Latest news with #RLY-2608
Yahoo
02-06-2025
- Business
- Yahoo
Relay Therapeutics Announces Updated Data for RLY-2608 + Fulvestrant Further Demonstrating Clinically Meaningful Progression Free Survival at ASCO 2025
Updated interim data remain consistent, showing 10.3-month median PFS overall and 11.0-month median PFS in 2L patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer Data continue to support planned initiation of pivotal study in mid-2025 Next-generation triplet combinations with atirmociclib (CDK4-selective) & ribociclib ongoing CAMBRIDGE, Mass., June 02, 2025 (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 announced updated interim clinical data for RLY-2608, the first known investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3Kα. The updated data have a median duration of follow-up of 12.5 months and remain consistent with data shared in December 2024. They show a median progression free survival (PFS) of 11.0 months in second line (2L) patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer who received RLY-2608 600mg twice daily (BID) + fulvestrant. These data are being presented today at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting. 'The treatment options for CDK4/6-experienced patients with PI3Kα mutations has not meaningfully advanced in the past 10 years and recent data disclosures and trial discontinuations highlight the level of unmet need in this population. We are encouraged by the consistency of these updated RLY-2608 + fulvestrant data, which continue to show the potential benefit of a mutant-selective PI3Kα inhibitor for improving both the tolerability profile and progression free survival compared to standard of care,' said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. 'We look forward to starting the first mutant-selective PI3Kα Phase 3 trial, ReDiscover-2, in the middle of this year.' ReDiscover – RLY-2608 First-in-Human Study RLY-2608 is currently being evaluated in ReDiscover, an ongoing first-in-human study, which was designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of RLY-2608 in combination with fulvestrant, and in combination with fulvestrant and ribociclib or atirmociclib (Pfizer's selective CDK4 inhibitor). The RLY-2608 + fulvestrant arm of the study, as of the March 26, 2025 interim data cut-off for this arm, had enrolled 118 patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer across all doses in both the dose escalation and dose expansion portions of the study, including 64 patients at the company's recommended Phase 3 dose (RP3D) of 600mg BID administered in the fasted state (fasted). Among these 64 patients, 31 had a kinase mutation and 33 had a non-kinase mutation. Twelve patients also had a PTEN or AKT co-mutation and were therefore excluded from the efficacy analysis, consistent with the planned pivotal population. All RLY-2608 + fulvestrant patients across doses had received a significant level of prior therapy in the advanced setting, including at least one prior endocrine therapy and at least one prior CDK4/6 inhibitor. Among the 64 patients who received the RP3D, 44% of patients (n=28) had received two or more prior lines of therapy. The RLY-2608 + atirmociclib + fulvestrant arm of the study, initiated in Q4 2024, continues to enroll patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer in dose escalation, as does the RLY-2608 + ribociclib + fulvestrant arm. Promising Efficacy Consistently Demonstrating mPFS Greater Than 10 Months Among the 52 RLY-2608 + fulvestrant patients who received the RP3D and did not have a PTEN or AKT co-mutation: Median follow-up was 12.5 months The median PFS was 10.3 months for all patients and 11.0 months for 2L patients For 2L patients, median PFS was 18.4 months for patients with kinase mutations and 8.5 months for patients with non-kinase mutations Clinical benefit rate (CBR) was 67% across all patients (35 of 52 CBR-evaluable patients; CBR defined as the proportion of patients with complete response, partial response or stable disease for at least 24 weeks) Among the 31 patients with measurable disease, 12 achieved a partial response (PR) (39% confirmed objective response rate, ORR) 81% of patients experienced tumor reductions (25/31) Among the 15 patients with measurable disease who had a kinase mutation, two thirds achieved a PR (67% confirmed ORR; n=10) Among the 15 patients who had received prior fulvestrant, 6 achieved a PR (40% confirmed ORR) Maintained Meaningfully Differentiated Tolerability Profile RLY-2608 + fulvestrant was generally well tolerated in the 118 patients treated across all doses as of the data cut-off date. The overall tolerability profile consisted of mostly low-grade treatment-related adverse events (TRAEs) that were manageable and reversible. Safety outcomes were generally as expected across dose levels based on exposure and consistent with mutant-selective PI3Kα inhibition. Among the 64 patients