On December 17, 2021 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, reported the strengthening of its cholestatic disease franchise through the 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 (Press release, Genfit, DEC 17, 2021, https://ir.genfit.com/news-releases/news-release-details/heels-global-strategic-partnership-announced-today-genfit [SID1234597355]). This announcement comes on the heels of today’s other announcement on our global strategic pharma partnership.
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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."
GENFIT will host a conference call on December 17, 2021 at 7:45am ET / 12:45pm GMT / 1.45pm CET in English and in French
Both the English and French conference calls will be accessible on the investor page of our website, under the events section at https://ir.genfit.com/ or by calling 800-289-0438 (toll-free U.S. and Canada), 0800 358 6377 (toll-free UK) or 0805 101 219 (France) five minutes prior to the start time (confirmation code: 9932717). A replay will be available shortly after the call.
ABOUT CHOLANGIOCARCINOMA
Cholangiocarcinoma is a type of cancer that forms in the slender tubes (bile ducts) that carry the digestive fluid bile. Cholangiocarcinoma occurs mostly in people over the age of 50. Cholangiocarcinoma is divided into intrahepatic and extrahepatic types based on where the disease occurs in the bile ducts. Cholangiocarcinoma is often diagnosed when it is advanced, making successful treatment difficult to achieve. Several risk factors of chronic inflammatory damage and increased cellular turnover have been established, such as primary sclerosing cholangitis (a cholestatic liver disease), liver flukes, biliary tract cysts, hepatolithiasis and toxins. Treatment options for Cholangiocarcinoma are limited and associated with high rates of tumor recurrence, and short survival times.
ABOUT GNS561
GNS561 is a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor that blocks autophagy. Autophagy is activated in tumor cells in response to certain conditions, due to a tumor cell growth in advanced cancers. One of the key organs implicated in the autophagy process is the lysosome. By entering the lysosomes and binding to its target, GNS561 has an important inhibiting activity on late-stage autophagy, which leads to tumor cell death. GNS561 is an investigational compound and has not been registered by any regulatory authority.