First to See the Light

Vesselon Discovery Protects and Expands Drug Franchises

Drug maker is seeking strategic relationship to deliver unprecedented levels of efficacy by making tissues more receptive to drugs.

GREENWICH, Connecticut, May 22, 2023 — 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.

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.

“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, INC.
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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The Immune Response Corporation

Revolution in Immunotherapy

DISCOVERY – Non-infectious viral vaccines.

INNOVATOR – In the history of medicine, few figures have had as profound an impact on human health and wellbeing as Dr. Jonas Salk. His polio vaccine breakthrough was the culmination of centuries of research, dating back to Louis Pasteur discovering inoculation. However, Salk’s method was different. He found a way to protect people from viruses without giving them the very disease the vaccine was designed to prevent.

Using this no-infection method, Salk worked with Kevin Kimberlin of Spencer Trask to develop cancer vaccines and an immunotherapeutic to slow or prevent AIDS. They patented and conducted preclinical studies on a cancer vaccine that demonstrated a startling 90% protection against lethal malignancies. 

IMPACT – A fusion of dendritic cells and the cancer antigen, their technology formed the basis for the first FDA-approved cell-based immunotherapy. Over 40,000 men with metastatic castrate-resistant prostate cancer have received the treatment, and it appears especially effective for African-American men who receive a 48% improved survival benefit compared to white men.

The team and facility making this immunotherapy also made clinical and commercial supplies of the first approved gene therapy, the CAT-T drug Kymriah.

The first approved cell-base immunotherapy and gene therapy prompted the FDA Commissioner to say, “New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses.”

The noninfectious vaccine approach developed by Jonas Salk eliminated polio from the developed countries, his flu vaccine mitigated the effects of influenza for the past 75 years, and finally, the cancer vaccine developed at his Immune Response Corporation led the way to gene, cell-based, and immune therapy innovations that will impact human health for generations. In summary, Salk released the last step in enabling the most important preventative medicine – non-infectious viral vaccination.