On August 24, 2020 In a mouse model for breast cancer, Spago Nanomedical AB (publ)reported that has shown that Tumorad statistically significantly reduces tumor growth and prolongs survival (Press release, Spago Nanomedical, AUG 24, 2020, View Source [SID1234563961]). Based on this and previously communicated progress in the project, the company has decided to appoint a product candidate ("candidate drug") and prepare the preclinical safety tests with Tumorad that are required before patient studies can begin.
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"This is an important step for the company and for Tumorad’s path to becoming part of the treatment arsenal against cancer. We are now entering the regulatory development phase with our second project and thus show the strength and breadth of our unique platform that has the potential to improve cancer care in several ways, "says CEO Mats Hansen.
Tumorad has previously shown good accumulation in tumors and a distribution and excretion profile that supports use in humans. The new study shows that Tumorad loaded with the isotope lutetium-177 (Lu177) delays tumor growth and prolongs survival in mice with aggressive breast cancer compared to the control group.
The product candidate, who has been named SN201, is now moving on to clinic-preparatory preclinical dosimetry and toxicology studies. The study program is designed in accordance with guidelines from the EMA and the FDA, as well as after discussion and advice with the Medical Products Agency. Next, internal production of materials for the regulatory program is carried out and, in parallel, the transfer of the production process to a contract manufacturer (CMO) for the production of SN201 on a larger scale before clinical studies begins. The goal is to start phase 1 in patients with cancer by 2022.
The clinical need for new types of cancer treatment is great. Tumorad is being developed as a new type of radionuclide therapy for the treatment of cancer, in which tumors are radiated locally inside the body. Because the material accumulates in fast-growing tumors, the treatment has the potential to reach both aggressive and disseminated tumors. It is judged to be able to treat tumors alone or in synergy with other types of therapies. The project is protected by approved patents in several strategically important regions, including the United States, the European Union, and Japan.