First Russian Targeted Therapy Drug to Undergo Clinical Studies

The Russian Ministry of Healthcare has issued a permit to conduct a clinical study of the safety and preliminary efficacy of alofanib, the first Russian targeted therapy drug. Alofanib will be studied in patients with gastric cancer who have exhausted all standard treatment methods.

The company behind alofanib is St.Petersburg-based Rusfarmtech. It has created the innovative drug in Russia with support from the Skolkovo Foundation. Alofanib is the world's first allosteric inhibitor of fibroblast growth factor receptor 2 (FGFR2).

Many cancer cells, including those of gastric cancer, contain the FGFR2 receptor on their surface. When it is activated, cell division, tumor growth and the spread of metastases occur. Unlike existing inhibitors working inside the cell, alofanib blocks the exracellular domain of the receptor and twists it to prevent its activation. Such a mechanism allows the receptor to be influenced regardless of the appearance of various FGFR isoforms and mutations that make the cell resistant to therapy. This mechanism of action has been recognized as innovative and patented by Ruspharmtech in Russia, the EEU countries, the USA, the European Union, Japan and China.

Preclinical results published in European Journal of Cancer, Medicinal Chemistry, and Investigational New Drugs, indicate the need for a clinical study of the drug. Currently, an extended phase 1b clinical study is initiated in patients with metastatic gastric cancer. The study will be conducted in Moscow, St. Petersburg, Omsk, and Rostov-on-Don.

“Gastric cancer is a major medical and social problem in Russia,” says Professor Sergey Tylyandin, chairman of the Russian Society of Clinical Oncology, deputy director for research at the Blokhin  Oncology Center. “In the disease distribution chart, it is the fourth and sixth most common type of cancer in men and women, respectively. Each year, more than 37,000 new cases of gastric cancer are recorded. Unfortunately, with the appearance of metastases, treatment options are extremely limited and the life expectancy of these patients is about one year.”

Rusfarmtech was founded in April 2012 by a group of scientists to discover, study and commercialize new drugs and innovative technologies for their production. The company's first and key project was the development of alofanib, an allosteric inhibitor of type 2 fibroblast growth factor receptor. Since 2012, the company has been a resident of the Skolkovo Foundation. Preclinical studies have been conducted with grant support from the Foundation. 

Skolkovo actively supports the development of targeted therapy drugs that affect specific parts of cancer cells, says Kirill Kaem, senior VP of innovations at the Skolkovo Foundation.

“The emergence of new classes of inhibitors can lead to dramatic changes and improve the life expectancy of patients. It is already happening in patients with lung cancer, breast cancer, kidney cancer and other tumors. The first Russian targeted drug alofanib has successfully completed the cycle of extended preclinical studies in accordance with international requirements and will be studied at the first stage in patients with gastric cancer. The grant committee of the foundation has decided to further support the project.”


22 may 2019