Peptomyc announces Research IND Approval for Innovative Window of Opportunity Trial in Collaboration with OHSU Knight Cancer Institute, Portland, Oregon, USA, in PDAC patients

On December 9, 2024 Peptomyc reported the approval of a Research Investigational New Drug (IND) application for a groundbreaking Window of Opportunity trial in collaboration with Oregon Health & Science University (OHSU) Knight Cancer Institute and Brenden-Colson Center for Pancreatic Care (BCCPC) (Press release, Peptomyc, DEC 9, 2024, View Source [SID1234648991]). This trial will evaluate the pharmacodynamic effects of OMO-103 in patients with pancreatic ductal adenocarcinoma (PDAC). The study aims to expedite drug development, improve understanding of pharmacodynamic parameters, and identify biomarkers for better patient selection.

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Dr. Manuela Niewel, Chief Medical Officer at Peptomyc, stated, "This collaboration with OHSU Knight Cancer Institute and BCCPC represents a significant step forward in our mission to develop more effective, personalized cancer treatments. The Window of Opportunity trial design allows us to gather crucial data on our investigational compound, potentially accelerating the drug development process."

This partnership combines Peptomyc’s expertise in anti-MYC mini-proteins (namely the investigational drug OMO-103) with OHSU’s state-of-the-art research facilities and multidisciplinary approach to cancer treatment.

"We are excited to collaborate with Peptomyc on this important trial," said Dr. Charles Lopez, Principal Investigator at OHSU Knight Cancer Institute and BCCPC. "By conducting this study, we hope to gain valuable insights that will ultimately lead to improved outcomes for cancer patients."

The trial is expected to begin enrollment in March 2025 and will focus on ≥18-year-old patients with advanced PDAC.

About PDAC

PDAC is an aggressive form of cancer with a poor prognosis and increasing incidence. It accounts for over 85% of all solid pancreatic tumors. The 5-year relative survival rate is only about 11% for all stages and 3% for metastatic disease. PDAC is characterized by late detection and particularly aggressive biology, which contribute to its dismal outcomes. Surgical resection followed by adjuvant chemotherapy is the only potentially curative treatment, but it is only possible for 10-20% of patients.

Given these challenges, PDAC remains a critical area for oncological research and innovative treatment approaches.

About MYC

MYC is the most dysregulated oncogene in human cancer, controlling multiple transcriptional programs associated to most hallmarks of cancers, including increased proliferation, metastatic potential, immune suppression and resistance to treatment.

About OMO-103

OMO-103 is a first-in-class and best-in-class mini-protein against MYC. It has successfully been tested in a Phase Ia study in all-comers solid tumors and is currently in a Phase Ib study in metastatic PDAC patients in combination with standard of care chemotherapy.