Diagnostics division diversifies PrimeStore® MTM utilization to include use by USDA for testing H5N1 in dairy cows
Vaccine development advances with IND-enabling studies underway for universal influenza vaccine LHNVD-110 ahead of Phase 1 clinical trial planned for first quarter 2025
Late-stage pre-clinical development progresses for LHNVD-302 anti-sepsis vaccine with extended half-life antibodies
July 31, 2024 08:00 AM Eastern Daylight Time
BETHESDA, Md. & GAITHERSBURG, Md.--(BUSINESS WIRE)--Longhorn Vaccines and Diagnostics, a One Health company developing vaccines and diagnostic tools for global public health and zoonosis concerns, provided an update on the company's year-to-date progress, highlighting significant accomplishments supporting its commitment to advancing sample collection technology for infectious diseases, and enhancing global health diagnostics and vaccines.
PrimeStore® Molecular Transport Media (MTM) is a patented, FDA cleared, state-of-the-art ambient temperature molecular diagnostic collection and transport device. Following its critical role during the Covid-19 pandemic, PrimeStore MTM has successfully transitioned to a premier sample collection device for a wide range of infectious diseases, including respiratory infections, sexually transmitted diseases, urinary tract infections, sepsis and gastrointestinal infections. Laboratories worldwide are using PrimeStore MTM to perform molecular testing across these panels using a single, versatile collection device, streamlining diagnostics and improving efficiency in clinical settings and supply chain management.
Longhorn is also advancing its pipeline of vaccines and monoclonal antibodies to combat antimicrobial resistance, sepsis and influenza. The Company’s technology is differentiated within the vaccine industry because it takes advantage of multiple well characterized targets in a single vaccine for influenza, and multiple targets that clear bacteria and toxins for the anti-sepsis vaccine. These targets have been chosen based on decades of infectious disease experience.
"The breadth of PrimeStore MTM use across human and animal disease testing and surveillance is attributed to the strength of our innovation developed over a decade ago," said Longhorn Vaccines and Diagnostics President Jeff Fischer. "Our team's dedication to advancing first-in-class diagnostic solutions and developing new ways to incorporate key targets into vaccines are driving meaningful change for governments and healthcare organizations globally. We remain committed to developing new approaches to technology that address the evolving needs of healthcare providers and patients worldwide."
PrimeStore MTM Advancements in Diagnostics in H1 2024
- PrimeStore MTM continues to play a pivotal role in addressing the recent H5N1 dairy outbreak in the US through the collection and testing of infected milk samples for rapid and accurate detection of the virus. With over a decade of extensive testing by the Foreign Animal Disease Laboratory and the Animal and Plant Health Inspection Service (APHIS), PrimeStore MTM is the trusted sample collection device for high consequence pathogens, supporting the USDA and the dairy industry in managing and mitigating the impact of this outbreak.
- Longhorn entered into a worldwide distribution agreement with Streck, an established leader in sample collection technology. Over the first six months of the collaboration, Longhorn has realized the partnership is a natural fit for the two companies, as they both focus on providing laboratories with stabilization solutions that optimize their workflow and results.
- PrimeStore MTM is helping to evolve tuberculosis (TB) testing in Africa by improving accessibility and accuracy. For patients who cannot produce sputum, PrimeStore MTM now facilitates testing through oral swabs, providing a non-invasive alternative that broadens access to diagnostics. Additionally, stool collection for children using PrimeStore MTM has proven to be much less invasive, significantly expanding the ability to diagnose TB in pediatric populations. These advancements can make a profound difference in TB management, particularly in resource-limited settings.
- PrimeStore MTM is at the heart of the new Prime External Quality Assessment (EQA) panels. These proficiency tests have undergone testing at the three Super-National TB labs across Africa. PrimeEQA TB offers a quicker, more cost-effective, and consistent method compared to standard testing procedures. Through the success of this innovative solution, Governments and non-Governmental Agencies are able to identify laboratories and processes that require additional training or updates, ensuring higher standards of diagnostic accuracy and reliability. The success of PrimeEQA has generated significant interest in developing expanded EQA panels for a wide range of tests and instruments. This demand highlights the critical need for comprehensive quality assurance in diagnostics, and Longhorn is poised to meet this need through our expertise, partnerships and technology.
Jeff Fischer explained, “These achievements underscore Longhorn’s ongoing commitment to working with governments, universities, and private laboratories to evaluate PrimeStore MTM against a wide range of pathogens and sample types, and publish that data to ensure that the results can drive improved testing, safer and faster responses to outbreaks, and further scientific development. Our years of working with the USDA, combined with their prior internal evaluation and use of PrimeStore MTM for Highly Pathogenic Avian Influenza, Longhorn is providing APHIS and the dairy industry with an immediate key tool for testing milk as H5N1 virus continues to be discovered in dairy cows.”
Developing Vaccines that Combat Highly Infectious Diseases in Animals and Humans
- New data presented in April at ECCMID 2024 on LHNVD-105, an adjuvanted composite dual peptide vaccine that targets multiple stages of the viral replication process, showcased how unconjugated multi-epitope peptides, formulated with AddaVax™ adjuvant, generated antibodies that were broadly reactive across multiple influenza virus strains when administered to pigs at low doses. Influenza is a prevalent zoonotic respiratory virus, with pigs acting as a middleman for generating new virus strains transferrable to humans, birds, and other swine with pandemic potential. This poses a major public health issue and challenges to the swine industry.
- At ECCMID 2024, Longhorn also presented data on LHNVD-301, a monoclonal antibody cocktail targeting the heat shock protein and a second cell wall target. It demonstrated strong activity against clinical tuberculosis isolates, confirming the vaccine has the potential to play a significant role in preventing and treating multi-drug resistant tuberculosis infections.
- Data presented at the World Vaccine Congress in April on LHNVD-110, an unconjugated single peptide vaccine comprised of same set of epitopes contained in the two peptides that make up LHNVD-105, demonstrated that it generated broadly reactive antibodies to human and highly pathogenic avian influenza viruses while neutralizing seasonal and pandemic influenza strains. Using a single peptide provides a more cost-effective and easily scalable approach to a universal influenza vaccine.
- LHNVD-302, a sepsis vaccine, moved into the late stage of pre-clinical development. The vaccine continues to generate strong data in animal models with monoclonal antibodies targeting clearance of both the bacteria and the toxins that produce sepsis have moved into extended half-life development. Advances in antibody half-life extension solve a key problem that prevented success in the use of these targets in previous studies.
“Based on multiple animal studies demonstrating equivalence, we are shifting our lead universal influenza candidate from a dual peptide formulation to a single peptide formulation, while maintaining all of the same validated targets. While the shift extends the clinical development timeline, it has the potential to bring significant benefits such as reducing development cost, and improving manufacturing efficiency, as well as ensuring the vaccine can be delivered in both developed and underdeveloped markets,” stated Longhorn Vaccines and Diagnostics CEO Gerald Fischer, MD. “I also look forward to seeing us advance our extended half-life anti-sepsis monoclonal antibodies quickly. In my 50 years of developing and testing antibodies for bacterial infections, these antibodies take advantage of the previous clinical success of the targets, while overcoming the dosing challenges that have held them back.”
For more information about Longhorn, visit www.LHNVD.com.
About Longhorn Vaccines and Diagnostics
Longhorn Vaccines and Diagnostics is a closely held One Health company based in Maryland that is developing broad coverage vaccines and diagnostic tools for worldwide public health concerns such as anti-microbial resistance, sepsis and to prevent future pandemics. Since its inception in 2006, Longhorn has focused on developing broad coverage vaccines and diagnostic tools that can impact a pandemic on a global scale and at all socio-economic levels. Since pandemics flow between humans and animals, Longhorn products play a significant role to surveil, diagnose, prevent and treat the next infectious disease.
Longhorn’s core product, PrimeStore® Molecular Transport Medium (MTM), is a patented, FDA cleared, state-of-the-art ambient temperature molecular diagnostic collection and transport device that can help governments, global health organizations, and drug manufacturers improve the diagnosis and treatment of highly infectious diseases such as Influenza, SARS-CoV-2, and Mycobacterium tuberculosis (TB). Unlike standard devices for collecting and transporting virus samples, PrimeStore® MTM is the first molecular transport device that can safely deactivate pathogens and stabilize RNA and DNA, allowing enhanced point of care and ambient temperature transport for laboratory based molecular testing and characterization.
Contacts
Longhorn Vaccines and Diagnostics LLC
Jeffrey Fischer
Email: jeff@lhnvd.com
Media
Alexis Feinberg – ICR Westwicke PR
Email: alexis.feinberg@westwicke.com
Investor Relations
Stephanie Carrington – ICR Westwicke IR
Email: stephanie.carrington@westwicke.com