Europe’s five-year plan to tackle COVID-19 and other coronavirus threats
IMI-backed CARE alliance launches to develop coronavirus therapies
The latest alliance formed in the wake of COVID-19, CARE, is looking beyond the pandemic to future coronavirus threats. Filling its ranks are companies representing every step of the drug discovery and development process.
CARE (Corona Accelerated R&D in Europe), supported by Europe’s Innovative Medicines Initiative (IMI), brings together 37 teams from academic and non-profit research institutions and pharmaceutical companies to accelerate coronavirus therapeutic development, including for COVID-19.
The EU, 11 companies in the European Federation of Pharmaceutical Industries and Associations (EFPIA) and three IMI associated partners are funding CARE, a five-year project, with cash and in-kind contributions totaling €77.7 million ($92.1 million).
J&J’s Marnix Van Loock and Takeda’s Kumar Saikatendu co-lead the project.
Van Loock is senior scientific director and R&D lead of emerging pathogens, global public health at Johnson & Johnson (NYSE:JNJ); and Saikatendu is director of global research externalization at Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK). Saikatendu’s postdoctoral work involved SARS-CoV in 2003.
Saikatendu told BioCentury it was “clear that there that are lessons that we learned back then that could come in handy.”
Although the funding announcement came Tuesday, the organizations started working on SARS-CoV-2 and other coronaviruses in February, and had cooperated to apply for IMI funding.
CARE is at least the fourth large COVID-19 collaboration involving biopharma companies. The other three are NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV); the COVID-19 Therapeutics Accelerator; and the COVID R&D Alliance (see “Collaborating to Clobber COVID-19”).
J&J is involved in all four, while Takeda is a member of three (see “CARE Initiative Members”).
Saikatendu said, “There is some overlap, but very little” between the different collaborations. He added that “the other consortia are largely focused on late-stage programs such as clinical trials and real-world evidence,” and CARE complements the other efforts by focusing on early discovery.
A COVID R&D leadership team within Takeda, which includes people involved in various COVID19 consortia meets weekly to align activities and share information, Saikatendu said.
Saikatendu said CARE, which is not pursuing vaccines, has two core missions: identifying existing drugs that might be repurposed for COVID-19 as an urgent need; and making direct acting antivirals that specifically target coronaviruses as a long-term goal.
“You cannot have the full toolbox in advance, but we will have a toolbox that will allow us to come up with the best possible compound much faster.”
Takeda leads the antibody side and J&J leads the small molecule arm of the consortium.
CARE’s 37 teams not only provide a large set of antiviral compounds with repurposing potential, but also ensure the necessary expertise to drive small molecule and antibody discovery through development to viable therapies.
For example, Boehringer Ingelheim GmbH is “contributing some small molecules, including legacy clinical candidates, and also a list of hits that we’ve carefully selected using screening against the main proteases of the virus,” Cyrille Kuhn, the company’s head of research beyond borders, told BioCentury.
Kuhn predicted a candidate will enter the clinic next year. He declined to comment on trial design; however, he said a goal is to identify disease markers, such as immune and metabolic profiles, in COVID-19 patients that may inform the design.
There is no specific manufacturing plan in place yet.
“We have a plan up to proof-of-clinical concept — end of Phase II — but we don’t know yet what kind of manufacturing we will need. The data will drive the decision on who will manufacture what and when,” said Kuhn.
The long-term plan is to have compounds ready for the emergence of future coronaviruses, though they will likely need to be tuned to the emergent pathogen.
“You cannot have the full toolbox in advance, but we will have a toolbox that will allow us to come up with the best possible compound much faster,” said Kuhn.
Both Kuhn and Saikatendu are confident that the collaborative spirit of COVID consortia will continue beyond the COVID-19 pandemic.