Oncgnostics GmbH is greatly honoured to have been selected by EURONEXT for the TechShare programme. We will be participating in top-class workshops and coaching sessions for half a year.

High-quality Coaching for Start-ups

As one of eleven German start-ups in the medical and biotech sectors, we will have the opportunity to broaden our horizons over the next six months. We will learn how a potential IPO should be prepared, and for which companies it can be useful. In addition, we can look forward to high-quality coaching directly at our premises in Jena. With the acquired knowledge, we will be able to constantly work on and strengthen our company strategy.

Learning from the Success of Others

Euronext TechShare Campus 2019 Rotterdam | photo: Robert Tjalondo © | www.rockinpictures.com

Dr Peter Haug, Head of Business Development & Licensing at oncgnostics, was present at the Kick-off Campus Erasmus Centre for Entrepreneurship at the University of Rotterdam. The extensive programme was supported by top speakers such as Onno van de Stolpe, CEO and founder of Galapagos NV. The Belgian drug research company was founded in 1999 and successfully went public just six years later: ‘It is very inspiring to hear about the success stories of former start-ups,’ says Dr Peter Haug, describing van de Stolpe’s presentation. ‘In addition, EURONEXT has put together a fascinating selection of high-profile European start-ups. I already knew some of them before, and look forward to networking with the others, all of whom are facing similar next steps and challenges as we are at oncgnostics GmbH.’

After the kick-off in Rotterdam with around 150 international participants, they will continue in different groups. Oncgnostics GmbH will participate in four workshops in Munich, together with six other companies from the Biotech and Medtech sectors. Next spring, all participants will meet in Lisbon for the closing event.

On 12 June, the conference ‘XIII Jornada de Formación en Patología del Tracto Genital inferior y Colposcopia‘ was held in Madrid. Oncgnostics’ managing director Dr Alfred Hansel was one of the speakers at the training event for gynaecologists.

Experts Exchange Knowledge

At the conference, experts updated their knowledge on HPV-related cancers in women’s genital tract. In his lecture, Dr Alfred Hansel described possible cervical cancer diagnostics that go beyond HPV testing. In addition, the participants were able to join various workshops, such as colposcopy courses. Furthermore, the participants had the opportunity to visit the NIMGenetics, distributor of GynTect® in Spain, booth at the industrial exhibition event, and inform themselves about the test.

On 18 June oncgnostics managing director, Dr Alfred Hansel, visited Investor Days Thüringen in Erfurt, and was pleased to receive the ‘bm|t sustainable business award’.

Thuringia’s Sector Network Meeting

As a large sector network meeting, Investor Days bring together the different parties involved: Young companies, investors, decision makers and representatives from economy, science and politics. Selected formats and an entertaining evening programme encourage visitors to get to know each other and exchange knowledge.

Meet the Rising Stars

During the so-called ‘Meet the Rising Stars’, Oncgnostics GmbH presented itself. Managing Director Dr Alfred Hansel presented the current developments of the company to the audience in a 7-minute pitch.

The surprise of the day was the awarding of the ‘bm|t sustainable business award’ to oncgnostics GmbH: ‘We are delighted to receive this award,’ says Dr Alfred Hansel, ‘especially since we did not expect it at all. Thank you very much!’

About Investor Days

The Investor Days Thüringen is an initiative of the Foundation for Technology, Innovation and Research Thuringia (STIFT) and the beteiligungsmanagement thüringen gmbh (bm|t) to bring together innovative start-ups and growth companies with potential cooperation or business partners, as well as investors and business angels.

The International Congress on Innovative Approaches in Head and Neck Oncology (ICHNO) took place, for the seventh time, in Barcelona from 14 to 16 March. Anna-Bawany Hums participated in the interdisciplinary exchange of experts on behalf of oncgnostics GmbH.

Specialists from all over the World

Among the approximately 600 international participants, there were clinicians from various disciplines, as well as representatives from the research field. This year, the focus of the specialist lectures was on the presentation of results of current researches on Carcinogenesis: The spread of the disease, the application of different therapeutic approaches, and treatment strategies for head and neck tumours, as well as background and state of research in Radiation Oncology.

