NIAID

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) has dosed the first participant in a Phase 1 trial of a trio of mRNA-based vaccines against HIV, according to a press release Monday from the U.S. National Institutes of Health.

Manufactured by Moderna through a NIAID-backed contract, each of the three candidates in the mRNA-1574 vaccine program encodes for “different but highly related, stabilized proteins” of HIV, the press release said. The U.S.-based study seeks…

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The state of the fight: 

Moderna pledged permanently to forgo enforcement of its Covid-19 vaccine patents for shots made “in or for” 92 LMICs.
  Aspen Pharmacare will market an Aspen-branded version of J&J’s vaccine in Africa.
  Fluvoxamine reduced the risk of Covid-19 hospitalization and clinical deterioration by 31% in a meta-analysis.   BOOSTERS

 
A WHO technical advisory group now “strongly supports urgent and broad access” to Covid-19 booster doses…

Emergent BioSolutions has dosed the first participant in an Australia-based Phase 1 trial of its nanoparticle-based universal flu vaccine candidate, the Maryland company announced last week.

The study will evaluate the influenza virus A component of EBS-UFV-001. Emergent plans future studies of additional components that would protect against all influenza A and B strains, according to its press release.

Emergent licensed the shot’s self-assembling nanoparticle technology from…

The state of the fight: 

COVAX will overhaul its vaccine allocation methodology.
  An investigational antiviral pill from Merck and Ridgeback Biotherapeutics cut the rate of hospitalizations or death some 50% in a Phase 3 trial.
  India plans to resume Covid-19 vaccine exports by the end of October.

 

Approved or authorized vaccines

 
The AstraZeneca/Oxford Covid-19 shot demonstrated 74% efficacy against symptomatic disease 15 days or more after a second…

Soligenix announced Wednesday positive preclinical data for its thermostable recombinant subunit vaccine candidates against Ebola Sudan, Ebola Zaire and Marburg viruses.

The shots—which use the novel CoVaccine HT adjuvant from BTG Specialty Pharmaceuticals—elicited “potent immune responses” that “suggest the feasibility” of formulating a multivalent filovirus vaccine to protect against all three pathogens, according to data published in collaboration with the University of Hawaiʻi at…

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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ImmunityBio launched a Phase 1 trial last week to evaluate whether its interleukin-15 (IL-15) superagonist Anktiva (N-803), used alone or together with broadly neutralizing antibodies, can control HIV following the interruption of antiretroviral therapy (ART). The California company said the randomized, open-label study—sponsored by the U.S. National Institute of Allergy and Infectious Diseases—will enroll about 46 people living with HIV who have suppressed the virus with ART for…

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The U.S. National Institutes of Health announced Tuesday the launch of a first-in-human Phase 1 trial of FluMos-v1, a nanoparticle universal influenza vaccine candidate developed by the U.S. National Institute of Allergy and Infectious Diseases.

Healthy adults age 18-50 will receive either the candidate vaccine or a shot of Flucelvax, the cell-based quadrivalent seasonal flu vaccine from Seqirus, per the press release.

In animal models, FluMos-v1 performed “as well as or slightly…

Boston University’s CARB-X consortium announced two new investments this week.

On Tuesday, the nonprofit said it will give Massachusetts-based Summit Therapeutics up to $4.1 million (plus up to $3.7 million in milestones) to develop its first-in-class SMT-738 antibiotic candidate for treating multidrug-resistant infections—specifically carbapenem-resistant Enterobacteriaceae (CRE) infections caused by pathogens including E. coli and K. pneumoniae. The funds will help advance the…

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.