EDP1503 / Evelo Biosci - LARVOL DELTA

Pembrolizumab and EDP1503 in Advanced Melanoma (clinicaltrials.gov) - P2 | N=8 | Terminated | Sponsor: University of Chicago | Trial completion date: Nov 2027 ➔ Jul 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Nov 2027 ➔ Jul 2025; Drug supply no longer available.

Trial completion date • Trial primary completion date • Trial termination • Melanoma • Oncology • Solid Tumor • BRAF

Phase 1/2, open-label study of oral bacterial supplementation (EDP1503) plus pembrolizumab in participants with advanced or metastatic microsatellite-stable colorectal cancer, triple-negative breast cancer, and checkpoint inhibitor-relapsed tumors. (PubMed, Invest New Drugs) - P1 | "Grade ≥ 3 adverse events occurred in 28 participants (40.6%), with no new safety signals. EDP1503 plus pembrolizumab had manageable safety but limited clinical activity.Trial registration: KEYNOTE-939, EDP1503-101 trial: ClinicalTrials.gov NCT03775850."

Checkpoint inhibition • Journal • P1/2 data • Breast Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Pembrolizumab and EDP1503 in Advanced Melanoma (clinicaltrials.gov) - P2 | N=8 | Active, not recruiting | Sponsor: University of Chicago | Suspended ➔ Active, not recruiting

Enrollment closed • Metastases • Melanoma • Oncology • Solid Tumor • BRAF

Pembrolizumab and EDP1503 in Advanced Melanoma (clinicaltrials.gov) - P2 | N=8 | Suspended | Sponsor: University of Chicago | Trial completion date: Nov 2023 ➔ Nov 2027 | Trial primary completion date: Nov 2023 ➔ Nov 2027

Metastases • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF

Pembrolizumab and EDP1503 in Advanced Melanoma (clinicaltrials.gov) - P2 | N=8 | Suspended | Sponsor: University of Chicago | Trial primary completion date: Nov 2022 ➔ Nov 2023

Metastases • Trial primary completion date • Melanoma • Oncology • Solid Tumor • BRAF

KEYNOTE-939: A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors (clinicaltrials.gov) - P1 | N=69 | Completed | Sponsor: Evelo Biosciences, Inc. | Phase classification: P1/2 ➔ P1

Checkpoint inhibition • Combination therapy • Metastases • Phase classification • Bladder Cancer • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

Monoclonal microbial EDP1503 induces anti-tumor responses via gut-mediated activation of both innate and adaptive immunity (SITC 2019) - P1/2, P2; "Together, these data clearly demonstrate the ability of an orally delivered non-colonizing monoclonal microbe to enhance innate and adaptive anti-tumor immunity and substantiates the rationale for ongoing clinical trials. EDP1503 is currently in Phase 1b/2 studies (NCT03775850; NCT03595683) with enrollment open at multiple sites."

IO Biomarker • PD(L)-1 Biomarker

Monoclonal microbial EDP1503 to induce antitumor responses via gut-mediated activation of both innate and adaptive immunity. (ASCO 2019) - P1/2, P2; "Together, these data clearly demonstrate the ability of an orally delivered non-colonizing monoclonal microbe to enhance innate and adaptive anti-tumor immunity and substantiates the rationale for ongoing clinical trials. EDP1503 is currently in Phase 1b/2 studies (NCT03775850; NCT03595683) with enrollment open at multiple sites."

IO Biomarker • PD(L)-1 Biomarker

KEYNOTE-939: A Study of EDP1503 in Patients With Colorectal Cancer, Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors (clinicaltrials.gov) - P1/2; N=69; Completed; Sponsor: Evelo Biosciences, Inc.; Recruiting ➔ Completed; N=120 ➔ 69; Trial completion date: Dec 2020 ➔ Oct 2021; Trial primary completion date: Dec 2020 ➔ Jun 2021

Checkpoint inhibition • Clinical • Combination therapy • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Bladder Cancer • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

[VIRTUAL] Oral delivery of a single microbial strain, EDP1503, induces anti-tumor responses via gut-mediated activation of both innate and adaptive immunity (ESMO-GI 2020) - P1/2, P2 | "In a phase I/II clinical trial, the safety, tolerability, and pharmacological effects of orally administered EDP1503 in combination with pembrolizumab are being evaluated in multiple tumor types: microsatellite stable (MSS) metastatic colorectal cancer, triple-negative breast cancer, and a basket of PD-1 relapsed solid tumors. Legal entity responsible for the study The authors. Funding Evelo Biosciences."

