The state of the fight: 

  • Gavi inked a 550-million-dose supply deal with China’s CNBG and Sinovac.
     
  • Bharat Biotech applied for WHO Emergency Use Listing of its inactivated vaccine.
     
  • Cuba authorized BioFarmaCuba’s Abdala vaccine.

 

Approved or authorized vaccines

The U.S. FDA granted Priority Review to Pfizer/BioNTech’s Comirnaty vaccine in the companies’ bid for full…

The novel 24-valent pneumococcal polysaccharide vaccine (PPSV) candidate from Affinivax and Astellas has notched U.S. FDA Breakthrough Therapy designation on the strength of new Phase 2 data, the companies announced Tuesday.

The results showed that ASP3772—based on Affinivax’s proprietary Multiple Antigen Presenting System (MAPS)—was well tolerated and induced antibody responses to each of its 24 serotypes, according to the press…

Brii Biosciences made its initial public offering (IPO) on the Hong Kong stock exchange on Tuesday. The 111.6 million shares—priced at $2.86 each—will raise nearly $320 million to advance the Sino-American biotech’s pipeline of more than 10 product candidates focused on infectious and central nervous system diseases, according to a company press release.

Brii’s portfolio includes candidate therapies for Covid-19, hepatitis B, HIV and…

The Geneva-based Global Antibiotic Research and Development Partnership (GARDP) announced Tuesday that it has signed a memorandum of understanding (MOU) with the Clinton Health Access Initiative (CHAI) and Shionogi to accelerate LMIC access to the Osaka-based drugmaker’s antibiotic cefiderocol (Fetroja).

The collaboration will help introduce the drug—indicated for bacterial infections in patients with limited treatment options—into…

J&J last week launched a research center hosted at the London School of Hygiene & Tropical Medicine (LSHTM) that will focus on antimicrobial resistance (AMR) and next-generation TB drug regimens. The J&J Satellite Center for Global Health Discovery at LSHTM marks the first in a planned series of academic research centers, according to a company press release.

Each center will partner with academic institutions to focus on…

Mentions: J&J, R&D, LSHTM, AMR, TB, drugs

The International AIDS Vaccine Initiative and Spanish biopharma Biofabri announced on Wednesday that they will collaborate on Phase 3 efficacy studies for the novel tuberculosis vaccine candidate MTBVAC. The trials are scheduled to start in several African countries this year.

Biofabri licensed MTBVAC for commercialization from Spain’s University of Zaragoza.

Mentions: IAVI, Biofabri, TB, vaccines

Touting their “commitment to openness,” AbbVie, Biogen and Pfizer last week launched a web-based tool giving access to results from analyses of whole exome sequencing data from 300,000 UK Biobank participants—producing “the world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease,” according to a joint press release.

The initiative may also be an effort to comply with government- and…

Colorado-based biotech VitriVax announced Wednesday it has raised an undisclosed amount of Series A financing from Adjuvant Capital to develop and commercialize its Atomic Layering Thermostable Antigen and Adjuvant (ALTA) technology which reformulates vaccines for extended shelf life and can compress multidose regimens into a single shot.

The ALTA platform works by protecting antigens and adjuvants against thermal and chemical…

Valneva announced Wednesday that the U.S. FDA has granted its VLA1553 single-shot chikungunya vaccine candidate (currently in Phase 3) Breakthrough Therapy Designation—adding to the PRIority MEdicines (PRIME) designation the EMA awarded the French company’s jab in 2020 and the FDA Fast Track status it received in 2018.

Britain’s Emergex Vaccines announced last week that it has received Swiss regulatory approval to launch Phase 1 trials of its T cell dengue vaccine candidate, PepGNP-Dengue.

The company raised $22 million last year to advance its synthetic T cell vaccine portfolio (delivered using a thermostable microneedle patch), including candidates for Covid-19, dengue and pandemic influenza.

Mentions: Emergex, dengue, vaccines

GSK’s board defended the company’s performance last week in response to an open letter from activist investor Elliott Advisors complaining that “GSK has failed to capture business opportunities due to years of under-management.”

A company press release said major progress has been achieved to “improve performance, strengthen R&D productivity, enhance commercial execution, and to streamline GSK’s portfolio and cost base.” The board…

California-based Meissa Vaccines began a Phase 1c trial last week to study its intranasal live attenuated RSV vaccine candidate in seronegative infants and young children.

The trial follows Phase 1a and 1b studies that evaluated MV-012-968 in adults and seropositive children between 15 and 59 months, respectively. The vaccine entered Phase 2 for adults in January.

Mentions: Meissa, RSV, vaccines

Moderna announced Wednesday that it has launched a Phase 1/2 study of mRNA-1010—its quadrivalent seasonal influenza vaccine candidate—in healthy adults in the United States.

The news follows Sanofi’s report last month that it has also begun Phase 1 trials of an mRNA-based candidate targeting A/H3N2 flu. BioNTech and Pfizer are also working on an mRNA-based flu candidate.

Mentions: Moderna, mRNA, flu, vaccines

Seres Therapeutics announced last week an agreement with Nestlé Health Science to jointly commercialize SER-109—the Massachusetts-based company’s investigational oral microbiome treatment for recurrent C. difficile infection—in the United States and Canada.

Under the deal, Seres will receive $175 million upfront in license payments, an additional $125 million upon U.S. FDA approval of the treatment, and up to $225 million in…

The University of Oxford announced Monday that its Jenner Institute has launched a Phase 1 trial in Britain of its HIVconsvX novel “mosaic” vaccine candidate that targets a broad range of HIV-1 variants.

The trial—which will test a single dose of the T cell-inducing candidate followed by a booster at four weeks in HIV-negative adults considered not to be at high risk of infection—is the first in a series of evaluations of HIVconsvX as…

Swedish CDMO Recipharm announced Tuesday that it will build a fill-finish facility in Morocco to supply vaccines and biotherapeutics in Africa by 2023. According to the press release, the Moroccan government and local banks will invest around $500 million to support the project.

FiercePharma reported that the facility will have an annual capacity of about 300 million units.

In other Recipharm news, Moderna announced last week that…

The state of the hunt: 

  • India authorized Moderna’s shot.
     
  • Zydus Cadila applied for authorization in India of its DNA-based vaccine, which proved 67% effective in Phase 3.
     
  • Five Indian generics manufacturers will conduct a joint trial of Merck’s molnupiravir antiviral.


Editor’s note: The Covid-19 R&D round-up will be on hiatus next week. Please look for our next issue on…

France’s bioMérieux and Specific Diagnostics announced Tuesday that bioMérieux will distribute the latter’s newly introduced REVEAL Rapid AST system in Europe.

The deal is a boost to the California-based CARB-X grantee’s antibiotic susceptibility testing (AST) system, designed to quickly detect the emitted volatile molecules that are the first sign of bacterial growth in the blood and to determine which antibiotic is most suited to…

Tianjin-based CanSino Biologics announced last week that the National Medical Products Administration of China has approved its “Menphecia” meningococcal AC (men AC) conjugate vaccine.

The Chinese biotech is also developing a quadrivalent meningococcal conjugate vaccine (Menhycia) that Pfizer will promote and market once it receives licensure.

A novel, temperature-stable, cholera toxin B (CTB) subunit vaccine candidate made of powdered, genetically modified Japanese short-grain rice produced no obvious side effects and generated a “good immune response” in a Phase 1 trial, the University of Tokyo announced last week.

Volunteers who responded to MucoRice-CTB showed increased CTB-specific antibodies in a “gut microbiota-dependent manner,” and those receiving a higher dose were…