On December 21, 2020 Peptomyc S.L., a biotech company specialized in the development of protein and peptide therapeutics for cancer treatment, reported that it has officially transitioned from pre-clinical to Clinical Stage, having filed its first Clinical Trial Application in Europe (Press release, Peptomyc, DEC 21, 2020, View Source [SID1234573128]). The company has recently completed the pre-clinical safety studies for its first-in-class MYC inhibitor, OMO103. MYC is an oncoprotein deregulated in most –if not all- types of cancer. Accordingly, OMO103 has demonstrated potent anti-tumor activity in multiple preclinical models of cancer, and is now ready to be tested in Phase I/II clinical studies. The treatment of the first patient with is expected to start in Q1, 2021.
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Manuela Niewel, MD, PhD, as Chief Medical Officer of the company, will assume the responsibility for leading Peptomyc’s clinical development, regulatory and medical affairs activities. "I am really excited about this important step and look forward to seeing OMO103 successfully acting in patients", Dr. Niewel says. " With OMO-103, we will address three major unmet medical needs in the oncology field: Non-Small-Cell Lung Cancer, Triple Negative Breast Cancer, and Colorectal Cancer.
The Phase I dose-escalation will start in three Spanish sites and later, in Phase II, we will expand the study to additional European sites".
Marie-Eve Beaulieu, PhD, co-founder and Chief Scientific Officer of Peptomyc adds: "The demonstration of our product’s quality, safety and stability, clearly represents a key milestone in our efforts to develop potentially life-saving cancer drugs. We are definitely thrilled to continue advancing Myc inhibition towards marketing approval".