The Omomyc drug developed at the Vall d’Hebron Institute of Oncology (VHIO) through its spin-off Peptomyc, has demonstrated its efficacy and safety in fighting cancer in the first phase of a clinical trial in which 22 patients have participated . Specifically, this therapeutic mini-protein is capable of inhibiting the action of the MYC gene – which is involved in the progression of many tumors – and stabilizing the disease.
Dr. Laura Soucek, co-director of the Translational and Preclinical Research Program and head of the VHIO Antitumor Therapies Modeling Group had already shown in laboratory tests that Omomyc (or OMO-103) can enter cells and reach its nucleus, where the MYC oncogene is found, and, once there, inhibit MYC’s ability to promote the growth of cancerous tumors.
The results of the phase I trial by Dr. Elena Garralda, director of the Molecular Cancer Therapy Research Unit (UITM)-CaixaResearch of the VHIO, have been presented at the international symposium on clinical trials ENA2022 organized by the main associations of cancer research from both sides of the Atlantic: the European Organization for Cancer Research and Treatment (EORT), the US National Cancer Institute (NCI) and the American Association for Cancer Research (AACR) , which is being held at the Barcelona International Convention Center (CCIB) and in which 1,500 international experts are taking part.
Slows tumor progression and increases patient survival
In cancer treatment research, it has been sought how to neutralize the MYC oncogene because it is involved in the growth of many tumors, therefore, although current research has only successfully passed the first phase of testing with human beings and three before a drug is approved and marketed, but it is the first time that a drug targeting MYC has performed well in a phase I clinical trial, opening up a hopeful avenue for advancing cancer treatment.
In a pancreatic cancer patient who remained in the study for more than six months, the tumor shrank by 8% and there was an 83% reduction in tumor-derived DNA circulating in the bloodstream
“MYC is one of the most sought-after targets in cancer because it plays a key role in driving and sustaining many common human cancers, such as breast, prostate, lung and ovarian cancer, and to date, it has not been no drug that inhibits it has been approved for clinical use”, pointed out Dr. Garralda.
Patients included in the trial had a variety of solid tumors, including non-small cell lung, bowel and pancreatic cancers, and had received at least three prior treatments. Eight of 12 patients who underwent CT scans after nine weeks of treatment had stable disease in which tumor growth had stopped.
“It is still too early to assess the activity of the drug, but we are seeing the stabilization of the disease in some patients. Of note is the case of a patient with pancreatic cancer who remained in the study for more than six months, and in whom the tumor shrank by 8% and there was an 83% reduction in tumor-derived DNA circulating in the bloodstream. There is also a patient with a salivary gland tumor whose disease remains stable and is still in the study after 15 months, and a patient with sarcoma, who had responded very poorly to previous treatments, who was stable for eight months.” explains Dr. Elena Garralda.
Regarding the adverse side effects associated with Omommyc treatment, they are generally mild, and the most common were mild reactions to the intravenous infusion, such as chills, fever, nausea, rash and hypotension. Dose escalation was associated with more infusion reactions, but these were easily treated.
“The most exciting thing is that the biological markers clearly show that we are successfully inhibiting MYC. Also, adverse side effects are mostly mild, which is important when we start thinking about the next steps and combining Omomyc with chemotherapy or other therapies”, adds Dr. Garralda.
“Omomyc is the first MYC inhibitor to successfully complete a Phase I clinical trial and is ready to move into a Phase II trial. This is a very important achievement as MYC is one of the most sought after targets in cancer treatment because it plays a key role in the development and maintenance of many common human cancers, and has not been approved for clinical use to date. no drug that inhibits MYC. This drug, developed at the VHIO, is the first mini-protein targeting MYC to be tested in a phase I trial and shows that it is capable of inhibiting the function of this oncogene in a safe and effective way”, concludes Dr. Garralda.
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