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Worldwide Clinical Trials - Oncology

Peptomyc Receives Approval for Phase 1b Trial Testing OMO-103 in Combination with Standard of Care for PDAC Patients

Friday, July 28, 2023

Peptomyc S.L. is a specialized biotech company dedicated to developing protein therapeutics for cancer treatment. The company has received full approval for its Phase 1b clinical trial, which aims to evaluate the combination of OMO103, a groundbreaking MYC inhibitor, with the standard of care (SoC) regimen Gemcitabine and Nab-Paclitaxel in first-line treatment for patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC). PDAC is the most common form of pancreatic cancer and ranks as the fourth leading cause of cancer-related deaths worldwide. Unfortunately, the available therapies for PDAC offer limited chances of a lasting cure, leading to one of the lowest five-year survival rates among common cancers.

The MYC protein is a known oncoprotein that is deregulated in most, if not all, types of cancers, including PDAC. It plays a significant role in driving the aggressiveness of the disease and contributing to its resistance to treatments. Peptomyc recently completed a Phase 1 study of OMO103 in solid tumor patients, which showed promising anti-tumor activity and excellent safety.

Dr. Manuela Niewel, Chief Medical Officer of Peptomyc, is leading the company's clinical development, regulatory, and medical affairs activities. She expressed her excitement about starting the Phase 1b study in PDAC patients with OMO-103, as it addresses a critical unmet medical need in the field of oncology.

The Phase 1b combination study is set to take place at four sites in Spain. Dr. Teresa Macarulla at the Vall d'Hebron Institute of Oncology in Barcelona will be the lead principal investigator, collaborating with Dr. Andres Muñoz at the Hospital Gregorio Marañon in Madrid, Dr. Mariona Calvo at the ICO-Hospitalet in Barcelona, and Dr. Roberto Pazo at the Hospital Miguel Servet in Zaragoza. The study is planned to commence in the third quarter of 2023.

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