Vaccine News

Nipah virus infection is an emerging serious zoonotic disease without a preventive vaccine. This virus is transmitted to humans through infected animals (fruit bats) or food contaminated with excretion and secretions from bats. 

Vaccine research is essential since the case fatality rate is estimated at 40% to 75%.

Phylex Biosciences announced today its new mRNA nanoparticle vaccine against the Nipah virus achieved positive results in an immunogenicity study conducted in collaboration with scientists from the U.S. Centers for Disease Control and Prevention (CDC).

The vaccine elicited a robust neutralizing antibody response, with neutralizing titers markedly higher than with several other Nipah vaccine designs and efficient neutralizing even with a single dose. In virus neutralization assays, neutralization titers of Phylex vaccine-elicited sera against Nipah virus were 3-fold the average titers of 14 individuals in Bangladesh who survived a Nipah virus infection.

The Phylex mRNA vaccine encodes for a nanoparticle displaying 60 copies of the antigen-based upon the head domain of the G protein of the Nipah virus.

On August 5, 2024, the company published a preprint of a research article on the immunogenicity of its Nipah mRNA nanoparticle vaccine.

"We are grateful to our co-authors at the CDC for their contribution in assessing our vaccine against this difficult pathogen," said Pascal Brandys, co-founder and CEO of Phylex Biosciences, in a press release.

"The results confirm the strong advantage of our mRNA vaccine encoding for a highly immunogenic nanoparticle, as compared with a variety of other technologies."

"Our vaccine combines the advantages of mRNA for speed of manufacturing and development and a nanoparticle for efficacy after one dose," Brandys continued. "We will aggressively pursue the clinical development of our vaccine candidate to initiate clinical trials with exposed individuals on a compassionate basis and save lives as soon as possible."

The Nipah virus is a pathogen that causes encephalitis and acute respiratory distress in humans. Recent outbreaks have occurred in Bangladesh, India, Malaysia, the Philippines, and Singapore, and the fatality rate is over 50%.

The virus's natural hosts are large fruit bats, which are present across South Asia, including India and Bangladesh.

To assist countries, a Technical Brief was developed In February 2024 as an interim document to guide countries in the readiness planning for a Nipah virus event, especially in countries that have not reported a Nipah virus event. 

The CDC has not approved a vaccine or therapeutics against the Nipah virus.

The African country of Mozambique today reached an important milestone in malaria prevention by introducing the R21/Matrix-M™ vaccine. This innovative vaccine brings the number of African countries offering malaria vaccines to eleven.

This vaccination program is essential since malaria is endemic in Mozambique, with a prevalence of 32% in children.

Through Gavi, the Vaccine Alliance, and co-financing from the Government of Mozambique, the country will vaccinate around 300,000 children through the country’s Expanded Programme on Immunization.

“The malaria vaccine, which is being rolled out initially in Zambezia today, is one of the latest approaches in the fight against the disease,” said Hon Dr Armindo Tiago, Minister of Health, in a press release on August 5, 2024.

“The choice of Zambezia as the launch site is due to the province's high burden of the disease. The vaccine will be administered in four doses to reduce the severe malaria illness and death.”

The World Health Organization (WHO) recommended that the malaria vaccine be administered in a 4-dose schedule, with the first dose covering children aged 6 to 11 months. A more extensive malaria vaccine rollout is expanding access to prevent additional disease.

Previously,  the R21/Matrix-M™ malaria vaccine was launched in Côte d'Ivoire.

John Jacobs, Novavax Inc.'s President and CEO, said in a press release on July 15, 2024, ".... marks a breakthrough in the fight to protect vulnerable children against a leading cause of death across the region while reinforcing our mission to create innovative vaccines that improve public health."

As of August 6, 2024, malaria vaccines are not offered in the United States. However, the majority of travel-related malaria cases diagnosed in the U.S. originate from African travelers.

ImmunityBio, Inc., today announced the opening of the National Cancer Institute-sponsored Phase 1/2 QUILT 502 clinical trial, which will study ANKTIVA® together with the investigational AdHER2DC vaccine in individuals with HER2-expressing endometrial cancer.

It marks the latest trial involving ANKTIVA, the company’s IL-15 superagonist immune enhancer. The aim of the trial is to evaluate ANKTIVA as an agent to replace the short-term activity of checkpoint inhibitor immunotherapies with long-term effectiveness. 

Endometrial cancer is the most common gynecological cancer in the U.S. and affects more than 65,000 women each year, with incidence peaking around 50-60 years of age. The 5-year overall survival rate in patients with metastasis is around 20 percent; treatment options after the second-line treatment are limited.

The AdHER2DC vaccine targets the HER2 protein, which is elevated in 30% of patients with endometrial cancer and in more than 50% of high-risk subtypes. The single agent AdHER2DC demonstrated a safety profile and immunogenicity in a phase 1 clinical trial.

The U.S. FDA recently approved ANKTIVA for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors.

“We are pleased to partner with the NCI on this important cancer control study involving ANKTIVA, which has demonstrated in clinical trials that activation of memory T cells may help deliver long-duration responses well beyond that of checkpoint inhibitors alone,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, in a press release on August 6, 2024.

“We are hopeful that the AdHER2DC investigational vaccine plus ANKTIVA will ‘rescue’ the checkpoint inhibitor pembrolizumab and kinase inhibitor lenvatinib and lead to an improved response compared with the current standard of care in this high-risk population.”

