{"success":true,"data":{"pressRelease":{"id":"125730","rtpr_id":"nGNX6fckcD","ticker":"GLUE","exchange":"NASDAQ","all_tickers":["GLUE"],"title":"Monte Rosa Therapeutics Announces First Patient Dosed in MODeFIRe-1, a Phase 2 Study of MRT-2359 in Combination with Apalutamide in Patients with AR Mutation-Positive Metastatic Castration-Resistant Prostate Cancer","author":"Globe Newswire","published_at":"2026-08-24T11:00:00.366Z","article_body":"Study will evaluate PSA and RECIST response, duration of response,\nradiographic progression-free survival (rPFS), and safety\n\nUpdated data from the initial Phase 1/2 study of MRT-2359 plus enzalutamide in\npatients with advanced CRPC expected by end of year\n\nBOSTON, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc.\n(Nasdaq: GLUE), a clinical-stage biotechnology company developing novel\nmolecular glue degrader (MGD)-based medicines, today announced that the first\npatient has been dosed in MODeFIRe-1 (clinicaltrials.gov identifier\nNCT07745361), a Phase 2 study evaluating MRT-2359 in combination with\napalutamide, a second-generation androgen receptor (AR) inhibitor, in patients\nwith metastatic castration-resistant prostate cancer (mCRPC) with AR\nmutations. The study follows encouraging clinical data previously shared from\nthe Company’s Phase 1/2 study of MRT-2359 in combination with enzalutamide\nin heavily pretreated mCRPC patients. MRT-2359 is an investigational, orally\nbioavailable, GSPT1-directed MGD discovered and developed by Monte Rosa.\n\n“Dosing the first patient in MODeFIRe-1 is an important step in advancing\nMRT-2359 as a potential therapy for patients with mCRPC with AR mutations, a\npopulation with limited therapeutic options,” said Filip Janku, M.D., Ph.D.,\nChief Medical Officer of Monte Rosa Therapeutics. “This study builds on the\nencouraging results we observed in our Phase 1/2 study of MRT-2359 in\ncombination with enzalutamide. As we disclosed previously, in that study of\nheavily pretreated, advanced CRPC patients – including those who had\nprogressed on prior second-generation AR inhibitors, chemotherapy, and\nradioligand therapy – 5 of 5 patients with AR mutations demonstrated a PSA\nresponse, with a 100% disease control rate and two RECIST responses.\nMODeFIRe-1 pairs MRT-2359 with apalutamide using a design intended to\nefficiently further evaluate and potentially confirm clinical activity in this\npopulation. We believe this study can position MRT-2359 for advancement into\nregistrational development if the data continue to support our earlier\nresults, with the potential to also extend clinical benefit to additional\nAR-driven patient populations including patients without prior\nsecond-generation AR inhibitors, as well as into combinations with radioligand\ntherapies independent of AR status.”\n\nMODeFIRe-1 will evaluate MRT-2359 at a dose of 0.5 mg administered orally on a\n21 days on, 7 days off schedule over 28-day cycles, in combination with\napalutamide. The study will enroll up to 25 patients with mCRPC with AR\nmutations, utilizing a Simon’s two-stage design. Eligible patients must have\nAR mutations, PSA with or without RECIST-measurable disease, and prior\ntreatment with a second-generation AR inhibitor. Study endpoints include PSA\nresponse, RECIST response, duration of response, radiographic progression-free\nsurvival (rPFS), PSA progression-free survival, and safety.\n\nEnrollment in the initial Phase 1/2 study expansion arm in patients with\nadvanced CRPC has been completed. A total of 6 patients with AR mutations were\nenrolled and treated with MRT-2359 in combination with enzalutamide. Monte\nRosa plans to provide an update on this patient subset by the end of the year.\nInterim data were presented\n(https://www.globenewswire.com/Tracker?data=t9Ka48dxJ7x7grnXklus0bm9DOHOcqPPLY6v733hp4TOv4q4Rxb9rFvUs7m_lpdPNzJR6sUZx7qkmdKt6IUx6FpuzcTKm4tm_H_7CLsp0i7bYx-kM1rfzaViFRsJcb8jOk8SNio3k5HCk_SfThUCBRTaWgfrSyAj1AfhXsK2lRCbvSC03O4Cl2tXNTKOHNOvHBmQAXAzyZIa1MSYSX3tp9bQKbgFDd_OWFhbaXk2Hfg=)\nat the ASCO Genitourinary Cancers Symposium (ASCO GU) in February.