NIAID

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-…

Mentions:

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…

Mentions:

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.

HDT Bio announced on Monday a three-year, $2.9 million grant from the U.S. National Institute of Allergy and Infectious Diseases to develop a “low cost and easy to manufacture” HIV-1 RNA vaccine.

The company said the shot will use the same Lipid InOrganic Nanoparticle (LION)-based self-replicating RNA technology as its Covid-19 vaccine candidate, HDT-301, which is currently in clinical trials in India.

Mentions:

Vaxess announced last week that the U.S. National Institute of Allergy and Infectious Diseases has awarded the Massachusetts-based company up to $2.9 million to advance the commercialization of its MIMIX smart release patch technology. The grant will accelerate the company’s CMC activities in preparation for a Phase 1 proof-of-concept trial—set to begin in the first half of 2022—of a MIMIX product with “a seasonal flu and a Covid-19 vaccine,” the press release said.

Recently awarded $2…

The state of the hunt:

Pfizer/BioNTech asked the U.S. FDA to expand its authorization of their vaccine to adolescents.
  Numerous countries restricted the use of the AstraZeneca/Oxford shot to older people—or discontinued it altogether—even as regulators concluded the benefits outweighed the risks.
  COVAX affirmed that SII’s supply commitments to the initiative remain “legally binding” amid continued export restrictions from India.

 

Vaccines


The state of the hunt:

The European Union and India made new moves to curtail vaccine exports.
  COVAX warned of delivery delays.
  Pfizer and BioNTech launched a pediatric trial of their vaccine in children as young as 6 months.

 

Vaccines


Approved or authorized vaccines
   
New data, new questions for AstraZeneca: If AstraZeneca thought higher-than-expected efficacy results this week from the U.S.-based Phase 3 trial of AZD1222 would…