[Translation] A multicenter, randomized, controlled, open-label, phase III clinical study to measure the efficacy and safety of EndoTAG-1 combined with gemcitabine versus gemcitabine alone in the treatment of locally advanced and/or metastatic pancreatic cancer

本研究的目的是评价EndoTAG-1联合吉西他滨治疗较之吉西他滨单药治疗局部晚期和/或转移性胰腺癌患者的有效性和安全性

[Translation]

The purpose of this study is to evaluate the efficacy and safety of EndoTAG-1 combined with gemcitabine compared with gemcitabine alone in patients with locally advanced and/or metastatic pancreatic cancer.

Start Date16 Aug 2021

Sponsor / Collaborator

SynCore Biotechnology Co., Ltd.

[+2]

NCT03126435

/ CompletedPhase 3

A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1+GEM vs GEM Alone in Patients With Measurable Locally Advanced/Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment

The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.

Start Date16 Oct 2018

Sponsor / Collaborator

SynCore Biotechnology Co., Ltd.

NCT03002103

/ SuspendedPhase 3

An Open-label, Randomized, Controlled Phase III 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

This is a prospective, multicenter, open-label, randomized, and controlled trial to test the superiority of EndoTAG®-1 in combination with paclitaxel and gemcitabine versus paclitaxel in combination with gemcitabine.
An independent data safety monitoring board (DSMB) will be established to decide on the recommended dose (RD) of EndoTAG®-1, paclitaxel and gemcitabine to be used throughout the trial and to monitor the patients' safety and treatment efficacy data

Start Date23 Nov 2016

Sponsor / Collaborator

SynCore Biotechnology Co., Ltd.

100 Clinical Results associated with EndoTAG-1

100 Translational Medicine associated with EndoTAG-1

100 Patents (Medical) associated with EndoTAG-1

Literatures (Medical) associated with EndoTAG-1

01 Mar 2025·Current pharmaceutical biotechnology

Nanotheranostics: A Cutting-edge Technology for Cancer Management

Review

Author: Swain, Shasank Sekhar ; Dash, Shwetapadma ; Sahoo, Sanjeeb Kumar ; Dutta, Sneha ; Khuntia, Auromira

Cancer is the second-leading cause of death in the 21st century, where early detection and appropriate therapeutic interventions are two components essential for effective cancer management. Despite the availability of several conventional diagnostics and therapeutic agents, cancer mortality rates are rising due to an increase in the frequency of recurrence and metastasis in cancer patients. Therefore, tremendous efforts have been expended to address this significant clinical issue and improve therapeutic efficacy. In this regard, nanotheranostic is a multipotential single platform for both cancer diagnosis and treatment through enhanced aqueous solubility and bioavailability of the encapsulated agent, stimulus responsiveness, tumor-specific targeting ability, precise tumor imaging, and real-time drug delivery. Nonetheless, the translational success of nanotheranostic platforms is still in its infancy and requires more extensive research in the context of tumor heterogeneity, safety profile, and regulatory issues, which pose one of the largest technological limitations. 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.

28 Dec 2022·ACS applied materials & interfaces

Paclitaxel-Loaded Cationic Fluid Lipid Nanodiscs and Liposomes with Brush-Conformation PEG Chains Penetrate Breast Tumors and Trigger Caspase-3 Activation

Article

Author: Ewert, Kai K. ; Teesalu, Tambet ; Fisher, William S. ; Scodeller, Pablo ; Sidorenko, Valeria ; Steffes, Victoria M. ; Safinya, Cyrus R. ; Simón-Gracia, Lorena

Novel approaches are required to address the urgent need to develop lipid-based carriers of paclitaxel (PTX) and other hydrophobic drugs for cancer chemotherapy. 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. Recent work found that the addition of a cone-shaped poly(ethylene glycol)-lipid (PEG-lipid) to PTX-loaded CLs (CLs_PTX) promotes a transition to sterically stabilized, higher-curvature (smaller) nanoparticles consisting of a mixture of PEGylated CLs_PTX and PTX-containing fluid lipid nanodiscs (nanodiscs_PTX). These CLs_PTX and nanodiscs_PTX show significantly improved uptake and cytotoxicity in cultured human cancer cells at PEG coverage in the brush regime (10 mol % PEG-lipid). Here, we studied the PTX loading, in vivo circulation half-life, and biodistribution of systemically administered CLs_PTX and nanodiscs_PTX and assessed their ability to induce apoptosis in triple-negative breast-cancer-bearing immunocompetent mice. We focused on fluid rather than solid lipid nanodiscs because of the significantly higher solubility of PTX in fluid membranes. At 5 and 10 mol % of a PEG-lipid (PEG5K-lipid, molecular weight of PEG 5000 g/mol), the mixture of PEGylated CLs_PTX and nanodiscs_PTX 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.

