The company has decided to formally appoint candidate drug and prepare the preclinical safety program with Tumorad required in preparation for clinical trials.
Spago Nanomedical has demonstrated, with statistical significance, that Tumorad reduces tumor growth and extends survival in a mice model for breast cancer. Based on this result and previously communicated progress in the project, the company has decided to formally appoint candidate drug (“CD”).
”This is an important step for the company and for Tumorad on its way to becoming an integral part of the treatment arsenal against cancer. It also marks the entry of our second project in regulatory development, which underlines the strength and scope of our unique platform that holds potential to improve cancer care in several ways,” says Spago Nanomedical’s CEO Mats Hansen.
Progressing towards preclinical dosimetry and toxicology studies
Tumorad has previously shown good accumulation in tumors and a distribution and excretion profile that supports use in humans. The current study confirms that Tumorad loaded with the isotope lutetium-177 (Lu177) significantly delays tumor growth and prolongs survival in mice with aggressive breast cancer compared with the control group.
The candidate drug, designated SN201, is now progressing towards preclinical dosimetry and toxicology studies. The study program is designed in concordance with EMA and FDA guidelines and following discussion and scientific advice with the Swedish MPA. Internal production of material for the regulatory program will now commence, and in parallel, a technology transfer of the manufacturing process to a CMO will be initiated to facilitate larger-scale production of SN201 for clinical studies. The aim is to start clinical trials in 2022.
A clinical need
There is major clinical need for new types of cancer therapies. Tumorad is developed as a novel type of radionuclide therapy for treatment of cancer, allowing tumors to be locally irradiated inside the body. As the material accumulates in fast-growing tumors, the treatment has potential to target both aggressive and metastatic tumors. It may be used for tumor treatment alone or in combination with other types of therapies. Patent protection is granted in several strategically important regions, including the USA, the EU, and Japan.
Illustration Tumorad: Emil Aaltonen