Although cancer mortality has fallen 31% in the past 30 years, three things threaten the continuation of this positive trend. Cancer drugs suffer from three recurring problems: 1). targeting, 2). toxicity and 3). degradation of certain drugs in circulation.
Vesselon solves all three problems. The process may be combined with virtually any drug to dramatically improve the efficacy and minimize its side effects.
Vesselon harnesses the physics of ultrasound energy to control the transportation of the cancer drug in circulation. Through its journey in the bloodstream, our protective lipid microsphere (Imagent) protects the drug from the body and the body from the drug. When the encapsulated drug reaches the tumor site, we apply proprietary parameters to a standard ultrasound device to expand and contract (cavitate) the microspheres. Cavitation 1). gently opens the vessels and tissue walls where the cancer resides, and 2). implodes the lipid, thereby releasing the drug. We have demonstrated that a 5 minute sonoporation process can deliver the desired efficacy of a toxic chemotherapy at levels as low as 1/14,000 of the standard dose, thus reducing or eliminating side effects and tolerance issues.
With this elegant procedure, encapsulation solves the toxicity and degradation problems while the sonoporation, by releasing the drug only at the tumor site, solves the targeting problem. This all occurs without altering the drug in any way.
Several elements of Vesselon made it an attractive venture:
1). Low regulatory risk — Each facet of the Vesselon system has been approved by the FDA. Vesselon conjugates its FDA-approved Imagent with approved drugs (such as Il-2) while the cavitation is controlled by its novel use of conventional ultrasound equipment. As a result, Vesselon represents a very low regulatory risk compared to other biotech investments.
2). Numerous Applications — This encapsulation and non-invasive targeting can be used with virtually any IV-delivered therapy to dramatically reduce toxicity and substantially improve efficacy. The platform provides multiple shots on goal as demonstrated in dozens of preclinical studies and three human clinical trials showing efficacy across a broad range of cancer types.
3). Proprietary drugs — The encapsulation of any drug inside Imagent is a patentable new chemical entity.
4). Positive FDA guidance — The safety of Vesselon’s drug is well established (65 animal and human clinical trials filed to obtain FDA approval). It is planning a single-arm, co-administration registration trial. Imagent will be used in combination with Keytruda to treat head and neck cancer, an indication in which Keytruda has had limited success.
5). Efficacy — In a preclinical study, its proprietary drug Sonoleukin doubled the effectiveness (2X) of an anti-PD1 Keytruda analog. In another study, Vesselon generated a 6.58-fold improvement in absorption of an anti-tumor drug, without any toxicity. That study also demonstrated complete regression in both primary and distant tumors in 44% of subjects, indicating that this Imagent procedure can induce a systemic immune response to specific malignancies lodged far from the treatment site.
6). Efficient operation — Vesselon does not require R&D capital. The drug and ultrasound equipment are already approved and Vesselon works with drugs on the market. This allows the company to focus on creating value by managing clinical trials, generating data and building pharma partnerships.