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Tuesday, August 21, 2007

Quark Biotech on Course to Submit 3 RNAi-based INDs in 2007

The speed with which Quark Biotech has been turning out clinical-stage siRNA drug development programs is quite remarkable. With one ongoing phase I study for age-related macular degeneration (AMD) and one submitted IND for acute kidney injury, the Fremont, California, based biotech company today announced plans to file a third IND in 2007 for an siRNA drug candidate, this time for preventing chemotherapy-induced hearing loss. More siRNA programs are already in the pipeline.

Quark Biotech is an interesting player in the RNAi Therapeutics field as it leverages genomic screening techniques to rapidly discover novel drug targets. Indeed, the discovery of RNAi in the era of the human genome could not have come at a better time. As RNAi can target virtually any gene, efforts like those of Quark Biotech will allow the genome-wide screen for drug candidates essentially based on their biological suitability and not limited by “druggability”. Further demonstrating the cross-fertilisation between genomics and RNAi, the inhibitor screens performed by Quark Biotech, Cenix BioScience, and a number of other commercial and academic groups, are largely based on RNAi itself. Thus, RNAi simultaneously functions both as a target validation tool and potential drug candidate and allows for such fast development time-lines.

Quark Biotech sees itself as part of a new type of triangular relationship in the RNAi space where its expertise and value-creative role is target discovery. It then licenses the rights to use RNAi against these targets from companies like Alnylam Pharmaceuticals and Silence Therapeutics, and partners with typically larger, deep-pocketed companies for clinical development and hopefully commercialisation of the drug. I, for one, will be watching very closely whether Quark Biotech’s aggressive development strategy will prove successful in the end.

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