From year-end report, February 23, 2022
Lately, we have been making great progress in our projects. LIDDS has been able to report topline results from the NanoZolid formulated docetaxel (nanodotax) project. The results show that the systemic exposure of docetaxel after treating solid tumors with nanodotax is low and that activity in both injected lesions and in systemic inflammatory markers was observed. We are pleased to see that the treatment is safe and well tolerated and that the reported adverse events are generally mild and local. 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. We intend to submit data from the study for publication in a scientific journal. Based on the unexpected immunological findings in the phase I study it is important to further investigate the treatment mechanism of NanoZolid formulated docetaxel. We plan to do so in the study approved by the Swedish Medical Product Agency (MPA) in May last year investigating docetaxel in prostate cancer patients preoperatively.
We have also reached a key milestone in January 2022 when the R&D project with Johnson & Johnson Enterprise Innovation Inc. progressed into next phase. The aim is to develop an oncology product based on the NanoZolid technology for an undisclosed indication. We are very proud of this collaboration which is also increasing our know-how and experience on both sides. The project has now entered stage 2 of the feasibility program.
An important regulatory milestone achieved is the scientific advice given by the European Medicines Agency (EMA) on our Liproca Depot phase III study protocol. Overall, EMA agreed with our proposed study design including most importantly the primary endpoint being time to progression and to the suggested number of patients. The scientific advice given by EMA is a key regulatory validation of our clinical plans.
In parallel to moving our clinical projects forward, we have continued to set a new direction for the company strategically. Our projects must meet certain requirements to be included in our project pipeline. Projects must have a clear benefit regarding efficacy and safety while simultaneously being able to meet certain commercial requirements. It may seem obvious, but those criteria have been the guiding stars in the strategic revisit of our portfolio meaning that we have decided to focus on the most promising projects. We have also renamed our projects in development. We are eager to give a detailed presentation of our new strategy, vision, and update on our project portfolio on our upcoming Capital Market Day on the 9th of March 2022. Don’t miss it.
The efforts on making the move to Nasdaq’s main market are continuing. A part of that process, but also as a part of visualizing that LIDDS is taking the next phase in its development, has been to develop a new graphic look and content impacting on both the Year-end report and our website. Our new website will be launched shortly. Please visit liddspharma.com for further information.
We are also happy to welcome Matthew Lindon as Chief Scientific Officer from March 1. Matthew has over 20 years’ experience of drug discovery and development from the pharmaceutical sector and will be an important asset when developing LIDDS project portfolio. It is also with great pleasure we can announce that LIDDS has recruited a new Project Manager in Charlotta Grånäs Folkesson. Charlotta has a background as a Project Manager at biotechnology companies such as BioImage A/S and Vipergen ApS and as a scientist at the pharmaceutical company Novo Nordisk A/S in Denmark.
The team that will realize LIDDS vision of becoming a global drug delivery company are starting to come together. LIDDS will, through a small, efficient, and highly specialized organization, continue to focus on developing better and safer treatments with a high value. We started this year with a lot of progress and my colleagues, and I are looking forward to an eventful 2022.
Thank you for your continued support of LIDDS!
Uppsala, February 2022
Nina Herne, CEO