\n\nAbout MRT-2359\nMRT-2359 is a potent, highly selective, and orally bioavailable\ninvestigational molecular glue degrader (MGD) of GSPT1. MYC-driven cancers,\nincluding prostate cancer, depend on enhanced translation of oncoproteins to\nsupport rapid growth. MRT-2359 exploits this therapeutic vulnerability by\ndisrupting translation through selective degradation of the translation\ntermination factor GSPT1. MRT-2359 treatment reduced cellular abundance of\nmany prostate cancer-relevant oncoproteins, including AR, MYC, and Cyclin\nD1-E2F, and demonstrated robust anti-tumor activity across multiple\npreclinical models of metastatic castration-resistant prostate cancer (mCRPC).\nMRT-2359 is being evaluated in combination with apalutamide in MODeFIRe-1, a\nPhase 2 study in mCRPC patients with AR mutations. In a Phase 1/2 study, the\ncombination of MRT-2359 with the AR inhibitor enzalutamide demonstrated\nencouraging early signals of clinical response in mCRPC patients with AR\nmutations.\n\nAbout Monte Rosa\nMonte Rosa Therapeutics is a clinical-stage biotechnology company developing\nhighly selective molecular glue degrader (MGD) medicines for patients living\nwith serious diseases. MGDs are small molecule protein degraders that have the\npotential to treat many diseases that other modalities, including other\ndegraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered\nElimination of Neosubstrates) discovery engine combines AI-guided chemistry,\ndiverse chemical libraries, structural biology, and proteomics to rationally\ndesign MGDs with unprecedented selectivity. Monte Rosa has developed the\nindustry’s leading pipeline of first-in-class and only-in-class MGDs,\nspanning autoimmune and inflammatory diseases, oncology, and beyond, with\nthree programs in the clinic. Monte Rosa has ongoing collaborations with\nleading pharmaceutical companies in the areas of immunology, oncology, and\nneurology. For more information, visit www.monterosatx.com.\n\nForward-Looking Statements \nThis communication includes express and implied “forward-looking\nstatements,” including forward-looking statements within the meaning of the\nPrivate Securities Litigation Reform Act of 1995. Forward-looking statements\ninclude all statements that are not historical facts and in some cases, can be\nidentified by terms such as “may,” “might,” “will,” “could,”\n“would,” “should,” “expect,” “intend,” “plan,”\n“objective,” “anticipate,” “believe,” “estimate,”\n“predict,” “potential,” “continue,” “ongoing,” or the negative\nof these terms, or other comparable terminology intended to identify\nstatements about the future. Forward-looking statements contained herein\ninclude, but are not limited to, statements about our ability to grow our\nproduct pipeline, our ability to successfully complete research and further\ndevelopment and commercialization of our drug candidates in current or future\nindications, including the timing and results of our clinical trials and our\nability to conduct and complete clinical trials, statements regarding the\nMODeFIRe-1 Phase 2 study evaluating MRT-2359 in combination with apalutamide\nin mCRPC patients with AR mutations, including the study design, planned\nenrollment of up to 25 patients, study endpoints, and the potential of the\nstudy to further evaluate clinical activity and position the program for\nadvancement into registrational development, subject to discussions with\nregulatory authorities, our expectations regarding the potential to extend\nclinical benefit to additional AR-driven patient populations, including\npatients without prior second-generation AR inhibitors and combinations with\nradioligand therapies independent of AR status, our plans to provide updated\ndata from the initial Phase 1/2 study expansion arm evaluating MRT-2359 in\ncombination with enzalutamide in patients with advanced CRPC by the end of the\nyear, statements regarding the clinical significance of the clinical data\nobserved in the Phase 1/2 study and the potential of MRT-2359 to benefit\npatients with mCRPC with AR mutations, statements around our ability to\ncapitalize on and potential benefits resulting from our research and\ntranslational insights, among