A month after stepping down as president of Takeda’s global vaccine business, Rajeev Venkayya has been named CEO of Aerium Therapeutics, an antibody specialist that emerged from stealth mode on Tuesday. The Boston- and Lausanne-based biopharma’s pipeline includes two monoclonal antibodies against SARS-CoV-2 aimed at “vulnerable populations for which vaccines do not provide adequate protection,” according to a press release.
Leaving Takeda after a decade, Venkayya told Reuters that with…
Newly revealed data have called into question last year’s exuberant claims from AstraZeneca and Sanofi about nirsevimab, their single-dose monoclonal antibody (mAb) to prevent RSV in infants, Endpoints News reported last week. Published in the New England Journal of Medicine, the Phase 3 data showed that the mAb’s effects on hospitalization were not statistically significant.
Hospitalization is a “key metric” for the potentially lucrative mAb because RSV manifests in most kids “as…
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…
Leyden Labs has raised $140 million in Series B financing, the intranasal therapeutic specialist announced Tuesday.
Leyden will use the funds to advance PanFlu, its preclinical monoclonal antibody influenza treatment candidate. Last week, the Netherlands-based company licensed PanFlu for mucosal administration from J&J’s Janssen, per a separate press release.
Former Vir executive Suha Jhaveri, who joined Leyden as chief commercial officer and head of business development in…
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…
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…
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.
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…
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-…