GILUPI extends Patent Portfolio - New European Patent granted
GILUPI GmbH announced that the company was granted a European patent protecting the unique and innovative GILUPI technology for the capture of circulating cancer cells (CTCs) and further applications.
The European Patent Office (EPO) issued patent EP2807979 B1 entitled “Detection device for in-vivo and/or in-vitro enrichment of sample material”. The patent describes a functionalized structured medical wire for the enrichment of sample material. The technology is already being used in clinical settings on national and international levels.
”With the issuance of this new European Patent we are further strengthening GILUPI’s superior intellectual property position in the area of CTC enrichment. The commercialization of this IP is already ongoing and we will continue to leverage our IP with new products that are currently in development.” said Dr. Christian Jurinke, CEO of GILUPI.
GILUPI´s patent portfolio consists of 11 patent families and further patent applications that are currently subject to examination procedures for a number of inventions.
New study extends application range of GILUPI CellCollector® towards quantitative analysis of gene expression in circulating tumor cells
GILUPI announces the publication of a peer reviewed study about a new and promising mRNA-based assay that allows detection and quantification of clinically relevant prostate and pancreas cancer markers in circulating tumor cells (CTCs).
CTCs are a surrogate marker for cancer progression and response to therapy. CTCs indicate tumor cell spreading and are a prerequisite for the development of metastasis. Detection and characterization of these rare cells could provide a powerful approach for early disease diagnosis as well as disease monitoring. The GILUPI CellCollector® offers medical personnel at any point-of-care with the unique opportunity to enrich these CTCs in vivo.
In this peer reviewed study, El-Heliebi from the Medical University of Graz and his coworkers combine the enumeration and expression analysis of CTCs by developing an in situ padlock probe assay. This method enables the quantitative analysis of mRNA expression for therapy relevant cancer markers. For this study, the GILUPI CellCollector® was applied to patients with prostate and pancreatic cancer and subsequent CTC enumeration and detection of mRNA transcripts were conducted by fluorescence microscopy.
In summary, CTCs were detected in 62% of prostate cancer and 47% of pancreatic cancer patients and therapy relevant cancer markers (e.g. AR-V7 transcripts or KRAS mutations) were identified in the majority of those cells.
This advanced approach will improve the predictive and prognostic value of CTC analysis in clinical practice and therefore lead to further advances in cancer research and patient care.
 El-Heliebi et al. " In Situ Detection and Quantification of AR-V7, AR-FL, PSA, and KRAS Point Mutations in Circulating Tumor Cells” Clin Chem. 2018 Jan4. pii:clinchem.2017.281295. doi: 10.1373/clinchem.2017.281295.
Appointment of Dr. Christian Jurinke as CEO completes
Management Team of GILUPI
GILUPI GmbH announces that Dr. Christian Jurinke is appointed to the position of CEO and together with Alexander Herrmann is now managing the company.
Alexander Herrmann, Managing Director of GILUPI, stated „Dr. Jurinke is an accomplished expert when it comes to the development and commercialization of innovative products in the field of cancer molecular diagnostics. Together with Dr. Jurinke we feel well prepared for future projects such as extending our solution platform or further internationalization of our GILUPI CellCollector®."
Dr. Jurinke has about 20 years of biomedical industry experience in technical and commercial positions. Starting his industry career as a Senior Scientist for Sequenom in Germany, Dr. Jurinke then moved to the USA to serve as Director Product Development and later Director Product Management for Sequenom. He returned to Germany to assume a role as Director Product Management, for start-up Caprotec Bioanalytics, from where he later joined Stratec Molecular as Managing Director. Dr. Jurinke holds a diploma in Biochemistry and Molecular Biology from the University of Hamburg and a doctoral degree in Biochemistry also from the University of Hamburg.
“I am excited and honored to be part of GILUPI a leading company in the field of cancer cell isolation. With the approval of the GILUPI CellCollector® by the European and Chinese authorities we have a strong foundation to build on,” said Dr. Jurinke. “Together with the great and passionate team here at GILUPI we will further extend this platform and develop and commercialize clinically relevant downstream applications for the benefit of cancer patients.”
Molecular characterization of Circulating Tumor Cells isolated with GILUPI technology from prostate cancer patients – A new promising diagnostic approach
GILUPI GmbH announces the recent publication of a clinical study demonstrating multiplex gene expression profiling of circulating tumor cells (CTCs) isolated in vivo from high-risk prostate cancer patients by the use of GILUPI CellCollector® .
