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Relay Therapeutics Announces Dosing of First Patient in First-in-Human Trial of RLY-2608 and Initiation of Expansion Cohorts for First-In-Human Trial of RLY-4008

Doses first patient in first-in-human trial of RLY-2608, a pan-mutant and isoform-selective PI3Kα inhibitor

Selects 70 mg once-daily dose for RLY-4008 and initiates expansion cohorts in patients with FGFR2-altered solid tumors, including cholangiocarcinoma and breast cancer

Excerpt from the Press Release:

CAMBRIDGE, Mass., Jan. 04, 2022 (GLOBE NEWSWIRE) — Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, today provided an update for two of its ongoing first-in-human trials, RLY-2608, the first known allosteric, pan-mutant and isoform-selective PI3Kα inhibitor in clinical development, and RLY-4008, a highly selective, irreversible and oral small molecule inhibitor of FGFR2.

“We now have three targeted therapeutics in clinical trials and a deep pipeline of preclinical precision medicine programs behind that, all with the potential to address major unmet medical needs for patients,” said Sanjiv Patel, M.D., president and chief executive officer. “With our growing multi-disciplinary team, strong balance sheet and constant focus on execution, we believe we are well poised to accomplish our goal of delivering new medicines to patients. 2021 was a pivotal year for Relay Therapeutics, having disclosed promising clinical data for RLY-4008, and we are confident this is only the beginning of what this platform and team can do.”

RLY-2608 First-in-Human Trial

For RLY-2608, Relay Therapeutics dosed the first patient in a first-in-human trial for patients with advanced solid tumors with a PIK3CA (PI3Kα) mutation.

The first-in-human trial for RLY-2608 is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity, and will consist of two separate arms. The first arm will assess RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors with PI3Kα mutation, while the second arm will evaluate RLY-2608 in combination with fulvestrant for patients with PI3Kα-mutant, HR+, HER2– locally advanced or metastatic breast cancer. Each arm will have two parts, first a dose escalation part to determine the maximum tolerated dose and/or recommended phase 2 dose, followed by a dose expansion part to evaluate RLY-2608 in genomically defined populations.

In the dose expansion part of the trial for RLY-2608 as a single agent, patients with the following unresectable or metastatic solid tumors with a PI3Kα mutation per local assessment will be enrolled in the following groups: 1) clear cell ovarian cancer; 2) head and neck squamous cell carcinoma; 3) cervical cancer; 4) other solid tumors; and 5) unresectable or metastatic solid tumors with PIK3CA double mutations defined as major (E542X, E545X, or H1047X), plus ≥1 additional PI3Kα mutations. For RLY-2608 in combination with fulvestrant, men or postmenopausal women with HR+, HER2– advanced or metastatic breast cancer patients with PI3Kα mutations will be enrolled in the following groups: 1) patients who have not received prior treatment with a PI3Kα inhibitor; and 2) patients who are intolerant to PI3Kα inhibitors. The trial is designed to enroll approximately 190 patients between both arms.

RLY-4008 Expansion Cohorts

Relay Therapeutics initiated expansion cohorts last month for the first-in-human trial for RLY-4008 in patients with FGFR2-altered cholangiocarcinoma, breast cancer and other solid tumors.

The ongoing first-in-human trial for RLY-4008 is designed to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy. Following a thorough assessment of the dose escalation data, the expansion portion of the trial has been initiated at a dose of 70 mg once daily.

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