ICHNO 2019 in Barcelona

Interactive Event

The fact that the exchange between experts in Barcelona is very important was demonstrated by, for example, the so-called active tumour board. At the event, all participants were invited to discuss a real (but already closed) case. Using an online voting system, medical professionals were able to decide to use different treatment methods at certain points during the presentation of the case. The result reflected the implementation of various therapeutic approaches and the increasing use of new therapeutic strategies. However, there were also panel discussions and poster exhibitions.

Head and Neck Tumours in Research

‘Such an interdisciplinary exchange opens up new perspectives on our work,’ states Anna-Bawany Hums. ‘In addition, the congress once again confirmed that biomarkers for the detection of malignant cells would offer many advantages for the affected patients, as a complement to current treatment strategies,’ continued the biologist with regard to the current research being conducted at oncgnostics, adding that ‘a cancer test for the detection of head and neck tumours such as the one we are developing requires only a saliva sample. For affected patients, this is a very gentle method for the clarification of cancer.’

Focus on the Oncological Patient

Fira de Barcelona - Veranstaltungsort der ICHNO 2019

Fira de Barcelona – Veranstaltungsort der ICHNO 2019

What does supportive care mean? What services do patients need, for example, to cope better with the side effects of cancer? The focus of the congress was not only the

disease, but also the patient: ‘The topic was particularly vivid at an event in which a patient reported on her medical history. She talked about how doctors informed her about her disease, what helped her after therapy, and what she would have liked in doctor-patient communication. It was quite enlightening,’ Anna-Bawany Hums says.

From the 9 to the 16 In February, our managing director Dr Martina Schmitz travelled to India as a participant of the delegation trip ‘Thuringia goes India’. There she got an impression of the Indian market and made first contacts. The trip took place under the direction of Wolfgang Tiefensee, Thuringia’s Minister for Economic Affairs, Science and Digital Society.

From Pune to Mumbai

Dr Martina Schmitz faced a tight programme at four cities in only one week. From New Delhi to Pune, Coimbatore and finally Mumbai. Her itinerary started in the north and continued in the south of India, returning to the north again. Together with the other participants, our managing director visited medium-sized companies, and took part in various round tables and receptions, such as those organised by the Federation of Indian Chambers of Commerce and Industry (FICCI). Dr Martina Schmitz also visited two hospitals in Pune to have the Indian healthcare system explained to her.

Promising Contacts with Indian Companies

Representatives of Indian companies met representatives of Thuringian companies in the so-called round tables. Some of the meetings were organised in advance, but many contacts also came about spontaneously. ‘I was able to have some promising conversations’, says Dr Martina Schmitz, ‘now, back in Germany, these contacts should be checked and a follow-up should be agreed on.’

India: A Country Full of Contrasts

Dr Martina Schmitz was impressed by the different worlds that meet in India: ‘On the way to a company I drive along an alley full of people. Power cables are laid open next to the houses. There is rubbish on the street. Then I reach my destination, enter the building, and I find myself inside a glamorous office.’ Tradition and modernity also coexist closely in India. Not only during temple visits did the travellers get a Bindi, a dot pressed on their foreheads, but also during business appointments: ‘This trip provided me with a good insight of the Indian market. I am looking forward to strengthening the contacts I have established’, summarises Dr Martina Schmitz on the results of the India trip.

Oncgnostics will discuss new clinical data with gynaecological key opinion leaders at EUROGIN 2018

SAN FRANCISCO, CA, USA, November 29, 2018 — Oncgnostics GmbH presents new clinical data on GynTect® Precision Diagnostics for triage of unclear cervical cancer screening tests.

Oncgnostics GmbH, a Jena/Germany based company, has developed GynTect® for precision detection of cervical cancer. GynTect® was tested and validated in clinical trials on more than 3,000 samples with a remarkable detection score of 100% in all cervical cancer cases. Moreover, GynTect® identifies all relevant pre-cancerous lesions due to its first-of-a-kind prognostic value.

“We have concluded further clinical trials on the performance of GynTect® in comparison to alternative cervical cancer triage approaches. These results are very convincing and we are happy to present them in 5 talks at the EUROGIN 2018 conference in Lisbon next week”, states Dr. Alfred Hansel, Oncgnostics Chief Executive Officer.

