UPPSALA, SWEDEN – LIDDS AB (publ) announced today 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 (abscopal effect).

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.

“Based on the exciting activation of immunoregulatory molecules we saw in the Phase I study, it is important to confirm the mechanism of action of nanodotax. The increased understanding of the mechanism will more promptly lead us to the right form of treatment and patient group. The results may possibly also pave the way for more effective combination treatments, which is considered crucial for the commercial positioning of nanodotax and it justifies a further study” said Nina Herne, CEO of LIDDS.

In December 2021, LIDDS announced the top-line data of the clinical Phase I study NZ-DTX-001. It was demonstrated that NanoZolid® in combination with docetaxel was safe and well tolerated, reaching the primary endpoint of the trial. The data also showed that the systemic docetaxel exposure was low and that activity in injected lesions was observed. Patients receiving docetaxel showed activation of systemic inflammatory biomarkers that are considered important for efficient recruitment and activation of immune effector cells and for creating a good environment for treatments with immune-modulating drugs such as check-point inhibitors.

For more information, please contact:

Nina Herne, CEO, Phone: +46 (0)70-714 74 57, Email: nina.herne@liddspharma.com

The information was submitted for publication, through the agency of the aforementioned contact person, on February 21, 2022 at 16.30 CET.

LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology NanoZolid®. NanoZolid® is a clinically validated drug development technology and superior in its ability to provide a controlled and sustained release of active drug substances for up to six months. LIDDS has licensing agreements where NanoZolid is combined with antiandrogens and in-house development projects in clinical and preclinical phase for cytostatics and immunoactive agents. LIDDS (LIDDS) shares are listed on Nasdaq First North Growth Market. Redeye AB, certifiedadviser@redeye.se, +46 (0)8 121 576 90, is a certified adviser to LIDDS.  For more information, please visit www.liddspharma.com.