Phase 1 of the open-label, two-arm Phase 1/2 study will determine the recommended dose of pembrolizumab, lenvatinib, ANKTIVA, and AdHER2DC in participants with HER2-positive endometrial cancer.

The Phase 2 portion of the study will assess the efficacy of the combination of pembrolizumab, lenvatinib, ANKTIVA, and the AdHER2DC vaccine in qualified participants as determined by the proportion of participants without disease progression at six months. The study will enroll 60 subjects and is expected to be completed in 2026.

ImmunityBio says these studies, along with the recent approval of ANKTIVA for bladder cancer, signal the advent of the era of cytokines as the next generation of immunotherapies.

Biopharmaceutical New Technologies (BioNTech) SE today announced about €807.8 million in losses in the second quarter of 2024. This negative report compares to $208 million during the same period in 2023. The increased operating loss was impacted by decreased demand for mRNA COVID-19 vaccines.

From a working capital perspective, the Company ended the second quarter of 2024 with €18.5 billion in cash, cash equivalents, and security investments.

Prof. Ugur Sahin, M.D., CEO, and Co-Founder of BioNTech, commented in a press release on August 5, 2024, “In addition, we have started commercializing variant-adapted COVID-19 vaccines for the upcoming season while accelerating our clinical development efforts to realize the full potential of our technologies."

On July 24, 2024, the United Kingdom’s Medicines and Healthcare products Regulatory Agency approved the companies’ Omicron JN.1-adapted vaccine.

Sahin added, "We are making progress towards our goal of becoming a company with marketed medicines for cancer and infectious diseases.”

BioNTech is also working on expanding its infectious diseases portfolio beyond COVID-19 with continued investments in influenza and cancer, with the BNT111 Melanoma mRNA immunotherapy candidate.

Visiting areas where Valley Fever is common can put any mammal at risk of infection from breathing in fungal spores. Over the past decade, Valley Fever fungus (coccidioidomycosis) has sickened thousands of healthy people.

This fungus is found in regions like the southwestern United States, Mexico, and Central and South America.

In 2022, U.S. states reported a total of 17,612 cases of Valley Fever to the Centers for Disease Control and Prevention.

To address this health risk, Anivive Lifesciences Inc. recently announced that the National Institute of Allergy and Infectious Diseases (NIAID has awarded (#75N93024C00009) worth up to $33M to support the development of a Valley Fever preventive vaccine.

The funding will address enabling activities, including additional manufacturing, formulation, extensive safety testing, and an IND submission, before completing a human Phase 1 clinical trial.

"Anivive is honored to receive this NIAID contract, which will greatly accelerate our efforts to commercialize a vaccine to protect people against Valley Fever," said Dr. Edward Robb, Anivive Lifesciences Chief Strategy Officer and Principal Investigator, in a press release on August 2, 2024.

"This collaborative effort has delivered a significant step forward in the field of vaccinology and holds the potential to be the first vaccine to prevent a serious systemic fungal infection common to humans and animals," said Robb.

As of August 5, 2024, details of the phase 1 study were pending.

Additionally, this program is supported by Valley Fever Center for Excellence at the University of Arizona College of Medicine for the non-clinical development, Recipharm for the contract manufacturing, Quigley BioPharma for vaccine development support, and Latham BioPharm Group, part of Sia Partners for the program management, financial compliance, quality assurance, and additional technical subject matter expertise.

The Africa Centers for Disease Control and Prevention (Africa CDC) has recently confirmed a 160% increase in mpox cases in Africa this year.

As of July 28, 2024, a total of 14,250 cases and 456 deaths (case fatality rate 3.2%) have been recorded in 10 African nations.

While the Democratic Republic of the Congo has reported the most cases in 2024, several other African countries, including Kenya, Cote d’Ivoire, and the Central African Republic, have reported new mpox outbreaks.

"While mpox is moderately transmissible and usually self-limiting, the case fatality rate has been much higher on the African continent compared to the rest of the world,” the Africa CDC wrote.

On June 27, 2024, the U.S. CDC provided a Mpox Update: Clinical Management and Outbreaks. The CDC recommends that people at high risk for this sexually transmitted disease should speak with a healthcare provider about vaccination options.

Since May 2022, the CDC has endorsed the use of Bavarian Nordic's JYNNEOS® (MVA-BN®, IMVAMUNE®, IMVANEX®) two-dose, mpox, and smallpox vaccine, which remains available at clinics and pharmacies in the U.S.

Throughout 2024, chikungunya virus disease cases have been reported in the United States, primarily in international travelers returning from endemic areas in the Region of the Americas.

In the U.S., the Centers for Disease Control and Prevention (CDC) reported 52 travel-related cases this year.

As of August 2, 2024, the Pan American Health Organization (PAHO) reported 366,186 chikungunya cases. This data reflects a surge in cases compared with 411,000 for all of 2023.

From a prevention perspective, the CDC has issued recommendations for the only approved chikungunya vaccine.

In February 2024, the CDC's vaccine committee reviewed the protection offered by Valneva SE's IXCHIQ® vaccine. The CDC presented:

Short-term protection (28 days after vaccination) – 98% (611 of 622) combined seroresponse rate from two studies.

Long-term protection (12 months after vaccination) – 99% (356 of 360) seroresponse rate from one study.

IXCHIQ is available at select travel clinics and pharmacies in the U.S. and for adults in Canada and Europe.