Together with CSO Dr. Martina Schmitz and three Oncgnostics R&D specialists for cervical cancer and head-and-neck cancer diagnostics, Oncgnostics will discuss the new clinical data with gynecological key opinion leaders at Oncgnostics booth for precision cancer diagnostics.

Oncgnostics technology has been exclusively licensed out in 2017 to Sinopharm Group for the greater China region.

Biotech Alliances International Inc., a Silicon Valley-based healthcare-focused investment bank, is serving as the lead investment banker to Oncgnostics globalization and partnering strategy. Meetings with Oncgnostics Management Team can be coordinated at EUROGIN 2018 or JPM2019.

 

About Oncgnostics GmbH

Oncgnostics GmbH, founded in early 2012 as a spin-off from the Jena University women’s hospital, is a molecular diagnostics company specializing in cancer diagnostics. Oncgnostics tests target epigenetic changes, so-called DNA methylations, that typically occur in cancer cells. The patented biomarkers, which are evaluated using a specific algorithm, are the core of the products and provide the basis for the company’s activities.

About Biotech Alliances International Inc.

Biotech Alliances International Inc. is a San Francisco-based investment bank serving life sciences companies, private equity, and venture capital funds. It provides independent financial and strategic advice including corporate finance, mergers & acquisitions, partnering & licensing, and strategic consulting.

Dr. Franck Brinkhaus
Biotech Alliances International Inc
+1 650-868-8511

The oncgnostics managers together with Geneo Dx managers and colleagues.

Dr. Martina Schmitz and Dr. Alfred Hansel, our CSO and CEO, have just come back from a visit in China, with days full of exciting events, dates and a few hours for sightseeing.

Shanghai at night

Shanghai at night

 

 

 

 

 

 

 

 

Shenzhen – Finals of the “Innovation & Entrepreneurship International Convention (IEIC)”

Having reached a second place at the European finals in Berlin, we were invited to participate in the IEIC Shenzhen. There, Alfred Hansel had the opportunity to present oncgnostics, to visit several science and technology parks and incubators, and to discuss cooperation options.

Shanghai – China International Medical Equipment Fair (CMEF)

Whereas Alfred Hansel visited Shenzhen, Martina Schmitz attended the international tradefair for medical technology CMEF in Shanghai. More than 4,000 exhibitors showed their latest developments and newest products to ca. 500,000 visitors. The chinese oncgnostics partner GeneoDx also had a booth – and presented our test GynTect!

CMEF

Luxiang Cheng, Business Development Manager at GeneoDx, and Dr. Martina Schmitz in front of the GynTect Roll-Up

 

 

 

 

 

 

 

 

 

Visit at GeneoDx

Finally, Martina Schmitz and Alfred Hansel visited our license partner GeneoDx. The contract for the exclusive cooperation concerning GynTect was signed a year ago, when GeneoDx still had its old name CJMT. Along with the renaming, GeneoDx moved to new facilities in Shanghai.

In the new facilities, GeneoDx has established the production of GynTect, and the CFDA has approved this production. Now GeneoDx will have to perform trials that are required in order to get final approval for the test. We discussed the trial design, in order to help GeneoDx design a trial protocol that may be discussed with the authorities. We also discussed options for further cooperation beyond GynTect.

„We could spend a lot of time with our partners at GeneoDx, and we were glad to meet some of the people again whom we had shown how to produce and how to perform GynTect last year in our labs. It was exciting to visit their new research labs as well as the GynTect production facility“, Martina Schmitz said.

The oncgnostics managers were then invited to get a taste of the typical Chinese cuisine, before they took their way back to Germany after some really exciting days.

Traditional Chinese Meal with the Colleagues from Geneo Dx.

Traditional Chinese Meal with the Colleagues from Geneo Dx.

Portugal Partnership

Lisbon/Jena, April 16th 2018 – Speculum S.A. is the exclusive licence partner of oncgnostics GmbH for the screening test GynTect® in Portugal. The test is designed to further specify abnormal results in screening examinations and to help determine the best treatment approach.

