ENB003 / ENB Therap - LARVOL DELTA

In October 2025, the Cancer Research Institute announced the first patient enrolled in the third cohort of the ongoing Immunotherapy Platform Study in Platinum-Resistant High-Grade Serous Ovarian Cancer (IPROC) (Coherus Press Release) - "The third cohort of the Phase 2 trial is evaluating LOQTORZI in combination with ENB Therapeutics' ENB-003 for the treatment of ovarian cancer."

Platinum resistant • Trial status • High Grade Serous Ovarian Cancer

CRI-CCTG-0003/IND.240: Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Platinum resistant • Trial completion date • Trial primary completion date • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

CRI-CCTG-0003/IND.240: Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Canadian Cancer Trials Group | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

ENBolden-101: ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors (clinicaltrials.gov) - P1/2 | N=137 | Active, not recruiting | Sponsor: ENB Therapeutics, Inc | Phase classification: P1b/2a ➔ P1/2

Combination therapy • Metastases • Phase classification • Breast Cancer • Gastrointestinal Cancer • Hepatology • Melanoma • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Thyroid Gland Papillary Carcinoma • Triple Negative Breast Cancer • MSI • PD-L1

Coherus Announces Clinical Collaboration with the Cancer Research Institute for a Novel Combination Evaluating LOQTORZI (toripalimab-tpzi) with ENB Therapeutics' ENB-003 for the Treatment of Ovarian Cancer (GlobeNewswire) - "Coherus BioSciences...announced that the Cancer Research Institute (CRI) and its Immunotherapy Platform Study in Platinum-Resistant High-Grade Serous Ovarian Cancer (IPROC) Drug Selection Committee (DSC) have selected LOQTORZI...to explore in combination with ENB-003...for the treatment of drug-resistant cancers in the iPROC platform study....Under the terms of a clinical supply agreement with the Cancer Research Institute (CRI), Coherus will supply toripalimab-tpzi for combination treatment with ENB-003 to be investigated in the iPROC platform study....The IPROC clinical trial uses an adaptive platform study design that utilizes a single master protocol to evaluate multiple immunotherapy combinations."

Licensing / partnership • Ovarian Cancer

ENB Therapeutics Presents Top-line Results from Phase 1b ENBOLDEN-101 Study in Platinum Refractory/ Resistant Ovarian Cancer at SITC 2023 (Businesswire) - P1b/2a | N=137 | ENBOLDEN-101 (NCT04205227) | Sponsor: ENB Therapeutics, Inc | "ENB Therapeutics...announced top-line results from the dual combination arm of the Phase 1b ENBOLDEN-101 study, evaluating ENB-003 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced refractory cancers....The data included 5 patients with metastatic microsatellite stable (MSS) PROC who had disease progression after one or more previous lines of treatment....The data demonstrated that the treatment regimen was safe and well tolerated. The objective response rate (ORR) and disease control rate (DCR- patients exhibiting a response or stable disease) in MSS PROC was 40% and 80% respectively (N=5), including 2 patients with partial responses showing a 95% and 33% reduction in tumor burden respectively, as well as 4 patients with stable disease; 80% of PROC patients demonstrated shrinkage of target lesions overall."

P1 data • Ovarian Cancer

ENB-003, an ETBR antagonist, in combination with pembrolizumab, shows promise in microsatellite stable platinum refractory/resistant ovarian cancer: data from the ENBOLDEN-101 phase 1B study (SITC 2023) - "Conclusions MSS OC patients historically demonstrate poor response to single agent anti-PD1. ETBR blockade with ENB-003 may expand the therapeutic benefit to patients who are refractory or resistant to anti-PD1 therapy"

Combination therapy • IO biomarker • Late-breaking abstract • P1 data • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor

ENB Therapeutics Presents Top-line Results from Phase 1b ENBOLDEN-101 Study in Solid Tumors Refractory to Standard of Care at the Immuno-oncology Summit 2023 (Businesswire) - P1b/2a | N=137 | NCT04205227 | Sponsor: ENB Therapeutics, Inc" | ENB Therapeutics, Inc...announced that the company has completed enrollment of its international Phase 1 ENBOLDEN-101 trial investigating the safety and efficacy of lead product ENB-003 in combination with KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy....The DCR across all cohorts irrespective of ETBR status was 33% (1 PR, 9 SD, 20 PD). The DCR in ETBR-Hi patients was 33% in cohorts 1-5 (4 SD, 1 PR, 10 PD) and 83% in cohort 6 (5 SD, 1 PD). The DCR for ETBR-Lo patients in cohort 6 was 0% (9 PD)....For microsatellite stable (MSS) platinum refractory/ resistant ovarian cancer there was an 80% DCR across all cohorts (1 PR, 3 SD, 1 PD) with a trend for durable responses at higher doses of ENB-003. A platinum refractory MSS ovarian cancer patient experienced a 95% PR of 12-month duration."

