Staten Biotechnology in $430m deal with Novo Nordisk

Under the agreement, Dutch Staten Biotechnology B.V. and Novo Nordisk A/S will collaborate to co-develop Staten's preclinical dyslipidemia candidate STT-5058 (ARGX-116). While Staten is eglible to receive upfront fees, R&D funding, and milestone payments worth €430m, Novo Nordisk has the option to gain exlusive worldwide rights to the SIMPLE antibody targeting ApoC3 and may acquire the developer.

Staten Biotechnology, which has got financing by Biogeneration Ventures and Forbion Capital Partners, licenced STT-5058 in 2015 from Argenx BV. The human antibody's target ApoC3 is known to inhibit the activity of lipoprotein lipase and to reduce the uptake of atherogenic lipoprotein particles by liver cells. Multiple studies have identified ApoC3 levels to be inversely associated with a favourable lipid profile, insulin resistance and cardiovascular mortality. ARGX-116 (STT-5058) is expected to lower triglyceride levels, increase clearance of ApoC3-containing atherogenic particles and improve insulin resistance, which are currently not addressed by treatment with statins or PCSK9 antagonists.

Novo Nordisk just in September announced its expansion into the highly competitive field of cardiovascular disease. The move followed a blow for a first-generation antisense drugs directed against the same target as the STT-5058 antibody. After occurence of severe bleedings in pivotal Phase III trails of Akcea's Waylibra, an ApoC3 antisense molecule, the FDA stopped the study in August. A second-generation anti-ApoC3 antisense molecule, AKCEA-APOCIII-L_Rx, (Akcea/Novartis) is expected to have read-out in Q1/2019. Another anti-ApoC3 antisense programme developed by Arrowhead  is in preclinical stage like STT5058. STT-5058 is expected to enter the clinic by H1/2020.