mAbs

A single-dose monoclonal antibody (mAb) to prevent RSV in infants met its primary Phase 3 endpoint “earlier than anticipated,” co-developers AstraZeneca and Sanofi announced Monday.

Nirsevimab reduced RSV-related lower respiratory tract infections in healthy infants compared to placebo through a typical RSV season, according to the press release.

Endpoints News quoted Sanofi CEO Paul Hudson as pledging to make the single-shot treatment “available for all infants, at vaccine…

GSK and Vir Biotechnology announced Wednesday that they are expanding their existing Covid-19 therapeutics collaboration to include research and development of treatments for influenza and other respiratory viruses, and exploration of up to three monoclonal antibodies to target non-influenza pathogens.

GSK will pay Vir $225 million upfront, increase its equity investment in the San Francisco-based biotech by $120 million, and shell out an additional $300 million if it exercises an…

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The state of the hunt:

Russia’s Sputnik V vaccine has reportedly been authorized in 26 countries.
  SAGE recommended that all countries proceed with planned rollouts of the AstraZeneca/Oxford jab, while the Africa CDC offered more cautious guidance, amid reports of low efficacy against viral variants.
  Tanzania has no plans to mount a Covid-19 immunization campaign.

 

Vaccines


Approved or authorized vaccines

SAGE backs AZ jab in all…

Evotec has dosed the first participant in a Phase 1 study of EVT894, its monoclonal antibody (mAb) to treat and potentially prevent chikungunya infections, the company announced last week.

Sanofi initially developed the mAb and licensed it to Evotec as part of the 2018 transfer of Sanofi’s Lyon-based infectious disease R&D unit to the German company, according to the press release.

CARB-X announced Wednesday an award of up to $13.6 million to fund Lumen Bioscience’s investigational oral monoclonal antibody cocktail for the prevention of diarrheal diseases caused by C. jejuni and E. coli.

Lumen hopes to produce a “food-grade immuno-prophylactic drug at low cost” suitable for use worldwide, including in areas lacking temperature control for health products, according to the CARB-X press release.

Florida-based Ridgeback Therapeutics on Tuesday announced U.S. FDA approval of its mAb114 (now branded as Ebanga) for treatment of Ebola in children and adults.

The monoclonal antibody therapy and Regeneron’s REGN-EB3 triple-antibody cocktail (now branded as Inmazeb) were shown to be superior in 2019 clinical trials to MappBio’s ZMapp and Gilead’s remdesivir for treatment of Ebola.

Regeneron’s Inmazeb won U.S. FDA approval in October.

CARB-X announced Wednesday an award of up to $14.3 million to fund Clarametyx Biosciences’ new treatment for serious bacterial biofilm infections.

Ohio-based Clarametyx is developing a monoclonal antibody (CMTX-101) to treat moderate-to-severe pneumonia through co-administration with standard antibiotic regimens, according to the company’s press release.

Maryland-based Sanaria announced last week that the EU Malaria Fund has awarded it $15.3 million to advance its two malaria vaccine candidates: PfSPZ and PfSPZ-CVac.

According to the press release, a portion of the funding will also support the development of a monoclonal antibody against malaria and of Sanaria’s oral, self-administered Covid-19 vaccine candidate, OraCOV.

Moderna has “regained all rights” to the respiratory syncytial virus (RSV) vaccine that it has been co-developing with long-time collaborator Merck, the Massachusetts-based company announced last week. The press release said Merck will complete ongoing Phase 1 trials of lipid nanoparticle-based mRNA-1172 before formally handing over the program and that Merck will focus on its RSV antibody program, currently in Phase 2.

With programs in various stages of clinical development, GSK, J…

The U.S. FDA on Wednesday approved Regeneron’s triple-antibody cocktail (REGN-EB3) for the treatment of Zaire ebolavirus in adults and children. Now branded as Inmazeb, the mixture of monoclonal antibodies becomes the first FDA-approved treatment for the disease.

The approval brings the New York-based company a priority review voucher and an estimated $335 million under a previously announced contract to supply the U.S. government.

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