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RGSH4K is an autologous personalized therapeutic cancer vaccine developed by Regeneus for the treatment of advanced solid tumours.[2][4][18] The vaccine is manufactured individually from each patient’s own tumour tissue: tumour cells are lysed to release tumour proteins, which are chemically modified and coupled to the bacterial protein streptavidin to enhance immunogenicity, and then combined with a proprietary immunostimulant adjuvant.[5][11] Administered intradermally, RGSH4K is designed to stimulate a systemic, durable anti-tumour immune response by activating and priming immune cells against the patient’s tumour antigens, aiming to induce immune memory capable of controlling both existing and future metastases.[1][4][10][11] The Phase 1 ACTIVATE trial in heavily pretreated patients with various advanced solid tumours demonstrated that RGSH4K was safe and well tolerated at all evaluated doses, with injection site reactions as the most common related adverse event and early signals of immune activation and potential anti-tumour activity.[2][4][6][15][16]
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