Periodic Reporting for period 1 - PEPTO1 (Feasibility study of a novel treatment for cancer based on a recombinant peptide therapy)
Reporting period: 2016-03-01 to 2016-07-31
Upon completion of phase I/II, Peptomyc plans to reach a licensing deal with a pharmaceutical company, which will take care of the subsequent development and commercialization of OMO-101. In the feasibility study proposed here, Peptomyc’s team has elaborated and refined the business development plan of this new therapy to maximize its social and commercial potential. Such study includes:
a. Management of the IPR strategy;
b. Completion of the best CRO partners selection for  execution of the safety studies,  clinical trials coordination,  Pre- IND and IND applications and other regulatory requirements;
c. EMA Briefing meeting;
d. Refinement of the business development plan, including market and risk analyses, cost and market analysis for the commercialization of research tools (i.e. antibodies, biomarker kit) deriving from Peptomyc’s activities.
This feasibility study provides a strong asset to advance this unique, innovative therapy towards its commercialization not only into the GB market, but eventually in multiple types of cancer, and concludes that the innovation has strong potential of commercialization and requires additional funding in order to be developed to the level of investment readiness/market maturity.
• M1. Complete FTO analysis: This was performed by the legal firm ABG Patentes. According to their report there does not seem to exist any substantial risk of infringements of granted patent rights in Australia, Brazil, Canada, China, States Member of the Eurasian Patent Organization, States Member of the European Patent Organization, Hong Kong, Israel, India, Japan, South Korea, Mexico, Singapore, United States of America and South Africa.
• M2. Selection of the best value-for-money CROs for the [a] execution of the safety studies (PK/PD, toxicology), [b] clinical trials planning and coordination, [c] Pre- IND and IND applications and other regulatory requirements. This selection was made on the basis of teleconferences with the CROs, reviewing the various quotations obtained and taking into account peer opinions when needed.
• M3: Briefing meeting at EMA: An initial briefing meeting in order to clarify the regulatory strategy of the product has been requested with the EMA and granted for September 19th 2016. A Briefing Meeting Document has been prepared.
• M4. Refined business plan, including market and cost analysis, funding strategy and meeting with VCs and business angels. In this context, the company has already completed a first round of seed capital funding for 1 M euros with VC (HealthEquity) and BAs in April 2016 and has raised approximately 1.5 M euros in public funding (RETOS grant from the Spanish Ministry of Science and Innovation and PAT grant from the Entrepreneurial Competitivity Agency (ACCIÓ) of the Catalan Government).
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).