etigilimab (MPH-313) / Mereo Biopharma - LARVOL DELTA

First Quarter 2025 Financial Results (GlobeNewswire) - "Total research and development ('R&D') expenses decreased by $0.1 million from $4.0 million in the first quarter of 2024 to $3.9 million in the first quarter of 2025. The decrease was primarily due to decreases of $1.2 million and $0.1 million in R&D expenses for alvelestat and etigilimab, offset by an increase of $1.3 million in R&D expenses for setrusumab. The decrease in program expenses for alvelestat was primarily due to undertaking reduced drug formulation and manufacturing activities in preparation for the Phase 3 study in the first quarter of 2025, compared to the first quarter of 2024."

Commercial • Alpha-1 Antitrypsin Deficiency • Graft versus Host Disease • Ovarian Cancer • Solid Tumor

EON: Phase II trial of etigilimab (MPH313) in combination with nivolumab in patients with recurrent platinum-resistant clear cell ovarian cancer. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05715216 The abstract will be released to the public on May 22, 2025 at 4:00 PM"

Clinical • Combination therapy • P2 data • Platinum resistant • Oncology • Ovarian Cancer • Ovarian Clear Cell Cancer • Solid Tumor

EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Feb 2026

Checkpoint inhibition • Enrollment closed • Platinum resistant • Trial completion date • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Completed ➔ Recruiting | N=10 ➔ 20 | Trial completion date: Apr 2024 ➔ Apr 2025 | Trial primary completion date: Apr 2024 ➔ Apr 2025

Checkpoint inhibition • Combination therapy • Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P2 | N=10 | Completed | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Completed | N=20 ➔ 10 | Trial completion date: Dec 2025 ➔ Apr 2024

Checkpoint inhibition • Combination therapy • Enrollment change • Trial completion • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor

Mereo BioPharma Reports Full Year 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Etigilimab (MPH-313): Etigilimab in combination with nivolumab, is being studied in an ongoing investigator-led single-arm, two-stage, open-label Phase 1b/2 trial in a subtype of platinum-resistant recurrent ovarian cancer (clear cell ovarian cancer) at the MD Anderson Cancer Center, financed by the Cancer Focus Fund. Based on the results to-date, the study has been expanded from the initial 10 patients to 20 patients and an update may be provided by the investigator in the second half of 2024 or early 2025."

P1/2 data • Trial status • Ovarian Cancer

ACTIVATE: A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors. (clinicaltrials.gov) - P1/2 | N=76 | Completed | Sponsor: Mereo BioPharma | Active, not recruiting ➔ Completed | Phase classification: P1b/2 ➔ P1/2 | N=125 ➔ 76 | Trial completion date: Dec 2023 ➔ Sep 2023

Enrollment change • Phase classification • Trial completion • Trial completion date • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Safety and efficacy of etigilimab (anti-TIGIT) with nivolumab (anti-PD1) in recurrent/advanced solid tumors (ESMO 2023) - P1b/2 | "Table: 1021MO Best Observed Response (BOR)1 - Days on study Cohorts -n Complete Response (CR) Partial response (PR) Stable disease (SD) Progressive disease (PD) CPI-n Cervical Cancer - 8 CPS>1% 3 pts – 163, 365, 386 2 pts – 174, 241 3 pts CPI-n Uveal Melanoma - 8 2 pts – 228, 608 2 pts – 175, 294 4 pts Dedifferentiated Liposarcoma - 10 1 pt – 512 4 pts – 162, 167, 191, 216 5 pts EC – CPI-n - 10 3 pts – 168, 2882, 394 3 pts – 120, 131, 378 4 pts GCT - 4 1 pt – 3722 3 pts Total = 40 (%) 3 pts (7.5) 7 pts (17.5) 11 pts (27.5) 19 pts (47.5) Conclusions Etig in combination with nivo is safe and well tolerated. Preliminary efficacy data of prolonged on study duration with clinical benefit in immune resistant tumors supports continued evaluation in tumor types not typically responsive to anti-PD(L)1 monotherapy."

Clinical • Metastases • Cervical Cancer • Endometrial Cancer • Eye Cancer • Germ Cell Tumors • Gynecologic Cancers • Liposarcoma • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Uveal Melanoma • TIGIT

Etigilimab Plus Nivolumab Shows Activity in Recurrent/Advanced Solid Tumors, and Possible Biomarkers Emerge (OncLive) - P1/2 | N=125 | ACTIVATE (NCT04761198) | Sponsor: Mereo BioPharma | "Combination treatment with etigilimab and nivolumab was well tolerated in patients with recurrent or advanced solid tumors and promising efficacy was seen for patients with PD-L1 low disease.... At the March 29, 2023, data cutoff, the objective response rate (ORR) was 25% in a total of 40 patients treated with the combination therapy including those from the checkpoint-inhibitor-naïve endometrial cancer (n = 10), cervical cancer (n = 8), uveal melanoma (n = 8), de-differentiated liposarcoma (n = 10), and germ cell tumor (n = 4) cohorts. The only complete responses (CRs) occurred in 3 patients in the cervical cancer cohort who received treatment for a median of 12.5 months."