who received the RP3D: The low rate of TRAE-related dose modifications allowed for 92% median dose intensity Only two patients discontinued treatment due to TRAEs (Grade 1 pruritis; Grade 1 nausea, loss of appetite) The majority of hyperglycemia was Grade 1; only two patients (3%) experienced Grade 3 hyperglycemia; no Grade 4-5 hyperglycemia Only 36% of patients experienced a Grade 3 TRAE; no Grade 4-5 TRAEs Continued Progression of Front-Line Breast Cancer Regimens Two front-line triplet regimens are being progressed – one with Pfizer's investigative selective-CDK4 inhibitor atirmociclib and one with the existing CDK4/6 standard-of-care ribociclib. Dose escalation is ongoing for both arms and both are currently at biologically active doses. Anticipated RLY-2608 Next Steps Breast Cancer: Initiate Phase 3 ReDiscover-2 (NCT06982521) study of RLY-2608 + fulvestrant in mid-2025 Continue dose escalation for additional breast cancer combination arms Vascular Malformations: Continue enrollment of Ph1/2 ReInspire study in vascular malformations The data presentation from ASCO is available on the Relay Therapeutics website in the 'Publications/Presentations' section through the following link: About RLY-2608 RLY-2608 is the lead program in Relay Therapeutics' efforts to discover and develop mutant selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers, with oncogenic mutations detected in about 14% of patients with solid tumors. RLY-2608 has the potential, if approved, to address more than 300,000 patients per year in the United States, one of the largest patient populations for a precision oncology medicine. Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo® platform enabled the discovery of RLY-2608, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of RLY-2608. RLY-2608 is currently being evaluated in a first-in-human study designed to treat patients with advanced solid tumors with a PIK3CA (PI3Kα) mutation. For more information on RLY-2608, please visit here. About Relay Therapeutics Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies with the goal of bringing life-changing therapies to patients. As the first of a new breed of biotech created at the intersection of complementary techniques and technologies, Relay Therapeutics aims to push the boundaries of what's possible in drug discovery. Its Dynamo® platform integrates an array of leading-edge computational and experimental approaches designed to drug protein targets that have previously been intractable or inadequately addressed. Relay Therapeutics' initial focus is on enhancing small molecule therapeutic discovery in targeted oncology and genetic disease indications. For more information, please visit or follow us on Twitter. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Relay Therapeutics' strategy, business plans and focus; the progress and timing of the clinical development of the programs across Relay Therapeutics' portfolio; the expected therapeutic benefits and potential efficacy and tolerability of RLY-2608, both as a monotherapy and in combination with other agents, and its other programs, as well as the clinical data for RLY-2608; the interactions with regulatory authorities and any related approvals; the potential market opportunity for RLY-2608; the cash runway projection and the expectations regarding Relay Therapeutics' use of capital and expenses. The words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'expect,' 'estimate,' 'seek,' 'predict,' 'future,' 'project,' 'potential,' 'continue,' 'target' and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of global economic uncertainty, geopolitical instability and conflicts, or public health epidemics or outbreaks of an infectious disease on countries or regions in which Relay Therapeutics has operations or does business, as well as on the timing and anticipated results of its clinical trials, strategy, future operations and profitability; the delay or pause of any current or planned clinical trials or the development of Relay Therapeutics' drug candidates; the risk that the preliminary or interim results of its preclinical or clinical trials may not be predictive of future or final results in connection with future clinical trials of its product candidates and that interim and early clinical data may change as more patient data become available and are subject to audit and verification procedures; Relay Therapeutics' ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of its planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled 'Risk Factors' in Relay Therapeutics' most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Relay Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. Relay Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contact:Pete Rahmerprahmer@ Media:Dan Budwick1AB973-271-6085dan@
Yahoo
05-05-2025
- Business
- Yahoo
Relay Therapeutics Reports First Quarter 2025 Financial Results and Corporate Updates
