The first clinical trial of Omomyc against cancer proves its safety and anti-tumor activity – La Manyana

The first clinical trial of Omomyc against cancer proves its safety and anti-tumor activity – La Manyana

The results of the first phase of the clinical trial of Omomyc (OMO-103) showed that the new drug is safe and has anti-tumor activity. Thus, in some patients, it is able to stabilize or even reduce the disease. Omomyc, developed at the Vall d'Hebron Institute of Oncology (VHIO) through its spin-off Peptomyc, targets the MYC oncogene, which is dysregulated in the vast majority of tumors but until recently considered therapeutically inaccessible. In this trial, 22 patients with various types of advanced metastatic cancer participated, who, after receiving between two and twelve lines of treatment, had no other treatment options. The results were published in the journal Nature Medicine.

The study also allowed the identification of two potential blood biomarkers that could be useful in managing the disease through liquid biopsy. A phase 1 clinical trial of Omomyc in combination with standard therapy in patients with metastatic pancreatic cancer is currently underway as researchers test the validity of these biomarkers.

Omomyc is a small therapeutic protein developed thanks to more than 20 years of work by Dr. Laura Soucek, Director of the Experimental Therapies Program and President of the VHIO Antitumor Therapies Modeling Group. ICREA Professor Soucek is the co-founder of the spin-off Peptomyc, which showed at the preclinical stage in the laboratory that the protein is able to enter cells and reach the nucleus, where the MYC oncogene is located. Once in the nucleus, Omomyc blocks MYC's ability to promote tumor growth.

The first human trial of Omomyc began in 2021, led by Dr. Elena Garalda, Director of the Molecular Cancer Therapy Research Unit (UITM) – CaixaResearch del VHIO, in collaboration with two hospitals in Madrid (Fundació Jiménez Díaz and HM CIOCC). The goal is to check if there are early signs that the cancer is under control. The patients who participated in the study had different types of advanced metastatic solid tumors.

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The researchers emphasize that the drug has been shown to be “very well tolerated by patients, with few mild side effects such as chills or nausea,” and that through very low doses, they have already verified clinical benefits. In 8 of the 12 patients who underwent CT scans after nine weeks of treatment, the researchers observed “stabilization of the disease as tumor growth stopped.”

Dr. Garalda, first author of the article along with Dr. Marie-Eve Beaulieu, scientific coordinator of Peptomyc, highlights the case of a patient with pancreatic cancer who participated in the study for more than six months. The diameter of the tumor was reduced by 8% and there was an 83% reduction in tumor-derived DNA circulating in the bloodstream. In this case, they also analyzed the reduction in the total volume of all the patient's metastases in collaboration with VHIO's Radiomics group and found that it was reduced by 49%. For the researchers, this is a “hopeful finding for a malignant tumor.”

The study also includes a patient with sarcoma, who responded very poorly to previous treatments and remained stable for 8 months, and a patient with a salivary gland tumor, who remained stable for 26 months.

“Since this is the first time this drug has been used in humans, one of our goals was to demonstrate that it indeed has an effect on a MYC target as well as to identify potential biomarkers,” explains Dr. Sosek. The goal now is to continue researching MYC's anti-tumor activity in order to find combinations with other already approved drugs that allow creating synergies and increasing the effectiveness of treatments against different types of cancer.

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