Vaccine News

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. 

The Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO) today called on researchers and governments to strengthen and accelerate global research to prepare for the next pandemic.

They emphasized the importance of expanding research to encompass entire families of pathogens that can infect humans–regardless of their perceived pandemic risk–and focusing on individual pathogens.

The report’s authors likened its updated recommendation to imagining scientists as individuals searching for lost keys on the street (the next pandemic pathogen).

The area illuminated by the streetlight represents well-studied pathogens with known pandemic potential. By researching prototype pathogens, we can expand the lighted area and gain knowledge and understanding of pathogen families that might be in the dark.

The dark spaces in this metaphor include many regions of the world, particularly resource-scarce settings with high biodiversity, which are still under-monitored and understudied. These places might harbor novel pathogens but lack the infrastructure and resources to conduct comprehensive research.

“WHO’s scientific framework for epidemic and pandemic research preparedness is a vital shift in how the world approaches countermeasure development and one that CEPI strongly supports.... this framework will help steer and coordinate research into entire pathogen families, a strategy that aims to bolster the world’s ability to swiftly respond to unforeseen variants, emerging pathogens, zoonotic spillover, and unknown threats referred to as pathogen X”, said Dr Richard Hatchett, CEO of CEPI, in a press release on August 1, 2024.

The prioritization work underpinning the report involved over 200 scientists from more than 50 countries, who evaluated the science and evidence on 28 virus families and one core group of bacteria, encompassing 1652 pathogens.

A seldom-discussed diarrheal disease that affects millions of children and adults may soon have a preventive vaccine available. Furthermore, the World Health Organization has identified Shigella prevention as a priority.

LimmaTech Biologics AG today announced that it entered into a strategic partnership and exclusive licensing agreement with Valneva SE for the development, manufacturing, and commercialization of Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate against Shigellosis.

As of August 1, 2024, no approved Shigella vaccine is available.

However, the global market opportunity for a vaccine against Shigella is estimated to exceed $500 million annually.

Shigellosis, caused by Shigella bacteria, is the second leading cause of fatal diarrheal disease worldwide. It is estimated that up to 165 million cases of disease and an estimated 600,000 deaths are attributed to Shigella each year.

Moreover, Shigellosis affects international travelers and military personnel in endemic regions.

Under the terms of the agreement with Valneva, LimmaTech confirmed it will receive an upfront payment of €10 million ($10.8m) and be eligible to receive additional regulatory, development, and sales-based milestone payments as well as low double-digit royalties on sales.

LimmaTech will be responsible for conducting a Phase 2 Controlled Human Infection Model and a Phase 2 pediatric study. Both clinical trials are expected to begin in the second half of 2024.

Dr. Franz-Werner Haas, LimmaTech's Chief Executive Officer, said in a press release, “Having developed the S4V Shigella vaccine candidate from its early discovery phase to the promising clinical data we have achieved to date, we are excited to accelerate the program with our partnership with Valneva."

"This agreement underscores our capabilities to leverage LimmaTech’s proficiency in vaccine development with the best path to develop programs rapidly."

LimmaTech initiated the tetravalent Shigella vaccine candidate and continued to lead its development as part of its ongoing collaboration with GSK. Later, it in-licensed the vaccine candidate from GSK.

In February 2024, LimmaTech reported positive interim Phase 1/2 data for the S4V vaccine candidate, including a favorable safety and tolerability profile and robust data on immunogenicity against the four most common pathogenic Shigella serotypes: S. flexneri 2a, 3a, 6, and S. sonnei4.

LimmaTech Biologics AG LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections.