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VANCOUVER – USA News Group – How we deal with future spikes in disease cases and potential global pandemics is evolving rapidly. Not only is the World Economic Forum championing more equitable access to medicines across the globe, but how we receive treatments is changing rapidly. Experts in drug delivery have highlighted the areas of innovation to watch in 2025, which include micro robotics, materials engineering, nanoparticles, extracellular vesicles, and normalizing biological systems. But ever since the 2019 global health crisis, one of the biggest areas of interest to capture attention have been how we receive vaccines and other treatments, from mRNA, to sublingual drugs, to patches and other needle-free methods. Working behind the scenes to improve the way we receive treatments are several innovators, including recent developments from BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), Savara Inc. (NASDAQ: SVRA), Thermo Fisher Scientific Inc. (NYSE: TMO), Aquestive Therapeutics, Inc. (NASDAQ: AQST), and Verve Therapeutics, Inc. (NASDAQ: VERV).
The article continued: According to analysts at Introspective Market Research the Global Advanced Drug Delivery Systems Market is projected to reach US$352.01 billion by 2032. With the advent of more mRNA vaccines on the horizon, Verified Market Research projects the Global mRNA Vaccine Market will reach US$48.6 billion by 2030, growing at a whopping 20.2% CAGR along the way. Even more optimistic, Business Research Insights projects a 19% CAGR for the Global mRNA Cancer Vaccines and Therapeutics Market to touch US$960 million by 2032.
BioVaxys Developing DPX to be the Carrier of Choice for mRNA Vaccines, a market projected to grow to more than US$48 billion by 2030
BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), a clinical-stage biopharmaceutical company, today highlighted the potential for its DPX™ non-systemic immune educating platform to address the inherent limitations of lipid nanoparticles (LNPs) for packaging and delivering mRNA and other polynucleotides. Continued development of DPX-mRNA formulations is one of BioVaxys’ objectives, with BioVaxys pursuing collaborations with companies and academic institutions that possess pipelines of promising tumor and virus-specific polynucleotide antigens.
“The DPX platform is essentially a ‘pipeline from a product’ and will play a significant commercial role for the Company as an enabling technology for delivering nucleic acids and other antigens. DPX is ideal for mRNA delivery, as it remains localized and does not spill out from the injection site and has superior stability than LNPs,” said Kenneth Kovan, President and Chief Operating Officer of BioVaxys. “With better manufacturing economics than LNPs, it is generating interest from potential partners in the mRNA vaccine field.”
BioVaxys’ DPX™ technology is a patented delivery platform designed to produce targeted, long-lasting immune responses by incorporating bioactive molecules such as mRNA, peptides, and virus-like particles. Unlike traditional lipid nanoparticle (LNP)-based systems, DPX targets regional lymph nodes, attracting a unique subset of antigen-presenting cells (APCs) to the injection site, resulting in enhanced immune activation and specific responses to encoded antigens. Pre-clinical and clinical studies for both cancer and infectious diseases have demonstrated robust and durable T and B cell responses using DPX.
While mRNA vaccines have proven highly effective, especially during the pandemic, their reliance on LNPs has posed challenges, including instability and adverse inflammatory reactions due to systemic delivery. DPX overcomes these limitations by improving the stability and delivery of mRNA, maintaining its integrity for up to 14 days in vivo, and minimizing systemic side effects. These advantages make DPX a promising platform for extending the use of mRNA vaccines to new applications, offering safer and more efficient immunotherapy options.
These unused lipids from the former IMV, Inc. (the intellectual property of which was officially acquired by BioVaxys in February), had been previously produced in advance of anticipated IMV clinical studies and commercial ramp up. In February 2024, BioVaxys acquired 100% of the intellectual property and programs formerly owned by IMV.
BioVaxys has also signed a binding LOI to develop DPX™-Based Vaccines for Life Threatening Food Allergies, and has highlighted DPX’s potential across multiple infectious disease studies and announced its plans for partnering and further development.
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In other industry developments and happenings in the market this week include:
Savara Inc. (NASDAQ: SVRA) is advancing a potential breakthrough treatment for autoimmune pulmonary alveolar proteinosis (aPAP), a rare and debilitating lung disease caused by the build-up of surfactant in the lungs. The company has initiated a rolling submission of its Biologics License Application (BLA) to the FDA for MOLBREEVI, an innovative inhaled therapy delivered through a specialized nebulizer designed to target the lungs directly.