 

In January, the biotech firm oncgnostics GmbH from Jena (Germany), concluded an exclusive sales partnership for the GynTect screening test in Slovakia and the Czech Republic. Now, Speculum S.A. in Portugal has become the newest sales partner to obtain an exclusive licence. As a result, Portugal becomes the fourth European country where GynTect will be offered.

 

Speculum S.A. is well positioned in Portugal

The Team of Speculum S.A. in Portugal

The Team of Speculum S.A. in Portugal. Source: Speculum S.A.

 

 

 

 

 

Speculum S.A. sells a range of medical devices focused on gynaecology. The firm is very extensively networked with professionals and leading figures in the area of women’s health. In addition, LAP Porto, the largest Portuguese diagnostic laboratory in the area of women’s health, cooperates with Speculum S.A.

Moreover, the company was mainly involved in the introduction of thin-layer cytology, an improved Pap smear method, which now has over 50% of the market share in Portugal. Since GynTect can be performed based on these improved Pap smears, the prospects are very good for the market introduction in Portugal.

 

GynTect provides rapid and reliable results

GynTect, the molecular biology test developed by oncgnostics, offers an early diagnosis for patients with abnormal Pap test results or evidence of human papillomavirus infection (HPV) to determine the presence of a treatable cervical cancer precursor and the likelihood of developing cervical carcinoma. The test provides rapid and reliable results and gives affected women certain guidance about how to proceed in the face of an abnormal prior examination in the best way. GynTect substantially simplifies risk assessment in the early detection of cervical cancer: on the one hand, it helps to avoid unnecessary premature surgery, and on the other hand, it can increase the chances for successful therapeutic interventions.

 

High death rates for cervical cancer in Portugal

The morbidity rate for cervical cancer in Portugal is higher than in Germany. In Portugal, 9 of 100,000 women develop the disease, compared to 8.2 per 100,000 in Germany. In Portugal, cervical cancer is the second-most common form of cancer among women between ages 15 and 44 years, whereas in Germany, the frequency of occurrence for women of this age puts is in 3rd place. However, the difference in death rates is far greater: in Portugal, 54% of all patients with cervical cancer die of the disease, whereas in Germany, the rate is about one out of three.

“By means of early recognition of cervical cancer, effective treatment can be performed and further complications can be prevented. With GynTect, we are counting on an effective measure in the fight against cervical cancer and its sequelae”, states Antonio Ferreira, Managing Director of Speculum S.A. in Lisbon.

 

Further partnerships planned

Europe-wide CE-IVD licensing for GynTect took place in 2015, opening the way to European partnerships. In the past year, oncgnostics also concluded an exclusive licensing agreement for the Chinese market with GeneoDx, a subsidiary firm of the state-owned Sinopharm Group.

Further partnerships for the internationalisation of GynTect are in negotiation.

 

 

 

About oncgnostics GmbH:

The oncgnostics GmbH was developed in 2012 from a university research group at the Jena University Gynaecology Department. As a molecular diagnostics firm, the Jena start-up has specialised in the early diagnosis of cancer. The tests demonstrate characteristic epigenetic changes in the cancer cells, known as DNA methylations. The patented biomarkers identified with specific algorithms form the central core of the products and are the foundation of the firm.

 

 

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and: www.oncgnostics.com/downloads

 

Medirex team in Bratislava

Jena, January 31th 2018 – oncgnostics GmbH partners with the MEDIREX Group. MEDIREX thus holds the exclusive rights for marketing the test for early and reliable detection of cervical cancer, GynTect®, for Slovakia and the Czech Republic.

 

Following their successful crowd-funding via the platform Seedmatch, oncgnostics GmbH takes the next step for internationalization: the company closed a partnership with the MEDIREX Group. The Slovak laboratory diagnostics group has more than 1700 employees, and is the biggest player in lab diagnostics, with >50% market share in the Slovak Republic. The contract has a term for three years, with option for extension.

 

GynTect gives certainty

The molecular test GynTect developed by oncgnostics helps to clarify early and reliably if a patient diagnosed with an abnormal Pap smear or/and with an HPV infection (already) has or develops a cervical precancerous lesion requiring treatment.

