EndoTAG-1 (paclitaxel liposomal) / Sinphar Pharma, Medigene - LARVOL DELTA

Nanotheranostics: A Cutting-Edge Technology for Cancer Management. (PubMed, Curr Pharm Biotechnol) - "The present review summarizes different nanotheranostic platforms and nanotheranostic candidates in clinical trials (AGuIX® , NBTXR3, Ferumoxtran, MM-398, EndoTAG-1, etc.), along with disadvantages and challenges to improving cancer diagnosis and treatment. Overall, the concept, platform, and technical knowledge of nanotheranostics are really helpful to academic and pharmaceutical researchers."

Journal • Oncology

Sialic Acid Conjugate-Modified Cationic Liposomal Paclitaxel for Targeted Therapy of Lung Metastasis in Breast Cancer: What a Difference the Cation Content Makes. (PubMed, Mol Pharm) - "Cationic lipids play a pivotal role in developing novel drug delivery systems for diverse biomedical applications, owing to the success of mRNA vaccines against COVID-19 and the Phase III antitumor agent EndoTAG-1...By leveraging electrostatic forces and ligand-receptor interactions, the SA-modified cationic liposomes specifically target malignant tumor-associated immune cells such as tumor-associated macrophages (TAMs), reduce the proportion of cationic lipids in the formulation, and achieve dual objectives: high cellular uptake and potent antitumor efficacy. These findings highlight the potential advantages of this innovative approach utilizing cationic liposomes."

Journal • Breast Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Solid Tumor

A Trial Evaluating the Efficacy and Safety of EndoTAG®-1 in Combination With Paclitaxel and Gemcitabine Compared With Paclitaxel and Gemcitabine as First-line Therapy in Patients With Visceral Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - P3 | N=420 | Suspended | Sponsor: SynCore Biotechnology Co., Ltd. | Trial completion date: Jun 2024 ➔ Jun 2027 | Trial primary completion date: Mar 2023 ➔ Mar 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

A randomized controlled, open-label, adaptive phase III clinical trial to evaluate safety and efficacy of EndoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas after FOLFIRINOX (ESMO Asia 2022) - "Conclusions Add-on EndoTAG-1 did not significantly improve survival over gemcitabine alone in patients with FOLFIRINOX-refractory APDAC. No new safety issues were noted and the safety profile is manageable."

Clinical • P3 data • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Paclitaxel-Loaded Cationic Fluid Lipid Nanodiscs and Liposomes with Brush-Conformation PEG Chains Penetrate Breast Tumors and Trigger Caspase-3 Activation. (PubMed, ACS Appl Mater Interfaces) - "Carriers based on cationic liposomes (CLs) with fluid (i.e., chain-melted) membranes (e.g., EndoTAG-1) have shown promise in preclinical and late-stage clinical studies...At 5 and 10 mol % of a PEG-lipid (PEG5K-lipid, molecular weight of PEG 5000 g/mol), the mixture of PEGylated CLs and nanodiscs was able to incorporate up to 2.5 mol % PTX without crystallization for at least 20 h. Remarkably, compared to preparations containing 2 and 5 mol % PEG5K-lipid (with the PEG chains in the mushroom regime), the particles at 10 mol % (with PEG chains in the brush regime) showed significantly higher blood half-life, tumor penetration, and proapoptotic activity. Our study suggests that increasing the PEG coverage of CL-based drug nanoformulations can improve their pharmacokinetics and therapeutic efficacy."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CASP3

A Trial Evaluating the Efficacy and Safety of EndoTAG®-1 in Combination With Paclitaxel and Gemcitabine Compared With Paclitaxel and Gemcitabine as First-line Therapy in Patients With Visceral Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - P3 | N=420 | Suspended | Sponsor: SynCore Biotechnology Co., Ltd. | Recruiting ➔ Suspended

Combination therapy • Trial suspension • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

A randomised phase III trial comparing two dose-dense, dose-intensified approaches (EPC and PM(Cb)) for neoadjuvant treatment of patients with high-risk early breast cancer (GeparOcto). (ASCO 2017) - P3; "...Background: The sequential use of intense does-dense (idd) epirubicin, paclitaxel, cyclophosphamide (EPC) and weekly paclitaxel/liposomal doxorubicin (+/- carboplatin (Cb) in triple negative breast cancer (TNBC) (PM(Cb)) are considered highly efficient regimens for high-risk early stage breast cancer (BC)...For HER2+ BC trastuzumab 6 (8) mg/kg q3w and pertuzumab 420 (840) mg q3w cycles were given concomitantly with P and C. Pts with histologically confirmed, cT1c - cT4a-d BC and central receptor assessment were included... In high-risk early stage breast cancer pts pCR rates of idd EPC compared to weekly PM(Cb) were not significantly different. PM(Cb) appeared to be less feasible."

Adverse events • Clinical • P3 data • Biosimilar • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Immunology • Triple Negative Breast Cancer

Chemotherapy (CT)-induced anaemia in patients (pts) treated with dose-dense regimen: Results of the prospectively randomised anaemia substudy from the neoadjuvant GeparOcto study (ESMO 2019) - P3; " In GeparOcto trial pts with primary BC were randomised to receive sequential, intensified, dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) or weekly paclitaxel/liposomal doxorubicin +/- carboplatin (PM(Cb)) (Schneeweiss et al. This is the first study investigating IV iron treatment for dose-dense CT-induced anaemia in BC. 32% of pts reached Hb ≥ 11g/dl at 6 wks. FCM treatment was not different than PhCh for anaemia therapy."

