Search API

0 min read

Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) today announced it is awarding $1.7 million to Syntiron to develop a maternal vaccine that targets Escherichia coli and Klebsiella pneumoniae.

Syntiron's Alloy-EK vaccine leverages iron receptor proteins (IRPs) as vaccine targets. IRPs are highly genetically conserved, which means they are less likely to change since they perform essential functions.

This makes these proteins reliable vaccine targets.

Syntiron developed the Alloy Platform to manufacture and formulate IRP vaccines safely that maintain robust immunity and cover a broad range of bacterial strains.

Neonatal sepsis is a life-threatening response to bloodstream infections that occur in newborns fewer than 28 days old. Due to their immature immune systems, newborns are particularly susceptible to infections.

Since neonatal sepsis progresses rapidly, the risk of death from neonatal sepsis increases by 7.6% every hour a treatment is delayed.

The BARNARDS study estimated that 2.5 million neonates or infants die in the first month of life of sepsis annually, with the most significant burden in low- and middle-income countries. 

"The bacteria targeted by this vaccine are a tremendous burden on public health for babies, children, and adults worldwide," said Lisa Herron-Olson, Ph.D., Managing Director of Syntiron, in a press release on January 18, 2024.

"Pregnant women are at particularly high risk of infection by these same bacteria that can cause neonatal sepsis in newborn babies."

"Preventing these infections by vaccination offers substantial potential health benefits to mothers and babies while reducing the spread of antimicrobial resistance."

Syntiron's innovation with the Alloy Platform leveraged molecular, bioinformatic, and immunological principles to engineer simpler proteins enriched in linear, immunodominant, and highly conserved peptides derived from IRPs.

Founded in 2004, Syntiron is a biotechnology company based in Saint Paul, MN, and has several vaccines in development that target bacterial infections.=

Vaccine Treats: 
Sepsis
Image: 
Image Caption: 
from Pixabay
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Minneapolis
Include in VBT newsletter: 
Tuberculosis cases

Is the U.S. CDC Expecting a Tuberculosis Outbreak

Tuberculosis vaccines are globally available in 2024
January 18, 2024
0 min read

Biological E. Limited today announced that the World Health Organisation (WHO) has granted an Emergency Use Listing (EUL) to their CORBEVAX® vaccine, India's first indigenously developed COVID-19 vaccine.

As of January 16, 2024, there are 13 COVID-19 vaccines granted EUL by the WHO. 

CORBEVAX's antigen's initial construct and production process were developed at Texas Children's Hospital in Houston, Texas, led by Drs. Bottazzi and Hotez and in-licensed from BCM Ventures.

CORBEVAX is a protein sub-unit vaccine not produced with mRNA technology. 

The Drugs Controller General of India (DCGI) has already approved CORBEVAX  for restricted use in emergencies among adults, adolescents, and young children in a sequential manner from December '21 to April '22, as well as India's first heterologous COVID-19 booster shot for adults age 18 and above in June '22.

BE supplied 100 Million Doses of CORBEVAX to the Government of India.

Ms. Mahima Datla, Managing Director of Biological E. Limited, said in a press release, "We understand that several countries come under a lot of fiscal pressure when dealing with COVID-19. We aim to reach the people in those countries with CORBEVAX, just as we have done with all our other vaccines."

"Our commitment is to provide affordable and accessible high-quality vaccines, and the WHO EUL lays a path for us to make that possible."

Ms. Mahima further added, "While several companies which entered the field of vaccine development & manufacturing during the COVID-19 pandemic exited soon afterward either due to paucity of funds or lack of success, BE continues to remain committed to develop and provide access to high-quality, affordable vaccines globally by constantly enlarging its portfolio of offerings."

As of January 17, 2024, CORBEVAX is not U.S. FDA-approved or available in the U.S.

