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Tonix Pharmaceuticals Holding Corp. and Bilthoven Biologicals (BBio) today announced a collaboration to advance TNX-801, a mpox vaccine candidate.
TNX-801 (recombinant horsepox virus) is a live replicating, attenuated, single-dose vaccine candidate based on horsepox in preclinical development to prevent mpox and smallpox.
TNX-801 is based on technology that has the potential to be used as a viral vector platform from which recombinant versions can be developed to protect against other infectious diseases.
BBio is a global vaccine company that produces prophylactic and therapeutic vaccines and is part of the world’s largest vaccine manufacturer, the Cyrus Poonawalla Group, which includes the Serum Institute of India.
BBio has been selected by the European Union for its pandemic preparedness program of ‘ever warm’ vaccine manufacturing companies.
“The recent mpox outbreak exemplifies precisely why we built the pandemic preparedness facility at BBio,” said Jurgen Kwik, Chief Executive Officer of Bilthoven Biologicals, in a press release on August 26, 2024.
“The establishment of the 'ever-warm' facility for pandemic preparedness underscores the critical importance of readiness in the face of global health emergencies, such as mpox. This collaboration encapsulates the essential role of the facility in bolstering pandemic preparedness and response capabilities."
Tonix has received an official written response from a Type B pre-Investigational New Drug Application meeting with the U.S. Food and Drug Administration to develop TNX-801 as a potential vaccine to protect against mpox and smallpox diseases.
Currently, four mpox / smallpox vaccines are in use globally.
Immorna Biotherapeutics Inc. today announced that it has received a $3.8 million grant from the Bill & Melinda Gates Foundation to support the clinical development of JCXH-108.
JCXH-108 is a Respiratory Syncytial Virus (RSV) monovalent vaccine candidate based on Immorna’s proprietary mRNA and ‘Ready-to-Use’ lipid nanoparticle technologies.
Available data suggest that the mRNA-RTU-LNP vaccine can achieve approximately 18 months of shelf-life at 2-8 °C, over two months of stability at room temperature, and at least 8 hours of in-use stability in the clinical setting. The enhanced stability is expected to significantly reduce the logistics complexity associated with mRNA vaccine storage, transportation, and distribution, hence enhancing this mRNA vaccine's accessibility.
The grant provides staged financial support to expedite JCXH-108’s clinical trials and clinical development of the multi-dose vial vaccine, the marketing application in the U.S., and the World Health Organization Pre-Qualification.
Dr. Zihao Wang, Co-Founder and CEO of Immorna, commented in a press release on August 26, 2024, “I believe that, if successfully approved for marketing, JCXH-108 may help protect millions of susceptible individuals and their families from the deadly diseases associated with RSV infection, which is particularly meaningful .... where RSV infection is prevalent."
"We are on track to enroll the first subject for our clinical trial by the end of August 2024."
As of August 2024, the U.S. CDC has approved three RSV vaccines and one monoclonal antibody. These products are available at clinics and pharmacies for the RSV 2024-2025 season.
The U.S. Food and Drug Administration has approved and granted emergency use authorization for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2 coronavirus.
Announced on August 22, 2024, the mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death.
“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release.
These FDA actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.
On August 19, 2024, Novavax Inc. announced, 'We are working productively with the FDA as they complete their review, including providing additional information as needed, and the FDA has committed to moving swiftly on regulatory authorization.'
'We expect authorization (protein-based vaccine) for peak vaccination season.'
The FDA states that vaccination is one of the most effective ways to prevent infectious diseases, disabilities, and deaths. In the U.S., routine childhood vaccines prevent many diseases, and immunization has reduced the occurrence of most vaccine-preventable diseases by over 95%.
The World Health Organization (WHO) today launched a global Strategic Preparedness and Response Plan to stop outbreaks of human-to-human transmission of the mpox virus. The plan covers the six months of September 2024-February 2025, envisioning a $135 million funding need for the response.
This plan follows the declaration of a public health emergency of international concern by the WHO Director-General on August 14, 2024.
The WHO stated on August 26, 2024, to interrupt transmission chains, that strategic mpox vaccination efforts would focus on individuals at the highest risk, including close contact with recent cases and healthcare workers.
The WHO's Strategic Advisory Group of Experts on Immunization has recommended two vaccines against mpox disease. In the U.S., Bavarian Nordic's JYNNEOS® vaccine is available.
With the 2024-2025 influenza season underway in the United States and cases of swine flu being reported in people attending county fairs, an innovative vaccine candidate may soon solve these severe health issues.
Emergex Vaccines Holding Limited recently announced that it received patent protection from the United States Patent and Trademark Office (USPTO) for its novel class of influenza vaccines.
