CureVac has dropped mRNA ornithine transcarbamylase (OTC) deficiency treatment ARCT-810. The action returns full rights to the candidate to Arcturus Therapeutics, which plans to file an IND by the end of the year.
Germany’s CureVac agreed to co-develop ARCT-810, Arcturus’ lead candidate, at the start of 2018. The agreement covered the 50/50 co-development of ARCT-810 and the joint advancement of up to three other assets built on CureVac’s mRNA sequence and Arcturus’ nucleic acid delivery system. Arcturus framed the deal as a way to manage costs and accelerate preclinical R&D.
Now, Arcturus will need to make do without the support of CureVac, at least for ARCT-810. CureVac has returned its rights to the program, leaving Arcturus with full ownership and responsibilities, but retained the chance to work with the San Diego-based biotech on other assets.
The U-turn follows a period in which CureVac has switched up its leadership. Ingmar Hoerr stepped down as CEO last year, enabling chief business officer Daniel Menichella to take his place. Since then, Menichella has put a new look R&D leadership team in place, with Dimitris Voliotis and Stefan Mueller coming on board as chief development officer and VP of preclinical, respectively.
CureVac framed the appointment of Voliotis as part of its efforts to move more assets from the lab to the clinic. Yet, in returning the rights to ARCT-810, CureVac has turned down the chance to add a drug to its clinical-phase pipeline.
Arcturus set its sights on getting ARCT-810, also known as Lunar-OTC, into the clinic in 2019 back when it unveiled a reverse merger with Alcobra in 2017. The timeline has slipped slightly since then, but Arcturus still expects to file an IND with the FDA in the fourth quarter. Arcturus CEO Joseph Payne said in a statement that the company has the “resources and expertise” to get into the clinic.
ARCT-810 is moving toward human testing on the strength of data showing it establishes levels of the OTC enzyme at well above 10% of normal in mice. Arcturus thinks getting levels to 10% of normal will result in a therapeutically significant therapy.