- Relay Therapeutics on Monday revealed three new drug candidates to expand its pipeline of targeted cancer treatments, while laying out a path to a potential approval application for its most advanced medicine.
- Relay, which was founded in 2015 with a mission to design drugs by studying how proteins move, expects to begin clinical testing on two of the three candidates by as early as next year. All three are meant to improve on current treatment options for a common form of breast cancer, and one targets tumors with mutations in a gene called PI3K.
- Relay’s most advanced drug, meanwhile, is for a type of bile duct cancer called cholangiocarcinoma. After discussions with the Food and Drug Administration, Relay plans to enroll 100 patients into a study cohort that, along with other supporting data, may support an accelerated approval filing.
Relay has raised more than $1 billion on the promise that its protein motion technology can help it discover and develop better drugs in less time. Its efforts remain in early stages and, so far, don’t prove its approach can be more productive.
Still, there’s considerable interest in Relay and companies like it that aim to marry traditional drug-hunting methods with “computational” techniques that can help predict how drug candidates affect the protein targets they’re designed to go after.
The combination of experimental and computational research led Relay to the drug candidates it revealed Monday, which the company plans to develop as treatments for breast cancers that are classified as HR-positive, HER2-negative. These so-called HR+, HER2- tumors can’t be treated with drugs like Herceptin that are aimed at the HER2 protein.
On a conference call, Don Bergstrom, Relay’s head of R&D, described two problems his company hopes to solve: current treatments can be toxic and, after they fail, there are few other options.
“Both of these challenges can be addressed by discovery and development of new medicines against validated targets and pathways in breast cancer that have greater selectivity and targeted efficacy, potentially leading to better compatibility with other agents,” Bergstrom said.
One of the candidates Relay plans to develop is aimed at a protein called CDK2 that’s in the same family as others already targeted by existing treatments. According to Relay, higher CDK2 activity is associated with worse responses to those drugs.
The biotech modeled how CDK2 moves to help design a candidate that can selectively bind to that protein and not others. Clinical testing will begin in the fourth quarter of 2023, or the first quarter of 2024, Relay said.
A second candidate is designed to degrade the estrogen receptor to help attack cancers that rely on that protein to grow, while the third targets mutations in the PI3K gene that similarly spur tumor growth.
Relay is already developing a PI3K inhibitor, but said it thought the new candidate may be more selective.
While testing remains some ways away for each of the three new candidates, Relay is moving ahead with study of its cholangiocarcinoma drug, which targets alterations in a gene called FGFR2. Preliminary data suggest it might be more potent than existing FGFR inhibitors that also bind to other proteins in the same family, while avoiding some of their common side effects.
Relay has selected a dose and will enroll 100 patients who have certain FGFR2 gene alterations and have not yet been treated with one of those other drugs. Positive data in that cohort and three others in different patient groups could support an accelerated approval application, Relay said.
The biotech currently has nearly $900 million in cash and other liquid resources, which it said could fund its development plans into 2025.
Shares in Relay, which have risen in value in recent weeks, fell by more than 10% on Monday morning.
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