Zika Breaking News

BioNTech SE today announced positive topline data from the ongoing Phase 2 clinical trial in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment.

The randomized trial evaluates the clinical activity and safety of the investigational mRNA cancer immunotherapy BNT111 in combination with Libtayo® (cemiplimab), an anti-PD-1 monoclonal antibody being developed by Regeneron, and assesses the two single agents alone.

The trial met its primary efficacy outcome measure, demonstrating a statistically significant improvement in the overall response rate in patients treated with BNT111 in combination with cemiplimab as compared to historical control in this indication and treatment setting.

Both randomized monotherapy arms showed clinical activity. The ORR in the cemiplimab monotherapy arm was in line with the historical control of anti-PD-(L)1 or anti-CTLA-4 treatments in this patient group.

The treatment was well tolerated and the safety profile of BNT111 in combination with cemiplimab in this trial was consistent with previous clinical trials assessing BNT111 in combination with anti-PD-(L)1-containing treatments.

The Phase 2 trial will continue as planned to assess further the secondary endpoints, which were not mature at the time of the primary analysis.

“These Phase 2 results mark a significant step towards our vision of personalized cancer medicine. We envision mRNA as a centerpiece in future treatment paradigms for cancer, helping to address unmet medical needs, such as for patients with anti-PD-(L)1 refractory or resistant melanoma,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech, in a press release on July 30, 2024.

“These data are a proof of concept for us in three dimensions: First, for our decade-long improved mRNA cancer vaccine technology that uses uridine mRNA chemistry, a non-coding backbone engineered for optimal translational performance, and our proprietary lipoplex formulation for delivery."

"Second, for our computational approaches for selecting suitable tumor antigens for our cancer indication-specific FixVac platform candidates."

"Third, for our strategy to combine synergistic modalities, in this case BNT111, with an established immune checkpoint treatment.”

BNT111 is based on BioNTech’s fully owned FixVac platform that utilizes a fixed combination of four mRNA-encoded, tumor-associated antigens designed to trigger an innate and tumor-antigen-specific immune response against cancer cells expressing one or more of the respective tumor antigens. 

The BNT111 program received a Fast Track designation and an Orphan Drug designation from the U.S. Food and Drug Administration in 2021.

GSK plc today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approval of GSK’s respiratory syncytial virus (RSV) vaccine Arexvy for the prevention of lower respiratory tract disease (LRTD) caused by RSV from adults aged 60 and above to include adults aged 50-59 years at increased risk for RSV disease.    

GSK said in a press release on July 29, 2024, that today’s positive opinion is the first time that CHMP has recommended an indication for adults aged 50-59 for an RSV vaccine. The European Commission’s final decision is expected by September 2024. 

The U.S. FDA approved Arexvy for adults aged 50-59 at increased risk of RSV in June 2024.

Since June 2023, Arexvy has been approved in Europe for adults aged 60 and over to prevent RSV-LRTD. 

GSK has also filed regulatory submissions to expand the use of its RSV vaccine to adults aged 50-59 at increased risk in Japan and other geographies, with regulatory decisions undergoing review.

Trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk due to certain underlying medical conditions and in immunocompromised adults aged 18 and over are expected to read out in H2 2024.   

Adults with underlying medical conditions, such as chronic obstructive pulmonary disease, asthma, heart failure, and diabetes, are at increased risk for severe consequences from an RSV infection. RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.

In the United States, three approved RSV vaccines are available in July 2024.

A new World Health Organization (WHO) project aims to accelerate the development and accessibility of human avian influenza (H5N1) messenger RNA (mRNA) vaccine candidates.

The Argentinian manufacturer Sinergium Biotech is leading this effort, leveraging the WHO and the Medicines Patent Pool mRNA Technology Transfer Programme.

Sinergium Biotech has developed candidate H5N1 vaccines and aims to establish proof-of-concept in preclinical models. Once the preclinical data package is concluded, the technology, materials, and expertise will be shared with other vaccine manufacturing partners, accelerating the development of H5N1 vaccine candidates and bolstering pandemic preparedness efforts.

The mRNA Technology Transfer Programme, jointly developed by WHO and MPP, was launched in July 2021.

"This initiative exemplifies why WHO established the mRNA Technology Transfer Programme – to foster greater research, development, and production in low- and middle-income countries so that when the next pandemic arrives, the world will be better prepared to mount a more effective and more equitable response," said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, in a press release on July 29, 2024.

Avian influenza viruses are a public health risk due to their global circulation in birds and mammals. According to the WHO, they have the potential to cause a future human pandemic.

However, the WHO says avian influenza viruses are currently a low risk for most people.

In the United States, avian influenza vaccines have been developed, candidates are under development, and one has been U.S. FDA-approved.

The U.S. Department of Health and Human Services recently published an amendment to a 2013 emergency declaration under the Food, Drug, and Cosmetic Act that broadens the scope of the agency's assistance in facilitating certain medical countermeasures in response to a public health emergency, such as a pandemic.

