Issued on behalf of BioVaxys Technology Corp.
VANCOUVER – USA News Group – In the field of medicine, many of the biggest breakthroughs have come from an innovation in how medicine is delivered. From the discovery of hypodermic syringes in the mid 1800s, to controlled release tablets in the 1950s, up to mRNA vaccine technology in 2020, drug delivery innovations can cause monumental shifts in the healthcare sector. Impelled by the emergence of advanced drug delivery systems, the Biologics Market Size is expected to reach nearly $700 billion by 2032 growing at 7.8% CAGR, according to IMARC Group. Working behind the scenes are some promising drug delivery innovators, including important developments from BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), Dianthus Therapeutics, Inc. (NASDAQ: DNTH), Aquestive Therapeutics, Inc. (NASDAQ: AQST), and Lexaria Bioscience Corp. (NASDAQ: LEXX, LEXXW).
Making a big splash in the delivery space, BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF) strategically acquired its now-flagship asset DPX™ technology, a patented delivery platform that can incorporate a range of bioactive molecules to produce targeted, long-lasting immune responses enabled by various formulated components.
Officially acquired in February, BioVaxys’s DPX platform is a novel lipid-in-oil delivery platform, that has already demonstrated potential across multiple infectious disease studies. Now BioVaxys has announced its plans for partnering and further development with DPX.
DPX facilitates antigen delivery to regional lymph nodes, and has been demonstrated to induce robust and durable T cell and B cell responses in pre-clinical and clinical studies for both cancer and infectious disease.
Key findings demonstrated in complete infectious disease studies have included: DPX-RSV demonstrated antigen-specific immune responses in 93% of subjects with 100% of responders in the 25μg dose cohort for respiratory syncytial virus (RSV); DPX-rHA achieved higher antibody levels than standard Alum rHA influenza vaccines in protection against multiple flu strains; DPX-Based Anthrax vaccine demonstrated 100% immunity in animal challenge studies following a single injection compared to current vaccines which require more than one dose.
"With data so compelling and supportive of the value of DPX-based vaccines for infectious diseases, we are seeking various off-balance sheet avenues to support development,” said Kenneth Kovan, President and COO of BioVaxys. “The significant cargo capacity of DPX and the proven ability to package diverse antigens such as that shown with our DPX-SurMAGE multi-antigen cancer vaccine, could also greatly benefit potential partnerships for developing more effective viral vaccines, such as a multivalent mRNA DTP vaccine to address the recognized problem of immunity to the Bordetella pertussis waning over time, or for emerging global diseases such as MPox, where a DPX-mRNA formulation could have significant advantage. This fits well with our strategy of expanding development partnerships with DPX beyond oncology."
Innovators of the patented Thin Film Freezing (TFF) technology platform TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) is building upon the momentum of positive outcomes from its Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial for the prevention of lung transplant rejection. At this stage of the trial, 9 out of 9 (100%) patients who completed the 12-week treatment chose to remain on TFF TAC, with the study observing a 6.5-fold reduction in the number of abnormally expressed rejection-related gene sets after treatment with TFF TAC.
TFF Pharmaceuticals quickly followed this up by beating expectations in its Q2 2024 financial results, which saw its revenue up 95% over the same quarter from 2023.
“Over the last several months, we have amassed a growing body of positive safety, efficacy and confirmatory biomarker data from our Phase 2 program that points towards TFF TAC becoming a significant new advancement for the prevention of lung transplant rejection,” said Harlan Weisman, M.D., CEO of TFF Pharmaceuticals. “Given our current financial resources, we are continuing to evaluate a number of different strategies to advance the TFF TAC clinical program in the most efficient manner possible.”
Dianthus Therapeutics, Inc. (NASDAQ: DNTH) is another drug delivery developer that beat expectations on its Q2 2024 financial results, backed by several milestones in its advancement of next generation antibody complement therapeutics to treat severe autoimmune diseases. Among the milestones in the quarter was the clearance by the FDA of IND for Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy (MMN) in June, with top-line results anticipated in H2 2026.
“The second quarter of 2024 highlighted the Dianthus team’s continued focus on execution and operational excellence as we advance our clinical programs for DNTH103 in generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy,” said Marino Garcia, CEO of Dianthus Therapeutics. “We believe DNTH103 may be a potentially best-in-class, potent classical complement pathway inhibitor with infrequent, subcutaneous self-administration and a differentiated safety profile across our three initial indications of gMG, MMN and CIDP. We continue to be confident in the pipeline-in-a-product potential of DNTH103 across multiple autoimmune diseases, supported by our proof-of-concept in vitro data presented at EAN and recent competitor clinical data that further validate targeting the classical pathway and active C1s.”
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is another drug delivery innovator that beat expectations in its Q2 2024 financial results, which included milestones such as its late-stage pipeline program Anaphylm™ (epinephrine) Sublingual Film, remaining on track for a near-term New Drug Application (NDA) submission to the FDA, and having a cash runway to take them into 2026.
“We continue to rapidly transform the Company through advancing our epinephrine prodrug platform," said Daniel Barber, President and CEO of Aquestive. “We have utilized this technology platform to drive the development of our product candidate Anaphylm™ as the first and only oral epinephrine product for the treatment of severe allergic reactions, including anaphylaxis. On a global basis, we believe Anaphylm has the potential to be a billion-dollar commercial opportunity. We also believe that our epinephrine prodrug platform branded as Adrenaverse™ is leading the way for potential multiple epinephrine prodrug pipeline opportunities that could produce another billion dollars in opportunities, if new product candidates developed by the Company are approved by the FDA. These opportunities, along with Libervant and our base business, have positioned the Company for continued growth over the next several years.”
In mid-August, Aquestive also commented on the recent FDA approval of another non-injection based epinephrine product for the treatment of anaphylaxis and reiterated its expected timing for an NDA filing of Anaphylm™ (epinephrine) Sublingual Film to the FDA in the first quarter of 2025.
“Use of epinephrine for the treatment of severe allergic reactions, including anaphylaxis, has been in needle-based form since its original U.S. FDA approval in 1939,” said Barber. “We are excited to see the FDA’s recent approval of an alternative non-injection-based device form of epinephrine. Literature and patient surveys indicate that adherence and compliance will likely improve as products become less invasive, easier to carry, easier to use, and easier to fit into daily life. We look forward to seeing more products in the hands of patients, including our lead pipeline program, Anaphylm™ (epinephrine) Sublingual Film, if approved by the FDA. Anaphylm is in late-stage development and has the potential to be the first and only oral epinephrine product for the treatment of severe allergic reactions, including anaphylaxis.”
Another drug delivery innovator that has recently seen positive results is Lexaria Bioscience Corp. (NASDAQ: LEXX, LEXXW), which recently shared 8-week weight results from is GLP-1 diabetes animal study, positive interim blood sugar results, and positive results from its molecular characterization study just three days prior. Back in mid-July, Lexaria announced a new strategic growth plan underway.
"Lexaria has certain initiatives underway that are increasing confidence in our medium-term and longer-term strategies," said Chris Bunka, CEO of Lexaria Bioscience Corp. "As a result of the success we are experiencing and the continued success we are anticipating, we will be implementing a number of strategic steps in the weeks and months to come."
Article Source: https://biotech-insider.com/the-phoenix-of-biotech-how-a-6m-junior-just-swooped-into-a-potential-billion-dollar-opportunity/
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