OncoArendi and Galapagos enter into exclusive collaboration on chitinase inhibitors in fibrosis

Galapagos NV ( Euronext & NASDAQ: GLPG) and OncoArendi Therapeutics SA (WSE: OAT), announced that they have signed an exclusive collaboration and license agreement for the global development and commercialization of OncoArendi’s OATD-01. OATD-01 is a Phase 2-ready chitotriosidase/acidic mammalian chitinase (CHIT1/AMCase) inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF) and other diseases with a fibrotic component.

Lung diseases like IPF are associated with an increased chitinase activity, which strongly correlates with disease stage, progression and prognosis. Chitinases (predominantly CHIT1) are involved in macrophage activation. Inhibition of chitinase activity translates into a potential therapeutic benefit, as shown in a range of preclinical models. OATD-01 has shown robust anti-fibrotic activity in multiple animal models, when compared with the standard of care.

OncoArendi has developed a portfolio of CHIT1/AMCase inhibitors, of which OATD-01 is the first-in-class frontrunner. OATD-01 is a novel, small molecule CHIT1/AMCase inhibitor targeting a key pathway in tissue remodeling. It has shown compelling translational data, a favorable profile in animal studies at expected therapeutic doses and it has successfully completed Phase 1 studies in healthy volunteers. Galapagos aims to bring OATD-01 to a Phase 2 clinical trial for the treatment of IPF and possibly other diseases with a fibrotic component.

Walid Abi- Saab , Chief Medical Officer of Galapagos said: “ Galapagos is very excited to gain access to OATD-01 and OncoArendi’s innovative pipeline of novel chitinase inhibitors, further strengthening and complementing our existing fibrosis portfolio. Bringing OATD-01 to our pipeline supports our ambition to lead the advancement of treatments in fibrosis and continues to show our commitment to push boundaries in the fight against IPF, a debilitating and fatal disease”.

“Converging human biology and preclinical data indicate that chitinases are highly relevant therapeutic targets for a range of inflammatory and fibrotic diseases. This unique area of disease biology enables development of novel therapies in biomarker-driven patient populations. OncoArendi is excited about the ability to tap into the scientific and clinical development expertise of Galapagos and we enthusiastically look forward to this long-term strategic collaboration in maximizing the potential of chitinase and chitinase-like proteins in treatment of severe human diseases involving organ fibrosis” said Marcin Szumowski, CEO of OncoArendi.

In exchange for global research, development and commercialization rights, OncoArendi will receive an upfront payment of €25 million and will be eligible to receive development, regulatory and commercial milestones on licensed products, for a total potential deal value of €320 million. OncoArendi is also eligible to receive tiered royalties ranging up to low double-digits, based on future net sales.

Additionally, under the terms of the agreement, Galapagos will pay OncoArendi €2 million for the right of first negotiation on all other earlier stage programs on its chitinase platform. OncoArendi remains responsible for all research activity until preclinical candidate selection, after which Galapagos can exercise the option to initiate negotiations to obtain development or commercialization rights for the selected molecules. Any such transaction will be subject to a separate set of payments.