E!10893 A liposomal cisplatin formulation (LiPlaCis) and companion diagnostics in the treatment of ABC/RBC

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A clinical phase II trial including 72 eligible subjects of which 52 subjects with advanced breast cancer who completed at least two cycle of treatment, where completed during the project period. Patients eligible to receive treatment in the study had a drug response prediction above 67% using the LiPlaCIS DRP screening. Results of the study show that the progression free survival and overall survival duration in evaluable population seem to be improved comparing to ITT population. A developmental plan for LiPlaCis have during the reporting period been developed and will be further updated base on the full study results. The partner Oncology Venture AS has during the reporting period signed an agreement with a developing partner for further development nad funding of LiplaCis and LiPlaCis drug response predictor (DRP).

We aim to advance the development of a new anti cancer drug for the treatment of Advanced or Refractory Breast Cancer (ABC/RBC) by introducing a new liposomal formulation of the well known anti-cancer drug, cisplatin (hereinafter referred to as LiPlaCis). A novel mechanism incorporates cisplatin into liposomes (LiPlasomes) which will lead to a triggered release of the encapsulated drug into a specific tumor tissue. Cisplatin was selected as it has been administered to a large number of patients with many different types of cancers and is administered both as monotherapy and in combination with other anti cancer products. Conventional cisplatin is associated with numerous and severe side effects, but because of the targeted release of cisplatin from the liposome, it is anticipated that LiPlaCis will provide improvements in terms of safety and tolerability. The tumor growth delay induced by LiPlaCis indicates that LiPlasomes accumulate in the tumor and that the sPLA2 triggered degradation of the liposomal carrier and drug release takes place. LiPlaCis may significantly increase the therapeutic index of cisplatin in cancer treatment compared to conventional cisplatin formulations on the market. Therefore, this novel targeted and triggered cisplatin-loaded liposomal delivery system meets a yet unmet need in the treatment of advanced or refractory breast cancer world wide. Advancing the clinical development of LiPlaCis in advanced or refractory breast cancer, from phase I to completion of a pivotal phase II study, will add significant value to the product, and take out a lot of the risk in the development. Completing the pivotal phase II study in the Eurostars project will thus enable us to commercialize the venture by raising private equity to take LiPlaCis further in the clinical development, before licensing out development and/or marketing rights to a bigger, global pharmaceutical partner.