Cancer Vaccine Breaking News

According to the World Health Organization (WHO), the global Dengue fever outbreak continues to expand in August 2024.

Dengue outbreaks are being reported by 90 countries in 2024, with most of these cases reported in the Region of the Americas.

As of August 8, 2024, 43 countries and territories in the Region have reported over 11.1 million Dengue cases and about 6,135 related deaths this year.

The updated data is over 120% greater than recorded throughout 2023.

In the United States, the U.S. CDC reported on August 7, 2024, that 52 jurisdictions, led by Florida, New York/New Jersey, and Puerto Rico, had confirmed 3,290 dengue cases.

In 2023, only 2,343 Dengue cases were reported to the CDC. 

The CDC says Dengue is endemic in the U.S. territories of Puerto Rico, American Samoa, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of Marshall Islands, and the Republic of Palau. 

Currently, the CDC says the best way to prevent this mosquito-transmitted disease is to wear protective clothing, as no Dengue vaccine is available in the U.S.

However, in 2024, Takeda's QDENGA® (TAK-003) two-dose vaccine is available in over 20 countries. The WHO added QDENGA to its List of Prequalified Vaccines effective May 9, 2024. 

Novavax, Inc. today announced its financial results and operational highlights for the second quarter ended June 30, 2024. The Company confirmed it achieved total revenue of $415 million in the second quarter of 2024 and ended the period with $1.1 billion in Cash.

John C. Jacobs, President and Chief Executive Officer of Novavax, commented in a press release on August 8, 2024, "We intend to drive future value for the business through not only the Sanofi partnership but also through our late-stage combination and influenza assets."

"We plan to unveil a new and expanded clinical pipeline by the end of this year and leverage the pipeline and our proven technology to drive additional partnerships and deals and ultimately drive significant, long-term value for our shareholders."

Additionally, Novavax has taken steps to enable a successful operationalization of the collaboration and license agreement with Sanofi Pasteur Inc. 

Effective January 1, 2025, Sanofi will assume primary commercial responsibility for Novavax's updated 2024-2025 formula COVID-19 vaccine (NVX-CoV2705) in the U.S., Europe, and select major markets not currently subject to Novavax Advance Purchase Agreements or existing partnership agreements.

Furthermore, the Company expects to deliver its updated 2024-2025 formula protein-based COVID-19 vaccine to the market by the start of the season, and it has advanced retail pharmacy contract negotiations to enhance access for the 2024-2025 vaccination season.

The COVID-19 vaccine was created using Novavax's nanoparticle technology, Matrix-M™, an adjuvant that enhances immune responses and stimulates high levels of neutralizing antibodies.

In the U.S. market, Novavax submitted an Emergency Use Authorization (EAU) amendment to the U.S. Food and Drug Administration (FDA); doses will be ready to ship upon receipt of the EUA. The FDA accepted the Biologics License Application for Novavax's COVID-19 vaccine with a Prescription Drug User Fee Act date of April 2025.

However, the U.S. FDA has not approved the trade name Nuvaxovid™.

According to Avian Flu Diary's report on August 6, 2024, Finland is offering bird flu vaccination to qualifying adults over 18 who, due to work or other circumstances, have an increased risk of contracting it.

Finland has received 20,000 doses of the H5N8 bird flu vaccine, enough to vaccinate 10,000 people with two doses.

The batch of vaccines received in Finland expires at the end of September 2024, so those at risk of infection should take the first vaccine dose in August.

So far, there are no human bird flu infections in Finland. Taking the bird flu vaccine is voluntary in Finland.

On July 15, 2024, a U.S. government spokesperson confirmed in an emailed statement, 'Avian influenza vaccination has not been recommended for any segment of the population, and the U.S. government continues to monitor the situation.'

As of August 7, 2024, the U.S. vaccine stockpile has access to various avian influenza vaccines, such as Audenz.

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.