P1/2 data • Cervical Cancer • Endometrial Cancer • Eye Cancer • Germ Cell Tumors • Gynecologic Cancers • Liposarcoma • Ocular Melanoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Uveal Melanoma

EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial primary completion date: Dec 2023 ➔ Jun 2024

Checkpoint inhibition • Combination therapy • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor

Mereo BioPharma Reports Interim Financial Results for the Six Months Ended June 30, 2023 and Provides Corporate Update (GlobeNewswire) - "An abstract entitled 'Safety and efficacy of etigilimab with nivolumab in select recurrent/advanced solid tumors' has been accepted for a mini-oral presentation at the upcoming European Society for Medical Oncology (ESMO) Annual Meeting, being held October 20-24, 2023 in Madrid, Spain."

Clinical data • Oncology • Solid Tumor

Etigilimab and Nivolumab for the Treatment of Platinum-Resistant Recurrent Clear Cell Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: May 2023 ➔ Dec 2023 | Trial primary completion date: May 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Etigilimab and Nivolumab for the Treatment of Platinum-Resistant Recurrent Clear Cell Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting

Checkpoint inhibition • Combination therapy • Enrollment closed • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Mereo BioPharma Reports Full Year 2022 Financial Results and Recent Highlights (GlobeNewswire) - "Enrollment in the Phase 1b/2 ACTIVATE trial has completed the Phase 1b part of the study, with a total of 76 patients enrolled....The Company expects to report additional data from the ACTIVATE study later in 2023. Etigilimab, in combination with nivolumab, is also being studied in an ongoing investigator-led single-arm, open-label Phase 1b/2 trial in a subtype of platinum-resistant recurrent ovarian cancer (clear cell ovarian cancer) at The University of Texas MD Anderson Cancer Center....MD Anderson are planning to follow per protocol procedure to expand the study from an initial 10 patients to 20 patients."

Clinical protocol • Enrollment status • P1/2 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2023 ➔ Mar 2023

Checkpoint inhibition • Combination therapy • Enrollment open • Trial initiation date • Oncology • Ovarian Cancer • Solid Tumor

ACTIVATE: A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors. (clinicaltrials.gov) - P1b/2 | N=125 | Active, not recruiting | Sponsor: Mereo BioPharma | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: Mar 2023 ➔ Sep 2023

Combination therapy • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Tumor mutational burden • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Anti-TIGIT therapies for solid tumors: a systematic review. (PubMed, ESMO Open) - "Vibostolimab was evaluated in a phase I alone or in combination with pembrolizumab...Etigilimab was tested in a phase I alone or in combination with nivolumab, but the study was stopped due to business reasons. In the phase II CITYSCAPE trial, tiragolumab demonstrated higher objective response rate and progression-free survival in combination with atezolizumab than atezolizumab alone in advanced PD-L1-high NSCLC...Anti-TIGIT antibodies are under development as a novel immunotherapy approach. A promising research area includes the combination with anti-PD-1 therapies in advanced NSCLCs."

Journal • Review • Dermatology • Fatigue • Immune Modulation • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pruritus • Solid Tumor • CTLA4 • LAG3 • TIGIT

EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

Checkpoint inhibition • Combination therapy • New P2 trial • Oncology • Ovarian Cancer • Solid Tumor

Interim biomarker analysis of a phase Ib/II study of anti-TIGIT etigilimab (MPH313) and nivolumab in subjects with select locally advanced or metastatic solid tumors (ACTIVATE) (ESMO 2022) - P1b/2 | "Additionally, reduction in ctDNA levels were noted in some subjects between Days 36 – Days 78. Conclusions These interim biomarker data from Etig+nivo combination therapy demonstrated robust target engagement and evidence of dual TIGIT/PD-1 blockade as seen by decreases in TIGIT hi cells (e.g., Tregs) and an associated increase in proliferating and cytokine producing T-cells in circulation."

