Vaccine News

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.

Biological E. Limited (BE) today announced that the World Health Organisation (WHO) has granted Pre-qualification (PQ) status to their Novel Oral Polio Vaccine type 2 (nOPV2).

In collaboration with PT Bio Farma (PTB) in Indonesia, the first manufacturer of the nOPV2 vaccine to receive WHO Pre-Qualification in January 2024, BE has successfully received technology from PTB and qualified to produce more than 500 million doses of nOPV2 vaccine annually.

As of July 2024, over 1 billion nOPV2 vaccine doses have been administered.

BE has been approved by the Indian regulatory authorities to manufacture the vaccine for export purposes.

This next-generation live, attenuated oral polio vaccine significantly reduces the risk of circulating vaccine-derived Poliovirus type 2 (cVDPV2) outbreaks, which continues in various countries in 2024.

With its improved genetic stability, nOPV2 has a significantly decreased chance of seeding new outbreaks in low-immunity environments.

Furthermore, nOPV2's real-world deployment in outbreak regions has shown that it can significantly decrease the incidence of cVDPV2 outbreaks, safeguarding communities from the ravages of polio.

Ms. Mahima Datla, Managing Director, BE, said in a press release on July 30, 2024, "This vaccine has been specifically designed to address concerns about Vaccine-Associated Paralytic Polio, which has occurred in approximately 2 to 4 cases per million births with the traditional oral vaccine due to the vaccine virus reverting to a virulent form."

Ms. Datla further expressed BE's gratitude for the collaboration with PTB and the support of a grant from the Gates Foundation, “The significance of this milestone extends beyond scientific achievement; it represents a beacon of hope for millions of children and families around the globe."

Since 2000, the IPV vaccine has been available in the U.S.

In late 2023, the U.S. CDC published updated recommendations for using the IPV vaccine. Fully vaccinated adults at increased risk for poliovirus exposure may receive a single lifetime booster dose of IPV.

BE is a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953 and is the first private-sector biological products company in India.

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.