GC Pharma

The state of the hunt:

Moderna began clinical trials of its vaccine in children.
  New vaccines from Iran and Vietnam entered human trials, and a Cuban shot reached Phase 3.
  France limited use of AstraZeneca’s vaccine to people 55 or older.

 

Vaccines


Approved or authorized vaccines
  
AZ jab is safe, EMA reaffirms—but will uptake suffer? A European Medicines Agency (EMA) risk assessment committee concluded a preliminary review…

The state of the hunt:

Serum Institute of India will export Covishield doses to the United Kingdom.
  COVAX unveiled initial vaccine allocations, and numerous COVAX participants received their first shipments and began administering jabs.
  Bharat Biotech’s Covaxin demonstrated 81% efficacy against symptomatic disease in an interim Phase 3 analysis.

 

Vaccines


Approved or authorized vaccines
  
U.S. regulators completed their signoff…

Vaxess announced last week that the National Science Foundation and the U.S. Defense Advanced Research Projects Agency have awarded the Massachusetts company up to $2 million to develop mRNA-based vaccines and “other medical countermeasures.” The projects will use the company’s MIMIX smart release patch technology to develop refrigeration-free, single-dose products.

Vaxess has several deals in the works for its MIMIX technology, including a collaboration with GC Pharma to combine the…

The state of the hunt:

The U.S. FDA approved Gilead’s Veklury (remdesivir) for hospitalized Covid-19 patients 12 and older.
  IAVI, Merck and Serum Institute of India will collaborate to develop anti-SARS-CoV-2 monoclonal antibodies they plan to make accessible to LMICs.
  AstraZeneca resumed U.S. Phase 3 trials of its AZD1222 Covid-19 vaccine candidate.

 

Vaccines

Phase 3 candidates:
 
J&J is “preparing to resume recruitment” for the…

Curevo announced Phase 1 results last week for its investigational shingles vaccine candidate. The biotech said CRV-101 showed robust antibody responses in 89 healthy adults after two injections, with a low incidence of the injection site events associated with existing vaccines from GSK and Merck.

The GC Pharma subsidiary expects to begin Phase 2 trials next year in adults 50 and older.

The state of the hunt:

Serum Institute of India is reportedly pursuing up to $1 billion in private equity funding for its Covid-19 vaccine projects.
  J&J plans 60,000-participant Phase 3 trials of its Janssen subsidiary’s vaccine candidate.
  Roche will help develop and manufacture Regeneron’s REGN-COV2 antibody cocktail, more than tripling production capacity of the drug.

 

Vaccines

Phase 3 trials:
 
Brazil approved Phase 3 trials of…

The state of the hunt:

Serum Institute of India inked a billion-dose deal to commercialize Novavax’s vaccine candidate in LMICs.
  SII will also collaborate with the Gates Foundation and Gavi to provide 100 million doses of an eventual vaccine to LMICs at $3 per dose or less.
  J&J will supply 100 million doses of its investigational vaccine to the U.S. as part of a $1 billion contract.

 

Vaccines

Clinical trials:

BioNTech and Fosun Pharma…

South Korea’s Research Investment for Global Health Technology (RIGHT) Fund launched a new Technical Accelerator Award last week, calling for early-stage research proposals for infectious diseases for which “there are no available therapeutics, vaccines or diagnostics options,” including Covid-19.

Founded in July 2018, the RIGHT Fund—with $39.8 million in available funding through 2022—is a public-private partnership between Korea’s health ministry, the Gates Foundation, and Korean…

The Lancet Infectious Diseases published interim Phase 1 results last week showing that a chimeric H1 haemagglutinin-based influenza shot induced a broad antibody response for currently circulating human strains, as well as avian and bat flu virus subtypes.

According to the Mount Sinai–led team, the novel approach targets the stem/stalk of the protein, which varies less between virus strains, instead of the head. The researchers anticipate additional results at the end of the year.…

Korea’s Research Investment for Global Health Technology (RIGHT) Fund announced its first four recipients of $5.8 million in grants last week at its 2019 investment forum.

EuBiologics (with Seoul’s International Vaccine Institute, Massachusetts General Hospital and Harvard Medical School) won support for its preclinical cholera conjugate vaccine.

SK Biotek (with the Medicines for Malaria Venture) will get funding for continuous process development and scale-up of new malaria…