Approval for German Medical Device in China
Successful cooperation of GILUPI GmbH with its Chinese partner Viroad
The GILUPI CellCollector® - the first medical device for in vivo CTC isolation, manufactured by GILUPI - has been approved by the Chinese registrations agency (China Food and Drug Administration – CFDA) in June. As a result, the Potsdam-based company gains access to one of the most significant geographical markets worldwide. This milestone was reached in close cooperation with GILUPIs strategic partner, Hebei Viroad Biotechnology Co. Ltd. (Viroad). Besides its role as strategic partner, Viroad is also the largest investor and shareholder of GILUPI.
Alexander Herrmann, Managing Director of GILUPI GmbH commented: “Viroad is an excellent partner and we achieved this important approval based on their outstanding knowledge of the Chinese market and their regulatory expertise. Together with Viroad, we can realize a rapid market access in China and expect a significant sales growth within the next years.”
The importance of the strategic partnership with Viroad to GILUPI is also pointed out by Brandenburgs Economic State Secretary Hendrik Fischer and the CEO of Brandenburg Invest (WFBB), Sebastian Saule, during their current delegation visit to China. Today, they visit Ms. Baozhi Xu the CEO of Hebei Viroad in Shijiazhuang, the capital of Brandenburgs partner province Hebei. State Secretary Fischer explained: “The economic relations with China are very important for the German county Brandenburg. We are pleased that a Brandenburg company is generating attention on the Chinese healthcare market”. WFBB CEO Saule says: “This is a new quality on external economic relations with China and at the same time strengthens the healthcare location Brandenburg. This is of course a wonderful success of the joint efforts in China and Brandenburg, supporting the develop of GILUPI.“
GILUPI extends its patent portfolio
- Second Chinese patent was granted in March 2017
GILUPI GmbH announced today that the company was granted a further Chinese patent protecting the unique and innovative GILUPI technology.
The patent (ZL201180024406.8), short titled “biodetector” is valid until 15 March 2031. The newly granted Chinese patent extends GILUPIs patent portfolio protecting next device generations with enhanced sensitivity and greater convenience for patients.
“The extension of our intellectual property into the Chinese market is important for our strategic orientation. It further significantly broadens our patent portfolio, protecting our proprietary GILUPI technology on a global scale” said Dr. Jens Pfannkuche, CEO of GILUPI GmbH.
GILUPI´s patent portfolio consist of 11 patent families and further patent applications that are currently subject to examination procedures for a number of inventions. Hence, further granted patents will follow soon.
Improved detection of circulating tumor cells in prostate cancer patients using the GILUPI CellCollector® in combination with two blood-based assays
GILUPI GmbH announces the release of clinical data from a prostate cancer clinical study in December 2016. The scientific paper demonstrates the isolation of circulating tumor cells (CTCs) from blood of non-metastatic high-risk prostate cancer patients with the GILUPI CellCollector® .
Liquid biopsy - isolating and analyzing circulating tumor cells (CTCs) from the blood of prostate cancer patients - can provide additional information on prognosis of patients, treatment efficacy and molecular tumor evolution. Prof. Klaus Pantel, Dr. Kuske and further researchers from the department of tumor biology at the University Medical Center Hamburg-Eppendorf investigated the prognostic relevance of CTCs in non-mestastatic prostate cancer. The goal of this study was to increase the sensitivity of CTC detection in patients with high-risk prostate cancer through the combination of three complementary assays. For this purpose the unique and innovative GILUPI CellCollector® in vivo technology was included in this study.
Peripheral blood was analyzed directly before and 3 month after radical prostatectomy to assess early dynamics in CTC counts. In total, 86 and 52 patients were enrolled before radical prostatectomy and 3 month after surgery, respectively.
In this clinical trial, combined application of the different CTC detection technologies revealed for the first time, a high incidence of CTCs in non-metastatic high-risk prostate cancer patients. Moreover, the researcher showed that the usual restriction of analyzing large blood volumes from cancer patients could be circumvented by GILUPI CellCollector® application, which resulted in equal or higher incidences CTC detection as comparator systems. More importantly, CTC rates detected by the GILUPI CellCollector® displayed a statistically significant decrease after surgery (66% to 34%, p = 0.031). These data revealed that after radical prostatectomy a reduced number of EpCAM-positive CTCs circulate in the blood stream, which is likely owed to the fact that the primary tumor as a major source of CTCs had been removed.
