In the project Syst-iMYC, we proposed to develop an innovative approach to inhibit Myc, a non-redundant and “most-wanted” therapeutic target in human cancer. Thanks to the ERC-2013-CoG n° 617473, linked to this PoC, we previously proved that Omomyc, a Myc mutant designed by Dr. Soucek and known to be the best direct Myc inhibitor characterized to date, presented unexpected cell-penetrating properties when produced as a purified Omomyc polypeptide. Such a polypeptide displayed anti-tumorigenic effect upon local administration to mice bearing lung and brain tumors, and could therefore become a first clinically-viable direct Myc inhibitor. With this ERC PoC, we made a further step towards a more clinically viable product, developing a new drug based on an Omomyc variant that enables systemic treatment of several cancer types including lung, breast, lymphoma, and melanoma. The forecasted peak revenue for such first-in-class drug in these indications could reach 2.612 M€ annually.
We are happy to confirm that, at the end of this project, we have a product active in vitro and in vivo and ready to enter clinical trials Phase I/II in patients in January 2021, to then continue its commercialization. During the duration of this project, we achieved essential milestones for the development of this innovative therapeutic polypeptide: we established its activity in vitro and in vivo, we defined its toxicology profile in mice and prepared for regulatory non-clinical studies in two other animal species, put together a commercial package (including market potential, IPR portfolio and strategy, and feedback from VCs) and established the feasibility of its industrial production.
