FHD-909 / Foghorn Therap, Eli Lilly - LARVOL DELTA

J5M-OX-JOXA: A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=340 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Dec 2028 ➔ Oct 2027 | Trial primary completion date: Dec 2028 ➔ Oct 2027

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

J5M-OX-JOXA: A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=340 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Oct 2027 ➔ Dec 2028 | Trial primary completion date: Oct 2027 ➔ Dec 2028

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase 1 trial enrolling well. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909, with NSCLC as the primary target population, is progressing well and the study remains on track. (GlobeNewswire)

Trial status • Non Small Cell Lung Cancer

Foghorn Therapeutics Provides Second Quarter 2025 Financial and Corporate Update (GlobeNewswire) - "FHD-909 (LY4050784) Phase 1 dose escalation trial in SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population....Phase 1 trial enrolling well and remains on track. Enrollment in the first-in-human Phase 1 multi-center trial of FHD-909 is progressing well."

Trial status • Non Small Cell Lung Cancer

J5M-OX-JOXA: A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=340 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: May 2028 ➔ Oct 2027

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

J5M-OX-JOXA: A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=340 | Recruiting | Sponsor: Eli Lilly and Company | N=160 ➔ 340 | Trial completion date: Oct 2027 ➔ May 2028

Enrollment change • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

LY4050784, a selective inhibitor of SMARCA2, demonstrates synergistic activity in combinations with pembrolizumab or KRAS inhibitors (AACR 2025) - P1 | "LY4050784 demonstrated robust activity in vitro and in vivo when combined with standard lung cancer chemotherapies (paclitaxel, cisplatin, and pemetrexed)...Finally, we explored the activity of LY4050784 in combination with both mutant-selective KRAS G12C and G12D inhibitors (olomorasib and LY3962673, respectively) and the isoform-selective pan-KRAS inhibitor LY4066434...These results demonstrate that LY4050784 exhibits robust antitumor activity in combination with chemotherapy, pembrolizumab, and multiple KRAS inhibitors in preclinical models of SMARCA4-mutant cancers. Investigation of these combinations clinically is warranted"

IO biomarker • Colon Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS • SMARCA2 • SMARCA4

Poster Presentation Title: A First-in-human Phase 1 Study of LY4050784, an Oral, Potent, and Selective SMARCA2 Inhibitor, in Patients with Advanced Solid Tumors with SMARCA4 Alterations (Trial in Progress) (GlobeNewswire) - "Foghorn Therapeutics...announced new...data for potential first-in-class medicines...at the 2025 American Association for Cancer Research (AACR) Annual Meeting....First-in-human trial of FHD-909 will evaluate patients with SMARCA4 mutated locally advanced or metastatic solid tumors who have exhausted standard treatment options. Upon completion of the dose escalation part of the study, two separate expansion cohorts will enroll either patients with NSCLC or with other advanced solid tumors harboring eligible SMARCA4 alteration(s)."

Clinical protocol • Solid Tumor

Oral Presentation Title: LY4050784, a Selective Inhibitor of SMARCA2, Demonstrates Synergistic Activity in Combinations with Pembrolizumab or KRAS Inhibitors (GlobeNewswire) - "Foghorn Therapeutics...announced new preclinical data for potential first-in-class medicines...at the 2025 American Association for Cancer Research (AACR) Annual Meeting....FHD-909 monotherapy selectively inhibits SMARCA4 mutant cancer cells in vitro, is well tolerated, and demonstrates robust anti-tumor efficacy in SMARCA4 mutant NSCLC xenograft models. FHD-909 shows additive activity with standard-of-care chemotherapies (platinum, paclitaxel, pemetrexed, gemcitabine and docetaxel) and synergistic activity in multiple combinations including KRAS G12C, KRAS G12D, and pan-KRAS inhibitors, as well as anti-PD-1 pembrolizumab."

Preclinical • Non Small Cell Lung Cancer

A first-in-human phase 1 study of LY4050784, an oral, potent, and selective SMARCA2 inhibitor, in patients with advanced solid tumors with SMARCA4 alterations (Trial in Progress) (AACR 2025) - P1 | "4Lee JY, et al. Poster presented at AACR 2024."

