mAbs

The wave of CDMO capacity expansions continued into the new year with contract manufacturer ZhenGe Biotech raising $100 million in series C funding to build “multiple” 15,000-liter production lines, according to its press release last week.

Founded in 2017, the Shanghai-based company—which also has facilities in Maryland—claims expertise in monoclonal and bispecific antibodies, antibody-drug conjugates, fusion proteins and vaccines. The new round brings its total financing to $225…

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What role can vaccines play in combatting antimicrobial resistance? A public-private partnership seeks to answer that question through an open-source, web-based analytic platform, Germany’s European Vaccine Initiative (EVI) announced last week.

The PrIMAVeRa project—coordinated by EVI and backed by $10.3 million from the Brussels-based Innovative Medicines Initiative—joins GSK, Janssen and Pfizer with 16 academic and SME partners across the E.U., Russia and the U.K.

The five-year…

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Chinese CDMO WuXi Biologics launched its new 12,000-square-meter facility in its eponymous hometown last week. The plant will produce monoclonal antibodies, bispecifics and fusion proteins, among other drug products, with up to 60 million vials per year in capacity, the press release said.

The investment delivers an eighth global facility to the company.

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The Gates Medical Research Institute (Gates MRI) has entered into a licensing agreement with Atreca to develop a novel monoclonal antibody (mAb) for the prevention of malaria, the California-based biotech announced last week.

MAM01/ATRC-501 is an engineered version of a human mAb that’s generated following vaccination with GSK’s RTS,S shot. The mAb targets the malaria circumsporozoite protein (CSP) and has been shown to protect animals against malaria infection in multiple in vivo…

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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