Relay details new research plans to design better cancer drugs

Diving brief:

  • Relay Therapeutics on Monday unveiled three new drug candidates to expand its portfolio of targeted cancer treatments, while paving the way for potential approval of its most advanced drug.
  • Relay, which was founded in 2015 with a mission to design drugs by studying the movement of proteins, plans to start clinical trials on two of the three candidates as early as next year. All three are intended to improve 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 in a study cohort which, with further supporting data, could support an expedited filing for approval.

Overview of the dive:

Relay has raised more than $1 billion on the promise that its protein movement technology can help it discover and develop better drugs in less time. His efforts are still in their infancy and, so far, do not prove that his approach can be more productive.

Yet Relay and similar companies are attracting considerable interest that aim to marry traditional methods of drug discovery with “computational” techniques that can help predict how drug candidates affect the protein targets they are supposed to target.

The combination of experimental and computational research led Relay to the drug candidates it revealed on Monday, which the company plans to develop as treatments for breast cancers classified as HR-positive, HER2-negative. These so-called HR+, HER2- tumors cannot be treated with drugs like Herceptin that target the HER2 protein.

In a conference call, Don Bergstrom, head of R&D at Relay, 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 through the discovery and development of novel drugs 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 targets a protein called CDK2 that belongs to the same family as others already targeted by existing treatments. According to Relay, higher CDK2 activity is associated with poorer responses to these drugs.

Biotechnology has modeled how CDK2 moves to help design a candidate that can selectively bind to this protein and not others. Clinical trials 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 this protein to grow, while the third targets mutations in the PI3K gene that similarly stimulate tumor growth.

Relay is already developing a PI3K inhibitor, but said it believes the new candidate may be more selective.

Although testing is still a long way off for each of the three new candidates, Relay is continuing to study its cholangiocarcinoma drug, which targets alterations in a gene called FGFR2. Preliminary data suggests it may be more potent than existing FGFR inhibitors that also bind other proteins in the same family, while avoiding some of their common side effects.

Relay has chosen a dose and will enroll 100 patients who have certain alterations in the FGFR2 gene and who have not yet been treated with any of these other drugs. Positive data in this cohort and three others in different patient groups could support a request for accelerated approval, Relay said.

The biotech currently has nearly $900 million in cash and other liquid resources, which it says could fund its development plans through 2025.

Shares of Relay, which have risen in value in recent weeks, fell more than 10% on Monday morning.

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