01 Jul 2019·ANNALS OF ONCOLOGY

EndoTAG-1 plus gemcitabine versus gemcitabine alone in patients with measurable locally advanced and/or metastatic adenocarcinoma of the pancreas failed on FOLFIRINOX treatment

Article

Author: Bosc, F ; Papai, Z ; Oh, S ; Artru, P ; Horváth, Z ; Choi, H ; Lee, W ; Kang, S ; Dvorkin, M ; Bazin, I ; Hitre, E ; Bodoky, G ; Bachet, J ; Ludovic, E ; Bai, L ; Chen, L ; Hwang, J ; Lee, M ; Chang, C ; Lin, J ; Su, M

News (Medical) associated with EndoTAG-1

16 Jun 2019

·www.syncorebio.com

SB05PC (EndoTAG®-1) Phase III been Approved in China by NMPA

China NMPA Approves SynCore Biotechnology to Conduct Phase III Human Clinical Trial for SB05PC (EndoTAG®-1), A First-Line Therapy for Pancreatic Cancer Taipei, Taiwan, Jun 16, 2019. SynCore Biotechnology Co. (4192:TT) announces that the company has been approved by China National Medical Products Administration (NMPA) to commence the Phase III human clinical trial for its oncology asset SB05PC (EndoTAG®-1), a novel drug for the first-line treatment of pancreatic cancer. According to World Health Organization (WHO), China holds the highest incidence and mortality of pancreatic cancer, being responsible for 116,300 occurrences and 110,400 deaths in 2018 respectively. The current standard of cares cannot significantly improve the overall survival rate, which leaves a great gap of unmet medical needs. Judging from the results of the completed Phase II study, SB05PC (EndoTAG®-1) shows great potential in prolonging overall survival when compared with Gemcitabine, the standard first-line therapy for pancreatic cancer in China. SB05PC (EndoTAG®-1) shall provide better treatment option and opportunity once been approved in China. SynCore holds diverse and strategic plans for SB05PC (EndoTAG®-1) in different countries. In China, Gemcitabine in the major drug in treating pancreatic cancer, standing for 25% of chemo drug usage. The incidence and mortality rates are also higher in tier 1 cities include Beijing and Shanghai due to highly-struggled lifestyle and intensive pressure. Owing to these, SynCore combines SB05PC (EndoTAG®-1), a cationic liposomal paclitaxel, with gemcitabine in targeting locally advanced and/or metastatic pancreatic cancer for first-line treatment, in comparison with gemcitabine monotherapy. The completed Phase II study shows not only prolonged overall survival but also ameliorated adverse events, which renders higher life quality for pancreatic cancer patients. SynCore will also set study centers at high tier cities in order to accelerate subject enrollment. Paclitaxel and gemcitabine are mature chemo options for various cancer types, both account for top 10 anti-cancer drugs in Chinese public healthcare systems. The annual revenue for these two blockbusters are RMB 5.7 billion and 2.5 billion, ranking as top 1 and top 9 sales in 2017 in Chinese public healthcare systems respectively. Serving as new formulation of paclitaxel, SB05PC (EndoTAG®-1) combines with gemcitabine to target first-line pancreatic cancer treatment, which is a promising new drug in China. SynCore is also actively seeking local partners for co-development and out-licensing for this project. Full News Release Download: Jun 16, 2019: SB05PC (EndoTAG®-1) Phase III been Approved in China by NMPA CONTACT Charles Liang, Investor Relations Phone: +886-2-27640826 Email: finance@syncorebio.com DISCLAIMER This press release may contain certain forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of SynCore Biotechnology Co., Ltd