“With GynTect we intend to improve the quality of cervical cancer screening in the Czech and the Slovak Republic. GynTect provides fast and reliable diagnostic results and thus women who are affected, certainty how to proceed after abnormal findings from earlier diagnostic measures,“ Jozef Gavlas, CEO of MEDIREX Lab diagnostics states, said.

GynTect drastically improves the risk assessment in cervical cancer screening: on the one hand it allows to avoid hasty and unnecessary surgeries, on the other hand it increases the chance for early, successful treatment measures.

 

Cervical cancer in numbers: Germany, Czech Republic and Slovak Republic

In Germany, ca. 5000 women are diagnosed with cervical cancer every year. Thus 8.2 of 100,000 women get a diagnosis annually. In the Czech Republic and in Slovakia, the disease rates are much higher, at 14.1 and 16.1 of 100,000 women annually, respectively. In all three countries, every third woman with cancer diagnosis dies.

Regular participation of women in cervical cancer screening programs, which are offered in all three countries, may contribute to significantly reduce the morbidity. HPV-induced changes may be detected early, and appropriate measures may be taken. Nevertheless only ca. 50% of all women participate regularly in the annual screening in Germany and the Czech Republic. In Slovakia, where triennial cervical cancer screening is implemented, even less than 50% participate regularly.

 

Further partnerships are planned

GynTect already has CE IVD mark for use in laboratories Europe-wide. Thus, the MEDIREX group immediately may start distribution as well as the use of the test in its own labs. CE IVD mark was received in 2015. In 2017, oncgnostics was able to close an exclusive license agreement for marketing in China with GeneoDx, an affiliate of the governmental Sinopharm Group.

Further partnerships within and outside of Europe are currently negotiated, with the aim to conclude agreements in 2018. The crowd-funding campaign, which very recently was concluded successfully, provided oncgnostics with 750,000 €, which significantly will contribute to plan, negotiate and close further agreements.

 

About oncgnostics

oncgnostics GmbH is a spin-off from the university women’s hospital Jena and was founded early in 2012. As a molecular diagnostic company, oncgnostics is specialized on cancer diagnostics. Oncgnostics tests target epigenetic changes, the so-called DNA methylations, that typically occur in cancer cells. The patented biomarkers, which are evaluated using a specific algorithm, are the core of the products and provide the basis for the company’s activities.

 

 

Contact:

oncgnostics GmbH

Dr. Alfred Hansel

Geschäftsführer

Winzerlaer Str. 2 (Bioinstrumentezentrum)

DE-07745 Jena

Tel. +49 3641 508456

pr@oncgnostics.com

www.oncgnostics.com

 

Media Agentur

Tower PR

Mälzerstraße 3

07745 Jena

Tel. +49 3641 87611-80

oncgnostics@tower-pr.com

www.tower-pr.com

Dr. Xia Xiaokai and Dr. Alfred Hansel, chairman of oncgnostics GmbH. In the background: Yang Xiaoming, chairman of CNBG, Wolfgang Tiefensee, Thuringia's Minister for economics, Dr. Michael Brandkamp, chairman of the High-Tech-Gründerfonds sowie Peter Haug, oncgnostics. photo: Christoph Worsch

Jena, April 5th, 2017: The Chinese pharma company Changchun Jienuo Medical Technology (CJMT), a subsidiary of the Chinese state-owned SINOPHARM Group (www.sinopharm.com/en), has purchased an exclusive license from oncgnostics (www.oncgnostics.com) for marketing GynTect® in China, Hongkong and Macao. The contract comprising four milestones rules the approval of GynTect® at the Chinese Food and Drug Agency (CFDA) within the coming three years. Oncgnostics will receive upfront and milestone payments as well as royalties on future revenues.

 

During a visit of the Chinese partner in the science city Jena the contracts were signed in the presence of the Chairman of the Sinopharm Group, Mr. Jianxin Guo, and of Thuringia’s Minister for Economics, Science and Digital Society, Mr. Wolfgang Tiefensee. “oncgnostics constitutes an exciting example how research in Jena is the basis of a promising business model. The cooperation with the Chinese partner which includes the distribution of the triage test GynTect, is the right and important step for the internationalization of the enterprise and the exploration of the by far largest patient market. This case shows that it is worth to support substantial innovative foundings, which are a main focus of our economic policy”, Wolfgang Tiefensee explained during the signing ceremony.

