- Relay Therapeutics Inc RLAY announced initial clinical data for RLY-2608, an investigational allosteric, pan-mutant, and isoform-selective inhibitor of PI3Kα.
- RLY-2608 is currently being evaluated in an ongoing dose-escalation portion of ReDiscover Phase 1 trial across two arms.
- The first-in-human trial evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity.
- The monotherapy arm started in December 2021 and enrolled 19 patients with unresectable or metastatic solid tumors with a PI3Kα mutation.
- Also Read: Relay Therapeutics' Stock Price Premium Vs. Peers Is Justified By Its Platform Technology, Analyst Says.
- The RLY-2608 + fulvestrant combination arm started in April 2022 and enrolled 23 patients with PI3Kα-mutant, HR+, and HER2– locally advanced or metastatic breast cancer.
- Multiple doses achieved sustained target exposure of ~80%+ mutant PI3Kα inhibition.
- A patient with metastatic HR+/HER2- breast cancer, with two PI3Kα mutations, who progressed following 12 lines of prior therapy, received RLY-2608 400mg BID monotherapy.
- An unconfirmed partial response was recorded at eight weeks. After the data cut-off, the partial response was confirmed, and the patient remains on treatment with no AEs reported as of April 4, 2023.
- Early anti-tumor activity was seen across various doses and helical, kinase, and other mutations, demonstrating selective target engagement of mutant PI3Kα.
- Nine of the 16 breast cancer patients with measurable disease experienced radiographic tumor reductions. Twelve exhibited a best overall response of stable disease and one partial response.
- Relay Therapeutics anticipates initiating dose expansion cohorts (part 2) in 1H of 2023.
- Price Action: RLAY shares are down 34.10% at $12 on the last check Tuesday.
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