 Kuske et al. "Improved detection of circulating tumor cells in non-metastatic high-risk prostate cancer patients.”, Scientific Reports, 2016 Dec 21; 6:39736. doi: 10.1038/srep39736. eCollection 2016.
GILUPI at the 17th World Conference on Lung Cancer
The investors AURELIA, High-Tech Gründerfonds (HTGF), KfW, ILB, the - venture capital fund of the Sparkassen of Brandenburg and Business Angels sell their GILUPI shares to the strategic partner VIROAD. GILUPI is a company developing and manufacturing personalized cancer diagnostics in Potsdam. Due to the takeover, GILUPI gets the opportunity to continue the development of its medical products and to diversify their range of products through in-vitro diagnostics. At the same time, the transaction allows the young biotechnology company the access to the attractive Chinese market.
Since December 2012, VIROAD is a strategic partner, largest investor and shareholder of GILUPI. The Chinese investor has many years of experience in the approval of medical devices. The approval procedure, including the associated clinical study for the GILUPI CellCollector® has already been started in China. The GILUPI CellCollector® isolates complete circulating tumor cells (CTC) - the so-called liquid biopsy. To ensure a stable future and sustainable growth prospects within international markets, VIROAD now takes over all company shares. The investors, who accompany GILUPI financially and commercially since 2006, are pleased with the attractive exit. The HTGF, that allowed the launch of GILUPI as seed investor, emphasizes that "even the facility in Germany will strengthen and expand by the Chinese involvement. VIROAD will market the products in China, but needs the German site for developments and also to address the European markets.” said Dr. Michael Brandkamp, CEO of HTGF.
The managing director at GILUPI, Dr. Jens Pfannkuche, is convinced that the company can market its promising technology and other diagnostic products, especially in Europe and Asia now: "Predictive and companion diagnostics are more and more important in the oncological area, since there are various treatment options. Together with VIROAD we can realize a rapid market access in China in addition to the core markets of Europe. Our current focus is on cell enumeration as a prognostic biomarker in the main oncological indications. Further, we are currently working on molecular assays, to detect genetic changes of CTCs on DNA and RNA level. Especially, therapy decisive measures in non-small cell lung cancer (NSCLC) are in our focus. The easy access to CTCs from the bloodstream using our GILUPI CellCollector® - when compared to tissue biopsy - particular for the detection of resistance mutations makes our Liquid Biopsy concept very attractive."
Xu Baozhi, general manager of the Chinese medical technology company VIROAD, emphasizes "The products of GILUPI have met the strong demand in our Chinese market. The population in our country is aging, and the market for diagnostics is growing dynamically. We are therefore looking forward to expand with our German partner. "
GILUPI at the 17th World Conference on Lung Cancer
GILUPI will participate at the 17th World Conference on Lung Cancer (WCLC) in Vienna, Austria. The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies. The meeting will take place from 4th to 7th December with more than 7.000 participants expected.
Liquid biopsy - isolating and analyzing circulating tumor cells (CTCs) from the blood of cancer patients - can provide additional information on prognosis of patients, treatment efficacy, resistance and molecular tumor evolution. Dr. Julia Herrmann, clinician at the SRH Wald-Klinikum Gera - a certified lung cancer center (DKG), will present first data from a clinical trial using the GILUPI CellCollector®, to monitor CTC counts before and after surgery in non-small cell lung cancer (NSCLC) patients. The CTCs were further characterized on a molecular level. First results from 20 patients show that CTCs were isolated independent from tumor stages and could even be detected in quite early cases. Moreover, the difference between CTC occurrence before and after surgery suggested the possibility to identify patients responding to therapy or patients with stable disease.
The poster presentation will take place on Monday the 5th December in Hall B between 2.30 pm and 3.45 pm (abstract ID 5975). You are invited to meet Dr. Julia Herrmann as well as Dr. Jens Pfannkuche (CEO, GILUPI GmbH) and Dr. Julia Schulz (GILUPI, R&D division), which will also participate at this poster session.