IO Biomarker • Colorectal Cancer • Gastrointestinal Cancer • Oncology • CD8 • IFNG

[VIRTUAL] A phase I/II clinical trial of EDP1503 with pembrolizumab for triple-negative breast cancer (SABCS 2020) - P1/2 | "EDP1503 administered with pembrolizumab is safe and well-tolerated with no Grade 4-5 TRAEs or SAEs. Clinical benefit was observed in a subset of TNBC patients treated with the combination of EDP1503 and pembrolizumab. This study is continuing to recruit TNBC patients at the high dose of EDP1503."

Clinical • IO biomarker • P1/2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • IFNG

Pembrolizumab and EDP1503 in Advanced Melanoma (clinicaltrials.gov) - P2; N=8; Suspended; Sponsor: University of Chicago; N=70 ➔ 8; Active, not recruiting ➔ Suspended; Trial primary completion date: Nov 2021 ➔ Nov 2022

Enrollment change • Trial primary completion date • Trial suspension • Melanoma • Oncology • Solid Tumor • BRAF

Evelo Biosciences Announces New Clinical Candidate in Oncology and Presents Additional Interim Data from Phase 1/2 Clinical Trial of EDP1503 in Patients with Triple-Negative Breast Cancer (GlobeNewswire) - P1/2, N=120; NCT03775850; Sponsor: Evelo Biosciences, Inc; "Evelo Biosciences, Inc...announced that it is prioritizing EDP1908 as its lead clinical candidate in oncology given its superior preclinical activity over EDP1503. The Company will halt patient recruitment in the Phase 1/2 clinical trial of EDP1503 and will wind down the study. The Company also announced that additional interim clinical data from its Phase 1/2 open-label study evaluating EDP1503 in combination with pembrolizumab in patients with triple-negative breast cancer (TNBC) were presented today in a poster session at the San Antonio Breast Cancer Symposium (SABCS) 2020 Virtual Meeting. The presentation showed that as of a cutoff date of October 30, 2020, EDP1503 was well-tolerated, with an overall response rate (ORR) of 17 percent and a disease control rate (DCR) of 25% in the 12 patients...'We are now scaling up manufacturing in order to advance EDP1908 into the clinic in the first half of 2022.'"

Clinical • P1/2 data • Preclinical • Trial status • Breast Cancer • Oncology • Triple Negative Breast Cancer

Evelo Biosciences Reports Third Quarter 2020 Financial Results and Business Highlights (GlobeNewswire) - “EDP1503: Additional data from Phase 1/2 trial in triple-negative breast cancer (TNBC) accepted for poster presentation at the 2020 San Antonio Breast Cancer Symposium (SABSC), to be held virtually from December 8-11.”

P1/2 data • Breast Cancer • Oncology • Triple Negative Breast Cancer

Evelo Biosciences to Present Clinical Data from Phase 1/2 Trial of EDP1503 at the ESMO World Congress on Gastrointestinal Cancer Virtual Meeting (GlobeNewswire) - "Evelo Biosciences, Inc…announced that clinical data from the Phase 1/2 open-label study of EDP1503, in combination with pembrolizumab, in patients with advanced metastatic microsatellite stable colorectal carcinoma (MSS CRC), triple-negative breast cancer (TNBC), and checkpoint inhibitor relapsed tumors, will be presented at the ESMO World Congress on Gastrointestinal Cancer Virtual Meeting being held July 1 - 4, 2020."

P1/2 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Triple Negative Breast Cancer

Evelo Biosciences Reports Second Quarter 2020 Financial Results and Business Highlights (GlobeNewswire) - "Additional data from Phase 1/2 trial of EDP1503 in TNBC expected in 4Q 2020."

P1/2 data • Breast Cancer • Oncology • Triple Negative Breast Cancer

Evelo Biosciences to Present Clinical Data from Phase 1/2 Trial of EDP1503 at the ESMO World Congress on Gastrointestinal Cancer Virtual Meeting (GlobeNewswire) - P1/2, N=120; NCT03775850; Sponsor: Evelo Biosciences, Inc; "In addition to data in MSS CRC patients, the poster reported preliminary data on 11 TNBC patients (8 on high dose and 3 on low dose EDP1503). An overall response rate (ORR) of 25% (2/8) and a disease control rate of 37.5% (3/8) were observed across all TNBC subjects receiving high dose EDP1503. ORR was 33% (2/6) amongst response-evaluable patients on the high dose, with 2 patients awaiting first response assessment....The study continues enrollment in TNBC, and further data from this cohort will be available in 4Q 2020....Author...Johanna C. Bendell..."

