nanoimod (NZ-IO-TLR9) / Lidds - LARVOL DELTA

LIDDS Interim report January – March 2021 (GlobeNewswire) - "JANUARY – MARCH 2021...Net sales amounted to MSEK 0.6 (0.0); New patients were recruited to the dose escalation part of the Phase I study NZ-DTX-001 where intratumoral injection of NanoZolid® in combination with docetaxel is being evaluated; The scientific journal European Urology Focus has accepted a scientific article describing LIDDS Phase IIb study results with Liproca® Depot; LIDDS has signed a manufacturing agreement for NZ-TLR9 with Pharmidea in Latvia; LIDDS has signed an R&D agreement with Johnson & Johnson Enterprise Innovation Inc. to develop an oncology product based on the NanoZolid® technology; LIDDS Chinese license partner, Puheng Pharma, informed that an international phase III multicenter study will be required, prior to market registration for Liproca Depot. Puheng Pharma will therefore not apply for Conditional Market Approval (CMA)."

Clinical • Enrollment status • Licensing / partnership • Sales • Oncology • Solid Tumor

LIDDS and Pharmidea signs manufacturing agreement (GlobeNewswire) - “LIDDS…announced today that a collaboration agreement has been signed with the R&D and Production company PharmIdea…The collaboration enables LIDDS to expand the manufacturing of new product candidates, e.g. including biomolecules and cytostatics, in addition to the already existing collaboration with Recipharm for Liproca Depot…LIDDS is preparing a clinical Phase I trial with intratumoral injections of NZ-TLR9 for treatment of solid tumors in patients with head/neck-, breast cancer, melanoma, sarcomas and lymphomas.”

Licensing / partnership • Trial status • Breast Cancer • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Melanoma • Oncology • Sarcoma • Solid Tumor

LIDDS Interim report January – September 2020 (GlobeNewswire) - "SIGNIFICANT EVENTS DURING THE THIRD QUARTER 2020...In the phase I trial where NanoZolid® is combined with docetaxel for the treatment of solid tumours, the dose escalation programme is ongoing. Since last summer, 1.5 ml of NZ-DTX has been administered intratumorally and all patients treated thus far have tolerated the treatment well....The preclinical programme for NZ-TLR9 has been completed with very positive results regarding tumour control and survival. The results confirm a depot effect from NZ-TLR9 for at least six weeks, which corresponds to the clinical need. Important immune markers have been identified ahead of the phase I trial, which is scheduled to commence in 2021."

Preclinical • Trial status • Oncology • Solid Tumor

A review article defines LIDDS as a key player in TLR9 agonist research field and being the only provider having a sustained release product in development (GlobeNewswire) - "'Repeated intratumoral injections are needed using standard formulations and our goal is to expand the commercial potential for TLR9 agonists as the NanoZolid® technology can offer fewer injections to reduce the burden on both patients and the healthcare system. It is especially interesting to see that LIDDS is the only provider in the list of active companies that can offer a TLR9 agonist depot with a sustained release'...LIDDS is preparing to initiate a Phase I study in 2021 to assess safety, tolerability and tumor effects when injecting NZ-TLR9 into solid tumors."

Clinical • New P1 trial • Oncology • Solid Tumor