others. By their nature, these statements are\nsubject to numerous risks and uncertainties, including those risks and\nuncertainties set forth in our most recent Annual Report on Form 10-K for the\nyear ended December 31, 2025, filed with the U.S. Securities and Exchange\nCommission on March 17, 2026, and any subsequent filings, that could cause\nactual results, performance or achievement to differ materially and adversely\nfrom those anticipated or implied in the statements. You should not rely upon\nforward-looking statements as predictions of future events. Although our\nmanagement believes that the expectations reflected in our statements are\nreasonable, we cannot guarantee that the future results, performance, or\nevents and circumstances described in the forward-looking statements will be\nachieved or occur. Recipients are cautioned not to place undue reliance on\nthese forward-looking statements, which speak only as of the date such\nstatements are made and should not be construed as statements of fact. We\nundertake no obligation to publicly update any forward-looking statements,\nwhether as a result of new information, any future presentations, or\notherwise, except as required by applicable law. Certain information contained\nin these materials and any statements made orally during any presentation of\nthese materials that relate to the materials or are based on studies,\npublications, surveys and other data obtained from third-party sources and our\nown internal estimates and research. While we believe these third-party\nstudies, publications, surveys and other data to be reliable as of the date of\nthese materials, we have not independently verified, and make no\nrepresentations as to the adequacy, fairness, accuracy or completeness of, any\ninformation obtained from third-party sources. In addition, no independent\nsource has evaluated the reasonableness or accuracy of our internal estimates\nor research and no reliance should be made on any information or statements\nmade in these materials relating to or based on such internal estimates and\nresearch.\n\nInvestors\nAndrew Funderburk\nir@monterosatx.com \n\nMedia\nCory Tromblee, Scient PR\nmedia@monterosatx.com \n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/20ed9999-454a-4e2a-aabc-217270a87d2d)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX6fckcD","title":"Monte Rosa Therapeutics Announces First Patient Dosed in MODeFIRe-1, a Phase 2 Study of MRT-2359 in Combination with Apalutamide in Patients with AR Mutation-Positive Metastatic Castration-Resistant Prostate Cancer","author":"Globe Newswire","ticker":"GLUE","created":"2026-08-24T11:00:00.366Z","tickers":["GLUE"],"exchange":"NASDAQ","article_body":"Study will evaluate PSA and RECIST response, duration of response,\nradiographic progression-free survival (rPFS), and safety\n\nUpdated data from the initial Phase 1/2 study of MRT-2359 plus enzalutamide in\npatients with advanced CRPC expected by end of year\n\nBOSTON, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc.\n(Nasdaq: GLUE), a clinical-stage biotechnology company developing novel\nmolecular glue degrader (MGD)-based medicines, today announced that the first\npatient has been dosed in MODeFIRe-1 (clinicaltrials.gov identifier\nNCT07745361), a Phase 2 study evaluating MRT-2359 in combination with\napalutamide, a second-generation androgen receptor (AR) inhibitor, in patients\nwith metastatic castration-resistant prostate cancer (mCRPC) with AR\nmutations. The study follows encouraging clinical data previously shared from\nthe Company’s Phase 1/2 study of MRT-2359 in combination with enzalutamide\nin heavily pretreated mCRPC patients. MRT-2359 is an investigational, orally\nbioavailable, GSPT1-directed MGD discovered and developed by Monte Rosa.