Enrollment closed • P1 data • Gastrointestinal Cancer • Gynecologic Cancers • Melanoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Skin Cancer • Solid Tumor

ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors (clinicaltrials.gov) - P1b/2a | N=137 | Active, not recruiting | Sponsor: ENB Therapeutics, Inc | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2024 ➔ Mar 2026 | Trial primary completion date: Apr 2024 ➔ Jan 2026

Combination therapy • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Gastrointestinal Cancer • Hepatology • Melanoma • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Thyroid Gland Papillary Carcinoma • Triple Negative Breast Cancer • MSI • PD-L1

ENB-003, an ETBR antagonist, in combination with pembrolizumab for advanced solid tumor: The ENBolden trial (AACR 2023) - P1b/2a | "We also observed a 7-month arrest of disease progression in a tonsillar SCC patient with innate resistance to anti-PD1. These data suggest that ETBR blockade is well tolerated, may expand the benefit of anti-PD1 in drug resistant solid tumors and warrants further study in subsequent trials."

Combination therapy • Metastases • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • PD-L1

[VIRTUAL] Phase 1/2 study using ENB-003, a first-in-class selective ETBRi, in combination with pembrolizumab in subjects with advanced refractory solid tumors (SITC 2020) - P1b/2a | "The combination of ENB-003 and pembrolizumab is well tolerated thus far and is demonstrating promising early signals of anti-tumor efficacy. Trial updates will be reported."

Clinical • Combination therapy • IO biomarker • Late-breaking abstract • P1/2 data • Bladder Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Melanoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Urothelial Cancer

ENB Therapeutics Announces Poster Presentation at the 2022 Summit for Cancer Immunotherapy (Yahoo Finance) - "ENB Therapeutics, Inc...announced that it will present a scientific poster on ENB-003 at the 2022 Summit for Cancer Immunotherapy in Montreal, Quebec November 19-21, 2022."

P1/2 data • Gastrointestinal Cancer • Gynecologic Cancers • Melanoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Skin Cancer • Solid Tumor

ENB Therapeutics Announces Orphan Drug Designation Granted by FDA for ENB-003 for the Treatment of Pancreatic Cancer (BioSpace) - "ENB Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, ENB-003, for the treatment of pancreatic cancer."

Orphan drug • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

[VIRTUAL] Phase 1/2 study using ENB-003, a first-in-class selective ETBRi, in combination with pembrolizumab in subjects with advanced refractory solid tumors (SITC 2020) - P1b/2a | "The combination of ENB-003 and pembrolizumab is well tolerated thus far and is demonstrating promising early signals of anti-tumor efficacy. Trial updates will be reported."

Clinical • Combination therapy • IO Biomarker • Late-breaking abstract • P1/2 data • Bladder Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Melanoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Urothelial Cancer

ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors (clinicaltrials.gov) - P1b/2a; N=130; Recruiting; Sponsor: ENB Therapeutics, Inc; Not yet recruiting ➔ Recruiting; Trial completion date: Nov 2023 ➔ Oct 2024; Trial primary completion date: Sep 2023 ➔ Apr 2024

Clinical • Combination therapy • Enrollment open • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Melanoma • Oncology • Ovarian Cancer • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Thyroid Gland Papillary Carcinoma • MRI • MSI • PD-L1

ENB Therapeutics Demonstrated Early Efficacy in Phase I Clinical Trial of ENB-003 in Combination with Pembrolizumab (Issuer Direct) - “ENB Therapeutics, Inc…announced the successful completion of the third dosing cohort in a Phase I dose escalation clinical trial of ENB-003 in combination with pembrolizumab. Doses of ENB-003 administered to date appear well-tolerated and as the trial progressed into the anticipated therapeutic range of ENB-003 has demonstrated its first efficacy signal as was reported at the SITC 2020 annual meeting.”

Trial status • Oncology • Solid Tumor