Clinical • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • SMARCA2 • SMARCA4

Foghorn Therapeutics to Host Virtual Investor Event to Review Pipeline Updates in Conjunction with 2025 AACR Annual Meeting (GlobeNewswire) - "Company to share new preclinical combination data for FHD-909 (LY4050784), a potential first-in-class selective SMARCA2 inhibitor, with non-small cell lung cancer (NSCLC) as the primary target population; Additional updates include new preclinical data for Selective CBP degrader program in combination with chemotherapy and targeted agents and for Selective EP300 degrader program in hematological malignancies."

Preclinical • Non Small Cell Lung Cancer

Foghorn Therapeutics Announces New Preclinical Data for Selective SMARCA2 Inhibitor FHD-909 and Selective CBP and EP300 Degrader Programs at 2025 AACR Meeting (GlobeNewswire) - "Poster presentations on the Phase 1 trial design for FHD-909 and on preclinical data for the Selective CBP program and the Selective EP300 degrader program will also be presented."

Clinical protocol • Preclinical • Hematological Malignancies • Solid Tumor

Lilly announces details of presentations at 2025 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "In an oral presentation, Lilly, in collaboration with Foghorn Therapeutics, will present new preclinical data for LY4050784, a selective inhibitor of SMARCA2, in combination with chemotherapy, pembrolizumab, and KRAS inhibitors in preclinical models of SMARCA4 mutant cancers. Preclinical data for LY4066434, a pan-KRAS inhibitor that is highly selective over HRAS and NRAS, will also be presented."

Preclinical • Solid Tumor

Foghorn Therapeutics Provides Financial Update for 2024 and 2025 Strategic Outlook (GlobeNewswire) - "Ongoing first-in-human Phase 1a/b open-label, multicenter trial design for FHD-909 will be presented at the AACR Annual Meeting (April 25-30, 2025)...In 2025, preclinical data for the Selective CBP degrader program, in combination with approved chemotherapeutics and targeted agents, will be presented at the AACR Annual Meeting (April 25-30, 2025)...In 2025, preclinical data for the Selective EP300 degrader program demonstrating biological activity in hematological malignancies will be presented at the AACR Annual Meeting (April 25-30, 2025)."

P1 data • Preclinical • Bladder Cancer • Endometrial Cancer • Gastric Cancer • Hematological Malignancies • Prostate Cancer • Solid Tumor

Foghorn Therapeutics Highlights Program Progress and Strategic Objectives for 2025 (GlobeNewswire) - "First-in-class oral selective SMARCA2 (BRM) inhibitor, FHD-909 (LY4050784), advancing in Phase 1 trial for SMARCA4 mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target patient population; FHD-909 preclinical combination data with pembrolizumab and KRAS inhibitors to be presented at the AACR Annual Meeting (April 25-30, 2025)."

Preclinical • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Foghorn Therapeutics Provides Update on FHD-286 Clinical Development Program and Strategic Priorities (GlobeNewswire) - "Foghorn Therapeutics Inc...announced today that it has made the decision to discontinue the independent development of FHD-286 in combination with decitabine in patients with relapsed and/or refractory acute myeloid leukemia (AML)....The Company will prioritize its proprietary pipeline and Lilly collaboration programs, including the clinical-stage selective SMARCA2 (BRM) inhibitor FHD-909 (LY4050784)....In the Phase 1 dose escalation trial of FHD-286 in combination with decitabine in relapsed and/or refractory AML, objective clinical responses were observed by standard response criteria. However, the observed response rate did not meet the Company’s threshold to continue development by Foghorn alone. Foghorn expects to report the results at a medical conference in 2025."