Vaccine Treats: 
COVID-19
Image: 
Image Caption: 
from Pixabay
Live Blog Update Author: 
Don Hackett
Location Tags: 
Hyderabad
Vaccine: 
Corbevax COVID-19 Vaccine
Include in VBT newsletter: 
0 min read

The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) today announced it is awarding $633k to Intravacc to support the development of the Avacc® 11 vaccine candidate that prevents Neisseria gonorrhoeae bacterial infections.

This CARB-X award supports the development of Intravacc's meningococcal outer membrane vesicle (OMV) vaccine that carries several important gonococcal antigens to prevent Neisseria gonorrhoeae (gonococci) infections.

Through the tailored gonococcal antigens on the surface of the meningococcal OMV, Intravacc anticipates a significant enhancement in the vaccine candidate's efficacy against gonorrhea.

"Drug-resistant strains of Neisseria gonorrhoeae have evaded all but one existing antibiotic (ceftriaxone)," said Erin Duffy, PhD, R&D Chief of CARB-X, in a press release on January 16, 2024. 

"Vaccines are powerful tools in the prevention of bacterial infections."

"With an appropriate vaccination strategy, Intravacc's vaccine project, if successful, could prevent the disease and significantly curb the spread of resistant bacteria across the globe."

The WHO Global Health Sector Strategy on Sexually Transmitted Infections (STI) has set goals for reducing gonorrhea incidence by vaccination by 90% by 2030. Gonorrhea is the world's second most reported STI, impacting about 82 million adults annually.

As of 2024, the U.S. FDA has not approved a gonorrhea vaccine.

However, a Research Letter published by the JAMA Network Infectious Diseases on August 31, 2023, concluded that the Outer Membrane Vesicles-based meningococcal group B vaccine was 47% (95% CI, 13%-68%) effective in preventing gonorrhea in young adults.

On November 10, 2023, the U.K.'s Joint Committee on Vaccination and Immunisation agreed that a targeted vaccination program should be initiated using the 4CMenB (Bexsero®) vaccine for the prevention of gonorrhea in those who are at most significant risk of infection. 

Intravacc is a global contract development and manufacturing organization at the Utrecht Science Park Bilthoven in the Netherlands. Intravacc is developing vaccines that target a range of diseases.

Vaccine Treats: 
Gonorrhea
Image: 
Image Caption: 
from Pixabay
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Boston
Vaccine: 
Bexsero Meningitis B Vaccine
Include in VBT newsletter: 

1 Billion Novel Polio Vaccinations Administered

nOPV2 polio vaccine availability expands in 2024
January 14, 2024
0 min read

HilleVax, Inc. and Chengdu Kanghua Biological Products Co., Ltd. today announced the entry into an exclusive license agreement for rights to Kangh's hexavalent virus-like particle (VLP) vaccine candidate for norovirus.

Referred by HilleVax as HIL-216, outside of Greater China, this VLP targets six of the most common norovirus genotypes, including GI.1, GII.2, GII.3, GII.4, GII.6, and GII.17.

HilleVax stated it intends to launch a Phase 1 trial in 2024.

According to the press release on January 8, 2024, the Investigational New Drug application for HIL-216 was cleared by the U.S. FDA in September 2023.

As of January 9, 2024, the FDA has not approved any norovirus vaccine candidate for use in the U.S.

Rob Hershberg, MD, Ph.D., Chairman and Chief Executive Officer at Hillevax, commented, "Our bivalent norovirus VLP vaccine candidate, HIL-214, remains the most advanced norovirus vaccine candidate in clinical development, and we are on track to report topline safety and efficacy data in mid-2024."

"We believe that HIL-214 will be the first norovirus vaccine submitted for registration and, if approved, would address the significant unmet medical need in infants and other at-risk populations."

"We further believe that HIL-216 is an exciting addition to the HilleVax portfolio as a next-generation, higher valency VLP-based vaccine and is an ideal fit with the expertise, capabilities, and long-term aspirations of HilleVax."

