Vesselon Discovery Protects and Expands Drug Franchises

22 May 2023
www.prnewswire.com
Immunotherapy
Drug maker is seeking strategic relationship to deliver unprecedented levels of efficacy by making tissues more receptive to drugs.
GREENWICH, Conn., May 22, 2023 /PRNewswire/ -- In a major development, Vesselon has discovered how to protect a superior method of delivering drugs shown to be effective in more than 1,700 independent preclinical and clinician-sponsored human trials. Despite compelling evidence that the method improves the Therapeutic Index of numerous drugs in many indications, its promise has been ignored by the pharmaceutical industry because it has not been patentable, until now.
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Based on this discovery, the drug maker has filed patents on its TriForm™ lipid platform. Because it requires no modification of the branded drug, or its manufacturing, packaging, or distribution processes, the platform can be deployed quickly. This could have significant implications for the product life cycle management of many drugs, including biologics.
"This IP can materially increase the value of marketed drugs as well as those in development." Vesselon CEO Clay Larsen
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"Executives with brands at risk due to patent expiration or price competition can use this platform to protect and grow their franchises," said Joe Truitt, a Vesselon board advisor and shareholder who has run and sold four biopharma ventures.
The on-site, in-vial mixing process instantly combines a therapeutic drug with the FDA-approved Vesselon lipid microsphere shown to have the same safety level as saline. After mixing a standard dose, each vial contains approximately 10 billion lipid microspheres encapsulating the active drug, 50 trillion liposomes loaded with the active drug, as well as the freely circulating drug. Any pharmaceutical agent combined with the TriForm platform is a new chemical entity that is patentable as well.
"This IP can materially increase the value of marketed drugs as well as those in development," said Vesselon CEO Clay Larsen. "For instance, our data suggests that the platform enhances the value of anti-PD1 products. This evidence adds to that reported in hundreds of independent, validating studies, including human trials demonstrating marked improvements in difficult-to-treat malignancies such as pancreatic cancer. We believe our capability should be valuable for any acquiror."
The lipid-drug combination is prepared on-site and administered intravenously, as the drug normally would be, so the process fits seamlessly into standard clinical practice workflows. FDA-cleared levels of ultrasound delivered from standard diagnostic ultrasound equipment, when directed at the diseased tissue or tumor, triggers biophysical interactions with the lipid drug combination. This activates up to nine synchronous and synergistic Modes of Action in the cellular and tumor microenvironment that work in concert with the molecular Mechanism of Action of the therapeutic drug. These Modes of Action (all reported in peer review publications) make the tissue or tumor far more receptive to the active drug, improving its pharmacokinetic and pharmacodynamic profile, and potentially improving the Therapeutic Index.
"Traditional drug delivery has focused on the transmit part of the equation. Vesselon transforms how drugs are received and acted upon by tissues and cells," added Larsen.
Vesselon board chairman and co-founder Kevin Kimberlin remarked: "With this IP, and our smooth regulatory path, we have cracked the code to improving drug efficacy. Now is the perfect time to build a strategic relationship to scale and commercialize this technology." Kimberlin, who serves as chairman of Spencer Trask & Co., co-founded genomics pioneer Myriad Genetics and the regenerative medicine company Osiris Therapeutics, which developed cell therapies that generated $1.5 billion in revenues. He also developed the first FDA-approved cell-based immunotherapy with Dr. Jonas Salk.
In addition to existing franchises, current and future pipeline drugs will also benefit from the Vesselon platform. For example, proprietary drugs can be made with monoclonal antibodies, proteins, cytokines, nucleic acids, peptides, small molecules, and antibody drugs, as well as larger drug vectors like oncolytic viruses and lipid nanoparticles.
About Vesselon, I
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Vesselon Inc. develops patentable drugs using an FDA-approved, biophysically activatable lipid microsphere and self-assembling liposome platform. It produces unprecedented levels of efficacy by transforming how drugs are received and acted upon by tissues and cells. The platform can extend patents and create an endless stream of proprietary drugs.
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