Periodic Reporting for period 1 - GBM-CPP (Developing an anti-Myc cell-penetrating peptide for cancer treatment)
Période du rapport: 2016-08-01 au 2017-07-31
Indeed, such peptides can spontaneously enter cells and localize in their nuclei to inhibit Myc function. Moreover, the peptides can be delivered by intranasal administration directly to the brain and lung (among other tissues), where it exerts its antitumorigenic
action (Beaulieu et al., submitted). In order to reach commercial translation of this innovative anti-cancer therapy, we founded Peptomyc S.L. (December 2014). One essential early milestone for the pharmaceutical development of the Omomyc peptides is to establish the feasibility and cost estimations for its industrial manufacturing in compliance with the European Medicines Agency (EMA) and Federal Drug Administration (FDA) recommendations for the manufacturing of recombinant protein therapeutic products. Hence, in this Proof of Concept application, we proposed to reach this key milestone by:
1- Establishing the feasibility of recombinant cGMP production of Omomyc-CPP in partnership with an experienced Contract Manufacturing Organization (CMO);
2- Defining the analytical profile to confirm the molecule identity and activity for Drug Substance (DS) release;
3- Covering the Intellectual Property Rights (IPR) Protection during the national phase of the Patent Cooperation Treaty (PCT);
4- Establishing a briefing meeting with the EMA (and FDA);
5- Contacting Venture Capital firms (VC) and Business Angels (BA).
Through these aims, this PoC grant enabled us to develop a solid partnership with the CMO and others crucial stakeholders early in the pre-commercial development process, to demonstrate the feasibility and cost of production and to ensure protection of the IPR, and therefore provided key support to assess and de-risk the product for its pre-commercialization, overall rendering this project more attractive to investors for the continuation of its development.