- Peptomyc has received full study approval for its Phase Ib clinical trial evaluating the combination of its first-in-class MYC inhibitor Omomyc (OMO-103) with standard of care in metastatic pancreatic ductal adenocarcinoma (PDAC) patients in first line.
- Developed in-house by VHIO spin-off Peptomyc, Omomyc targets the MYC oncogene which is found deregulated in most—if not all— tumor types.
- Peptomyc recently completed a first-in-human Phase I study of OMO-103, an Omomyc-based mini-protein therapeutic, in all-comers with solid tumor malignancies, demonstrating promising anti-tumor activity and excellent safety. To be conducted at four sites in Spain, this new combination Phase Ib study will be led by VHIO’s Teresa Macarulla and is planned to start during the third quarter of 2023.
Pancreatic cancer is currently the fourth highest cause of cancer mortality worldwide, with incidence on the steep rise. This tumor type has one of the lowest five-year survival rates of all cancers, and current therapies offer limited chance of a lasting cure. Pancreatic ductal adenocarcinoma (PDAC) is the most common form of pancreatic cancer.
Under normal conditions MYC is a transcription factor that regulates the activation of genes related to cell division in an orderly manner. Frequently dysregulated in many human cancers, MYC drives the transcription of genes implicated in the uncontrolled growth of tumor cells and the development of metastasis and disease recurrence. MYC is activated in many PDAC cases, where it contributes to the aggressiveness of disease and resistance to treatments.
Omomyc is a therapeutic mini-protein targeting the MYC oncogene that has been developed by Peptomyc based on an important body of research led by Laura Soucek, co-Director of VHIO’s Preclinical and Translational Research Program, Principal Investigator of our Models of Cancer Therapies Group, an ICREA Research Professor, and Chief Executive Officer of Peptomyc.
“This is the first mini-protein MYC inhibitor to have successfully completed a phase I trial, demonstrating promising anti-tumor activity and excellent safety” says Laura Soucek, who has dedicated more than 25 years to research aimed at targeting MYC.
Anti-tumor efficacy in combination with standard of care
The next step is to evaluate the antitumor activity of this drug in combination with other treatments. Peptomyc has announced that it has received full study approval from the Spanish Agency of Medicines and Medical Products (AEMPS) for its new Phase Ib study, which will evaluate the combination of its first-in-class MYC inhibitor, OMO-103, together with the standard of care (SoC) regimen gemcitabine and nab-paclitaxel in metastatic PDAC patients in first line.
Manuela Niewel, Chief Medical Officer of the company, leading Peptomyc’s clinical development, regulatory and medical affairs activities, says: “I am excited to be able to start our new Phase Ib study in PDAC patients. With OMO-103, we hope to address this devastating disease that represents a major unmet clinical need in the oncology field.”
Teresa Macarulla, Principal Investigator of VHIO’s Upper Gastrointestinal and Endocrine Tumors Group, Head of our Upper Gastrointestinal Cancer Translational Research Laboratory, and Medical Oncologist at the Vall d’Hebron University Hospital (HUVH), will be the study’s lead investigator in collaboration with Andrés Muñoz at the Hospital Gregorio Marañón in Madrid, Mariona Calvo at the ICO-Hospitalet in Barcelona, and Roberto Pazo at the Hospital Miguel Servet in Zaragoza. The study is planned to start in Q3/2023 and will include a limited number of patients meeting the inclusion criteria.
“We can only hope to improve outcomes for patients with pancreatic cancer through research and the rapid translation of results from the laboratory to the clinic. Our purely translational research model enables us to develop and evaluate novel therapeutic strategies in combination with other therapies in clinical trials toward improving the survival of our patients,” concludes Teresa Macarulla.