HilleVax confirmed it will pay Kangh an upfront payment of $15 million with the potential for additional payments of up to $255.5 million upon achieving specific development and sales milestones. Kangh can also receive a single-digit tiered royalty on net sales outside of Greater China.

Globally, norovirus is estimated to result in approximately 700 million cases of acute gastroenteritis and 200,000 deaths per year, resulting in over $4 billion in direct health system costs and $60 billion in societal costs per year. 

According to the U.S. CDC, norovirus is a contagious virus that causes vomiting and diarrhea. Anyone can get infected and sick with norovirus. Most norovirus outbreaks in the U.S. happen from November to April.

From August through November 13, 2023, there were 202 norovirus outbreaks reported by NoroSTAT-participating states. During the same period last season, 134 norovirus outbreaks were reported by these states, according to the CDC.

HilleVax is a clinical-stage biopharmaceutical company based in Boston, MA, focused on developing and commercializing novel vaccines.

Vaccine Treats: 
Norovirus
Image: 
Image Caption: 
Norovirus Outbreaks Reported by NoroSTAT-Participating States Per Week, 2012–2024
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Boston
Vaccine: 
HIL-214 Norovirus Vaccine
0 min read

Transgene and NEC Corporation today announced the signing of a further development collaboration agreement to continue the clinical evaluation of the individualized neoantigen cancer vaccine TG4050.

TG4050 is currently being evaluated in a randomized multicenter Phase I trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers. Based on promising data obtained in this Phase I trial, Transgene and NEC are preparing a randomized Phase I/II extension of this trial slated to start in 2024.

This new trial builds on compelling first signs of efficacy and induction of specific T-cell responses to generate a comprehensive set of immunological and clinical data to demonstrate the potential of TG4050 further.

Additional immunological and clinical data from the Phase I trial is expected at a scientific conference in the first half of 2024.

Alessandro Riva, Chairman and CEO of Transgene, commented in a press release, "We are pleased to announce the extension of our agreement with NEC, which marks a significant milestone in our collaboration."

"We look forward to continuing to treat patients with our individualized cancer vaccine TG4050. The compelling initial Phase I data presented with NEC at ASCO 2023 showed that all evaluable patients treated with TG4050 monotherapy developed a specific immune response and remained disease-free."

"Our joint clinical development plan builds on these promising data in a setting where there is no approved treatment to prevent patient relapse after adjuvant chemoradiotherapy."

"We believe that TG4050, by combining a powerful and immunogenic viral vector with an extremely sophisticated neoantigen selection tool, has the potential to address major medical needs in the adjuvant treatment of solid tumors."

TG4050 is based on Transgene's viral vector-based myvac® platform and powered by NEC's cutting-edge AI capabilities for identifying and predicting the most immunogenic neoantigens.

Vaccine Treats: 
HPV Cancers
Image: 
Image Caption: 
US CDC 2024
Live Blog Update Author: 
Don Hackett
Location Tags: 
Tokyo
Vaccine: 
TG4050 Cancer Vaccine

Influenza Vaccine Candidates 2024

Influenza Vaccine Candidates 2024

A report indicates over 110 influenza vaccine candidates are under development in 2024.

A mosaic influenza nanoparticle vaccine (FluMos-v1) is unique in that it is designed to co-display four recently circulating haemagglutinin (HA) strains. A phase 1 clinical study demonstrates that FluMos-v1 nanoparticles are predominantly quadrivalent. Imaging by TIRFM allowed direct visualization of the co-localization of HA trimers from multiple strains, and imaging of more than 10 thousand nanoparticles revealed individual nanoparticles with four, three, two, and one color.

CSL sa-mRNA bicistronic influenza vaccine candidates produced a potent, cross-reactive immune response against pandemic and seasonal influenza strains A(H5N1) and A(H1N1). In addition, the mRNA platform recently reported results from a significant Phase III vaccine study, meeting its primary and secondary endpoints of infection prevention and severe disease with a favorable safety and tolerability profile.

