Vesselon Inc. introduced the first on-site co-formulation platform that can enhance cellular uptake and response to therapy, without altering the active drug in any way.
By extending patents, the co-formulation and ultrasound activation at the clinic helps drug companies better manage product life cycles, protect franchises, differentiate their portfolios, and generate an endless stream of blockbusters.
GREENWICH, Conn., Aug. 28, 2023 /PRNewswire/ -- Vesselon Inc. introduced the first on-site co-formulation platform that can enhance cellular uptake and response to therapy, without altering the active drug in any way. Compared to traditional administration methods, Vesselon drugs penetrate targeted cells more effectively and improve a drug’s bioavailability by multiple fold.
The low-risk platform consists of an FDA-approved lipid that is co-formulated with an FDA-approved active drug and targeted at diseased tissue by FDA-authorized levels of ultrasound. Without changing pharmaceutical manufacturing, CMC, or distribution practices, the platform can protect and differentiate an endless stream of blockbuster drugs.
In-clinic mixing and administration offers numerous advantages. It requires no specialized training, device, or equipment because the formulation “manufacturing” is done by clinical staff in a 5-minute mixing process. The drug company sales force simply provides the active drug along with a vial containing the lipid. The combination is biophysically activated during infusion by standard ultrasound equipment.
Each co-formulation is a new chemical entity (NCE) with no change in the drug, or the manufacturing, packaging, or distribution processes. By extending mature drug patents, pharmaceutical firms can better manage product life cycles.
“We encapsulate many different classes of drugs, from small molecules, monoclonal antibodies, nucleic acids to viruses,” said Clay Larsen, CEO of Vesselon. “I think the best way to think about our approach is that it changes the ability of tissues to receive and act on the drug. This is not just a delivery platform.”
The ultrasound energy releases the drug at the target by while activating up to nine synchronous and synergistic Modes of Action including:
Open Tissue and Capillary Barriers
1. Capillary Permeability: Cavitation pressure opens nanoscale pores in capillary walls, improving access to targeted tissues (sonoporation).
2. Deep Tissue Penetration: Biophysical pressure releases the encapsulated drug at the target and facilitates its movement through dense tissue (inertial cavitation).
3. Improved Access to Cells: Reduces interstitial fluid pressure so more drug reaches the intended target cells.
Trigger Cellular Actions
4. Enhanced Cell Entry: Alters cell wall polarity, facilitating drug access to target cells through endocytosis.
5. Cell Membrane Fusion: The liposomes enhance fusion with cell membranes, aiding drug delivery.
6. Induction of Cell Death: The liposomes induce apoptosis in tumor cells, contributing to therapeutic effects.
7. Increased Cell Membrane Permeability: Rearranges the cell cytoskeleton to enhance cell membrane permeability, improving drug uptake.
8. Suppression of Drug Efflux: Down-regulates PGP efflux pumps, ensuring more drug remains within cells.
Initiate Immune and Abscopal Effects
9. Immune Response Activation: Stimulated cell membranes recruit T-cells to the tumor, enhancing the immune response and strong abscopal activity.
Each of these Modes of Action have been described in peer-reviewed publications. As noted in a July 23 The Wall Journal article, the cutting-edge approach of sonicating microspheres “could hold a key to a problem that has long challenged drug developers: getting medicines to hard-to-reach places.”
Numerous human studies and over 1,600 independent preclinical studies provide a wealth of evidence validating the safety and efficacy of sonicated microspheres and yet no major drug company has participated in this research, other than with Vesselon. This platform overcomes the major reasons drug companies have avoided this technology.
First, the technology is protected with manufacturing trade secrets and filed patents covering the never-observed-before self-assembly and self-encapsulation of an active drug in up to 10 billion lipid microspheres and 50 trillion liposomes.
Second, Vesselon offers a “no change in practice” adoption methodology, as there is no need to modify the active drug or change its packaging, manufacturing, or distribution. The drug is delivered as is with co-formulation done in the clinic.
Finally, a low friction regulatory path provides a rapid path-to-market with an FDA-approved lipid activated at ultrasound intensity levels authorized by the FDA, to release already approved drugs at the target.
Experienced drug industry executive Joe Truitt said, “This platform really does not pose many risks. With minimal technology, clinical, manufacturing, and regulatory issues, the risk boils down to executing life cycle trials. But these are for approved products. The promise of potential better efficacy along with the new chemical entity designation and patent is attractive for any franchise.”
Larsen concluded, “We believe that the platform has the ability to produce multiple billion-dollar drug co-formulations before 2030.”
A commitment to this proprietary, practical, and FDA-savvy system positions Vesselon as the frontrunner in turning older drugs into market leaders and offering step-function improved performance for future blockbusters.
About Vesselon Inc.
Vesselon is a biotech firm that develops patentable drug co-formulations using an FDA-approved, biophysically activated lipid microsphere and self-assembling liposomes. These co-formulations safely make targeted tissues more receptive to therapeutic drugs, producing unprecedented levels of efficacy. For additional information, please visit www.Vesselon.com.
Additional materials:
- Roland, Denise, “New Ultrasound Therapy Could Help Treat Alzheimer’s, Cancer,” The Wall Street Journal, July 31. 2023.
- XU J. et al. “Sonoporation-Enhanced Delivery of STING Agonist Induced Robust Immune Modulation and Tumor Regression,” Advanced Therapeutics, 2021. 2100154.
- Qin, Jiale, Wang, Tzu-Yin, Willmann, Jurgen K., “Sonoporation: Applications for Cancer Therapy, Therapeutic Ultrasound,” Advances in Experimental Medicine and Biology, Vol. 880.
- Dimcevski, Georg et al, “A human clinical trial using ultrasound and microbubbles to enhance gemcitabine treatment of inoperable pancreatic cancer,” Journal of Controlled Release 243, October 12, 2016.
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SOURCE Vesselon, Inc.