Cash runway extended into 2029 Initiation of Phase 3 ReDiscover-2 trial on track for mid-2025 Initiated Phase 1 RLY-2608 vascular malformations clinical trial in Q1 Extended cash runway expected to fully fund the Company meaningfully past topline data for ReDiscover-2 trial and through clinical proof-of-concept data in Vascular Malformations Approximately $710 million in cash, cash equivalents and investments at end of Q1 2025 CAMBRIDGE, Mass., May 05, 2025 (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 reported first quarter 2025 financial results and corporate updates. '2025 is a year of execution across a range of high value clinical programs,' said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics. 'The ongoing changes to our cost base are designed to enable a full funding of key initiatives including generating topline data from the ReDiscover-2 trial and clinical proof-of-concept data in vascular malformations.' Strategic Cost Reductions Implemented to Extend Runway into 2029 and to Fully Fund Key Value Drivers These reductions help extend operating runway into 2029 and are aimed at funding key objectives, including: Completion of ReDiscover-2 Phase 3 trial of RLY-2608 + fulvestrant in metastatic breast cancer well past topline data readout and additional breast cancer clinical trials Execution of RLY-2608 Phase 1 vascular malformations trial through clinical proof-of-concept data Advance Fabry and NRAS program to Investigational New Drug application (IND) readiness Advance one research-stage program Specific cost reductions include: Over the past year, focused the research portfolio and platform on the highest value areas resulting in a reduction in the research run rate spend by approximately 80% Reduced research-stage programs from four to one Recent reduction in force by approximately 70 people Executed a global out-license of RLY-4008 with Elevar Therapeutics, Inc. (Elevar) with potential for downstream economics Phased the timing of entry into the clinic for Fabry and NRAS targeted programs RLY-2608 Highlights Breast Cancer Initiation of Phase 3 ReDiscover-2 trial of RLY-2608 + fulvestrant in PI3Kα-mutated, CDK4/6 pre-treated, HR+/HER2- advanced breast cancer remains on track for mid-2025 Abstract accepted to ASCO for update of Phase 1b ReDiscover trial of RLY-2608 + fulvestrant Focus of the abstract is updated 600mg BID (fasted) doublet data with median follow-up now greater than 12 months Poster Title: Updated efficacy of mutant-selective PI3Kα inhibitor RLY-2608 in combination with fulvestrant in patients with PIK3CA-mutant HR+HER2- advanced breast cancer: ReDiscover trial Date/Time: Monday, June 2, 10:00-1:00 p.m. ET (9:00-12:00 p.m. CT) Continued advancement of the ongoing triplet cohorts with RLY-2608 + fulvestrant + atirmociclib or ribociclib Planning continues for development of next-generation endocrine therapy combinations with RLY-2608 Vascular Malformations Initiation of Phase 1 vascular malformations clinical trial in the first quarter of 2025 First Quarter 2025 Financial Results Cash, Cash Equivalents and Investments: As of March 31, 2025, cash, cash equivalents and investments totaled $710.3 million, as compared to $781.3 million as of December 31, 2024. The company expects its current cash, cash equivalents, and investments will be sufficient to fund its operating expenses and capital expenditure requirements into 2029. Revenue: Revenue was $7.7 million for the first quarter of 2025, as compared to $10.0 million for the first quarter of 2024. The revenue recognized in the first quarter of 2025 was due to completion of all performance obligations under the company's Exclusive License Agreement with Elevar. The revenue recognized in the first quarter of 2024 was due to a milestone achieved under the Collaboration and License Agreement with Genentech, Inc. R&D Expenses: Research and development expenses were $73.8 million for the first quarter of 2025, as compared to $82.4 million for the first quarter of 2024. The decrease was primarily due to the series of strategic choices made to streamline the research organization throughout 2024. G&A Expenses: General and administrative expenses were $18.7 million for the first quarter of 2025, as compared to $19.8 million for the first quarter of 2024. The decrease was primarily due to a decrease in stock compensation expense, partially offset by costs to obtain the agreement with Elevar, which were expensed commensurate with the timing of revenue recognized. Net Loss: Net loss was $77.1 million for the first quarter of 2025, or a net loss per share of $0.46, as compared to a net loss of $81.4 million for the first quarter of 2024, or a net loss per share of $0.62. About Relay Therapeutics Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies with the goal of bringing life-changing therapies to patients. As the first of a new breed of biotech created at the intersection of complementary techniques and technologies, Relay Therapeutics aims to push the boundaries of what's possible in drug discovery. Its Dynamo® platform integrates an array of leading-edge computational and experimental approaches designed to drug protein targets that have previously been intractable or inadequately addressed. Relay Therapeutics' initial focus is on enhancing small molecule therapeutic discovery in targeted oncology and genetic disease indications. For more information, please visit or follow us on Twitter. