Compared to current therapies in oncology, OmomycCPP presents several advantages. First, in contrast to targeted therapies, Myc inhibition has proven to be effective against several types of tumors independently of their mutational status or Myc expression levels, without evidence of any resistance to it even after long term treatment. In contrast to competitor Myc inhibitors in the Pharma industry’s pipeline, OmomycCPP constitutes the most direct and specific Myc inhibitor available to date and acts against all members of the Myc family, c-, N- and L-Myc, which are usually mutated or amplified in a mutually exclusive manner in multiple types of cancers, increasing the spectrum of treatable tumors. In addition, Omomyc selectively blocks a subset of Myc functions, resulting in only mild, well-tolerated and completely reversible side effects in vivo. Moreover, in the context of glioblastoma as a first indication, OmomycCPP’s ability to efficiently reach the brain following nasal administration is a significant advantage compared to chemotherapy, small molecule approaches and nucleic acid delivery, which often have limited efficacy in CNS diseases. While personalized therapies tend to atomize the glioblastoma and oncology market by being applicable to specific subsets of the patient population, our approach has the potential to treat all cancer patients, regardless of their mutational status.
It is important to keep in mind that glioma is the most common malignant primary brain tumor and high grade glioma, glioblastoma multiforme (GB), is the most aggressive one. About 23.000 patients are diagnosed with GB each year (US and EU), with a dire prognosis and a median survival of only 15 months. No current therapy for GB is curative. Eventually, we aim at expanding Omomyc’s applications to most oncological diseases.
Thanks to this Instrument, we have managed our IPR strategy completing a Freedom-to-operate analysis (with excellent results) for the use of our product; we have selected the best CRO partners selection for safety studies, clinical trials coordination, and regulatory requirements; we have also requested and obtained an appointment with EMA for a briefing meeting in September 2016; finally, we have refined our business development plan (including market and cost analysis, and funding strategy).