This USPTO patent covers Emergex’s vaccine candidate, which comprises immunogenic peptides encoded by a negative sense open reading frame (ORF) from segment 8 of the influenza A genome. This vaccine can potentially provide long-term T-cell immunity against legacy strains of influenza A, seasonal variants, and heterosubtypic changes.
To Emergex’s knowledge, this represents the first known patent for viral peptides derived from antigenomic translation, suggesting that segment 8 of influenza A is ambisense (negative and positive sense ORFs).
In addition, this grants the company exclusive rights to develop a vaccine that incorporates these immune elements, offering a level of immune recognition that existing flu vaccines cannot provide because of composition or method of administration.
Additionally, incorporating avian—and equine species-specific NEG8-derived peptides in a vaccine can potentially expand protection against zoonotic transmissions.
This is an essential feature of a universal flu shot. As influenza viruses change from year to year, influenza vaccines must be updated annually to include the viruses that will most likely circulate in the upcoming season.
Professor Thomas Rademacher, Co-Founder and Chief Executive Officer at Emergex, commented in a press release on August 22, 2024, “Our research into NEG8 has revealed exciting potential for a new approach to influenza vaccines. We believe that a vaccine composition including conserved NEG8-derived MHC class I peptides could protect against past, existing, and emerging human influenza viruses and prevent zoonotic influenza viruses from establishing themselves in the human population and causing a pandemic."
Emergex is set to advance its first-in-class influenza vaccine into the clinic, with Phase I trials anticipated to begin in the first half of 2025.
As of August 25, 2024, various U.S. FDA-approved cell, egg, and nasal flu shots are readily available at health clinics and pharmacies in the U.S.
Over 157 million flu shots were distributed during the 2023-2024 season.
In the U.S., flu vaccines for the 2024-2025 season will be trivalent, and most (91%) will be thimerosal-free or thimerosal-reduced vaccines. About 21% of flu vaccines will be egg-free.
For the first time, messenger RNA (mRNA) immunotherapy will be studied in a phase 1 clinical trial for lung cancer in the UK, where the University College London Hospitals (UCLH) Clinical Research Facility is the lead research site.
As of August 23, 2024, a lung cancer patient at UCLH became the first person to receive a novel cancer vaccine candidate designed to prime the immune system to recognize and fight cancer cells.
Made by BioNTech SE, the investigational mRNA cancer immunotherapy/vaccine for non-small cell lung cancer (NSCLC) known as BNT116 is designed to enhance immune responses against targets primarily expressed by cancer cells.
This process reduces the risk of toxicity to healthy, non-cancerous cells—unlike chemotherapy, which often affects both cancerous and healthy cells.
UCLH consultant medical oncologist Siow Ming Lee, who leads the national study, said in a press release, “Lung cancer remains the leading cause of cancer deaths worldwide, with an estimated 1.8 million deaths in 2020."
“We are now entering this exciting new era of mRNA-based immunotherapy clinical trials to investigate lung cancer treatment, thanks to the foundation laid by the Office for Life Sciences within the Department for Science, Innovation and Technology and the Department for Health and Social Care.
The trial will enroll patients at different stages of NSCLC, from early-stage NSCLC before surgery or radiotherapy (Stages 2 and 3) to late-stage disease (Stage 4) or recurrent cancer.
The trial aims to establish the safety profile and safe dose of BNT116 monotherapy combined with established NSCLC treatments to see if it has a synergistic anti-tumor effect when given with these established chemotherapy or immunotherapy treatments.
Approximately 130 participants will be enrolled in the study across 34 research sites in seven countries, with six UK sites selected. Patients interested in participating in the trial should be directed to their GP or oncologist in the first instance, and their doctor can refer them to the study's trial centers to assess suitability.
BNT116 is also being evaluated in a Phase 2 trial as a first-line treatment for patients with metastatic NSCLC in combination with cemiplimab, a PD-1 inhibitor, and cemiplimab alone.
Bavarian Nordic A/S recently announced it received a new contract of 440,000 doses to supply its MVA-BN® smallpox and mpox vaccine from an undisclosed European country.
The Company confirmed all vaccines under this contract will be delivered in 2024.
Immediate access to these vaccines is essential since the mpox clade 1b outbreak is spreading in Africa.
Paul Chaplin, President & CEO of Bavarian Nordic, said in a press release on August 21, 2024, “Bavarian Nordic can still supply up to 10 million doses of our smallpox and mpox vaccine by the end of next year, with 2 million doses of this capacity available during the remaining part of this year.”
The MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic (JYNNEOS®, IMVANEX®, and IMVAMUNE®) is a non-replicating vaccine approved by several countries, including the United States.
