Marina suggests IND application could be ready for submission during second half of 2011.
Debiopharm and Marina Biotech have established a collaboration to develop and commercialize the latter’s preclinical-stage bladder cancer RNAi therapeutic. Under terms of the deal Debiopharm will shoulder all Marina’s associated R&D costs and also retain full responsibility for the development and commercialization of any resulting products. Marina could receive up to $25 million in R&D milestones, plus royalties. The firm claims studies with the candidate in a mouse model of bladder cancer have demonstrated a significant reduction in tumor growth following intravesical treatment. Submission of an IND with FDA is projected for the second half of 2011.
Marina is exploiting what it describes as a “target to clinic” discovery and development engine for RNAi therapeutics and their delivery. Two product families are being developed. TauRNAi combines the firm’s UsiRNA technology for the construction of small interfering RNA (siRNA), with a dialkylated amino acid-based liposome (DiLA2) delivery system. The TransKingdom RNAi™, or tkRNAi, platform is being developed as an expressed RNA in a bacterial delivery system. Marina claims these two approaches provide the flexibility to optimize oral, systemic, and local delivery of RNAi-based therapies to a range of human diseases.
The firm’s lead Phase I-stage candidate CEQ508 is in development for the treatment of familial adenmatous polyposis and targets the production of β-catenin in dysplatic tissue. The preclinical-stage bladder cancer candidate comprises a target-specific UsiRNA, encapsulated in a DiLA2 liposome, and is designed for local administration. Marina is separately utilizing the tauRNAi platform in preclinical studies of a potential systemic therapeutic for hepatocellular carcinoma.