The FDA’s pre-IND response to Virpax Pharmaceuticals Inc.’s MMS-019, a molecular masking spray being developed as an over-the-counter product to limit transmission of SARS and influenza, has the company breathing easier and ready to chase an NDA. The company joins the COVID-19 inhalation race, which includes 43 intranasal vaccine and therapeutics programs looking for approval. Preclinical data from ex vivo studies showed MMS-019 demonstrated reduction of infectivity from respiratory viruses such as influenza and SARS-COV-2. The polymer is being developed as a pharmaceutical excipient for clinical use under IND-enabling studies using an analgesic molecule, with ongoing research funded by the U.S. NIH’s National Center for Advancing Translational Sciences.

Alexion’s phase III Ultomiris trial in ALS fails

A month after Astrazeneca plc’s $39 billion takeover of Alexion Pharmaceuticals Inc. was finalized, the merged company has hit its first speed bump after the new unit discontinued a phase III rare disease trial. Alexion said it has axed the 382-patient CHAMPION-ALS trial of its long-acting C5 complement inhibitor Ultomiris (ravulizumab) in amyotrophic lateral sclerosis (ALS). The randomized, double-blind placebo-controlled study’s Independent Data Monitoring Committee recommended the trial should be discontinued because of a lack of efficacy.

Biopharma M&As rise on AZ/Alexion merger, but still down from last year

Completion of the third largest biopharmaceutical acquisition on record has significantly boosted M&A values in 2021, although the industry still falls more than 38% below the same period last year. In July, Astrazeneca plc sealed its $39 billion deal with Alexion Pharmaceuticals Inc., while Morphosys AG also played its part, closing a $1.7 billion buyout of Constellation Pharmaceuticals Inc. That narrows the M&A value gap with 2020 from 76% in June to just over 38% currently. This year’s 94 completed M&As worth $74.5 billion compare with 82 worth $121.4 billion by this point in 2020. BioWorld also has recorded 1,296 deals valued at $113.3 billion in 2021 vs. 1,337 worth $127.65 billion last year.

COVID-19 antibody therapies advance with new data, U.K. green light

Astrazeneca plc, playing catch-up among its peers in the race to deliver an antibody therapy for COVID-19, has cleared a crucial hurdle after its long-acting combination therapy, AZD-7442 met the goals of a phase III pre-exposure prophylaxis trial. The U.K.-based pharma’s report came just as Regeneron Pharmaceuticals Inc. announced the MHRA’s conditional marketing authorization for its Roche Holding AG-partnered COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), also known as REGEN-COV.

Gene therapy ameliorates androgen receptor-driven neuromuscular disease

For most people, neither polyglutamine disorders nor neuromuscular disorders are likely to be among the things they associate with androgen receptor (AR) dysfunction. But the three are indeed linked. And researchers have reported new insights into the nature of those links that could lead to a treatment for Spinal and Bulbar Muscular Atrophy, and possibly other disorders linked to AR signaling dysfunction.

Abogen raises $700M to help fund first Chinese COVID-19 mRNA vaccine

Suzhou Abogen Biosciences Co. Ltd.’s $700 million series C fundraising provides tailwinds for the development of its messenger ribonucleic acid (mRNA) platform. The company plans to accelerate its COVID-19 mRNA vaccine clinical trial, develop other vaccine candidates and oncology programs.

Imugene raises AU$90M to progress pipeline, pursue Celularity deal

PERTH, Australia – Imugene Ltd. has closed an AU$90 million (US$64 million) placement and an AU$5 million share repurchase plan (SPP) that will allow the company to progress its CAR T pipeline through 2025 and pursue a collaboration with Celgene Corp. spinoff Celularity Inc.

Also in the news

AB Science, Alloplex, Amyris, Astellas, Astrazeneca, Bionova, Covis, Daewoong, Dialectic, Fate, Geovax, Gilead, Hanall, Hebabiz, Insilico Medicine, Kadmon, Lantern, Marker, Ortho Regenerative Technologies, Palisade, Plus, Progenity, Regencell, Regeneron, Sonnet, Sorrento, Vitality