After 14 years, Agios is looking for a partner to tango with, but tough changes lie ahead

After going it alone for the past 14 years, Agios is ready to find a dance partner to help move its pipeline forward. But as part of the hunt for a company or companies that may nod back to Agios’ cabeceo, some tough choices lay ahead.

Agios will be letting go of 50 employees and shuffling its R&D leadership team to focus internal research efforts on its lead programs, CEO Jackie Fouse, Ph.D., told Fierce Biotech. Chief Medical Officer Sarah Gheuens, M.D., Ph.D., will add the title of head of R&D as Chief Scientific Officer Bruce Car, Ph.D., steps down. The changes will unlock about $40 million to $50 million in cost savings.

All of this is an effort to prepare Agios for its next phase: For the first time, the company is opening up to business development and partnerships to advance its programs. Agios has for its entire 14 years of existence done everything in-house, according to Fouse. That helped bring forward the company’s recently approved pyruvate kinase (PK) deficiency med Pyrukynd to the market and lock down a $1.8 billion deal to sell its oncology assets to Servier.

“We've been looking at our model for literally a few months now as a team and thinking about what we're doing internally and what we might be able to do with external partners who are also innovating,” Fouse said in an interview.

The decision was to keep going on programs that have been validated as long as they were in the later stages of development. But earlier work will be cut.

Jackie Fouse Agios
Jackie Fouse (Agios)

“We decided to trim back on the pure exploratory research where it takes a long time, your chances of success are relatively low, you have to run a lot of ideas through the funnel to come out with something there,” she said.

Agios will now look to external opportunities, in-licensed assets or other collaborations.

“We were heavily skewed to internal-only efforts in the past, and innovation comes from a lot of different places,” Fouse said. The company’s research organization will now lose 50 people, while 50 others will stay. “It's not that we're getting out of the research business. We're just focusing our efforts in a little bit different way to reduce the early, early, early part and keep more of the later-stage research work.”

So why now? Fouse said Agios has been examining its future for a while. The Servier deal wrapped up at the end of last year, giving the company some leeway to make big decisions. Fouse is well aware of the mass layoffs that have spread across the biotech industry but says Agios is coming from “a position of strength.”

“We've actually had everything go well in terms of delivering on our corporate objectives and moving our clinical programs forward and making progress on our preclinical programs,” Fouse said. “And so, the reason for us to do this now is we like to get ahead of things.”

But with turmoil in the biotech markets, Fouse said there is plenty of openness at this time for companies to partner up.

Fouse couldn’t say what kind of deals Agios has been entertaining, only that the conversations are happening, and her team is looking at some “interesting things.” 

“It always takes two to tango, right, when you want to put a collaboration together, but I think we're seeing some interesting ideas that could work for both parties,” Fouse said.

As Agios pivots from being a lone wolf to a team player, Fouse said that meant the structure of the R&D organization itself had to change. The decision was made to consolidate R&D under the chief medical officer, Gheuens, and part ways with Car—whom Fouse said has been incredibly helpful in the transition.

As for what the pipeline will look like post-overhaul, Fouse said not much will noticeably change on Agios’ customary listing of drugs in development. It’s full-steam ahead on Pyrukynd, also known as mitapivat, which the biotech has put plenty of resources into already. The therapy is being tested in additional indications like sickle cell disease, thalassemia and other types of PK deficiency and for other populations.

The novel PK activator AG-946 will continue in a phase 2a low- to intermediate-risk myelodysplastic syndrome study, and preclinical activities will continue for candidates in PAH stabilization in the rare inherited metabolic disorder phenylketonuria and for BCAT inhibition in methylmalonic and propionic acidemias.

Agios plans to package up work on a PKM2 program, which is in preclinical studies at the moment, and seek a partner because that particular therapy is not “in our sweet spot,” Fouse said. Other research on the PKM2 mechanism, which is believed to play a role in metabolism and cellular energetics, will also be offered up for a new partner.

Fouse said the changes will not necessarily free up more assets to kick the Pyrukynd program into a higher gear, as the company had already planned a comprehensive program for that med. Instead, it can now explore bringing in new assets from external sources through business development.

“We're going to see a little bit of a shift. We want to move the internally discovered programs that we've already gotten to a certain stage forward as fast as we can, and then we want to see if we can bring some assets in that would be closer to the [Investigational New Drug] stage,” Fouse said. The hope is that those assets could “be moved along faster than if we were trying to discover those ourselves from the exploratory research side of things.”