\n\n“Dosing the first patient in MODeFIRe-1 is an important step in advancing\nMRT-2359 as a potential therapy for patients with mCRPC with AR mutations, a\npopulation with limited therapeutic options,” said Filip Janku, M.D., Ph.D.,\nChief Medical Officer of Monte Rosa Therapeutics. “This study builds on the\nencouraging results we observed in our Phase 1/2 study of MRT-2359 in\ncombination with enzalutamide. As we disclosed previously, in that study of\nheavily pretreated, advanced CRPC patients – including those who had\nprogressed on prior second-generation AR inhibitors, chemotherapy, and\nradioligand therapy – 5 of 5 patients with AR mutations demonstrated a PSA\nresponse, with a 100% disease control rate and two RECIST responses.\nMODeFIRe-1 pairs MRT-2359 with apalutamide using a design intended to\nefficiently further evaluate and potentially confirm clinical activity in this\npopulation. We believe this study can position MRT-2359 for advancement into\nregistrational development if the data continue to support our earlier\nresults, with the potential to also extend clinical benefit to additional\nAR-driven patient populations including patients without prior\nsecond-generation AR inhibitors, as well as into combinations with radioligand\ntherapies independent of AR status.”\n\nMODeFIRe-1 will evaluate MRT-2359 at a dose of 0.5 mg administered orally on a\n21 days on, 7 days off schedule over 28-day cycles, in combination with\napalutamide. The study will enroll up to 25 patients with mCRPC with AR\nmutations, utilizing a Simon’s two-stage design. Eligible patients must have\nAR mutations, PSA with or without RECIST-measurable disease, and prior\ntreatment with a second-generation AR inhibitor. Study endpoints include PSA\nresponse, RECIST response, duration of response, radiographic progression-free\nsurvival (rPFS), PSA progression-free survival, and safety.\n\nEnrollment in the initial Phase 1/2 study expansion arm in patients with\nadvanced CRPC has been completed. A total of 6 patients with AR mutations were\nenrolled and treated with MRT-2359 in combination with enzalutamide. Monte\nRosa plans to provide an update on this patient subset by the end of the year.\nInterim data were presented\n(https://www.globenewswire.com/Tracker?data=t9Ka48dxJ7x7grnXklus0bm9DOHOcqPPLY6v733hp4TOv4q4Rxb9rFvUs7m_lpdPNzJR6sUZx7qkmdKt6IUx6FpuzcTKm4tm_H_7CLsp0i7bYx-kM1rfzaViFRsJcb8jOk8SNio3k5HCk_SfThUCBRTaWgfrSyAj1AfhXsK2lRCbvSC03O4Cl2tXNTKOHNOvHBmQAXAzyZIa1MSYSX3tp9bQKbgFDd_OWFhbaXk2Hfg=)\nat the ASCO Genitourinary Cancers Symposium (ASCO GU) in February.\n\nAbout MRT-2359\nMRT-2359 is a potent, highly selective, and orally bioavailable\ninvestigational molecular glue degrader (MGD) of GSPT1. MYC-driven cancers,\nincluding prostate cancer, depend on enhanced translation of oncoproteins to\nsupport rapid growth. MRT-2359 exploits this therapeutic vulnerability by\ndisrupting translation through selective degradation of the translation\ntermination factor GSPT1. MRT-2359 treatment reduced cellular abundance of\nmany prostate cancer-relevant oncoproteins, including AR, MYC, and Cyclin\nD1-E2F, and demonstrated robust anti-tumor activity across multiple\npreclinical models of metastatic castration-resistant prostate cancer (mCRPC).\nMRT-2359 is being evaluated in combination with apalutamide in MODeFIRe-1, a\nPhase 2 study in mCRPC patients with AR mutations. In a Phase 1/2 study, the\ncombination of MRT-2359 with the AR inhibitor enzalutamide demonstrated\nencouraging early signals of clinical response in mCRPC patients with AR\nmutations.\n\nAbout Monte Rosa\nMonte Rosa Therapeutics is a clinical-stage biotechnology company developing\nhighly selective molecular glue degrader (MGD) medicines for patients living\nwith serious diseases. MGDs are small molecule protein degraders that have the\npotential to treat many diseases that other modalities, including other\ndegraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered\nElimination of Neosubstrates) discovery engine combines AI-guided chemistry,\ndiverse chemical libraries, structural biology, and proteomics to rationally\ndesign MGDs with unprecedented selectivity. Monte Rosa has developed the\nindustry’s leading pipeline of first-in-class and only-in-class MGDs,\nspanning autoimmune and inflammatory diseases, oncology, and beyond, with\nthree programs in the clinic. Monte Rosa has ongoing collaborations with\nleading pharmaceutical companies in the areas of immunology, oncology, and\nneurology. For more information, visit www.monterosatx.com.