On July 27, 2023 Peptomyc S.L., a biotech company specialized in the development of protein therapeutics for cancer treatment, reported that it has received full study approval for its new Phase 1b clinical trial, which will evaluate the combination of the first-in-class MYC inhibitor, OMO103, together with the standard of care (SoC) regimen Gemcitabine and Nab-Paclitaxel in metastatic Pancreatic Ductal Adenocarcinoma (PDAC) patients in first line (Press release, Peptomyc, JUL 27, 2023, View Source [SID1234633483]). PDAC is the most common form of pancreatic cancer. Currently, it is the fourth highest cause of cancer mortality worldwide and its incidence is rising steeply. Current therapies offer limited chance of a lasting cure and the five-year survival rate is one of the lowest among the most commonly occurring cancers.
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MYC is an oncoprotein deregulated in most –if not all- types of cancers. It is activated in many PDAC cases, where it contributes to aggressiveness of the disease and resistance to treatments. The company recently completed a FIH Phase 1 study of OMO103 in all-comers solid tumor patients, demonstrating excellent safety and promising anti-tumor activity.
Manuela Niewel, MD, PhD, 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 1b study in PDAC patients. With OMO-103, we hope to address this devastating disease and one of the highest unmet medical needs in the oncology field".
This Phase 1b combination study will be conducted in four sites in Spain. The lead PI will be Dr. Teresa Macarulla at the Vall d’Hebron Institute of Oncology in Barcelona, and she will collaborate 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 start in Q3/2023.