Exhibit 99.2
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Relay Therapeutics Announces Interim Clinical Data that Support RLY-4008 as a Highly Selective FGFR2 Inhibitor
Interim data suggest that RLY-4008 is a highly selective FGFR2 inhibitor that has not shown to be limited by off-target toxicities of hyperphosphatemia (FGFR1) and diarrhea (FGFR4)
RLY-4008 demonstrated tumor shrinkage in all six pan-FGFR treatment-naïve FGFR2 fusion positive cholangiocarcinoma patients with three achieving confirmed partial responses
Interim data support potential clinical benefits of optimized inhibition of FGFR2 regardless of alteration (fusions, mutations, and amplifications), line of treatment or tumor type
Relay Therapeutics anticipates selecting a once daily recommended phase 2 dose and initiating expansion cohorts prior to the end of 2021
Relay Therapeutics to host a conference call today at 12:30 pm E.T.
Cambridge, MA – October 08, 2021 – 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 announced interim clinical data for RLY-4008, a highly selective irreversible and oral small molecule inhibitor of FGFR2, in a first-in-human trial in patients with FGFR2-altered cholangiocarcinoma and multiple other solid tumors. The data are being presented today at the virtual AACR-NCI-EORTC Molecular Targets Conference and suggest that RLY-4008 is the first investigational therapy designed to selectively bind to FGFR2 to avoid off-isoform toxicities for the treatment of patients with FGFR2-altered tumors.
As will be presented at the conference, study investigators reported robust inhibition of FGFR2 in the first 49 subjects that was not shown to be limited by off-target toxicities, including hyperphosphatemia and diarrhea, in the interim clinical data. The initial toxicity data suggest that certain dose levels administered can achieve >85% continuous inhibition of FGFR2. At those levels, acute toxicities that would limit dose intensity have generally not been observed to date. The interim clinical data included results from FGFR2-altered solid tumors, with approximately 80% of all patients treated achieving reductions in tumor size at the cut-off date of September 9, 2021. In pan-FGFRi treatment-naïve cholangiocarcinoma patients, RLY-4008 demonstrated tumor shrinkage in all six pan-FGFR treatment-naïve FGFR2 fusion positive cholangiocarcinoma patients, with three achieving confirmed partial responses. Three of these six patients remain on study and a fourth patient went on to surgery with curative intent. Relay Therapeutics anticipates selecting a once daily recommended phase 2 dose and initiating expansion cohorts prior to the end of 2021.
“RLY-4008 clinical data exemplifies the power of the Relay Therapeutics Dynamo™ platform and approach to discovering innovative medicines,” said Don Bergstrom, M.D., Ph.D., executive vice president of R&D at Relay Therapeutics. “Not only has the platform succeeded in creating a selective and purpose-built investigational therapy, but the initial clinical evidence of RLY-4008 has also shown the potential to positively impact the course of disease for patients with FGFR2 altered cancers. We continue to evaluate the once daily dose schedule to determine which dose to take forward into expansion cohorts before year-end. Using the same approach, we are building a deep portfolio of precision medicine programs that have the potential to impact patients with the hard-to-treat diseases. Thank you to the patients, investigators and clinical trial teams who have put their faith in our investigational therapy.”