Cidara Therapeutics's CD388 is a highly potent long-acting antiviral immunotherapy in phase 1 study, designed to deliver universal seasonal and pandemic influenza prevention.

CureVac's second-generation mRNA influenza vaccine candidate, CVSQIV, was developed with GSK. An extended preliminary phase 1 data from Joint COVID-19 and Flu mRNA Vaccine Development Programs was launched on May 8, 2023. The Phase 1 study's best-performing candidate providing broad antigen coverage against WHO-recommended flu strains selected for Phase 2, following positive data from Phase 1 interim analysis. Dosing of the first Phase 2 participant is anticipated in Q4 2023.

The Emergex universal influenza vaccine candidate is designed to induce CD8+ T cells specific to highly conserved parts of the influenza virus from both the positive and negative sense reading frames. 

Flu-v Influenza Vaccine is a synthetic universal flu vaccine candidate that offers protection across a broad influenza spectrum forcing 1+NP forcing vaccine candidate consisting of MVA, a replication-deficient pox viral vector safely tested in thousands of patients, generates strong immune reaction against Matrix 1 Nucleoprotein influenza antigens. 

NasoVAX is a recombinant intranasal vaccine developed for both seasonal and pandemic use.

NanoFlu is a quadrivalent recombinant hemagglutinin (H.A.) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses H.A. amino acid protein sequences similar to the recommended wild-type circulating virus H.A. sequences. In addition, NanoFlu contains Novavax's patented saponin-based Matrix-M™ adjuvant. CD388 (drug-Fc conjugate) is a highly potent, long-acting antiviral immunotherapy designed to deliver universal prevention and treatment of seasonal and pandemic influenza. Cidara Therapeutics intends to initiate a Phase 1 study in healthy volunteers in 2022.

The U.S. NIH's BPL-1357 is a whole-virus vaccine candidate comprising four non-infectious, chemically inactivated, low-pathogenicity avian flu viruses conducting a phase 1 study.

Novavax investigational influenza (qNIV) vaccine is our quadrivalent nanoparticle vaccine candidate, targeting seasonal flu. qNIV is designed using our recombinant technology, with four forms of wild-type hemagglutinin (H.A.) protein from the influenza virus as antigens. Antigens are organized into distinct nanoparticle complexes recognized by the immune system, working in concert with our Matrix-M™ adjuvant.

Osivax' OVX836 targets the nucleoprotein (N.P.), a highly conserved internal antigen. Unlike surface antigens, the N.P. is much less likely to mutate, alleviating the need for annual vaccination updates. The latest results from the Phase 2a dose-optimization study (OVX836-003) found that OVX836 maintained an excellent safety profile at all doses and provided protective efficacy in reducing PCR-confirmed influenza-like illnesses by 78%. Topline results from both studies are anticipated in the first half of 2023. 

Sinovac Biotech Ltd.'s two-dose inactivated quadrivalent influenza vaccine is conducting a phase 3 study with children in Chile.

Revelation Biosciences Inc. intranasal REVTx-99a is for the preventive treatment of H3N2 influenza (influenza A and B) infection in healthy humans, parainfluenza, rhinovirus, respiratory syncytial virus, and SARS-CoV-2 including its variants.

Redeeflu (M2SR) is a nasal vaccine candidate utilizing a proprietary M2 deleted, single replication influenza virus.

Vaxess Technologies, Inc. MIMIX-Flu Vaccine Patch is conducting Phase I Clinical Trial, a first-in-man trial of VX-103. On June 5, 2023, the Company stated the MIMIX-Flu vaccine patch elicited robust, durable, and broadly protective immune responses. And titers did not differ significantly for the two dose levels, indicating a fractional dose can be delivered without substantially impacting immunogenicity.

PDS Biotechnology Corporation's investigational universal influenza vaccine PDS0202 demonstrated active neutralization across multiple influenza viruses. 