GILUPI at the 6th Herbsttreffen AG Molekularpathologie
At the 6th Herbsttreffen AG Molekularpathologie in Karlsruhe, Germany, from 21th to 22th November 2016, GILUPI will be one of the exhibitors and sponsors of the event. The medical device company will be presenting its current product, the GILUPI CellCollector®, to an interested audience.
Liquid biopsy - isolating and analyzing circulating tumor cells (CTCs) from the blood of cancer patients - can provide additional information on prognosis of patients, treatment efficacy, resistance and molecular tumor evolution. Whereas CTCs represent the liquid phase of current tumor progression, cell free tumor DNA is apoptotic/necrotic cell material representing past cell death. CTC detection is challenging due to their extremely low frequency amongst millions of leucocytes and billions of red blood cells. The advanced GILUPI technology allows for the detection and characterization of CTCs combined with the proof of the malignant origin of the cells. The tumor cells are captured in vivo with high sensitivity and selectivity providing compelling and improved diagnostic use for personalized medicine, early diagnostic and clinical monitoring.
You are invited to visit our exhibition booth at the 6th Herbsttreffen AG Molekularpathologie. For further information on this congress, see here
About GILUPI GmbH
GILUPI GmbH is a medical device company founded in 2006 with focus on the development and production of innovative products for the in vivo isolation of rare cells from the blood circulation. Currently, the main focus of GILUPI is the diagnostics market for cancer.
Individual oncological targeted therapies become increasingly important in personalized medicine. The identification of the right drug for the individual patient is todays challenge in clinical practice. To address this medical need, the GILUPI CellCollector® is used to enrich rare cells by immune capture - i.e. directly "fishing" of CTCs in the patient's bloodstream. This methodology has proven to yield highest cell numbers and patient positivity rates in various cancer types. Applying diagnostic analyses ranging from immunostaining, DNA- and RNA-based methods, the isolated cells can be characterized and/or analyzed down to a molecular level.
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide that is CE approved.
For further information visit www.gilupi.com
Enumeration and molecular characterization of circulating tumor cells in prostate cancer patients using the GILUPI CellCollector®
GILUPI GmbH announces the release of clinical data from a prostate cancer setting in August 2016. The scientific paper demonstrate the isolation of circulating tumor cells (CTCs) from blood of prostate cancer patients with GILUPI CellCollector®.
Liquid biopsy - isolating and analyzing circulating tumor cells (CTCs) from the blood of prostate cancer patients - can provide additional information on prognosis of patients, treatment efficacy and molecular tumor evolution. Dr. Gerit Theil and further researcher from the Martin Luther University Halle-Wittenberg wanted to investigate the use of the GILUPI CellCollector® - in a proof of concept study. After in vivo isolation, CTCs underwent enumeration and characterization using molecular methods.
The researcher tested the functionality of the GILUPI CellCollector® in a preclinical step. They studied blood samples of 43 prostate cancer patients by applying the medical devices ex vivo.
Detection of CTCs in all tumor stages could be shown. The mean CTC count was 4.6 CTCs in patients with localized prostate cancer, 16.8 CTCs in patients with locally advanced prostate cancer, and 26.8 CTCs in patients with metastatic prostate cancer. More importantly, it could be shown that there was a significant difference in the cancer-specific survival rates. Patients with CTC counts < 5 CTCs had significant longer survival rates than patients with more than 5 CTCs. Furthermore, Theil et al. demonstrated that the captured CTCs could be characterized on a molecular level. The investigators detected tumor-associated transcripts of epidermal growth factor receptor (EGFR) and prostate-specific membrane antigen (PSMA) in patients with metastatic PCa in 42.8% and 14.3% of the analyzed samples, respectively. The above data was generated to demonstrate to the Federal Institute for Drugs and Medical devices (Germany, BfArM) the safe and effective use prior to in vivo application of the GILUPI CellCollector® in this indication. Further studies are ongoing to validate this finding as further diagnostic tool in the treatment of patients with prostate tumors.
