IVN201 for cat dander allergy
One of the most common IgE-mediated allergies results from hypersensitivity to airborne particles originating from domestic cats (Felis domesticus). There are currently about 50 million patients suffering from allergies against cat dander in the USA and in Europe and 39% of all allergic patients in the USA and 30% in Europe are allergic to cat dander. However, current specific immunotherapy of this allergy is inadequate. Injections of suitably efficacious doses of cat dander extracts induces unacceptably high levels of adverse reactions. For that reason, it is only administered on rare occasions and for the majority of people with cat dander allergy, it is not a viable option.
ImVisioN’s lead product, IVN201, is a safe, efficacious alternative developed using the proprietary MAT ™ technology for intralymphatic immunotherapy. The therapy uses the molecule Fel d1 (the major cat dander allergen) for the allergen module of the MAT ™ molecule. Fel d1 is a potent allergen with more than 80% of cat allergy patients exhibiting IgE antibodies to it.
Preclinical Development
IVN201 has been shown to be immunogenic in mice and to be effective in a disease relevant animal model. Furthermore, ongoing preclinical safety and toxicology studies indicate that IVN201 is safe and well tolerated.
Clinical Development
A Phase I/II double-blind, placebo controlled clinical study which started in August 2008 enrolling 20 patients allergic to cat dander was recently completed. Three intralymphatic injections of increasing doses of IVN201 at monthly intervals were well tolerated and no severe side effects were observed. In addition, immunogenicity and indications of efficacy of IVN201 were demonstrated in this first-in-human study. ImVisioN plans to start a Phase II clinical study (double-blind, placebo controlled) to evaluate the safety, immunogenicity and efficacy of different dose levels of IVN201 immunotherapy in 2009. This multi-center study is expected to enrol 120 to 150 patients in several clinical sites in Germany and Switzerland.