The universal influenza vaccine candidate FluMos-v2 (VRC- FLUMOS0116-00-VP, start date: 2023-08-09) was designed by researchers at NIAID's Vaccine Research Center (VRC) and is conducting a phase 1 clinical trial. FluMos-v2 is intended to induce antibodies against various influenza virus strains by displaying part of the influenza virus hemagglutinin (H.A.) protein in repeating patterns on self-assembling nanoparticle scaffolds (SAPNs). Exposure to these harmless fragments of virus proteins prepares the immune system to recognize and fight the virus. When tested in animals, the experimental vaccine resulted in robust antibody responses. It is an adaptation of an earlier U.S. NIH universal flu vaccine candidate, FluMos-v1, which began first-in-human testing in 2021 and is still undergoing clinical trials.

5 min read
Last Reviewed: 
Monday, February 26, 2024 - 11:35
Description: 
Influenza Vaccine Candidates under development in 2024
Condition: 
Influenza
0 min read

Inventprise Inc. today announced the completion of vaccination in their Phase 2 dose-ranging study of its 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in young adults.

On January 2, 2023, the company stated that this Phase 2 study is essential in developing an affordable, expanded-coverage pneumococcal conjugate vaccine (PCV). This vaccine candidate is designed to help prevent pneumococcal disease caused by serotypes not covered in the current PCVs.

“PCVs are the world’s most complex vaccines, and increasing the number of serotypes (25) and manufacturing capacity has been challenging since conjugate vaccines were first developed,” commented Yves Leurquin, President & CEO of Inventprise, in a press release.

As of 2024, several approved PCVs and vaccine candidates are conducting research. However, some do not include critical disease-causing serotypes.

“This study was designed to evaluate safety and antibody responses following single doses of three different formulations of IVT PCV-25 in young adults to pave the way for future studies in infants and older adults. In Canada, as well as elsewhere in the world, there continues to be significant rates of disease due to serotypes not covered in licensed vaccines so we are very interested in the potential for broader coverage,” says Dr. Joanne Langley, the study’s principal investigator at the Canadian Center for Vaccinology.

As a leading cause of deadly childhood pneumonia, sepsis, meningitis, and debilitating middle-ear infections, the pneumococcus bacterium is responsible for an estimated 300,000 deaths per year in children less than five years of age worldwide.

Inventprise is producing the IVT PCV-25 vaccine at its automated manufacturing facilities in Washington State. Funding for the development of IVT PCV-25 has been achieved with support from the Bill & Melinda Gates Foundation.

Vaccine Treats: 
Pneumococcal
Image: 
Image Caption: 
by L. Ordmok
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Seattle
Vaccine: 
Pneumococcal Vaccines
0 min read

Novotech recently released the latest global clinical trial landscape report on HIV, a condition now affecting more than 39 million people.

According to the HIV Global Clinical Trial Landscape report published on December 18, 2023, the biopharma industry has initiated over 1,000 HIV clinical trials worldwide since 2018.

The distribution of the trials is as follows: Asia-Pacific accounts for 29% of trials, Europe at 28%, and North America at 26%, while the Rest of the World contributes a moderate share of 17%.

The report delves into the multifaceted landscape of HIV, focusing on its impact, treatment, and global initiatives.

It begins by elucidating HIV's progression, from its attack on the immune system to the potential development of AIDS. In the United States, there were 1.2 million HIV cases, leading to 19,986 deaths in 2022.

At the report's core lies the worldwide strategy articulated by organizations such as WHO, the Global Fund, and UNAIDS to eradicate the HIV epidemic by 2030.

Moreover, the report explores cutting-edge research, including long-acting injectables, HIV vaccines, and gene editing, underscoring the potential to find an HIV cure.

As of December 31, 2023, there are no approved HIV vaccines available, but several vaccine candidates are conducting studies.

Novotech's research analyst team provides these expert reports every month, free of charge.

Vaccine Treats: 
HIV
Image: 
Image Caption: 
by Gerd Altmann
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Boston
Vaccine: 
HIV Vaccines