Phase 2Drug ApprovalPhase 3

21 Dec 2015

·www.biospace.com

Amgen Acquires MediGene AG Spinoff Catherex for $10.5 Million Upfront

December 22, 2015 By Mark Terry , BioSpace.com Breaking News Staff Munich, Germany-based Medigene AG announced yesterday that it had sold its spinoff company, Catherex, Inc. , to Amgen . Medigene , as primary Catherex shareholder, will receive about 40 percent of the payments from Amgen . Catherex shareholders will receive an upfront payment of $10.5 million from Amgen , as well as milestone payments based on Amgen ’s Imlygic, formerly T-Vec. Also, royalty payments on Imlygic will be paid until the end of 2020. Imlygic was approved by the U.S. Food and Drug Administration (FDA) in Oct. 2015 for the treatment of advanced, metastatic melanoma. It was also recently approved in the European Union. “With this transaction we have achieved our goal to profitably realize the previous investments made in Catherex ,” said Peter Llewellyn-Davies , Medigene AG ’s chief financial officer, chief operating officer and managing director, in a statement. “The upfront and milestone payments and the expected cash inflow of regular royalty payments from Amgen is part of our strategy to tap additional financial resources for the ongoing clinical development programs of our innovative immunotherapies.” Catherex is located in Philadelphia. In April 2010, Medigene spun off the company with the development of a cancer-killing herpes simplex virus (oHSV). At that time Medigene received a 40 percent stake in the company. In 2014, Catherex spun off some of its patents and research-and-development programs into a company called Aettis Inc. Medigene holds a 39 percent stake in Aettis. Amgen , which for the most part has stayed out of this year’s merger-and-acquisitions frenzy, indicated in November that they were evaluating acquisition targets in the $10 billion range and in companies that have drugs close to market. The Catherex buy is well shy of the $10 billion range, although it would seem to strengthen Amgen ’s work in the immuno-oncology arena. Catherex is privately-owned, so financial data is not available. Imlygic (taalimogene laherparepvec) was approved by the FDA in October. It is a genetically modified herpes simplex virus type 1 that is engineered to replicate within tumors and manufacture a protein called granulocyte-macrophage colony-stimulating factor (GM-CSF), which causes the cells to rupture, thus releasing tumor-derived antigen. Then, along with GM-CSF, it stimulates an anti-tumor immune response. “This sale of an equity stake to Amgen enables Medigene to commercialize further assets derived from our portfolio,” said Frank Mathias , chief executive officer of Medigene AG and president of Medigene, Inc. , in a statement. “In addition to our recent announcement regarding the transfer of EndoTAG, this step supports Medigene ’s focus on immunotherapy as our core business.” On Dec. 17, Medigene inked a deal with Taiwan-based SynCore Biotechnology Co., Ltd. to sell its EndoTAG platform to SynCore , which replaced and ended a May 2013 license agreement. In addition to 6.3 million euros in licensing payments and proceeds, Medigene received a payment of 5 million euros that will be paid in five annual installments. EndoTag is a composition of neutral and positive lipids. These lipids can be loaded with the cytostatic drug Paclitaxel, which builds the drug candidate EndoTag-1. EndoTag-1 works to attack the blood supply to tumor cells without affecting healthy endothelial tissues.

Drug ApprovalLicense out/inImmunotherapyAcquisition

100 Deals associated with EndoTAG-1

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Pancreatic Adenocarcinoma	Phase 3	United States	SynCore Biotechnology Co., Ltd.	16 Oct 2018
Locally Advanced Pancreatic Adenocarcinoma	Phase 3	France	SynCore Biotechnology Co., Ltd.	16 Oct 2018
Locally Advanced Pancreatic Adenocarcinoma	Phase 3	Hungary	SynCore Biotechnology Co., Ltd.	16 Oct 2018
Locally Advanced Pancreatic Adenocarcinoma	Phase 3	Israel	SynCore Biotechnology Co., Ltd.	16 Oct 2018
Locally Advanced Pancreatic Adenocarcinoma	Phase 3	Russia	SynCore Biotechnology Co., Ltd.	16 Oct 2018
Locally Advanced Pancreatic Adenocarcinoma	Phase 3	South Korea	SynCore Biotechnology Co., Ltd.	16 Oct 2018
Locally Advanced Pancreatic Adenocarcinoma	Phase 3	Taiwan Province	SynCore Biotechnology Co., Ltd.	16 Oct 2018
Metastatic Pancreatic Cancer	Phase 3	United States	SynCore Biotechnology Co., Ltd.	16 Oct 2018
Metastatic Pancreatic Cancer	Phase 3	France	SynCore Biotechnology Co., Ltd.	16 Oct 2018
Metastatic Pancreatic Cancer	Phase 3	Hungary	SynCore Biotechnology Co., Ltd.	16 Oct 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03126435 (CTgov)	Phase 3	Pancreatic adenocarcinoma \| Metastatic Pancreatic Cancer \| Locally Advanced Pancreatic Adenocarcinoma	218	Gemcitabine+EndoTAG-1 (EndoTAG-1 and Gemcitabine)	typoyfiqfd(rrmgcafjgb) = jedszaifgq zqaibbesay (bqwgmtmfak, zxzyisqvex - bwabsyphdf) View more	-	24 Mar 2023
				Gemcitabine (Gemcitabine Monotherapy)	typoyfiqfd(rrmgcafjgb) = lygkjsmjjf zqaibbesay (bqwgmtmfak, ejvqrieaaj - nalkwhngyd) View more
ESMO_ASIA2022	Phase 3	Second line	218	EndoTAG-1 plus gemcitabine	wygyfaeqdy(fcrddatrer) = nhobkjsgdb opirmmdbtl (kalqgisija ) View more	Negative	03 Dec 2022
				Gemcitabine alone	wygyfaeqdy(fcrddatrer) = zniwfhpkxz opirmmdbtl (kalqgisija ) View more

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