The scientific paper entitled "The Use of a New CellCollector to Isolate Circulating Tumor Cells from the Blood of Patients with Different Stages of Prostate Cancer and Clinical Outcomes - A Proof-of-Concept Study.” by Theil et al., was published in PLoS One., 11(8):e0158354. doi: 10.1371/journal.pone.0158354. eCollection 2016. (1th August 2016).
GILUPI GmbH Receives ISO 13485 Certification for Manufacturing and Distribution of Cell Separation Devices
After the 68th AACC Annual Scientific Meeting & Clinical Lab Expo (AACC), GILUPI GmbH announces that it has received EN ISO 13485 certification for its German operations. This ISO 13485 certification is an important milestone in the development of the GILUPI GmbH medical device and downstream in vitro diagnostics (IVD) business, particularly in the fields of liquid biopsy, molecular diagnostics and clinical oncology.
Dr. Jens Pfannkuche, Managing Director of the GILUPI GmbH, commented: “This is an important step forward for the further growth of our business. Our ISO 13485 certification now allows us to seek market clearance and approval for our liquid biopsy CE-marked medical devices in regulated markets and to manufacture in vitro diagnostic kits for downstream molecular diagnostics. Our lead product, the GILUPI CellCollector® Detektor CANCER01 is already being adopted in clinical practice to accumulate circulating tumor cells (CTCs) in the European Union. Together with our partner company Hebei Viroad Biotechnology Co., Ltd. located in China, we are also very excited about achieving Chinese Food and Drug (CFDA) clearance in the near future for oncology use. The certification enables us to fully leverage our current and future B2B channels in Pharma and Diagnostics by broadening their trail protocols and product labels including CTCs next to cell-free tumor DNA and FFPE tissue for their oncology and product pipeline. We expect the emergence of future IVD molecular diagnostic kits referring to our CTC enrichment device due to increased sensitivity for downstream mutation analysis and subsequent selected therapies.”
GILUPI Strengthens Executive Team - Appoints Dr. Jens Pfannkuche as General Manager
GILUPI GmbH, a developer and manufacturer of medical devices to enrich circulating tumor cells (CTCs) in the human blood stream, announces that Dr. Jens Pfannkuche has been appointed to the position as General Manager of the GILUPI GmbH effective July 2016.
Previously, Dr. Pfannkuche worked in research and development, regulatory affairs, clinical studies, business development and licensing in the medical device industry including B.R.A.H.M.S - part of Thermo Fisher Scientific. Most recently, he served in various functions at B.R.A.H.M.S - part of Thermo Fisher Scientific and as Vice President Clinical Business Development and Regulatory Affairs at BRUKER Daltonik GmbH, where he carried global responsibility for the IVD product line regarding the clinical business development and licensing and the regulatory market access. Dr. Pfannkuche also led the MALDI mass spectrometry Imaging business entering the clinical pathology market. Dr. Pfannkuche studied Biology at the University of North West Wales /UK and University of Otago / NZ and did his doctoral thesis in vibrational spectroscopy at the Polish Academy of Science. He has more than 15 years of experience in the field of implantable medical devices and in vitro diagnostic products in ophthalmology, oncology, infectiology and cardiovascular indications, and has been active in global clinical development and business-to-business licensing and deal-making projects with global medical device and IVD companies.
“I am proud to be part of GILUPI and to enable leveraging GILUPIs potential in liquid biopsy technology for the clinical, industrial and research markets”, says Jens Pfannkuche. “In light of my experience and network in the diagnostic industry regarding break-through technology, I foresee that GILUPI will play a major role in the growing circulating tumor cell market to serve patients with less invasive, cost effective diagnostic solutions in the near future. I would like to thank the shareholders for their trust and I am looking forward to fully utilize the commercial potential of GILUPI in this attractive and growing market“.
First Chinese and further European patent for GILUPI were granted in 2016
GILUPI detection device for in vivo and/or in vitro enrichment of sample
GILUPI GmbH announced today, that the company received the first Chinese and another European patent protecting the unique and innovative GILUPI technology.
The Chinese patent (ZL201080027208.2) as well as the European patent (EP2442726 B1) titles “detection device for in vivo and/or in vitro enrichment of sample material” describes a functionalized structured medical wire for the accumulation of sample material. The device comprising a biocompatible polymer and a functional surface equipped with detection receptors which for example enables the isolation of cells directly from the blood of patients (in vivo). This patented technology is already being used in clinical settings on national and international level.