The new declaration enables the U.S. Food and Drug Administration (FDA) to extend the expiration date of certain medical products and allow HHS to issue an emergency use authorization for unapproved drugs, devices, or products, among other actions, including vaccines.

As of July 18, 2024, the amendment now applies to pandemic influenza A viruses and others with pandemic potential, such as the current H5N1 strain of avian influenza (bird flu, cow flu).

Previously, the declaration specifically covered just the H7N9 strain.

In June 2024, the U.S. Administration for Strategic Preparedness and Response announced the Pandemic Influenza Preparedness and Response Strategy. The Strategy outlines how the U.S. government will leverage existing infrastructures and capabilities to respond to the current Highly Pathogenic Avian Influenza H5N1.

In April 2024, the FDA's Dr. Peter Marks informed the media that the U.S. stockpile of avian influenza-specific vaccines would work well if deployed. Over the past few years, the U.S. has invested hundreds of millions of dollars in various bird flu vaccines.

As of July 27, 2024, FDA-approved avian influenza vaccines are not commercially available in the U.S.

The Minnesota Department of Health (MDH) recently confirmed three additional measles cases in unvaccinated children in Anoka, Hennepin, and Ramsey counties.

MDH stated that based on current information, these cases are not directly linked and have not traveled, so there is concern for the possible spread of measles in the community.

As of July 26, 2024, Minnesota has confirmed 15 measles cases in 2024, and is an increase compared to other years. All the cases have occurred among unvaccinated children.

Minnesota isn’t the only state to have seen an increase in measles cases. Just to the south, Chicago, Illinois, reported a significant outbreak (64 cases) this year.

MDH is working with local health departments and other locations to notify people who may have been exposed directly. However, health officials note that anyone not vaccinated against measles could be at risk and should watch for symptoms of measles.   

“Measles spreads easily, and it finds those who are vulnerable,” said Jessica Hancock-Allen, infectious disease division director at MDH, in a press release.

“That is why families need to ensure their children are up to date on their immunizations to protect them from this potentially serious disease.” 

"The best way to prevent measles is through immunization."

Measles vaccines are generally available at clinics and pharmacies throughout the U.S.

The Ontario Ministry of Health has announced the first publicly funded universal program with Beyfortus® (nirsevimab) for all newborns and infants born in 2024 and through the 2024-2025 respiratory syncytial virus (RSV) season in the Northern Hemisphere.

Beyfortus single-dose administration can be timed to the start of the RSV season.

RSV is a common respiratory virus that often impacts children and can lead to lung infections such as bronchiolitis and pneumonia.

As of July 25, 2024, this new passive immunization program also includes some high-risk children up to 24 months old.

Beyfortus is administered directly to newborns and infants and offers rapid protection via an antibody without requiring immune system activation.

Delphine Lansac, General Manager, Vaccines, Sanofi Canada. commented in a press release on July 25, 2024, "Today's announcement by the Government of Ontario is a significant milestone. Providing universal access to Beyfortus® to help protect all infants in Ontario means that parents can focus on the joys of a new baby and worry less about experiencing a severe RSV infection."

"This new program builds on our 110-year heritage as a committed partner supporting public health in Canada. Our objective continues to be protecting the health of Canadians with innovative solutions and introducing Beyfortus® is a step forward to protect babies and make a positive difference for families and the healthcare system."

Health Canada issued a Notice of Compliance for Beyfortus in April 2023. Additionally, the single-dose, extended half-life monoclonal antibody was approved by the U.S. FDA in July 2023 and the European Union in October 2022.

According to media reports, access to Beyfortus is expected to meet demand in the United States during the second half of 2024.

AstraZeneca, responsible for Beyfortus manufacturing, confirmed regulatory applications for two additional filling lines have been submitted to health authorities to expand supply. This production expansion is anticipated to augment capacity compared to the one licensed line.

Sanofi today announced strong performance and increasing sales growth. In Q2 2024, Sanofi's sales were €10,745 million, up 10.2%.

In a press release on July 25, 2024, Paul Hudson, CEO, commented, “We are continuing our strong performance in 2024 and delivered broad-based, double-digit sales growth in the second quarter."

However, its very popular single-dose, extended half-life monoclonal antibody Beyfortus™ (Nirsevimab) offers passive immunization to prevent lower respiratory tract infections caused by the respiratory syncytial virus (RSV) to newborns and infants experiencing slow sales growth.

Beyfortus sales were limited to €18 million (USD $19.6), reflecting the global vaccine seasonality towards the second half-year. In the first quarter of 2024, Beyfortus produced €200 in sales.

In collaboration with AstraZeneca, responsible for Beyfortus manufacturing, the regulatory applications for two additional filling lines have been submitted to health authorities to expand supply for the Northern Hemisphere ahead of the 2024 - 2025 RSV season.

This production expansion is anticipated to augment capacity compared to the one licensed line.

According to media reports, access to Beyfortus is expected to meet demand in the United States during the second half of 2024.