Clinical

EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment (clinicaltrials.gov) - P3; N=218; Completed; Sponsor: SynCore Biotechnology Co., Ltd.; Active, not recruiting ➔ Completed; Trial completion date: Jan 2023 ➔ Oct 2021; Trial primary completion date: Nov 2021 ➔ Jul 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment (clinicaltrials.gov) - P3; N=218; Active, not recruiting; Sponsor: SynCore Biotechnology Co., Ltd.; Trial completion date: Jun 2022 ➔ Jan 2023; Trial primary completion date: Jul 2021 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

EndoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatment (ESMO-GI 2019) - "Introduction Pancreatic cancer is the 4th deadliest cancer in Europe, with more than 95% of those affected dying from the disease and it is set to become the second greatest cause of death from cancer by 2020 (ECPC, European Cancer Patient Coalition). 2011) and 7.3 months for gemcitabine + paclitaxel combination (Portal et al. 2015) was used for the sample size calculation."

Clinical

Germline mutation status and therapy response in patients with triple-negative breast cancer (TNBC): Results of the GeparOcto study (ESMO 2018) - P3; "NCT02125344.;Background: The phase III neoadjuvant GeparOcto trial (NCT02125344) randomized patients with triple negative breast cancer (TNBC) to receive treatment with intensified dose-dense epirubicin (E), paclitaxel (P), and cyclophosphamide (C; iddEPC) or weekly paclitaxel/liposomal doxorubicin (PM), plus carboplatin (Cb). Our data confirm that BRCA1/2 germline mutations represent a predictive biomarker for the achievement of pCR following neoadjuvant anthracycline-taxane-containing chemotherapy for TNBC."

BRCA Biomarker • Clinical • Triple Negative Breast Cancer

A randomized controlled, open label, adaptive phase III Trial to evaluate safety and efficacy of endoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatment (ESMO 2019) - P3; "Legal entity responsible for the study: SynCore Biotechnology Co., Ltd. Funding: SynCore Biotechnology Co., Ltd."

Clinical • P3 data

[VIRTUAL] EndoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatment (NCT03126435). (ASCO 2020) - P3 | "The trial will continue as planned from the last review in January 2020. Research Funding: SynCore Biotechnology Co., Ltd., Other Government Agency"

Clinical • Breast Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer

EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment (clinicaltrials.gov) - P3; N=218; Active, not recruiting; Sponsor: SynCore Biotechnology Co., Ltd.; Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Nanoparticle albumin-bound paclitaxel/liposomal-encapsulated doxorubicin in HER2-negative metastatic breast cancer patients. (PubMed, Future Oncol) - "Aim: To investigate the toxicity of nab-paclitaxel (wNP)/nonpegylated liposome-encapsulated doxorubicin (wNPLD) combination in HER2-negative metastatic breast cancer (MBC) patients as first-line treatment. The objective response rate was 68% (response mean duration: 12.6 months). wNP/wNPLD combination constitutes an active regimen with mild toxicity."

Clinical • Journal • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Immunology • Mucositis • Neutropenia • Oncology • HER-2

[VIRTUAL] SynCore Biotechnology (BIO 2020) - "Currently, the lead asset, SB05 EndoTAG-1 for pancreatic cancer second-line treatment is undergoing global phase III clinical trial in Asia, US and Europe. Interim analysis is expected to be released in Q3 this year, showing data on clinical efficacy and safety profile. SynCore is actively looking for commercialization partners in US and Europe, as well as co-development partners in China and Japan."

Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Indication additional solid tumors removed from pipeline for EndoTAG-1 (MediGene) - EndoTAG-1 / Medigene

Corporate Pipeline Update

Company Presentation (MediGene) - "PFS rate (16 wks) in combination therapy group 59.1%; mOS (41 wks) in combination therapy group up to 13.0 months, in subgroup (ECOG 0/1, first line) up to 17.8 months"

P2 data • Breast Cancer

A Trial Evaluating the Efficacy and Safety of EndoTAG®-1 in Combination With Paclitaxel and Gemcitabine Compared With Paclitaxel and Gemcitabine as First-line Therapy in Patients With Visceral Metastatic Triple-negative Breast Cancer (clinicaltrials.gov) - P3; N=420; Recruiting; Sponsor: SynCore Biotechnology Co., Ltd.; Trial completion date: Dec 2022 ➔ Jun 2024; Trial primary completion date: Dec 2021 ➔ Mar 2023

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment (clinicaltrials.gov) - P3; N=218; Recruiting; Sponsor: SynCore Biotechnology Co., Ltd.; Trial completion date: Jul 2020 ➔ Jun 2022; Trial primary completion date: Dec 2019 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Chemotherapy (CT)-Induced Anaemia in Patients (PTS) Treated with Dose-Dense Regimen: Results of the Prospectively Randomised Anaemia Substudy from the Neoadjuvant Geparocto Study (DKK 2020) - " In GeparOcto trial pts with primary BC were randomized to receive sequential, intensified, dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) or weekly paclitaxel/liposomal doxorubicin +/- carboplatin (PM(Cb))1 . This is the first study investigating IV iron treatment for dose-dense CT-induced anaemia in BC. 32% of pts reached Hb≥11g/dl at 6 wks, irrespective of anaemia therapy. FCM treatment increased ferritin and TSAT levels but did not improve anaemia in comparison to PhCh in this setting."

Clinical

EndoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatment. (PubMed, Ann Oncol) - No abstract available

Clinical • Journal

Syncore to begin phase III trial of cancer drug (Taipei Times) - “Pharmaceutical company SynCore Biotechnology Co Ltd…said that it plans to begin a phase III clinical trial of its new pancreatic cancer drug SB05PC in China, after gaining the approval of the Chinese regulator last month….expects to complete the trial by the fourth quarter of 2021…The company is to conduct interim analysis of the trial at the end of this year…”

New P3 trial • P3 data • Trial completion date