Vaccitech

The Lancet Microbe published results last week from a Phase 1b study evaluating the safety and tolerability of U.K.-based Vaccitech’s ChAdOx1 MERS vaccine candidate.

The results—from Saudi Arabia’s first clinical trial—showed the simian adenovirus-vectored shot was safe and well-tolerated at all dosage levels while a single high-dose jab improved immunogenicity through six months.

The vaccine uses the same platform as the AstraZeneca/Oxford Covid-19 shot, which Jenner Institute…

Mentions:

Vaccine makers Vaccitech and Valneva separately filed plans last week for initial public offerings on Nasdaq.

Oxford-based Vaccitech is the Jenner Institute spinout that owns the technology underlying the AstraZeneca/Oxford Covid-19 vaccine. Its pipeline includes a Phase 1 MERS vaccine and a preclinical zoster shot.

France’s Valneva, already listed on Euronext and proposing to list American depositary shares via a new offering, is seeking regulatory clearance to advance its…

The state of the hunt:

Novavax brought its vaccine candidate to Phase 2.
  WHO reportedly offered wealthier countries new, more flexible terms for the COVAX Facility.
  The U.S. FDA expanded the Emergency Use Authorization for Gilead’s Veklury (remdesivir).

 

Vaccines

Phase 3 candidates:
 
Pfizer and BioNTech have enrolled more than half of the 30,000 people they seek for U.S.-based Phase 3 trials of their mRNA Covid-19 vaccine candidate,…

The Lancet Infectious Diseases published two Phase 1 studies this week evaluating separate vaccine candidates for Middle East respiratory syndrome (MERS).

In the first study, a team of Oxford-led researchers found that university-spinoff Vaccitech’s simian adenovirus-vectored ChAdOx1 MERS vaccine was safe and well-tolerated at all tested doses, and a single high-dose shot improved immunogenicity at 12 months.

Next, German researchers found that a two-dose regimen of IDT Biologika…

Vaccitech announced last week that its universal influenza vaccine candidate VTP-100 failed to reach its primary endpoint in a Phase 2 trial. The Oxford University spinoff will also discontinue an ongoing Phase 2b study of the shot per recommendations by a trial monitoring committee.

University of Oxford spinoff Vaccitech announced last week that it has started a Phase 1 trial in Saudi Arabia of its Middle East respiratory syndrome coronavirus vaccine candidate, ChAdOx1-MERS.

In 2018, the Coalition for Epidemic Preparedness Innovations awarded Oxford’s Jenner Institute $14.6 million to support Phase 1 testing and manufacturing for later phases of the shot.

CEPI is funding other MERS candidates from IDT Biologika, Inovio and Themis. Chinese company Zhifei is…

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) announced today that it has started a Phase 1 study of its universal flu vaccine, H1ssF_3928. Researchers expect to enroll 53 healthy adult participants in Maryland by the end of the year and report preliminary results in early 2020.

H1ssF_3928 is NIAID’s first universal flu vaccine to enter human studies. Other companies with in-human candidates in the running include Wisconsin-based FluGen, Britain’s Imutex,…

An experimental oral medicine developed by J&J’s Janssen subsidiary successfully blocked a wide range of influenza strains in mice, according to results of a study published in last week’s Science. Treated mice exposed to lethal doses of multiple strains of the flu did not get sick, according to the company’s research team and their external collaborators. The treatment consists of a molecule which binds to various forms of the virus, blocking fusion with animal cells.

In other flu…

Wisconsin-based FluGen announced this week that its M2 gene-deleted, single replication (M2SR) intranasal universal influenza vaccine candidate has passed Phase 2.

The vaccine matched a 2007 flu strain; however, the company used a highly mismatched H3N2 strain from the 2014-2015 flu season for its test challenge. Despite the mismatch, participants generated significant antibodies to both the vaccine and challenge strains, and also showed a reduction in symptoms.

BiondVax, CureVac…

British biotech Imutex’s universal flu vaccine candidate is ready to enter Phase 3, its owners hVIVO plc and the SEEK Group announced this week after FLU-v met endpoints in its latest Phase 2b trial.

BiondVax, CureVac, Inovio, FluGen and Vaccitech are among the companies also in the race to develop the world’s first universal flu vaccine.