\n\nForward-Looking Statements \nThis communication includes express and implied “forward-looking\nstatements,” including forward-looking statements within the meaning of the\nPrivate Securities Litigation Reform Act of 1995. Forward-looking statements\ninclude all statements that are not historical facts and in some cases, can be\nidentified by terms such as “may,” “might,” “will,” “could,”\n“would,” “should,” “expect,” “intend,” “plan,”\n“objective,” “anticipate,” “believe,” “estimate,”\n“predict,” “potential,” “continue,” “ongoing,” or the negative\nof these terms, or other comparable terminology intended to identify\nstatements about the future. Forward-looking statements contained herein\ninclude, but are not limited to, statements about our ability to grow our\nproduct pipeline, our ability to successfully complete research and further\ndevelopment and commercialization of our drug candidates in current or future\nindications, including the timing and results of our clinical trials and our\nability to conduct and complete clinical trials, statements regarding the\nMODeFIRe-1 Phase 2 study evaluating MRT-2359 in combination with apalutamide\nin mCRPC patients with AR mutations, including the study design, planned\nenrollment of up to 25 patients, study endpoints, and the potential of the\nstudy to further evaluate clinical activity and position the program for\nadvancement into registrational development, subject to discussions with\nregulatory authorities, our expectations regarding the potential to extend\nclinical benefit to additional AR-driven patient populations, including\npatients without prior second-generation AR inhibitors and combinations with\nradioligand therapies independent of AR status, our plans to provide updated\ndata from the initial Phase 1/2 study expansion arm evaluating MRT-2359 in\ncombination with enzalutamide in patients with advanced CRPC by the end of the\nyear, statements regarding the clinical significance of the clinical data\nobserved in the Phase 1/2 study and the potential of MRT-2359 to benefit\npatients with mCRPC with AR mutations, statements around our ability to\ncapitalize on and potential benefits resulting from our research and\ntranslational insights, among others. By their nature, these statements are\nsubject to numerous risks and uncertainties, including those risks and\nuncertainties set forth in our most recent Annual Report on Form 10-K for the\nyear ended December 31, 2025, filed with the U.S. Securities and Exchange\nCommission on March 17, 2026, and any subsequent filings, that could cause\nactual results, performance or achievement to differ materially and adversely\nfrom those anticipated or implied in the statements. You should not rely upon\nforward-looking statements as predictions of future events. Although our\nmanagement believes that the expectations reflected in our statements are\nreasonable, we cannot guarantee that the future results, performance, or\nevents and circumstances described in the forward-looking statements will be\nachieved or occur. Recipients are cautioned not to place undue reliance on\nthese forward-looking statements, which speak only as of the date such\nstatements are made and should not be construed as statements of fact. We\nundertake no obligation to publicly update any forward-looking statements,\nwhether as a result of new information, any future presentations, or\notherwise, except as required by applicable law. Certain information contained\nin these materials and any statements made orally during any presentation of\nthese materials that relate to the materials or are based on studies,\npublications, surveys and other data obtained from third-party sources and our\nown internal estimates and research. While we believe these third-party\nstudies, publications, surveys and other data to be reliable as of the date of\nthese materials, we have not independently verified, and make no\nrepresentations as to the adequacy, fairness, accuracy or completeness of, any\ninformation obtained from third-party sources. In addition, no independent\nsource has evaluated the reasonableness or accuracy of our internal estimates\nor research and no reliance should be made on any information or statements\nmade in these materials relating to or based on such internal estimates and\nresearch.