Peptomyc’s Omomyc as the first MYC-targeted therapy to successfully complete a phase I clinical trial

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Omomyc (OMO-103) is a therapeutic mini-protein developed by Peptomyc SL, a spin-off company by the VHIO and Catalan Institute of Research and Advanced Studies’ (ICREA), which was co-founded by Laura Soucek in 2014. Having previously shown the preclinical efficacy and safety of this novel cell-penetrating mini-protein in mouse models, Laura Soucek’s team successfully developed anti-MYC peptides for the treatment of several tumor types, the first of which, OMO-103, now shows promise in becoming the first ever clinically viable and direct inhibitor of MYC – a protein implicated in driving and maintaining cancer.

They enrolled 22 patients to a phase I clinical trial in April 2021 to determine the safety, tolerability, pharmacokinetics and pharmacodynamics, and proof-of-concept of OMO-103. These heavily pre-treated patients had a range of solid tumors including pancreatic, bowel, and non-small cell lung cancers, and had received at least three prior lines of therapy. Results of the CT scans of the 17 evaluable patients showed that 8 had stable disease, with the treatment having halted tumor growth.

“While it is still very early days to assess the activity of Omomyc, we are observing stabilization of disease in some patients. Notably, one patient with pancreatic cancer remained on the study for more than six months and his tumor shrank by eight per cent with an eighty-three per cent decrease in the quantity of circulating tumour DNA in the bloodstream,” said Elena Garralda, Principal Investigator of VHIO’s Early Clinical Drug Development Group and first author of this present study that was carried out in collaboration with two other Spanish sites.

“For many years this cancer-causing protein has been thought to be undruggable. OMO-103 is the first MYC inhibitor to successfully complete a phase I clinical trial and is ready to move to a phase II study over the coming weeks. This is a remarkable achievement considering that MYC is one of the most sought-after drug targets in cancer,” added Laura Soucek, an ICREA Research Professor, co-founder and Chief Executive Director of Peptomyc SL.

She concluded, “Based on these preliminary data, we have reason to be optimistic that Omomyc-based therapy will continue to step up in more effectively treating several different tumor types and ultimately improve patient outcomes.”


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