Data from lead candidate, elacytarabine, for AML is expected in mid-2012.
Clavis Pharma raised €19 million in a private placement with new and existing investors. The funds will be used to continue development of the firm’s clinical-stage candidates as well as progress another drug into clinical development and continue development of companion diagnostics for the hENT1 biomarker in hematological and solid cancers.
Clavis Pharma is developing a pipeline of drugs based on its lipid vector technology (LVT). The platform involves the chemical linking of lipid vectors to a parent drug to generate a new chemical entity (NCE). The ultimate aim is to develop drugs that are effective in patients whose disease would otherwise be refractive to the original parent therapeutic.
Lead candidate elacytarabine is in Phase III development for the treatment of advanced acute myeloid leukemia (AML). Randomized data from the Phase III Clavela study is expected in mid-2012, after which Clavis may be in a position to prepare for filing and commercilization. Elacytarabine is a lipid-conjugated derivative of cytarabine, which is designed to improve the efficacy of cytarabine therapy by enabling the drug to enter cancer cells without requiring uptake by the reporter protein human equilibrative nucleoside transporter 1 (hENT1).
A second clinical-stage candidate, CP-4126, is in Phase II evaluation against pancreatic cancer. Data from this trial is also expected in mid-2012. CP-4126 is in development in partnership with Clovis Oncology, and is designed to improve the therapeutic profile of gemcitabine by allowing the anticancer drug to bypass cellular uptake mechanisms requiring the hENT1 molecule.
Clavis and Clovis signed their CP-4126 development and commercialization deal in November 2009. The original agreement covered development of the drug against pancreatic and other solid tumors, in North and South America and Europe. Just last week the firms expanded the agreement to give Clovis worldwide rights to CP-4126. Under the terms of the new agreement Clavis will receive an up-front cash payment of $10 million, and will be eligible to receive further payments of $30 million on the successful attainment of development and regulatory milestones in Asia, and up to $165 million in sales milestones. Clovis has responsibility for the commercialization of CP-4126 globally, and Clavis retains an option to co-promote the drug in Europe.