for 50% inhibition (EC50) of less than 100 picomolar and an EC95 of less than 1 nanomolar in the redacted live virus model measuring inhibition of infectious virion production. Further, -2703 has predicted reactivity against greater than 99.9 percent of the over 4300 redacted genomes currently available in public databases that meet analysis requirements, and is also predicted to have reactivity toward the redacted-CoV genome from the 2003 redacted outbreak. With this DC selection, Vir and Alnylam will work closely together to generate the data required to enable rapid commencement of clinical studies.

-2703 is an inhaled redacted-targeting siRNA that may have utility for prevention or for treatment. It leverages Alnylam Pharmaceuticals, Inc.’s latest advances in lung delivery of siRNAs and may have applicability to other redactedes as well. -2703 is the first development candidate selected in the company’s expanded collaboration with Alnylam for up to four RNAi potential therapeutics for redacted.

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines, known as RNAi therapeutics, is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.