The recently received patents are an important supplementation of GILUPI`s intellectual property portfolio. Thus, the company has a broad and strong intellectual property position required to run the GILUPI businesses. GILUPI has filed further patent applications that are currently subject to examination procedures for a number of inventions, hence further granted patents will follow soon.
Change in management at GILUPI GmbH
Alexander Herrmann starts as new managing director at the medical device company
With immediate effect, Alexander Herrmann will be responsible as managing director of medical device company, located in Potsdam and Greifswald. He succeeds Klaus Lücke, who is leaving GILUPI after more than 10 years to move on to new professional challenges. Having a master degree in Business Administration, Alexander Herrmann (43) counts many years of experience in leadership at biotechnology companies. He is supposed to speed-up the GILUPI CellCollector® marketing as well as the necessary restructuring of the company.
Mr. Herrmann commented: “The GILUPI CellCollector® is a unique and innovative product. Our target for the coming months is to enhance the GILUPI CellCollector® application by adding further molecular analytical tools, thus making the application even more valuable for our customers. Moreover, we will upscale our production capacity in Greifswald and complement our team by additional experts.
GILUPI participates in European consortium „CANCER-ID“ to validate blood-based biomarkers for cancer
Blood-based biomarkers such as circulating tumor cells (CTCs), circulating free tumor DNA (cfDNA) and microRNAs (miRNAs) are established indicators of tumor burden in cancer patients. Assessment of these markers from blood provides an invaluable tool for modern cancer therapy.
In addition to being of high importance when biopsies of the original tumor are not accessible, blood-based liquid biopsy tests allow for close follow-up of disease markers to monitor treatment efficacy and potentially improve the choice of treatment options.
CANCER-ID is a newly formed European consortium funded by the Innovative Medicines Initiative (IMI) comprised of 33 partners from 13 countries focused on establishment of standard protocols and clinical validation of blood-based biomarkers (EGFR and HER2) in NSCLC and HER2-therapy resistant metastatic breast cancer.
The consortium brings together experts from academic and clinical research, innovative Small-to-Medium sized Enterprises (SMEs), diagnostics companies and the pharmaceutical industry - thus providing a unique setting for expanding the clinical utility of liquid biopsies. The project is supported by a substantial budget of EUR 14.5 million provided by industry partners (8.2 million EUR) as well as the IMI Joint Undertaking (EUR 6.3 million).
The academic leads of the CANCER-ID consortium are Prof. Klaus Pantel, Head of the Department of Tumor Biology at the University Medical Center Hamburg-Eppendorf, Germany, and Prof. Leon Terstappen, Head of the Department of Medical Cell Biophysics at the University of Twente, The Netherlands. Both are leaders in the field and have an impressive track record in basic research and applied science including device development. The EFPIA lead companies of the CANCER-ID consortium are Bayer HealthCare and Silicon Biosystems, a Menarini Group Company.
Klaus Luecke, founder of GILUPI commented: “This project is a major step for GILUPI, as it will demonstrate the superior performance of GILUPI technology in the isolation of CTCs for testing and monitoring of cancer patients. The isolation and subsequent characterization of blood-based biomarkers will become increasingly important as a method to monitor disease progression and therapy response. We believe that the liquid biopsy approach - with less-invasive and more frequent testing - will soon become part of the clinical routine for the benefit of a wide range of cancer patients.
GILUPI investor Hebei Viroad Biotechnology Co. Ltd. inaugurated ca. 2000 square meters of cutting-edge laboratory facilities in Shijiazhuang, China to produce the GILUPI CellCollector™ for the Asian market
Ray of hope for pancreatic cancer care
GILUPI collaborates successfully with EKF Diagnostics Holdings to detect gene mutations
First Molecular Mutation Analysis of CTCs isolated with the GILUPI technology
Neue Server-Infrastruktur für GILUPI in Potsdam und Greifswald
Image: GILUPI GmbH, Fujitsu Technologies, "microscope" by University of Liverpool Faculty of Health & Life Sciences
GILUPI was nominated for the CAI- Future award of the state of Brandenburg