Prostate cancer is a very common cancer and accounts for one of the most related cancer deaths among men. About 15%-30% of patients with prostate cancer are diagnosed with high-risk disease, often treated with local therapy. Nevertheless, the incidence of a relapse or a metastatic disease stresses the need for optimizing the treatment. The researcher Markou and colleagues from the University of Athens in Greece investigated, if combination of in vivo CTC isolation with downstream RNA analysis can be a useful tool to optimize individual treatment of high-risk prostate cancer patients. Therefore, EpCAM-positive CTCs were isolated in vivo using the GILUPI CellCollector® from 105 high-risk prostate cancer patients. Additionally, a group of 36 healthy volunteers were enrolled as noncancerous controls. For molecular characterization of CTCs the researcher developed a multiplex RT-qPCR assay for 14 genes, including epithelial markers, stem cell markers and epithelial-to-mesenchymal-transition (EMT) markers.
For the first time, a publication of a clinical study presented RNA analysis of in vivo isolated CTCs in cancer patients. They observed a high heterogeneity in gene expression in the captured CTCs for each patient. The expression of at least one marker was detected in the vast majority of enrolled prostate cancer patients (70.5%), but not in healthy individuals. Moreover, at least 2 markers were positive in 45 of 105 patients (40.9%), and 3 markers in 16 of 105 patients (15.2%). More importantly, they observed a change of marker expression before and after treatment. In conclusion, combining in vivo isolation of CTCs using GILUPI CellCollector® with downstream RT-qPCR assay is a minimal-invasive, highly specific and sensitive approach for molecular diagnostics in cancer patients.
Markou et al. "Multiplex Gene Expression Profiling of In Vivo Isolated Circulating Tumor Cells in High-Risk Prostate Cancer Patients.“ Clin Chem. 2017 Nov 9.pii:clinchem.2017.275503. doi:10.1373/clinchem.2017.275503.
Early lung cancer screening with CTC detection using the GILUPI CellCollector® and Low-Dose Computed Tomography
GILUPI GmbH announces the release of a scientific article about the detection of circulating tumor cells (CTCs) from blood of different groups of pulmonary disease patients by the use of GILUPI CellCollector® .
Lung cancer is worldwide the most common cause of cancer-related death in men with a five-year survival rate lower than 20%. Two of three lung cancer patients have an advanced stage disease at initial diagnosis. Cancer mortality might be reduced dramatically, when the disease and its metastatic spread are detected and characterized early on and consequently treated in an optimal fashion. Yutong He and colleagues from the Fourth Hospital of Hebei Medical University in China investigated if combining to methods – Low-Dose Computed Tomography (LDCT) and enumeration of CTCs using the GILUPI CellCollector® - improves early detection of lung cancer. To explore the effectiveness of combined methods, 8313 volunteers were screened by LDCT: 32 ground-glass nodules (GGNs) and 19 healthy volunteers were randomly selected. Additionally, 15 lung cancer patients were enrolled. In the selected cohorts, CTCs were detected with the GILUPI CellCollector®.
In this study, about 73% of the lung cancer patients were detected as CTC positive. Detection rate of CTCs in GGN patients, a cohort that has a 5 to 10% risk to develop lung cancer in future, was lower (16%) when compared to the lung cancer group, but higher than in the healthy control group, where not CTCs were detected. Moreover, all CTCs isolated from GGN patient were analyzed with next-generation sequencing (NGS), finding mutations in three cancer-related genes (KIT, SMARCB1 and TP53 genes). In conclusion, the clinicians showed that combining LDCT with CTC analysis using the GILUPI CellCollector® is a promising way to screen for early-stage lung cancer.
 He et al. " Using the New CellCollector to Capture Circulating Tumor Cells from Blood in Different Groups of Pulmonary Disease: A Cohort Study.” Sci Rep. 2017 Aug 25; 7(1):9542. doi: 10.1038/s41598-017-09284-0.
GILUPI will attend at the ACTC congress in Rhodes
GILUPI GmbH is pleased to announce its participation at the 2017 ACTC (Advances in Circulating Tumor Cells) congress.
The 3rd ACTC meeting will take place from 4th to 7th October in Rhodes, Greece and is focused on “Liquid Biopsy in clinical practice”. This congress brings together researchers, clinicians and companies, to discuss practical implementation of CTCs (circulating tumor cells) and ctDNA (circulating tumor DNA) and translate much of the excellent basic research in this field into clinical practice.
GILUPI will use this opportunity to present interim data from a clinical trial at the SRH Wald-Klinikum Gera - a certified lung cancer center in Germany. The clinical investors Dr. med. habil. Thomas Lesser and Dr. med. Julia Herrmann using the GILUPI CellCollector®, to monitor CTC counts before and after surgery in non-small cell lung cancer (NSCLC) patients. First results from 20 patients show that CTCs were isolated independent from cancer grade and could even be detected in quite early tumor stages. The difference between CTC occurrence before and after surgery suggested the possibility to identify patients responding to therapy or patients with stable disease. Moreover, a correlation between CTC numbers and clinical lack of recurrence was observed. In addition, patients were tested positive for PDL1 (Programmed death-ligand 1 / CD274) expression in CTCs.
