Hemorrhagic Fevers, Viral

Work on the vaccine dates back to at least 2016, when Moderna announced that BARDA was providing $8 million to finance a phase 1 toxicology study. Moderna does not plan to advance a midstage Zika vaccine without additional outside cash, despite receiving U.S. funding thus far, according to a regulatory disclosure.  The news, tucked into Moderna’s annual report released Friday, throws cold water on the most mature vaccine in Moderna’s public health pipeline. The company is also working on vaccines for mpox and Niphah under the public health umbrella, both of which are in phase 1 studies. The Flagship biotech’s Zika vaccine, mRNA-1893, is currently in a phase 2 study that’s fully enrolled some 800 patients in the mainland U.S. and Puerto Rico. The primary completion date is late July 2024, according the study’s clinical trial record.  Work on the vaccine dates back to at least 2016 when Moderna announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) was providing $8 million to finance a phase 1 toxicology study. BARDA also offered $117 million for future phase 2 and phase 3 studies, plus large-scale manufacturing.  When Moderna finalized plans for an mRNA manufacturing site in Kenya last year, CEO Stéphane Bancel specifically mentioned the potential to develop vaccines for "persistent infectious diseases like HIV and outbreak threats such as Zika and Ebola," according to a release.  Moderna's Hamilton Bennett, who serves as senior director of Vaccine Access and Partnership, mentioned the vaccine as being a key part of the company's global health portfolio in a December 2023 ESG Day. At that time, she noted that partnerships would be key to the global health portfolio.  "The value in mRNA access is that the exploratory research that our academic collaborators are conducting is taking place on a platform and a platform that is built an early development engine, an engine that can accelerate products not only into the clinic but to licensure," Bennett said. "It's this kind of collaborative model for innovative research and the type of bold approach that Moderna is willing to take in our mission to advance the greatest impact on public health." Spokespeople for BARDA and Moderna did not immediately respond to requests for comment on the decision and on how much money had been awarded thus far.  This is the latest example of Moderna reallocating resources as it tries to stave off evaporating COVID vaccine sales with near-term launches. The company recently confirmed that some employees would be laid off after reducing its COVID manufacturing investments. Executives described 2023 as a pivot year after the commercial COVID market shaped up and demand dwindled.  Now, Moderna is looking elsewhere to resuscitate revenue and investor excitement. First and foremost is the company’s respiratory syncytial virus vaccine, slated for a decision by the FDA in May. If approved, it would join the likes of GSK and Pfizer in the older adult population. Moderna also expects interim phase 3 data on its cytomegalovirus vaccine this year. A phase 3 trial is underway testing Moderna’s individualized neoantigen therapy plus Keytruda in patients with high-risk melanoma.

BEVERLY, Mass.--(BUSINESS WIRE)-- Akston Biosciences, dedicated to accelerating the next revolution in Animal Health, announced the publication in Frontiers in Immunology of a study on AKS-107, an innovative antigen-specific immunotherapy based on Akston's Ambifect® Fc-fusion protein platform. The study demonstrated AKS-107's potential to target and delete insulin-specific B cells, which are implicated in the development of Type 1 Diabetes (T1D). Fc-fusion proteins based on this platform can be designed to interact only with parts of the immune system related to the target disease while minimizing off-target effects. AKS-107 is a human IgG1 Fc-fusion protein engineered to retain conformational insulin epitopes that bind to B cell receptors while preventing binding to the insulin metabolic receptor. The study conducted in non-obese diabetic (NOD) mice and insulin-reactive B cell receptor transgenic mouse strains showed that AKS-107 can safely prevent spontaneous diabetes, demonstrating durable immune tolerance. Studies have shown that AKS-107 has a protracted pharmacokinetic pro was well-tolerated in both mice and non-human primates, making it a promising candidate for clinical development in T1D prevention settings. "Akston has confirmed the versatility of the Ambifect® platform across diverse treatment areas, including extended duration insulin therapies, infectious disease vaccines, and, with AKS-107, interrupting an autoimmune cascade," said Todd Zion, Ph.D., President & CEO of Akston Biosciences. “We are now exploring its application to therapeutic vaccination, where the immune system is recruited to target proteins involved in non-communicable diseases," he added. “Using a common platform allows Akston to reduce development time and manufacturing costs across its entire pipeline.” As part of its renewed focus on Animal Health, Akston recently spun out all applications for human T1D prevention and treatment, including AKS-107 for disease prevention and AKS-440, its once-a-week basal insulin therapy. Akston also spun out all human clinical vaccine applications with lead candidates targeting misfolded proteins involved in neurodegenerative diseases including Alzheimer’s and infectious diseases including Middle East Respiratory Syndrome (MERS) and Dengue fever. Regarding its Animal Health applications, Akston is partnered with Dechra Pharmaceuticals PLC to commercialize canine and feline ultra-long insulins. The company is also advancing lead therapeutic vaccines against nerve growth factor for chronic pain and IL-31 for atopic dermatitis. About Akston Biosciences: Akston Biosciences Corporation is dedicated to accelerating the next revolution in Animal Health by inventing, developing, and manufacturing breakthrough protein therapeutics for veterinary use. Its vertically integrated capabilities, including a kilogram-scale cGMP manufacturing facility dedicated to Animal Health, can significantly reduce the time and cost from discovery to commercial introduction. Akston leverages its Ambifect® Fc-fusion protein platform to create innovative, extended-duration biologics and therapeutic vaccines. Its facilities are located in Beverly, Mass. Additional information is available at akstonbio.com.

