nanodotax (NZ-DTX) / Lidds - LARVOL DELTA

LIDDS Next Step with NanoZolid formulated docetaxel (GlobeNewswire) - "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)."

New trial • Oncology • Solid Tumor

NZ-DTX-001: Intratumoural Injection of a Novel NanoZolid®-Docetaxel Depot Formulation in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1a/1b; N=6; Terminated; Sponsor: Lidds AB; N=28 ➔ 6; Trial completion date: Sep 2022 ➔ Oct 2021; Recruiting ➔ Terminated; Trial primary completion date: Sep 2022 ➔ Oct 2021; Strategic decision

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

LIDDS announces positive topline results from the phase I dose-escalating study of NanoZolid-formulated docetaxel (GlobeNewswire) - P1, N=28; NZ-DTX-001 (NCT04810208); Sponsor:Lidds AB; "LIDDS AB...announced today that the systemic exposure of docetaxel after treating solid tumors with NanoZolid®-docetaxel is low and that the study demonstrated activity in both injected lesions and in systemic inflammatory markers.It was demonstrated that NanoZolid® in combination with docetaxel was safe and well tolerated, reaching the primary endpoint of the trial. After further analysis it is also concluded that the systemic NanoZolid®-docetaxel exposure is low and that activity in injected lesions is observed. Patients receiving docetaxel showed activation of systemic inflammatory biomarkers including IFN-gamma, CXCL9 and CXCL10. These molecules 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."

P1 data • Oncology • Solid Tumor

LIDDS patent covering the NanoZolid production process granted in Russia and Australia (GlobeNewswire) - "LIDDS AB...announces today that its most recent patent family on the NanoZolid® production process, and hence achieved pharmaceutical products, has been granted in Russia and Australia. The patent provides protection until 2037 in these markets....LIDDS has received patent approvals in Russia (patent no. 275334) and Australia (patent no. 201734489)."

Patent • Oncology

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

Prostate cancer study to be initiated at Uppsala University Hospital with NanoZolid technology (GlobeNewswire) - "LIDDS...LIDDS AB (publ) announced today that an application for a new clinical study at Uppsala University Hospital has been submitted. The study will assess intratumoral injections of NZ-DTX Depot, containing the cytotoxic agent docetaxel, in men with prostate cancer who are scheduled for prostatectomy....The study is planned to start in mid of this year and it will enroll 10- 15 patients to be treated with NZ-DTX prior to planned surgery."

New trial • Genito-urinary Cancer • Oncology • Prostate Cancer

Intratumoural Injection of a Novel NanoZolid®-Docetaxel Depot Formulation in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1a/1b; N=28; Recruiting; Sponsor: Lidds AB

Clinical • New P1 trial • Oncology • Solid Tumor

LIDDS files patent application for method to treat brain cancer with intratumoral depot injections (GlobeNewswire) - "LIDDS AB (publ) announced today that a patent application related to NanoZolid® for treatment of brain cancers was filed to the European patent office. The patent application relates to a method to treat brain cancer with intratumoral depots providing a controlled drug release at the tumor site."

Patent • Brain Cancer • Oncology • 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

Additional patients treated in LIDDS clinical study NZ-DTX-001 (GlobeNewswire) - "LIDDS AB (publ) announces that the dose escalation in the Phase I study NZ-DTX is proceeding according to the protocol, with additional patients being treated at a higher dose level of NZ-DTX at the Vilnius National Cancer Institute and the Kaunas University Hospital, Lithuania. Three sites are now actively recruiting in the study, where NanoZolid® combined with docetaxel is administered as an intratumoral injection in patients with solid tumors."

Enrollment open • Trial status

LIDDS announces positive preclinical data for NanoZolid-TLR9 agonist project (GlobeNewswire, LIDDS AB) - “LIDDS AB (publ) has performed preclinical studies using a TLR9 agonist formulated with NanoZolid® (NZ-TLR9) showing that a single NZ-TLR9 injection is reducing tumor growth and improves the survival rate. The in vivo efficacy is as good as with repeated injections of the standard TLR9 agonist. The pharmacokinetic analysis of treated tumors has confirmed the depot function of NZ-TLR9. Clinical data have shown that intratumoral delivery of TLR9 agonists can effectively treat solid cancers…The first human study is planned to start in 2021.”

Preclinical • Trial initiation date

LIDDS: Second patient treated in the Phase I study, NZ-DTX-001 (GlobeNewswire, LIDDS AB) - “The National Cancer Institute in Vilnius, Lithuania, has enrolled and dosed their first patient. The aim of the phase I dose escalation clinical trial is to assess the tolerability and safety of intratumoral injections of NanoZolid® with docetaxel, a well-established cytostatic used in the treatment of cancer with an estimated global market of over USD 1 billion.”

Clinical • Enrollment open

LIDDS adds Lithuanian clinics to phase I study (GlobeNewswire, LIDDS AB) - " LIDDS AB (publ) has received approval from authorities in Lithuania to conduct its Phase I study, NZ-DTX-001. The aim of the phase I dose escalation clinical trial is to assess the tolerability and safety of intratumoral injections of NanoZolid® with docetaxel, a well-established cytostatic used in the treatment of cancer with an estimated global market of over USD 1 billion. LIDDS enrolled the first patient in spring and further patients are planned to be treated in Q4, 2019."

Clinical • Enrollment status • New trial

LIDDS: First patient receives intratumoral NanoZolid®-docetaxel in Phase I study (GlobeNewswire, LIDDS AB) - The first patient has now been enrolled in the Phase I NanoZolid®-docetaxel study where NanoZolid® combined with docetaxel will be injected into solid tumors. The first part of the Phase I study (NZ-DTX-001) will enroll patients for dose escalation after which patients will be treated intratumorally at a fixed dose to confirm tolerability. The primary objective is to study tolerability of NanoZolid®-docetaxel and a secondary objective is to assess efficacy on tumor regression.

Enrollment open