mAbs

Eli Lilly announced Tuesday that its Lilly Bio-Medicines unit will split into separate neuroscience and immunology business units, effective September 5.

Lilly Neuroscience—to be led by current oncology chief Anne White—will manage the company’s Phase 3 portfolio in pain and neurodegeneration, including the “potential launch of donanemab,” its U.S. FDA Breakthrough Therapy candidate for Alzheimer’s disease, the press release said.

Meanwhile, veteran executive Patrik Jonsson will…

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The New England Journal of Medicine published Phase 1 results Wednesday from a small trial showing that a single infusion of an investigational antimalarial monoclonal antibody (CIS43LS) prevented infection for up to nine months in malaria-naïve adults exposed to P. falciparum.

The drug—developed by the U.S. National Institute of Allergy and Infectious Diseases—is also being tested in a larger Phase 2 trial in Mali to evaluate its ability to prevent infection in adults during a six-…

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Corporate restructuring, clinical trial results, and a new business investment kept Sanofi in the news this week.

First, the company announced Monday that as part of its “ongoing efforts to reduce the complexity of its Consumer Healthcare portfolio and accelerate its growth trajectory,” it will offload 16 products to Germany’s STADA Arzneimittel. Neither firm disclosed deal terms.

The same day, Sanofi announced that its respiratory syncytial virus (RSV) single-dose monoclonal…

Maryland’s Integrated BioTherapeutics announced Wednesday a U.S National Institute of Allergy and Infectious Diseases contract worth up to $16.3 million to develop IBT-T03H, a monoclonal antibody for treatment of Marburg virus disease, and potentially bring the candidate to Phase 1.

The company previously won CARB-X support for its Staphylococcus aureus vaccine candidate, IBT-V02.

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.