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The biotechnology company SOTIO Biotech, which belongs to the PPF group, announced on Wednesday the interim results of an ongoing clinical study called AURELIO-03 phase 1 / 1b, which focuses on the safety and efficacy of its medicinal product SOT101.
In patients, there was a partial regression of the tumor, but also long-term stabilization of the disease or complete disappearance of tumor foci.
The results were presented by Dr. Stephane Champiat from the Gustav Roussy Institute of Oncology in Paris at the most important conference of the American Cancer Research Association (ACCR), where experts in the field of research and development of new methods of cancer treatment meet.
SOT101 is a preparation based on the protein interleukin 15, which stimulates white blood cells to kill tumor cells. It focuses on skin and kidney tumors. In immunooncology, it is a promising therapeutic substance, which also combines well with established oncological drugs.
The substance stimulates the immune system by activating white blood cells, which then kill the tumor cells – mainly T-lymphocytes or NK cells. The so-called T-lymphocytes are white blood cells that are important for the immune system, which can kill tumor cells, and NK cells are also cells of the immune system that develop in the bone marrow.
In addition to the administration of SOT101 alone, the AURELIO-03 study also evaluates its combination with pembrolizumab (a humanised monoclonal antibody) in patients with advanced tumors. The study showed that the combination of these medicines was beneficial in 12 of 16 patients, including those who did not take the checkpoint inhibitors (CPI).
In the future, patients who do not have other treatment options could benefit from its ability to strengthen the body’s innate and adaptive immune response to cancer.
“The results of SOT101 in combination with pembrolizumab and its efficacy as monotherapy in the autumn demonstrate the great potential of interleukin 15 in immunooncology,” says Dr. Stephane Champiat from the Drug Development Department of the Gustav Roussy Institute of Oncology and the coordinating physician of the AURELIO-03 clinical trial.
“Patients who do not have other treatment options could benefit from its ability to strengthen the body’s innate and adaptive immune response to cancer in the future. Personally, I am very much looking forward to progress in the next stages of clinical development, “says Champiat.
Patient safety data indicate that SOT101 in combination with pembrolizumab was well tolerated and most of the adverse reactions were not serious. Based on the results of the study, the recommended dose for the next phase two clinical study was also determined.
“Dosage level settings for the Phase 2 clinical trial and demonstration of safety and efficacy in combination with pembrolizumab in Study AURELIO-03 were a key clinical milestone for Sotio in the development of our SOT101,” says prof. Radek Špíšek, CEO of Sotio.
Another study in cooperation with a renowned company
Efficacy data will provide the basis for further evaluation in the follow-up clinical trial AURELIO-04, which evaluates the efficacy and safety of SOT101 in combination with pembrolizumab in patients with six types of advanced tumors. The study will be conducted in cooperation with the American company Merck & Co. (MSD), which is one of the largest and oldest pharmaceutical companies in the world. The study is expected to begin during the second quarter of 2022.
Sotio is an international biotechnology company that oversees research and development of new anticancer drugs. In addition to the results of the AURELIO-03 study, it presented data from the testing of SOT201 and BOXR1030 products at this year’s AACR conference. Both products have shown promising antitumor efficacy in laboratory tests.
“At this year’s AACR, we presented the results of our preclinical studies with SOT201 and BOXR1030 to scientists and experts from around the world for the first time. These two other anticancer drugs should enter the clinical phase this year, “added Špíšek.
In the case of SOT201, it is a substance that combines SOT101 and a so-called checkpoint (PD-1) inhibitor. BOXR1030 is the company’s flagship project on CAR-T cell therapies for solid tissue tumors. This therapy is prepared for each patient separately and uses his own immune system. Laboratory-treated white blood cells (T-cells) are returned to the patient’s body in the form of an injection, where they find the tumor cells and destroy them.