LIDDS AB (publ) announced that the next step in the development of NanoZolid®-formulated docetaxel (nanodotax) will be to conduct a short clinical study to understand the immunological effects observed in the Phase I clinical study NZ-DTX-001. In the NZ DTX-001 study, activation of systemic inflammatory biomarkers was observed, which can provide improved conditions for treatment with so-called checkpoint inhibitors and result in treatment effect in non-injected tumors. In the clinical phase I study with nanodotax, which ended in October 2021, an activation of systemic inflammatory biomarkers was observed, which may open up the possibility of a combination therapy with so-called checkpoint inhibitors in cancer immunotherapy.

Clinical studies have shown that systemically administered docetaxel significantly improves the response to treatment with checkpoint inhibitors. If LIDDS can show a similar effect with locally administered nanodotax but without systemic side effects, which risk inhibiting the specific immune response against the tumors, both improved efficacy and safety could be achieved. LIDDS has shown in preclinical studies that locally administered nanodotax has as good effect as systemically administered docetaxel but without systemic side effects.

In order to provide a better foundation for decision-making in the clinical development of nanodotax, LIDDS has chosen to take over the sponsorship of the previously approved investigator driven trial on prostate cancer patients. The study provides an important analysis opportunity of the immunological response as the included patients will have their prostate surgically removed, which can be analyzed in detail. The study is planned to be conducted at one clinical site and is expected to include ten patients.