12 month contract focused on the development of new antiviral drugs Novel candidates to be produced using Kimer Med's broad-spectrum antiviral platform 95% of viral diseases lack an approved antiviral treatment Download high resolution images here: NELSON, New Zealand, March 7, 2024 /PRNewswire/ -- Kimer Med, a New Zealand-based biotech start-up, today announced it has signed a contract valued at up to USD$750,000 (NZD$1.3 million) with Battelle, the world's largest independent, nonprofit research and development organisation. The 12 month contract is funded by the United States government through the Defense Threat Reduction Agency (DTRA), and will fall into Battelle's Accelerated Therapeutics for Combating Acute Viral Epidemics programme. The contract is focused on the discovery and development of new antiviral drug candidates for the treatment of alphaviruses. Spread mostly by infected ticks and mosquitoes, alphaviruses cause significant human and animal disease. Infections that result in encephalitis - inflammation and swelling of the brain - are often fatal and can cause ongoing neurological problems. There is currently no effective antiviral treatment for alphavirus infection. "Approved antiviral drugs are currently available for only 11 out of more than 200 viruses that cause widespread sickness, suffering and death in humans," said Kimer Med's CEO, Rick Kiessig. "Our mission is to change that. We're developing a family of broad-spectrum antivirals capable of treating many of these infections." "This contract is an important milestone for Kimer Med, as it provides another opportunity to prove the capability of our platform for rapid, broad-spectrum antiviral development," said Kiessig. Since the company's launch in 2020, Kimer Med has developed antivirals that have shown in vitro efficacy against 11 different viruses, including the priority viruses Dengue (all four serotypes) and Zika. Their technology holds significant promise to deliver vital broad-spectrum antiviral treatments with a range of applications, including: Infectious diseases: Half the world's population is at risk from mosquito-borne viral infections for which there are no antiviral treatments available. Pandemic protection: Vaccines will not be ready and waiting when the next pandemic occurs, but broad-spectrum antivirals can be stockpiled for early protection. Military use: Broad-spectrum medical countermeasures to protect military personnel against a range of existing and emerging viral threats. Healthcare and First Responders: Vital protection for frontline health workers and other first responders in the event of viral outbreaks, especially when the pathogen is unknown. "With broad-spectrum antivirals, we have within our grasp the potential to revolutionise the treatment and prevention of viral infections in the way that penicillin did for bacterial infections. We're looking forward to working with such a highly-regarded and well-resourced organisation as Battelle to advance antiviral drug candidates that will be able to treat these alphaviruses, and hopefully a range of other viruses as well," said Kiessig. About Battelle Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit . About Kimer Med Founded by Rick Kiessig and Phil Oliver in 2020, Kimer Med is a biotech start-up, based in Nelson, New Zealand. Backed by a multi-million dollar seed funding round, the company has designed a platform for the rapid development of novel, broad-spectrum antivirals. Kimer Med launched a Series A capital raise in September 2023 to progress development of their lead antiviral candidate through to Phase 1 clinical trials. For more information, visit . SOURCE Kimer Med