 

The molecular diagnostic test GynTect (https://www.oncgnostics.com/gyntect-cervical-cancer/?lang=en) clarifies timely if a patient with abnormal Pap smear and/or positive HPV test result develops or already has a cervical cancer requiring treatment. GynTect provides fast and reliable results and thus certainty for women affected. Therefore, risk assessment in cervical cancer screening is significantly improved: on the one hand hasty and unnecessary surgeries can be avoided, on the other hand the chances for obtaining a successful treatment can be improved.

 

GynTect has received CE IVD mark for the EU market already in 2015. Together with its clinical partner at the University women’s hospital in Jena, oncgnostics has driven forward validation of the markers, development of the test format and CE IVD mark of GynTect, using more than 2,000 clinically well-characterized samples. Together with its new partner CJMT oncgnostics intends to enter the enormous market in China. Cervical cancer diagnostics based on HPV screening yields a market potential of >1 bn €.

 

In China, more than 550 million women aged >15 years are at risk of developing cervical cancer. “China has a very high demand for screening and triage tests. GynTect will help us to diagnose cervical cancer and its precancerous stages reliably, in order to prevent unnecessary surgeries and to detect malignant tissue alterations early,” Dr. Xiaokai Xia, director of the Chinese partner CJMT stated.

 

CJMT, a subsidiary of the China National Biotech Group (CNBG; http://en.cnbg.com.cn/html/about/show_1.html), is specialized on clinical diagnostics. Both companies belong to the governmentally held SINOPHARM group (www.sinopharm.com/en), which with more than 100,000 employees and more than $40 bn annual turnover constitutes one of the largest pharma companies world-wide.

 

The exclusive license contract was signed on 5th of April 2017 at the BioInstrumentation center in a top-class event. Wolfgang Tiefensee, Thuringia’s Minister for Economics, Science and Digital Society, welcomed the Chinese delegation comprising of 13 representatives. With Jianxin Guo, Chairman of the Sinopharm Group, Shengyi Shi, Vice President of Sinopharm Group and Xiaoming Yang, Chairman of CNBG, the top-level management of Sinopharm visited Jena. Besides the founders and the management of oncgnostics GmbH, the lead investors of the first two financing rounds High-Tech Gruenderfonds and beteiligungsmanagement thueringen GmbH, represented by their CEOs, Dr. Michael Brandkamp and Udo Werner, respectively, joined the signing ceremony.

 

About GynTect

In Germany 5000 new cases of cervical cancer are diagnosed, and approx.1600 women die from the disease annually. On the other hand, more than 200,000 women receive an abnormal result in the Pap smear diagnosis, the current cervical cancer screening method. Only a minority of these women, however, have a disease requiring treatment, as most of the diagnosed cervical dysplasias (cellular changes) will heal spontaneously. The early detection test GynTect yields fast and reliable results and thus certainty after an abnormal Pap smear and/or a positive HPV test result. GynTect may be performed on residual material from a cervical smear taken for liquid-based cytology. GynTect detects cancer cases with a sensitivity of 100% – all cancer cases included in studies so far yielded a positive GynTect result. The test is based on biomarkers that are present in cervical carcinomas as well as cervical dysplasias that develop into cancer.

 

About oncgnostics

oncgnostics GmbH is a spin-off from the university women’s hospital Jena and was founded early in 2012. As a molecular diagnostic company oncgnostics is specialized on cancer diagnostics. Oncgnostics tests target epigenetic changes, so-called DNA methylations, that typically occur in cancer cells. The patented biomarkers which are evaluated using a specific algorithm are the core of the products and provide thus the basis for the company’s activities.

 

About Sinopharm Inc. and CJMT

China National Pharmaceutical Group Corp. (CNPGC) known as Sinopharm is a Chinese state-owned enterprise. In 2015, Sinopharm Group had 104.464 employees, annual sales of more than $44bn and was ranked 205 in the global Fortune500 list (http://beta.fortune.com/global500/sinopharm-205).