liposomal vinorelbine (TLC178) / Taiwan Liposome Company - LARVOL DELTA

Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy (clinicaltrials.gov) - P1/2; N=46; Completed; Sponsor: Taiwan Liposome Company; Active, not recruiting ➔ Completed

Trial completion • Oncology • Solid Tumor

Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy (clinicaltrials.gov) - P1/2; N=51; Active, not recruiting; Sponsor: Taiwan Liposome Company; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2020 ➔ May 2021; Trial primary completion date: Dec 2020 ➔ May 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

TLC Provides Corporate Update at Investor Conference (GlobeNewswire) - P1/2, N=51; NCT02925000; Sponsor: Taiwan Liposome Company; "The maximum tolerated dose of the oncology program TLC178 has been found to be 31mg/m2 from its Phase I/II, open-label, dose escalation study, which treated 33 patients. 50% of patients with soft tissue sarcoma had durable stable disease (SD) (24 to 31 mg/m2 dose) for at least 4 months. Disease control rate (DCR) in all types of tumor was found to be 41%, of which 1 patient with apocrine adenocarcinoma (28 mg/m2 dose level) completed study and showed partial response (PR) up to the 10th month follow-up, 2 patients (31 mg/m2 dose level) with NSCLC and pancreas cancer, respectively, had durable SD for at least 8 months, and 1 patient with metastatic ovarian cancer (31 mg/m2 dose level) had durable SD for at least 4 months."

P1/2 data • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma

Dose-escalation Study of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy (clinicaltrials.gov) - P1/2; N=51; Recruiting; Sponsor: Taiwan Liposome Company; Trial completion date: Sep 2019 ➔ Dec 2020; Trial primary completion date: Jun 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

In vivo efficacy and enhanced tumour accumulation of liposomal vinorelbine (TLC178) in human sarcoma xenograft mice model (ESMO 2019) - " In efficacy studies (Study #PD17060, #PD17069 and #PD17008), TLC178 not only showed better inhibitory effect than that of VNB alone and VNB+CTX treatments in the SJCRH30 RMS xenograft model, but also remarkably suppressed HT1080 human fibrosarcoma compared with doxorubicin, an approved drug for treatment of sarcomas. TLC178 demonstrated improved in vivo systemic VNB PK profile and tumor distribution, which resulted in superior anti-cancer efficacy compared to traditional VNB treatment. Therefore, TLC178 may have potential as a single or combination treatment for sarcomas with decreased dosage and/or frequency, reduced toxicity, and enhanced efficacy. Legal entity responsible for the study: Taiwan Liposome Company, Ltd."

Preclinical

TLC to present preclinical data on TLC178 at ESMO 2019 (GlobeNewswire) - "TLC...announced that new in vivo data on the efficacy and enhanced tumor accumulation of TLC178 will be presented at the European Society for Medical Oncology Congress (ESMO 2019). ESMO 2019 takes place from September 27 to October 1, 2019 in Barcelona, Spain. TLC178 is a proprietary NanoX™ formulation of vinorelbine, an anticancer drug frequently used off-label to treat soft tissue sarcoma."

Preclinical

EMA grants Orphan Drug Designation to TLC178 for the treatment of soft tissue sarcoma (GlobeNewswire) - "Taiwan Liposome Company, Ltd...announced that the European Medicines Agency (EMA) has granted orphan drug designation for TLC178 for the treatment of soft tissue sarcoma....A Phase I/II, open-label, multicenter, dose escalation clinical trial is currently underway to evaluate the maximum tolerated dose of TLC178 in adults with advanced malignancies; to date, no dose limiting toxicity has been reported."

European regulatory • Orphan drug