The poster presentation will take place on Thursday 5th of October at 3.30 pm - 4.30 pm. You are invited to meet Dr. Johanna Schiller from the GILUPI R&D department.
In vivo detection of CTCs in head and neck cancer patients using the GILUPI CellCollector®
GILUPI GmbH announces the recent publication of a clinical study demonstrates the isolation of circulating tumor cells (CTCs) from blood of squamous cell carcinoma of head and neck (SCCHN) patients with the GILUPI CellCollector® .
Isolating and analyzing CTCs from the blood of cancer patients can provide additional information on prognosis, course of disease, treatment efficacy and molecular tumor evolution. CTC detection is challenging due to their extremely low frequency amongst millions of leucocytes and billions of red blood cells. Especially in SCCHN, the sensitivity of CTC isolation with conventional in vitro methods is low and insufficient to satisfy clinical requirement. Zhang and further colleagues from the Nanjing Tongren Hospital in China wanted to overcome this limitation by using the in vivo GILUPI CellCollector® technology. Therefore, from November 2016 to April 2017 the clinicians enrolled 22 newly diagnosed SCCHN patients as well as 9 healthy volunteers.
Published data are already available for CTC isolation using the GILUPI CellCollector® technology in patients with prostate cancer, neuroendocrine tumors, metastatic breast and lung cancer with high positivity rates (54 – 97%). In addition, this Chinese study revealed for the first time, a high incidence of CTCs in patients with squamous cell carcinoma of head and neck. In total, 72.7% (16/22) were positive for ≥ 1 CTC (range 1-17 cells). The CTC detection rate was higher in patients with late stages than in patients with early stages. More importantly, CTC number changes as a marker for analyzing surgical response was tested. Zhang et al. showed that positivity rate decreases from 72.7% with median CTC number of 2 before surgical treatment to 46.7% with median CTC number of 0 after surgical treatment. Moreover, the expression of a therapy relevant oncogene (EGFRVIII) was detected on CTCs and this positive expression was also found in both primary and metastatic tumor tissue. These data revealed that an in vivo detection of CTCs had high sensitivity in SCCHN, which might improve CTC application in clinic.
 Zhang et al. "Enumeration and molecular characterization of circulating tumor cell using an in vivo capture system in squamous cell carcinoma of head and neck.” Chin J Cancer Res. 2017 Jun;29(3):196-203. doi: 10.21147/j.issn.1000-9604.2017.03.05.
Detection of circulating tumor cells in breast cancer patients using the GILUPI CellCollector®
GILUPI GmbH announces that a scientific article about a multicenter, clinical trial in China has been published in the current issue of "National Medical Journal of China". The scientific paper demonstrates the isolation of circulating tumor cells (CTCs) from blood of breast cancer patients with the GILUPI CellCollector® .
Isolating and analyzing CTCs from the blood of cancer patients can provide additional information on prognosis of patients, treatment efficacy and molecular tumor evolution. Li and further colleagues from four different cancer centers in China investigated the prognostic relevance of CTCs in metastatic breast cancer (MBC). For this purpose the unique and innovative GILUPI CellCollector® in vivo technology was included in this clinical trial.
From April to August 2016, 127 patients diagnosed with metastatic breast cancer and 63 patients diagnosed with benign breast disease were enrolled. MBC patients received a GILUPI CellCollector® application before treatment and approximately 4 weeks after starting treatment, while benign patients had one GILUPI CellCollector® application.
Published data are already available for CTC isolation using the GILUPI CellCollector® technology in patients with prostate cancer, neuroendocrine tumors and lung cancer with high positivity rates (54 – 97%). In addition, this chinese study revealed for the first time, a high incidence of CTCs in newly progressive metastatic breast cancer patients. In metastatic breast cancer group 74.8% were positive for CTCs and the number of CTC detected in the benign group was 0 in each case. More importantly, CTC rates detected by the GILUPI CellCollector® displayed a decrease after 4 weeks treatment to 45% positivity rate. Li et al., showed also that the captured CTCs could be characterized on a molecular level. In conclusion, the researchers revealed a high specificity and sensitivity of CTCs as prognostic value.
 Li et al. " Circulating tumor cells in patients with breast tumors were detected by a novel device: a multicenter, clinical trial in China”, Zhonghua Yi Xue Za Zhi. 2017 Jun 27;97(24):1857-1861. doi: 10.3760/cma.j.issn.0376-2491.2017.24.003. Article in Chinese; For English version please contact GILUPI
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