Leave cellular therapy without technology

Leave cellular therapy without technology

As it became known to Kommersant, the German Miltenyi Biotec, due to the situation in Ukraine, stopped supplying technologies and equipment for cellular therapy of patients with oncological diseases and bone marrow transplantation to Russia. This will have a particularly strong impact on the Rogachev Center, which has left three or four children with materials available for CAR-T therapy. The problem is exacerbated by the fact that it is difficult to find an alternative to retired techniques.

The fact that Miltenyi Biotec, due to hostilities in Ukraine, has stopped the supply of equipment and technologies to the Russian Federation, says CEO of Biocommersant (the company’s official distributor) Ivan Chistov. “Everyone is in shock, because so many patients and scientists are dependent on supplies,” he says. Miltenyi Biotec did not respond to Kommersant’s request.

The position will hit Dmitry Rogachev’s National Medical Research Center for Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev, which uses Miltenyi Biotec technologies to conduct CAR-T therapy among children.

The essence of this method is that T-lymphocytes are taken from the patient, reproduced, genetically modified, taught to recognize cancer cells using special proteins on the surface, and injected back into the patient. The Rogachev Center began transferring the Miltenyi Biotec technology in 2015, and in 2018 performed the procedure on the first patient.

Treatment is carried out in an experimental form: it is prescribed by decision of the medical board to patients with incurable forms of the tumor, when all possibilities have been exhausted. By August 2021, NMIC had treated more than 60 patients, 90% of whom were in remission, according to Mikhail Mashan, deputy director general of the Institute of Molecular and Experimental Medicine at the Rogachev Center, previously to Vademecum. On Wednesday, the NMIC did not respond to Kommersant’s request.

A Kommersant source close to the center confirmed that Miltenyi Biotec has halted deliveries, and materials remain available to treat three to four patients. According to him, NMIC, whose treatment is completely connected with Miltenyi Biotec technologies, will monitor the situation.

CAR-T therapy is also being tested in adult oncology.

Since 2018, such a project using Miltenyi Biotec technologies has been carried out by Petrov National Research Medical Oncology Center in Saint Petersburg together with Gorbacheva Institute of Children’s Oncology, Hematology and Organ Transplantation and Pavlov State Medical University. The Petrov National Research Center told Kommersant that the project had been temporarily put on hold due to logistical difficulties in delivering the equipment. However, they continue to develop CAR-T technology with the Institute of Molecular and Cell Biology of the Siberian Branch of the Russian Academy of Sciences, and expect to receive additional budget funding to complete the research.

Miltenyi Biotec also supplied bone marrow transplant equipment in Russia, notes Ivan Chestov. In addition, reagents were provided to “clean up” the implant, obtaining individual cell lines and cell products, adds Andrei Abrosimov, a medical expert from the Tinkoff family. According to him, the search for options for replacing Miltenyi Biotec equipment is a long process. Tatiana Jabunova, deputy director general of the National Research Center for Hematology, believes that Miltenyi Biotec equipment is not unique and an alternative can be found.

Some of the techniques presented by Miltenyi Biotec have been attempted to be developed at the Almazov National Research Center.

In 2021, the center announced that it would conduct preclinical trials of CAR-T lymphocytes. But little is known about the status of these developments. The center did not respond to Kommersant’s request. In addition, Swiss Novartis plans to introduce its commercial product CAR-T Kymriah to the Russian market. In the summer of 2021, the company submitted a file to register the drug in accordance with the rules of the Economic and Social Union. But these plans are also in question. In mid-March, Novartis also announced the suspension of investments in Russia, while maintaining supplies of essential medicines. The company left Kommersant’s question about Kymriah unanswered.

After the article was published, the Ministry of Health told the Kommersant newspaper that in Russia “in the near future” it will be possible to use its cellular technologies that are not based on foreign components. The project to establish a full production cycle of CAR-T is being carried out at the National Research Center of Hematology, and the clinical studies of CAR-T for the treatment of solid tumors will be carried out by the Russian Scientific Center for Radiology Roentgen. In addition, the federal project “Medical Sciences for Humans” provides for the creation of a production site with immersion of cellular technologies.

Polina Gritsenko

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