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Relay Therapeutics' strategy, business plans and focus; the progress and timing of the clinical development of the programs across Relay Therapeutics' portfolio; the expected therapeutic benefits and potential efficacy and tolerability of RLY-2608, both as a monotherapy and in combination with other agents, and its other programs, as well as the clinical data for RLY-2608; the interactions with regulatory authorities and any related approvals; the potential market opportunity for RLY-2608; the cash runway projection; the expected benefits resulting from the implementation of the cost saving measures and potential ability to fund key value drivers; and the expectations regarding Relay Therapeutics' use of capital and expenses. The words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'expect,' 'estimate,' 'seek,' 'predict,' 'future,' 'project,' 'potential,' 'continue,' 'target' and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: Relay Therapeutics' restructuring activities may be more costly or time-consuming than we expect or may not achieve their intended results; the timing, execution, and expected impact of Relay Therapeutics' restructuring plans (including the scope and timing of workforce reductions); the expected decrease in annual spending; the expected sufficiency of Relay Therapeutics' existing cash resources; the internal and external costs required for Relay Therapeutics' ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected, which may cause the company to use cash more quickly than expected or to change or curtail some of Relay Therapeutics' plans or both; the impact of global economic uncertainty, geopolitical instability and conflicts, or public health epidemics or outbreaks of an infectious disease on countries or regions in which Relay Therapeutics has operations or does business, as well as on the timing and anticipated results of its clinical trials, strategy, future operations and profitability; significant political, trade, or regulatory developments, such as tariffs, beyond Relay Therapeutics' control; the delay or pause of any current or planned clinical trials or the development of Relay Therapeutics' drug candidates; the risk that the preliminary or interim results of its preclinical or clinical trials may not be predictive of future or final results in connection with future clinical trials of its product candidates and that interim and early clinical data may change as more patient data become available and are subject to audit and verification procedures; Relay Therapeutics' ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of its planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled 'Risk Factors' in Relay Therapeutics' most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Relay Therapeutics' views only as of today and should not be relied upon as representing its views as of any subsequent date. Relay Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contact:Pete Rahmerprahmer@ Media:Dan Budwick1AB973-271-6085dan@ Relay Therapeutics, Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited) Three Months Ended March 31, 2025 2024 Revenue: License and other revenue $ 7,679 $ 10,007 Total revenue 7,679 10,007 Operating expenses: Research and development expenses $ 73,809 $ 82,403 Change in fair value of contingent consideration liability — (1,832 ) General and administrative expenses 18,739 19,799 Total operating expenses 92,548 100,370 Loss from operations (84,869 ) (90,363 ) Other income: Interest income 7,813 8,951 Other (expense) income (9 ) 25 Total other income, net 7,804 8,976 Net loss $ (77,065 ) $ (81,387 ) Net loss per share, basic and diluted $ (0.46 ) $ (0.62 ) Weighted average shares of common stock, basic and diluted 169,233,155 130,843,013 Other comprehensive income (loss): Unrealized holding gain (loss) 1,029 (962 ) Total other comprehensive income 1,029 (962 ) Total comprehensive loss $ (76,036 ) $ (82,349 ) Relay Therapeutics, Condensed Consolidated Balance Sheet Data(In thousands)(Unaudited) March 31,2025 December 31,2024 Cash, cash equivalents and investments $ 710,355 $ 781,323 Working capital (1) 702,607 758,475 Total assets 799,362 871,296 Total liabilities 78,281 93,504 Total stockholders' equity 721,081 777,792 Restricted cash 2,119 2,119 (1) Working capital is defined as current assets less current in to access your portfolio