Biomarker • Clinical • IO biomarker • P1/2 data • Oncology • Solid Tumor • CD4 • CD8 • FCGR2A • IFNG • IL2 • PD-L1 • TIGIT

Safety and efficacy of etigilimab in combination with nivolumab in select recurrent/advanced solid tumors. (ASCO 2022) - P1b/2 | "Etig+nivo is safe and well tolerated with no new safety signals. Early efficacy was noted in cervical cancer (1CR, 1PR and 1SD) and uveal melanoma (3 SDs >20 weeks). Encouraging activity was also noted in ovarian cancer and post-CPI treated TMB-H/MSS NSCLC."

Clinical • Combination therapy • Cervical Cancer • Endometrial Cancer • Eye Cancer • Germ Cell Tumors • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Uveal Melanoma • TIGIT • TMB

A Phase 1a/b Open‑Label, Dose‑Escalation Study of Etigilimab Alone or in Combination with Nivolumab in Patients with Locally Advanced or Metastatic Solid Tumors. (PubMed, Clin Cancer Res) - "Etigilimab had an acceptable safety profile with preliminary evidence of clinical benefit alone and in combination with nivolumab and warrants further investigation in clinical trials."

Clinical • Combination therapy • IO biomarker • Journal • P1 data • Fatigue • Immune Modulation • Inflammation • Oncology • Solid Tumor • TIGIT

Mereo BioPharma Reports Clinical Update and Interim Biomarker Analysis Presented at ESMO 2022 from ACTIVATE Phase 1b/2 Open Label Study of Etigilimab (Anti-TIGIT Antibody MPH-313) plus Nivolumab (Anti-PD-1 Antibody) in Solid Tumors (GlobeNewswire) - P1b/2 | N=125 | ACTIVATE (NCT04761198) | Sponsor: Mereo BioPharma | "Mereo BioPharma Group plc...reported updated clinical data and promising biomarker data from ACTIVATE, a Phase 1b/ 2 study of anti-TIGIT antibody, etigilimab, in combination with nivolumab, in select recurrent advanced / metastatic solid tumors....Cervical cancer: 3/7 PD-L1 combined positive score CPS>1%, CPI-naïve cervical cancer subjects with confirmed complete responses (cCRs) ORR of 43%, 2 ongoing at >284 days and >142 days, and 1 withdrew consent with ongoing cCR at 163 days....Uveal melanoma: 1/6 evaluable subjects, with confirmed partial response (cPR) at >347 days, ORR 17% and 2 patients were SD, for 175 and 294 days DCR 50%. The subject with cPR was noted to have high CD226+CD8+ co-expression, and was PVR positive and PD-L1 negative (CPS <1%)."

P1/2 data • Cervical Cancer • Gynecologic Cancers • Melanoma • Oncology • Solid Tumor • Uveal Melanoma

"Eagerly waiting Phase 1b/2 Study of Etigilimab #TIGIT and Nivolumab #cervicalCancer cohort already reported 2 complete responses. $MREO @MereoBioPharma $BMY @bmsnews" (@ej23ny)

Clinical • P1/2 data • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor • TIGIT

Mereo BioPharma To Present Data Update for the Phase 1b/2 Study (ACTIVATE) of Etigilimab and Nivolumab at 2022 ASCO Annual Meeting; Mereo Also Updates Capital Allocation and Portfolio Prioritization Plan (GlobeNewswire) - P1/2 | N=125 | ACTIVATE (NCT04761198) | Sponsor: Mereo BioPharma | "The data will be presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on June 5, 2022...As of the cut off date of April 20, 2022, there were 38 efficacy-evaluable subjects with a minimum of 1 staging scan or documented clinical progression. Treatment of etigilimab in combination with nivolumab has shown preliminary efficacy across multiple tumor types with 2 complete responses (CRs), 4 partial responses (PRs), and 10 stable disease (SDs) for an overall response rate (ORR) of 15.8% and disease control rate (DCR) of 42.1% in heavily pre-treated, CPI-naïve subjects. Additionally, 7 subjects with clinical benefit remained on study treatment for ≥ 18 weeks. Clinical benefit was noted in tumor types not typically responsive to immune checkpoint inhibitor monotherapy. The combination of etigilimab and nivolumab has been safe and well tolerated,..."

P1/2 data • Oncology • Solid Tumor

Mereo BioPharma Announces the Presentation of Updated Data From a Phase 1b/2 Study of Etigilimab as a Poster at the 2022 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "Mereo BioPharma Group plc...announced the presentation of interim clinical data from its Phase 1b/2 Study of Etigilimab and Nivolumab in Subjects with Select Locally Advanced or Metastatic Solid Tumors in a poster at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 3 – 7, 2022 in Chicago IL."

P1/2 data • Oncology • Solid Tumor