LILLE, FRANCE: GENFIT (Nasdaq: GNFT), a late-stage biopharmaceutical company, announced acquisition of exclusive rights from Genoscience Pharma to develop and commercialize the investigational treatment GNS561 in cholangiocarcinoma in the United States, Canada and Europe, including the United Kingdom and Switzerland.
This announcement comes on the heels of today’s other announcement on our global strategic pharma partnership.
GNS561 is a novel clinical-stage autophagy/PPT1 inhibitor developed by Genoscience Pharma and cholangiocarcinoma is an orphan disease. It has completed pre-clinical studies and a Phase 1b trial confirming the rationale for targeting cholangiocarcinoma, a rare liver malignancy with high mortality and with limited treatment options.
Under the agreement, Genoscience Pharma is eligible for clinical and regulatory milestone payments and tiered royalties. The first payable milestone is contingent on positive Phase 2 clinical trial results. GENFIT is also committed to take a €3 million equity stake in Genoscience Pharma through the subscription of new ordinary shares.
Pascal Prigent, CEO of GENFIT, stated: “This licensing agreement with Genoscience Pharma comes as an immediate follow-up to the global strategic partnership announced today. Proceeds from this strategic agreement will strengthen the trajectory of our long-term growth and pipeline expansion, which is exemplified by the acquisition of GNS561’s rights in cholangiocarcinoma. This decision fully aligns with our strategic roadmap by broadening our asset portfolio within our cholestatic disease franchise through the addition of an innovative drug candidate, with the potential to address considerable unmet needs for patients. The scientific rationale, together with preclinical and clinical evidence, support further development of the asset, and our plan is to start a Phase 2 program in the first half of 2022. We believe that GNS561’s mechanism of action is very promising. Given the current landscape, standard of care, lack of marketed options and, based on KOL opinions, we will interact with regulatory agencies to investigate accelerated paths to approval, post Phase 2.”
Philippe Halfon, CEO of Genoscience Pharma, added: “This is a great step for the development of GNS561 as a new potential treatment option in liver cancer, as it offers an innovative mechanism of action for patients with high unmet needs. We believe that GENFIT is a highly qualified partner for the development of GNS561 in cholangiocarcinoma and we will provide GENFIT with our expertise to support their development plan. On our side, we will pursue, at Genoscience Pharma, the development of GNS561 in other oncology indications as well as research in other therapeutic areas.”
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