Thursday, August 08, 2019
Vesselon, an oncology therapeutics company, today announced the acquisition of an FDA-approved drug Imagent®. Vesselon will use Imagent to create novel therapeutic complexes in four classes of cancer drugs: cytokines, oncolytic viruses, monoclonal antibodies, and nucleic acid constructs.
Vesselon incorporates Imagent into its Vascular Encapsulation Sonication Targeting (VESTTM) system that combines three FDA-approved elements: the Imagent drugs, conventional ultrasound, plus an approved cancer drug. The ultrasound is used to actively target the drugs by aiming the ultrasound precisely at the tumor, causing the Imagent drug to oscillate in the capillaries to selectively open vessel wall barriers (e.g., the tumor microenvironment or blood-brain barrier). In addition, certain drugs can be encapsulated inside the Imagent microsphere to be released by ultrasound only at the tumor site. This combination of precise tumor targeting and the release only at the tumor addresses the three major issues facing all cancer therapy: toxicity, degradation, and targeting.
Imagent is approved by the FDA (NDA 21-191) for diagnostic purposes as a contrast agent for diagnostic ultrasound. There is an extensive body of preclinical and clinical evidence that microspheres and ultrasound act at the capillary level to both carry and deposit drugs directly to tumors. This protective mechanism avoids the degradation and limits toxicity associated with most advanced anti-cancer agents. In addition to protecting the drug while in circulation in the body, this therapy also precisely targets the malignant tissue, significantly reducing the toxicity and side effects of anti-cancer and immuno-oncology drugs.
“We are eager to combine our FDA-approved drug with approved immuno-oncology drugs to address unmet needs in solid tumor cancer therapy,” said Rhodemann Li, Founder and Executive Vice President of Vesselon. “This increases the beneficial drug activity in the tumor while reducing off-target adverse reactions in normal tissues and organs. Together, those effects lengthen and improve the quality of life for patients with solid tumors,” Li added.
Four broad classes of drugs are being developed by Vesselon: 1.) cytokines (interleukins), 2.) nucleic acids (mRNA), 3.) monoclonal antibodies (checkpoint inhibitors), and 4.) oncolytic viruses designed to replicate only in cancer cells. VESTTM is particularly valuable for the cutting-edge immuno-oncology products – drugs that use the body’s own immune system to counteract the growth and spread of malignant tumors.
“Even with the burgeoning research and investment focus on immuno-oncology, once inside the body, each class of drugs have significant toxicity, degradation and targeting issues,” said Vesselon President and CEO Clay Larsen. “Our VESTTM enabled drug/drug complexes address these common and obstinate challenges in many different tumor types,” Larsen continued.
Because Imagent has been approved for use by the FDA, and considering that VESTTM will be used only with already FDA-approved therapeutic agents, Vesselon expects the regulatory process for its drug/drug complexes to be straightforward.
“When Vesselon solves the fundamental problems associated with immuno-oncology, these wondrous advances can realize their full potential,” said Kevin Kimberlin, lead investor and Chairman of Spencer Trask & Co. “By changing the rate of progression or stopping cancer in its tracks, Vesselon can change the cancer landscape,” Kimberlin added.
