OMO-103 / Peptomyc - LARVOL DELTA

Phase Ib study of OMO-103 in combination with gemcitabine and nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Clinical • Combination therapy • Metastases • P1 data • Oncology • Pancreatic Ductal Adenocarcinoma

Dose escalation study of OMO-103, a first in class Pan-MYC-Inhibitor in patients (pts) with advanced solid tumors (AACR-NCI-EORTC 2022) - "RP2D has been determined to be DL5 with 6.48mg/kg. Dose expansion cohorts (Phase 2a) are already planned."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Salivary Gland Cancer • Sarcoma • Solid Tumor

MYC Inhibition with OMO-103 Restores TNF-Superfamily Signaling and Uncovers Actionable Immunotherapy Vulnerabilities in KRAS-Mutant NSCLC (EORTC-NCI-AACR 2026) - "Abstract will be available on the day of the presentation"

IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

MYC targeting by OMO-103 in solid tumors: a phase 1 trial. (PubMed, Nat Med) - P1/2 | "In addition, we identified soluble factors that are potential pharmacodynamic and predictive response markers. Based on all these data, the recommended phase 2 dose was determined as DL5 (6.48 mg kg-1).ClinicalTrials.gov identifier: NCT04808362 ."

Journal • P1 data • Oncology • Solid Tumor

Targeting MYC-Driven Cancers: From Oncogenic Addiction to Therapeutic Vulnerability. (PubMed, BioDrugs) - "Importantly, the first direct MYC inhibitor evaluated in humans, OMO-103, recently demonstrated promising antitumor activity in phase I clinical trials. Indirect approaches have focused on suppressing MYC transcription, translation, or stability by targeting upstream signaling pathways, as well as by exploiting MYC-associated cofactor interactions and synthetic lethal vulnerabilities to improve therapeutic specificity. In this review, we highlight the multifaceted roles of MYC in different cancer types and provide a comprehensive overview of current therapeutic strategies targeting MYC with a particular focus on epigenetic modifiers and metabolic vulnerabilities."

Journal • Review • CNS Disorders • Oncology • Psychiatry • MYCL • MYCN

The MYC network: Hub of malignancy and blueprint for intervention. (PubMed, Biochim Biophys Acta Rev Cancer) - "Recent clinical progress with Omomyc-derived OMO-103 and other MYC-network-targeting agents supports the feasibility of therapeutically intercepting this historically challenging pathway. However, because many MYC-directed strategies affect essential transcriptional, chromatin, and metabolic programs, future development will require careful biomarker selection, rational combinations, and rigorous evaluation of therapeutic windows. By integrating mechanistic and translational literature, this review highlights MYC as a dynamic cancer dependency and discusses opportunities for precision intervention."

Journal • Review • Immune Modulation • Immunology • Oncology • MYC • MYCL • MYCN

Restoring antitumor immunity and improving immunotherapy outcomes in KRAS-mutant NSCLC through MYC inhibition by OMO-103 (AACR 2026) - P1/2 | "MYC inhibition with OMO-103 not only suppresses tumor growth but also reprograms the TIME to promote anti-tumor immunity and enhance response to immunotherapy. These findings support MYC blockade as a promising therapeutic strategy to overcome immunotherapy resistance in KRAS-mutant NSCLC."

IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IFNG • KRAS • MYC • TNFA

Deconstructing the paradigm of oncogene cooperation: Targeting MYC to enhance response and overcome resistance to KRAS inhibitors (AACR 2026) - "Although KRAS-G12C inhibitors (KRASi) such as sotorasib and adagrasib are approved for NSCLC, their clinical benefit is frequently limited by intrinsic and acquired resistance. These findings demonstrate critical cooperation between MYC and KRAS in driving tumor survival and resistance to KRAS inhibition. Direct MYC blockade enhances the therapeutic activity of KRAS inhibitors and represents a promising strategy to overcome both intrinsic and acquired resistance in multiple KRAS-mutant cancer types."

Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

Targeting MYC as a novel therapeutic strategy for an epigenetic-driven cancer: NUT Carcinoma (AACR 2024) - "It induces cell apoptosis, differentiation, and cell cycle arrest in vitro, and when tested in xenografts in vivo, OMO-103 reduces tumor growth and enhances mouse survival, particularly when combined with a chemotherapy regimen. This study presents a promising therapeutic strategy for an incurable and aggressive cancer type."

NUT Midline Carcinoma • Oncology • BRD4 • SOX2 • TP63

OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: OHSU Knight Cancer Institute | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2025 ➔ Jan 2026

Enrollment open • Trial initiation date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

VHIO23003(OMO-103-03: A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients with Advanced High-Grade Osteosarcoma (clinicaltrialsregister.eu) - P1/2 | N=10 | Suspended | Sponsor: Vall D Hebron Institute Of Oncology | Recruiting ➔ Suspended

Trial suspension • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

OMO-103-02: Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered iv in Patients With PDAC (clinicaltrials.gov) - P1 | N=26 | Active, not recruiting | Sponsor: Peptomyc S.L. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2025 ➔ May 2026

Enrollment closed • Trial primary completion date • Endometrial Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

MYC as a Target for Cancer Treatment: from Undruggable to Druggable? (PubMed, Target Oncol) - "Recently, however, these problems appear to have been successfully resolved, with the discovery of promising anti-MYC compounds such as Omomyc or MYCi975. Results from a phase I trial with OMO-103 (a form of Omomyc) suggest that the inhibitor is well tolerated, with most of its adverse effects being at grade 1 level. Evidence of target inhibition was the finding of decreased expression of multiple MYC regulated genes."