\n\nInvestors\nAndrew Funderburk\nir@monterosatx.com \n\nMedia\nCory Tromblee, Scient PR\nmedia@monterosatx.com \n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/20ed9999-454a-4e2a-aabc-217270a87d2d)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-08-24T11:00:00.572822311Z","server_sent_at_ms":1787569200572},"received_at":"2026-08-24T11:00:00.624Z","source_url":null},"analysis":{"id":"114673","press_release_id":"125730","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Monte Rosa Therapeutics dosed the first patient in the Phase 2 MODeFIRe-1 study, evaluating MRT-2359 combined with apalutamide for AR mutation-positive metastatic castration-resistant prostate cancer.\n\nThe study advancement is supported by prior Phase 1/2 data where all five patients with AR mutations achieved a PSA response and a 100% disease control rate.\n\nThe new trial plans to enroll up to 25 patients using a 0.5 mg dose on a 21-days-on, 7-days-off schedule, with updated data from the earlier study expected by year-end.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Phase 2 initiation for MRT-2359 in mCRPC targets high-response patient subset with 100% disease control signal seen earlier."},"keyFigures":{"drugName":"MRT-2359","phaseOfTrial":"Phase 2","customDimensions":{"dose_mg":0.5,"schedule":"21 days on, 7 days off","planned_enrollment":"up to 25 patients","prior_psa_response_count":"5 of 5 patients","prior_disease_control_rate":"100%"}},"quotedText":"Dosing the first patient in MODeFIRe-1 is an important step in advancing MRT-2359 as a potential therapy for patients with mCRPC with AR mutations, a population with limited therapeutic options","namedEntities":{"people":[{"name":"Filip Janku","role":"Chief Medical Officer"},{"name":"Andrew Funderburk","role":"Investor Contact"},{"name":"Cory Tromblee","role":"Media Contact"}],"products":["MRT-2359","apalutamide","enzalutamide"],"companies":[{"name":"Monte Rosa Therapeutics, Inc.","ticker":"GLUE"},{"name":"Scient PR","relationship":"PR firm"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Initiation of a Phase 2 study represents a significant de-risking milestone for a clinical-stage biotech, particularly following early signals of 100% disease control in the target patient subset."},"tickerRelevance":{"others":[],"primary":"GLUE"},"globalImportance":30,"audienceRelevance":25,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap","eventGravity":"phase_2_initiation","sectorWeight":"biotech"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Monte Rosa Therapeutics dosed the first patient in the Phase 2 MODeFIRe-1 study, evaluating MRT-2359 combined with apalutamide for AR mutation-positive metastatic castration-resistant prostate cancer.\n\nThe study advancement is supported by prior Phase 1/2 data where all five patients with AR mutations achieved a PSA response and a 100% disease control rate.\n\nThe new trial plans to enroll up to 25 patients using a 0.5 mg dose on a 21-days-on, 7-days-off schedule, with updated data from the earlier study expected by year-end.","key_figures":{"drugName":"MRT-2359","phaseOfTrial":"Phase 2","customDimensions":{"dose_mg":0.5,"schedule":"21 days on, 7 days off","planned_enrollment":"up to 25 patients","prior_psa_response_count":"5 of 5 patients","prior_disease_control_rate":"100%"}},"named_entities":{"people":[{"name":"Filip Janku","role":"Chief Medical Officer"},{"name":"Andrew Funderburk","role":"Investor Contact"},{"name":"Cory Tromblee","role":"Media Contact"}],"products":["MRT-2359","apalutamide","enzalutamide"],"companies":[{"name":"Monte Rosa Therapeutics, Inc.","ticker":"GLUE"},{"name":"Scient PR","relationship":"PR firm"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-24T11:04:33.484Z","global_importance":30,"audience_relevance":25,"importance_components":{"tickerTier":"small-cap","eventGravity":"phase_2_initiation","sectorWeight":"biotech"}},"durationMs":66035,"modelName":"glm-4.7"}}