Enrollment status • P1/2 data • Breast Cancer • Oncology • Triple Negative Breast Cancer

Pembrolizumab and EDP1503 in Advanced Melanoma (clinicaltrials.gov) - P2; N=70; Active, not recruiting; Sponsor: University of Chicago; Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor

Evelo Biosciences reports first quarter financial results and business highlights (GlobeNewswire) - "Evelo expects to present results of this study, including the TNBC cohort, at a future medical conference…Clinical data from a cohort of individuals with TNBC in the Phase 1/2 trial of EDP1503 in 2H 2020."

P1/2 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Evelo Biosciences reports fourth quarter and full year 2019 financial results and business highlights (GlobeNewswire) - "Additional data from the ongoing Phase 1/2 clinical trial evaluating EDP1503 in combination with Merck’s anti-PD-1, KEYTRUDA® (pembrolizumab), in individuals with microsatellite colorectal cancer, triple-negative breast cancer, or other tumor types who have relapsed on prior PD-1/L1 inhibitor treatment, are expected in the first half of 2020."

P1/2 data

Evelo provides update on recent positive EDP1815 regulatory interactions on phase 2 trial design resulting in shorter development timeline to registration (GlobeNewswire, Evelo Biosciences, Inc.) - “EDP1503 – Phase 1/2 in oncology: Further data from the ongoing Phase 1/2 clinical trial evaluating EDP1503 in combination with Merck’s anti-PD-1, KEYTRUDA® (pembrolizumab), in individuals with microsatellite colorectal cancer, triple-negative breast cancer or other tumor types who have relapsed on prior PD-1/L1 inhibitor treatment, in the first half of 2020.”

P1/2 data

Evelo Biosciences to present preclinical data from its EDP1503 oncology program at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting (GlobeNewswire) - “Evelo Biosciences…announced that preclinical data from its oncology program, EDP1503, will be presented during the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting being held November 6–10, 2019 in National Harbor, Maryland.”

Preclinical

Evelo Biosciences announces positive interim phase 1b clinical data and provides second quarter 2019 financial results (GlobeNewswire) - “Oncology: Clinical Studies and Anticipated Milestones - EDP1503 - Phase 1/2; Evelo is conducting a Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in microsatellite stable colorectal cancer, triple-negative breast cancer, and patients with other tumor types that have relapsed on prior PD-1/L1 inhibitor treatment. Initial clinical data is expected in the first half of 2020.”

P1/2 data

Evelo Biosciences Reports First Quarter 2019 Financial Results and Recent Business Highlights (GlobeNewswire, Evelo Biosciences, Inc.) - “Ongoing Clinical Studies and Anticipated Milestones: Oncology: EDP1503 - Phase 1/2, Evelo is conducting a Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in microsatellite stable colorectal cancer, triple-negative breast cancer, and patients with other tumor types that have relapsed on prior PD-1/L1 inhibitor treatment. Initial clinical data is expected in the first half of 2020; EDP1503 - Phase 2a, The University of Chicago is conducting a Phase 2a investigator-sponsored clinical trial of EDP1503 in combination with KEYTRUDA in naive melanoma patients and melanoma patients who have relapsed on prior PD-1/L1 inhibitor treatment. Initial clinical data expected in second half of 2020.”

Clinical data

Evelo Biosciences announces dosing of first patient in investigator-sponsored phase 2a clinical trial of EDP1503 in combination with Keytruda in patients with metastatic melanoma (GlobeNewswire) - P2a, N=70; NCT03595683; "Evelo Biosciences...announced that the University of Chicago has dosed the first patient in an investigator-sponsored Phase 2a clinical trial evaluating EDP1503 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy...This open-label clinical triall...will evaluate the safety, tolerability, and efficacy of EDP1503 in combination with KEYTRUDA in up to 70 patients with metastatic melanoma who are previously untreated or who have relapsed following treatment with an anti-PD-1 inhibitor...Evelo anticipates initial clinical data from the trial in the second half of 2020."

Enrollment open • P2 data