[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 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 ; Hwang, J ; Lee, M ; Bai, L ; Chen, L ; Chang, C ; Lin, J ; Su, M

01 Nov 2017·MedicineQ4 · MEDICINE

Effect of antitumor treatments on triple-negative breast cancer patients

Q4 · MEDICINE

ReviewOA

Author: Qiuhong Tian ; Zhenzhu Bai ; Yong Yang ; Peng Du ; Sen Li ; Jinsheng Zeng

BACKGROUND:

Triple-negative breast cancer (TNBC) lacks the expression of the estrogen receptor, progesterone receptor, and receptor tyrosine-protein kinase erbB-2 (HER2/neu), which renders hormone-related endocrine and targeted therapy essentially futile.

OBJECTIVE:

We performed a meta-analysis to assess the effects of antitumor regimens in the treatment of TNBC patients.

METHODS:

We searched electronic databases, including PubMed, Embase, and the Cochrane Library, through January 2017 using the following keywords: "triple negative breast cancer," "TNBC," and "random*" without language restrictions. The major outcome in the present analysis was the overall response rate (ORR), and the secondary outcomes were progression-free survival (PFS) and overall survival (OS). A network meta-analysis and multilevel mixed-effects logistic regression were used to compare antitumor regimens.

RESULTS:

We included 35 articles assessing a total of 8476 TNBC patients in our systematic review. The regimen of Bevacizumab, Carboplatin, and Paclitaxel (78.2%) was the most likely to improve the ORR in TNBC patients, followed by EndoTAG-1 and Paclitaxel (69.7%), Carboplatin and Paclitaxel (65.0%), and Bevacizumab and Paclitaxel (61.8%). In the patients without metastasis, the regimen of Bevacizumab, Carboplatin, and Paclitaxel (74.9%) remained the most likely to improve the ORR. We could not analyze the results for patients with metastasis or outcomes of PFS and OS because no >4 regimens formed a network. In the regression analysis, Bevacizumab (odds ratio [OR], 1.71; 95% confidence interval [CI], 1.43-2.05; P < .001) and Carboplatin (OR, 2.07; 95% CI, 1.62-2.64; P < .001) correlated with superior ORR outcome, and Iniparib (OR, 1.51; 95% CI, 1.11-2.07; P = .009) correlated with superior OS outcome.

CONCLUSION:

The regimen including Bevacizumab, Carboplatin, and Paclitaxel was the most likely to improve the ORR in TNBC patients and in advanced metastatic TNBC patients. The administration of Bevacizumab and Carboplatin provided greater benefit toward improved patient ORR.

01 Apr 2014·Annals of oncology : official journal of the European Society for Medical OncologyQ1 · MEDICINE

A randomized controlled phase II trial of a novel composition of paclitaxel embedded into neutral and cationic lipids targeting tumor endothelial cells in advanced triple-negative breast cancer (TNBC)

Q1 · MEDICINE

Article

Author: E. Nowara ; J. Bonneterre ; I. N. Bondarenko ; A. V. Bakshi ; J. M. Ferrero ; M. Piccart ; for the CT4002 study group ; C. Wilke ; A. Awada

BACKGROUND:

EndoTAG-1, composed of paclitaxel embedded in liposomal membranes targeting tumor endothelial cells, was evaluated for safety and efficacy in advanced triple-negative breast cancer (TNBC).

PATIENTS AND METHODS:

One hundred and forty patients were treated with weekly EndoTAG-1 (22 mg/m²) plus paclitaxel (70 mg/m²), twice weekly EndoTAG-1 (2× 44 mg/m²), or weekly paclitaxel (90 mg/m²) for greater than or equal to four cycles (3-week treatment + 1-week rest) or until progression/toxicity. Primary end point was progression-free survival (PFS) rate evaluated centrally after four cycles of therapy (week 16). The study was not powered for intergroup comparisons.

RESULTS:

The PFS rate at week 16 was 59.1% [one-sided 95% CI: 45.6, ∞] on combination treatment, 34.2% [21.6, ∞] on EndoTAG-1, and 48.0% [30.5, ∞] on paclitaxel. Median PFS reached 4.2, 3.4, and 3.7 months, respectively. After complete treatment (week 41 analysis), median overall survival (OS) was 13.0, 11.9, and 13.1 months for the modified Intention-to-Treat (ITT) population and 15.1, 12.5, and 8.9 months for the per-protocol population, respectively. The clinical benefit rate was 53%, 31%, and 36% for the treatment groups. Safety analysis revealed known toxicities of the drugs with slight increases of grade 3/4 neutropenia on combination therapy.

CONCLUSION:

Treatment of advanced TNBC with a combination of EndoTAG-1 and standard paclitaxel [Taxol® (Bristol-Myers Squibb GmbH), or equivalent generic formulation] was well tolerated and showed antitumor efficacy. The positive trend needs to be confirmed in a randomized phase III trial.

STUDY REGISTRATION:

European Clinical Trials Database: EudraCT number 2006-002221-23. ClinicalTrials.gov identifier: NCT00448305.

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

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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

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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)	leksiempzl(vrkqjseuta) = yduszxswwc mtdtycfpko (jkamjgocfk, jdxfsvgoso - bistafzhga) View more	-	24 Mar 2023
				Gemcitabine (Gemcitabine Monotherapy)	leksiempzl(vrkqjseuta) = sbxyomrsbt mtdtycfpko (jkamjgocfk, hoswwnmvpj - zynycdjyms) View more
ESMO_ASIA2022	Phase 3	Second line	218	EndoTAG-1 plus gemcitabine	npshahfupc(ntxwupyujk) = wxanfwsvkk rhpahdailn (knmuksqnqs ) View more	Negative	03 Dec 2022
				Gemcitabine alone	npshahfupc(ntxwupyujk) = mhzjhbuaek rhpahdailn (knmuksqnqs ) View more

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