IO biomarker • Journal • Review • Oncology

OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: OHSU Knight Cancer Institute

New P1 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Targeting MYC as a promising therapeutic strategy for pediatric medulloblastoma (EACR 2025) - "When overactivated, it drives tumorigenesis and tumor maintenance, and until recently, MYC has been considered undruggable.Material and Omomyc is a MYC dominant negative inhibitor, currently in clinical trials for adults with advanced solid tumors as an Omomyc-based mini-protein (OMO-103)... Overall, our work discovers that Omomyc may be a promising therapy for a subset of MB patients with high-MYC expression, particularly at recurrence. Moreover, we have identified a combinatorial treatment strategy with synergistic effect in vitro, and next steps include its validation in vivo. COI: LS is CEO and employee of Peptomyc, a company developing MYC inhibitory peptides."

Clinical • Alzheimer's Disease • Brain Cancer • Cognitive Disorders • Medulloblastoma • Oncology • Pediatrics • Solid Tumor • MYC

Rethinking MYC inhibition: a multi-dimensional approach to overcome cancer's master regulator. (PubMed, Front Cell Dev Biol) - "However, recent advances are overturning this view, with direct inhibitors like Omomyc (OMO-103) and PROTAC-based degraders such as WBC100 showing promising clinical progress...Moreover, combination therapies integrating MYC inhibitors with chemotherapy, radiotherapy, or immunotherapy demonstrate synergistic potential. This article advocates for a multi-dimensional, biomarker-guided approach to MYC targeting, emphasizing rational drug combinations and continued innovation to overcome resistance and improve outcomes in MYC-driven cancers."

IO biomarker • Journal • Review • Oncology • Targeted Protein Degradation

c-Myc-targeted therapy in breast cancer: A review of fundamentals and pharmacological Insights. (PubMed, Gene) - "Notably, the c-Myc inhibitor OMO-103 has shown promise in a Phase II clinical trial for advanced cancer patients. Further research is needed to develop new drugs targeting this gene, protein, or its pathways, and additional studies on cancer patients are encouraged."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • MYC • PGR

Osteomyc: A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients With Advanced High-Grade Osteosarcoma (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Vall d'Hebron Institute of Oncology | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

OSTEOMYC: A PHASE 2 PILOT STUDY TO EVALIATE THE SAFETY AND THE ANTITUMOR ACTIVITY OF THE MYC INHIBITOR OMO-103 ADMINISTERED INTRAVENOUSLY IN PATIENTS WITH ADVANCED HIGH GRADE OSTEOSARCOMA (CTOS 2024) - "In addition,it will explore potential biomarkers. Patients ≥12 years with locally advanced/metastatic high-grade osteosarcoma who have received at least one line of standard chemotherapy containing cisplatin and anthracycline, and no more than 2 previous lines, will be included. N/A,N/A,N/A"

Clinical • Metastases • P2 data • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • MYC

OMO-103-02: Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered Iv in Patients with PDAC (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Peptomyc S.L. | Phase classification: P1b ➔ P1 | N=18 ➔ 30

Enrollment change • Metastases • Phase classification • Endometrial Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Discovery of a covalent inhibitor targeting the undruggable oncogene cMyc (EORTC-NCI-AACR 2024) - "Numerous efforts to target this notorious protein have been made, yet only OMO-103, a mini-protein drug, has demonstrated safety and anti-tumor activity in clinical trials...Our research underscores how covalent small molecules can open the door to transformative treatment options by targeting previously undruggable proteins such as cMyc. BridGene Biosciences aims to address the large patient population with cMyc amplification by developing a potent and selective covalent therapeutic, which could be crucial for reversing cancerous growth and restoring antitumor immune responses in cMyc-driven cancers."

Oncology • MYC

MYC Inhibition by OMO-103 Reprograms Tumor Immunity and Enhances Immunotherapy Efficacy in KRAS Mutant NSCLC (EORTC-NCI-AACR 2024) - P1/2 | "By upregulating activation molecules of the TNFR superfamily, MYC inhibition re-activates immune recognition, improving the therapeutic effect of immunotherapies. This presents a promising therapeutic approach for KRAS NSCLC, highlighting MYC inhibitors such as OMO-103 as potent candidates to overcome immunotherapy resistance and provide better cancer treatments."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS • TNFA

Pharmacokinetic and pharmacodynamic analyses of OMO-103 in preclinical and patient tissues (EORTC-NCI-AACR 2024) - P1/2 | "Our results show evidence of the long-lasting half-life of functional OMO-103 in tumour tissues, suggestive of a different PK profile between serum and tissue. We also demonstrate target engagement by OMO-103 at the transcriptomic and proteomic levels, correlating clinical benefit with more efficient shutdown of MYC targets."

PK/PD data • Preclinical • Oncology • Solid Tumor • MYC

Osteomyc: A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients with Advanced High-Grade Osteosarcoma (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Vall d'Hebron Institute of Oncology

Metastases • New P2 trial • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Pharmacokinetic analysis of OMO-103 in patient tissues with advanced solid tumors. (ASCO 2024) - P1/2 | "We demonstrate the utility of targeted MS assay for precise quantification of therapeutic (mini)proteins in clinical tissue samples. Thanks to its multiplexing capability, up to 60 peptides (epitopes) can be monitored simultaneously which enables high sequence coverage and profiling of additional PD or other supporting biomarkers. Clinical trial information: NCT04808362."

Clinical • Metastases • PK/PD data • Oncology • Solid Tumor