Discontinued • P1 data • Pipeline update • Acute Myelogenous Leukemia

Foghorn Therapeutics Announces First Patient Dosed with First-in-Class Oral SMARCA2 Selective Inhibitor FHD-909 in a Phase 1 Trial for SMARCA4 Mutated Solid Tumors (GlobeNewswire) - "Foghorn Therapeutics Inc...today announced that the first patient has been dosed with FHD-909 (LY4050784) in the Phase 1 trial for SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target patient population....A Phase 1 open-label, multicenter trial will assess the safety, tolerability and initial efficacy of FHD-909 in patients with locally advanced or metastatic solid tumors harboring a SMARCA4 alteration."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Foghorn Therapeutics Provides Second Quarter 2024 Financial and Corporate Update (GlobeNewswire) - "FHD-909: Dosing of the first patient in the Phase 1 trial for FHD-909 is planned to begin in the second half of 2024; Selective CBP degrader program: IND-enabling studies on track to initiate by the fourth quarter of 2024."

Preclinical • Trial status • Non Small Cell Lung Cancer • Oncology

A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=160 | Not yet recruiting | Sponsor: Eli Lilly and Company

Metastases • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Foghorn Therapeutics Provides First Quarter 2024 Financial and Corporate Update (GlobeNewswire) - "In the first quarter of 2024, Lilly selected FHD-909 for clinical development and in April the investigational new drug (IND) application was submitted. The primary target patient population is BRG1-mutated NSCLC....Dosing of first patient in Phase 1 trial for FHD-909 in BRG1-mutated NSCLC is expected in the second half of 2024."

IND • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Foghorn Therapeutics Presents New Preclinical Data on Potential First-in-Class BRM Selective Inhibitor FHD-909 and Selective CBP and Selective EP300 Degrader Oncology Programs (GlobeNewswire) - "Poster 3230 / 14:...Preclinical data presented at AACR support FHD-909 as an oral, novel, potent and selective BRM inhibitor with robust anti-tumor monotherapy activity: ~ 30-fold selectivity for BRM inhibition over BRG1 in cell-based assays; Dose-dependent and robust tumor growth inhibition and regression as a monotherapy in multiple BRG1 mutant xenograft models; Favorable tolerability with dose dependent modulation of BRM target genes in vivo; Lilly plans to file an IND application for potential first-in-class orally bioavailable, selective BRM inhibitor, FHD-909, with initial focus in BRG1 mutated NSCLC in Q2 2024."

IND • Preclinical • Non Small Cell Lung Cancer

Foghorn to Host Conference Call and Webcast on Pipeline of Potential First-in-Class Medicines in Conjunction with the 2024 AACR Annual Meeting (GlobeNewswire) - "Foghorn Therapeutics Inc...announced plans to host a conference call and webcast on April 9th at 5 p.m. ET / 2 p.m. PT. Foghorn management will review key programs in its pipeline, including FHD-286 for acute myelogenous leukemia (AML), and new preclinical data being presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting for potential first-in-class medicines including FHD-909, a BRM (SMARCA2) selective inhibitor, and for the selective CBP and selective EP300 degrader programs."

Clinical • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Foghorn Therapeutics to Present New Preclinical Data at 2024 AACR Annual Meeting, Reflecting Advances with Multiple Potential First-in-Class Medicines, including the Selective Inhibitor of BRM, FHD-909 (GlobeNewswire) - "Poster presentation of FHD-909, a first-in-class oral BRM selective inhibitor, highlighting preclinical efficacy and safety in multiple mouse models of NSCLC....IND filing planned in Q2 2024; Oral presentation demonstrating preclinical efficacy and tolerability data for Selective CBP and Selective EP300 degraders; Significant anti-tumor activity observed, with no thrombocytopenia as historically observed with dual CBP/EP300 inhibitors; Additional poster presentation demonstrating long-acting degrader capabilities confirming up to once-a-month dosing for protein degrader programs."

IND • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Foghorn Provides Pipeline Update on FHD-909 BRM Selective Inhibitor (GlobeNewswire) - "Foghorn Therapeutics Inc...today announced that Lilly has selected FHD-909, a first-in-class oral BRM selective inhibitor, for clinical development. Lilly plans to file an IND for FHD-909 in Q2 2024. The primary target patient population is BRG1 mutated non-small cell lung cancer (NSCLC)."

IND • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor