Disruptive biomarker platform for Antibody Drug Conjugates

Antibody Drug conjugates (ADCs) is an explosively growing class of anticancer therapeutics. The drugs in ADCs have to enter into the cancer cells. We have found the biological markers, the rab GTPase family of proteins, regulating the entering into the cells and thus the therapeutic outcome in each patient. The mail goal of the company Rab Diagnostics project is to develop an In vitro Diagnostic (IVD) technology platform, named RabCANCER, for better prediction of the therapeutic outcome of treatment with ADCs and thus provide better selection of patients for ADC treatment. In the Accelerator program a CE-marked kit, named Rab5BREAST-HER2, will be developed for better selection of patients for treatment with trastuzumab emtasine (T-DM1) for HER2+-breast cancer patients. Currently, the objective response is only approx. 40% based on only HER2 expression analyses, but can be substantially improved by utilizing the Rab5BREAST-HER2 kit. The development of the new kit, documenting the expression of rab proteins, will include standardization and quality control of all kit components and documentation of the final kits ability to provide better selection of patients for T-DM1 treatment. The project is already at TRL5 and the goal is to develop the Rab5BREAST-HER2 kit towards the market and TRL9. This is based on well established technologies that will be implemented through partnership with relevant partners and technology providers. Unforseen challenges with the kit development or collaborations with partners og technology providers cannot be completely excluded.