"Given the positive results of the pivotal, Phase 3 IMPALA-2 trial, we believe MOLBREEVI demonstrates a favorable benefit-risk profile and could fundamentally change the way aPAP is treated," said Matt Pauls, Chair and CEO of Savara. "Initiation of the BLA is an important milestone in potentially addressing the unmet need in aPAP, for which there are no approved medicines in the U.S. and Europe. We look forward to working closely with the FDA throughout the review process and expect to complete the submission of the rolling BLA by the end of 1Q 2025."
With Fast Track and Breakthrough Therapy Designations, MOLBREEVI offers hope to aPAP patients who currently lack approved treatments. If approved, this therapy could set a new standard in managing this chronic condition.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, recently announced that the UK Biobank Pharma Proteomics Project (UKB-PPP) has selected its Olink® Explore Platform for the world’s largest human proteomics study. The project will analyze over 5,400 proteins from 600,000 samples, aiming to discover biomarkers that can predict, diagnose, and treat diseases, marking a significant step forward in precision medicine.
"Studies on the human proteome are having a profound impact on our customers’ fundamental understanding of disease and the advancement of life sciences research," said Marc N. Casper, chairman, president, and CEO of Thermo Fisher. "The unprecedented scale of this project, with support from our next-generation proteomics solution, underscores the potential to deepen their knowledge and develop new applications to improve human health."
The Olink Explore Platform enables deep analysis of thousands of proteins, providing researchers with powerful insights into the role of proteomics in disease progression. Building on a successful pilot project published in Nature, which identified protein risk factors for cancers years before diagnosis, UKB-PPP is set to transform drug discovery and diagnostics. This groundbreaking collaboration, supported by 14 leading biopharmaceutical companies, promises to accelerate targeted treatments and improve global health outcomes.
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is making significant strides in advancing innovative treatments for severe allergies, alopecia areata, and epilepsy. In 2025, the company plans to submit a New Drug Application (NDA) for Anaphylm™, a groundbreaking sublingual epinephrine film designed for severe allergic reactions, potentially becoming the first orally delivered epinephrine product on the market. Aquestive is also launching a Phase 2a trial for AQST-108, a topical epinephrine gel targeting alopecia areata, offering a potential alternative to JAK inhibitors with fewer side effects. Additionally, Libervant®, the first orally administered rescue treatment for seizure clusters in young children, received FDA approval in 2024, securing orphan drug exclusivity until 2031.
“In 2024, we significantly advanced the Company and delivered on our key milestones," said Dan Barber, CEO of Aquestive. "We believe our long-term growth strategy remains compelling with the potential approval and launches of Anaphylm, Libervant, and AQST-108 in the U.S. and around the world. This is truly an exciting time at Aquestive.”
With these innovations, Aquestive continues to position itself as a leader in novel drug delivery technologies.
Verve Therapeutics, Inc. (NASDAQ: VERV), a clinical-stage company developing genetic medicines for cardiovascular disease, recently announced significant progress across its pipeline and outlined key 2025 milestones. Verve expects initial Phase 1b data for its lead program, VERVE-102, targeting the PCSK9 gene, in the second quarter of 2025, with final dose-escalation data expected later in the year. The company is also advancing VERVE-201, targeting ANGPTL3, in a Phase 1b trial, and recently nominated VERVE-301, a therapy targeting the LPA gene, as a development candidate under its collaboration with Eli Lilly. With a well-capitalized position extending into mid-2027, Verve remains focused on its mission to create lifelong cholesterol-lowering treatments.
“Our mission is to advance a new class of in vivo gene editing medicines for cardiovascular disease that address key drivers of high cholesterol," said Sekar Kathiresan, M.D., CEO of Verve. "With multiple programs utilizing our GalNAc-LNP liver delivery technology, 2025 will bring critical milestones that underscore our potential to transform treatment for millions worldwide."
Verve’s partnership with Eli Lilly for the LPA program also includes up to $465 million in milestone payments, strengthening its ability to fund groundbreaking genetic therapies.
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