mRNA

Serum Institute of India (SII) will pursue an mRNA vaccine against shingles under a tie-up with Boston-based GreenLight Biosciences, the companies announced Monday. Under the agreement, GreenLight “will work to discover and design” a shingles jab and up to two other products for SII to develop, manufacture and commercialize in emerging markets in Africa, parts of Asia, Latin America and the Middle East, per a joint press release. GreenLight will retain rights for markets in Australia, China…

Moderna on Monday unveiled a sweeping global health strategy that includes an mRNA manufacturing facility in Kenya, an expanded pledge not to enforce patents on its Covid-19 shot in certain countries, and a portfolio of 15 vaccine programs targeting emerging or neglected infectious diseases. But the company also made clear it would pursue these objectives on its own terms, brushing aside activist demands that it share intellectual property with the WHO-led mRNA technology transfer hub in…

Moderna’s mRNA-based RSV vaccine candidate (mRNA-1345) has advanced to Phase 3 in adults age 60 and older, the Massachusetts-based company announced Tuesday. The U.S. FDA Fast Track-designated shot joins RSV candidates from J&J and Pfizer in late-stage trials. Numerous other vaccine makers are also in the race to bring the first RSV jab to market.

In other RSV news, Enanta Pharmaceuticals last week touted positive Phase 2 data on EDP-938, the Massachusetts-based firm’s N-protein…

WHO has established a “global biomanufacturing training hub” in South Korea that will serve LMICs aspiring to manufacture their own vaccines and therapies, according to a joint announcement Wednesday from the U.N. health agency, the South Korean government and the WHO Academy.

The selected facility outside Seoul has already been training domestic biomanufacturing companies, and will now work with the WHO Academy to expand its curriculum and accommodate researchers from around the…

CureVac has dosed the first participant in a Phase 1 trial of its multivalent mRNA-based seasonal influenza vaccine candidate (CVSQIV) developed with GSK, CureVac announced last week. The companies inked an mRNA collaboration deal in 2020 when GSK invested in the German biopharma.

In other flu news, Cidara Therapeutics announced Monday that the U.S. FDA has accepted its Investigational New Drug (IND) application for the company’s universal influenza antiviral CD388. J&J’s Janssen…

BioNTech on Wednesday introduced the modular mRNA vaccine manufacturing platform it plans to deploy in Africa. But the fanfare was overshadowed by allegations—published last week in The BMJ—that a consultancy in the pay of the German company has sought to “undermine” a WHO-managed initiative for a multilateral mRNA technology transfer hub in South Africa. According to the BMJ article, the Malta-based Kenup Foundation circulated a report last year to South African government officials arguing…

Moderna and the International AIDS Vaccine Initiative (IAVI) have dosed the first participants in a Phase 1 trial of an experimental mRNA-based HIV vaccine (mRNA-1644) and boost candidate (mRNA-1644v2-Core), according to a joint press release issued last week.

The trial builds off a previous proof-of-concept study showing that a compound (developed by IAVI and Scripps Research) in mRNA-1644 generated a B-cell response in 97% of recipients. Both trials are part of a Gates Foundation-…

Current winners of the Covid-19 vaccine race previewed plans for their windfalls at last week’s 40th J.P. Morgan Healthcare Conference, which took place virtually for the second consecutive year.

Moderna trumpeted $17.5 billion in 2021 Covid-19 product sales and sounded an optimistic note about the year ahead, claiming $18.5 billion in advance purchase agreements for vaccine or booster doses for delivery in 2022. Also, CEO Stéphane Bancel embraced the goal of bringing to market a “pan…

Merck KGaA will bolster its mRNA contract manufacturing business with the $780 million acquisition of Exelead, an Indiana-based CDMO, the multinational announced last week.

Exelead’s specialties include lipid nanoparticle-based drug delivery technology used in mRNA-based therapeutics, according to a Merck press release.

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Pfizer and BioNTech will jointly develop a third mRNA-based vaccine using Pfizer’s antigen technology and BioNTech’s mRNA platform—this time against shingles.

Under deal terms announced Wednesday, BioNTech will lock up $75 million in cash and an equity investment of $150 million from Pfizer. The German company could also earn milestone payments worth up to $200 million and a share of the profits, according to a joint press release. Pfizer, meanwhile, will get $25 million upfront from…