Biochemistry + Biophysics

Vesselon 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.

Improve Efficacy and Extend Patents

Discover how your drugs can benefit from Vesselon’s platform.

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CEO and Co-founder Clay Larsen: Vesselon’s drug platform has the ability to produce multiple billion dollar drug coformulations before 2030

More than 1,600 independent preclinical trials support the use of microsphere sonication

Despite efficacy improvements seen in this corpus of work across a wide range of indications, drug firms have not exploited this technology due to patentability concerns, implementation practicality, and regulatory uncertainty.

We have overcome these barriers with:

Patent protection,
FDA-approved drug and a smooth regulatory path, and
An in-clinic, 5-minute conjugation process that requires no modification of the therapeutic agent, or change in pharmaceutical manufacturing, packaging, or distribution.

With this three-part strategy, Vesselon is poised to have a profound impact on lifecycle management and future drug development.

Vesselon Enhances the Biodistribution and Efficacy of Drugs

By supplementing biochemistry with biophysics, we can target, deliver, and release pharmaceuticals with unprecedented levels of efficacy. Our FDA-approved lipid microspheres and liposomes protect the drug from the body, and the body from the drug side effects and toxicity. Our sonication method can target virtually any tissue.

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iECURE Inc. CEO Joe Truitt & EPISTAT CEO Dr. Llew Keltner explain how Vesselon’s co-formulation platform can protect and expand existing drug franchises

Vesselon Extends the Lifecycle of Virtually Any Drug

Vesselon gives drug firms the ability to extend the lifecycle of a brand, grow its market share or market size, enable new indications, protect a portfolio of drugs, and supercharge pipeline products.

Three features make our platform ideal for product lifecycle management.

First, is the intellectual property fortress. The proprietary system encapsulates, on-site, an active pharmaceutical ingredient (API) drug in both lipid microspheres and liposomes – a TriForm phenomenon never observed before. This conjugation is activated by FDA-sanctioned ultrasound settings (e.g., safe enough for fetal imaging) that cause a biophysical interaction with the conjugated lipid drug. This interaction initiates up to nine cellular Modes of Action that work synergistically to enhance the uptake of any therapeutic drug without affecting its molecular Mechanism of Action. Each such TriForm conjugation constitutes a new chemical entity.

Second, TriForm conjugation does not require any change in traditional pharmaceutical industry practices nor any change to the drug. There is no modification of the drug, CMC labeling, or distribution processes.

Third, our lipid drug product was approved by the FDA under NDA 21-191 based on five human clinical trials and 67 animal studies at an estimated cost of $150 million. In the filing, our lipid drug was shown to be safe-as-saline which would be expected because lipids comprise an astonishing 34.3% of the average human cell dry weight mass, and our lipid (dimyristoylphosphatidylcholine – DMPC) is made from the most abundant lipid in the human body.

Adoption

Previously, sonicated microspheres required time consuming and specialized equipment, and therefore was impractical. We overcome this obstacle with an on-site, in-the-vial mixing process that conjugates any IV-administered drug in 5-minutes. The process does not require any modification of the active pharmaceutical agent, nor any change in manufacturing, controls, packaging, sales or distribution processes.

EPISTAT CEO Dr. Llew Keltner on the flexibility of Vesselon’s drug platorm

Low Risk FDA Path

This safety profile led us to a unique regulatory strategy for these reasons:

each component of our platform has been approved by the FDA;
the biophysical oscillation of our FDA-approved lipid drug is triggered by Agency-cleared ultrasound levels; and
we encapsulate already marketed drugs

This produces an unusually low-friction, low-risk regulatory path for product lifecycle management.

Joe Truitt: How acquiring companies should assess Vesselon’s risk

FDA-Approved Drug

“safe-as-saline”

Imagent®

lipid powder
(NDA 21-191)

FDA-Cleared Ultrasound

safe, cleared intensity settings

universally safe
modality

FDA-Approved Biologic

unaltered, same dose

use approved,
packaged drug
products

Endless Stream of Proprietary Drugs

Amidst an ocean of opportunity that covers much of pharmacology, we focused our drug development on expanding the market for Keytruda, the best-selling cancer drug. In that pursuit, we have demonstrated that our platform can deliver enhanced monoclonal antibody, small molecule, cytokine, and protein drugs that generate significant improvements in anti-PD-1 performance.

These demonstrations are steppingstones toward improving the value of innumerable monoclonal antibody drugs. Beyond this, proprietary conjugates can be made with proteins, cytokines, nucleic acids, peptides, small molecules and antibody drug conjugates, as well as larger drug vectors like oncolytic viruses and lipid nanoparticles.

In short, our platform can produce an endless stream of proprietary pharmaceuticals.

VESSELON DRUG	FORMULATION	INDICATIONS
SonoPembro™	TriForm formulation of Imagent microspheres and liposomes encapsulating pembrolizumab	Multiple Solid Tumors to improve Keytruda ORR
SonoLeukin™	Microdoses of unaltered Interleukin-2 encapsulated in Imagent microspheres	Multiple Solid Tumors with Various Combinations
SonoVastin™	TriForm formulation of Imagent microspheres and liposomes encapsulating unaltered bevacizumab	Multiple Solid Tumors with Various Combinations
SonoFeron™	TriForm formulation of Imagent microspheres and liposomes encapsulating unaltered Interferon-γ	Multiple Solid Tumors with Various Combinations
SonoVec™ p53	Vesselon proprietary Ad5/3 multi-targeting adenovirus expressing p53 in microdoses of Imagent microspheres	Multiple Solid Tumors with Checkpoint Inhibitor
SonoVec™ PembrOV™	Vesselon proprietary Ad5/3 multi-targeting adenovirus expressing pembrolizumab in microdoses of Imagent microspheres	Multiple Solid Tumors in lieu of Keytruda

Clay Larsen on Vesselon’s third generation adenovirus

Joe Truitt: Vesselon’s drug platform can extend the terminal date to a new IP, in a new chemical entity

Intellectual Property

VESSELON made a profound discovery about the biophysical interaction between ultrasound wave propagation and our lipid drug. The never-before-observed insight is the subject of composition of matter and method patent filings that cover the instant, on-site encapsulation of any active drug in lipid microspheres and, simultaneously, in self-assembling liposomes. After conjugation, each vial contains approximately 10 billion lipid microspheres encapsulating active drug, 50 trillion liposomes loaded with active drug, as well as freely circulating drug.

Each such conjugated drug is a new chemical entity, and thus patentable as well.

Contact

101 Merritt 7
Norwalk, CT 06851

Tel.: 203 989 0500

Email: [email protected]