10 November 2008
Indivumed receives research contract from FDA for drug safety assessment in cancer

10th of November 2008, Hamburg, Germany — Growth factor receptors serve as potential candidates for new and more specific anti-cancer drugs if differentially expressed between cancer and normal tissue. On the other side, growth factors and their receptors are also used to minimize side effects of cancer therapeutics, e.g. by stimulating hematopoietic cell proliferation for the treatment of chemotherapy induced anaemia. In both circumstances it is important to know about the expression level of these targets in cancer and normal tissue and their impact on cell growth.

Only in recent years, it has been widely recognized that processing of tissue can dramatically affect data about target expression. In particular, molecules that are related to low oxygen levels can be significantly up- or down regulated within the time interval between surgical tumor removal (disconnection of blood supply) and stabilization by freezing or chemical fixation.

The FDA has decided to use Indivumed’s resources to obtain clinically relevant data regarding target expression and for analyzing drug effects in viable cancer tissue. Within the scope of the FDA-funded research project Indivumed will analyze the safety pattern of clinically used drugs which are under suspicion to have serious side effects in cancer patients.

For Indivumed, this project is of special value. “Collaborating with the FDA, the world-wide leading regulatory institution for drug safety and drug approval and using our unique resource is obviously very meaningful to us. Thereby, we make an important step forward to get recognized as a research partner for target validation and drug development with the ultimate goal to improve cancer therapy” says Prof. Hartmut Juhl, founder and CEO of Indivumed.

31 July 2008
Georgetown University Medical Center Collaborates with Indivumed to Develop Cancer Research Database
Washington, DC—The field of personalized cancer research and treatment grows with each day. And a new collaboration with Washington’s largest biomedical research organization and an international research and biobanking company is contributing to that growth.

Georgetown University Medical Center announced today an agreement with Indivumed GmbH, based in Hamburg, Germany, which provides the foundation for the analysis of complex clinical molecular signatures from cancer patients, enabling researchers and physicians to better diagnose and tailor cancer treatments for individual patients.  This  arrangement builds upon a one-year agreement currently in place at Georgetown that established a high-quality tumor biobank and clinical database for pancreatic cancer and which now also includes cancer of the breast and colon.

The expanded collaboration will grow to include a clinical database of prostate, glioblastoma and renal cancer. Together, the institutions will work to establish a robust portfolio of research collaborations, supported by a state-of-the-art biobanking infrastructure and protocol, using Indivumed’s established scientific approach, and a multidimensional, integrated clinical and molecular database of cancer.

“Integrating scientific, medical, and technological expertise and assets will transform our ability to analyze complex clinical data relating to specific diseases, employing a more comprehensive, system-level approach to how we treat patients,” says Howard J. Federoff, MD, PhD, Executive Vice President for Health Sciences at GUMC. “We’re starting with cancer, and hope this kind of research will lead to better, more individually targeted treatments.”

The agreement will expand upon the Indivumed biobank protocol already begun at Georgetown University Hospital, expanding the collection, storage, analysis and utilization of biospecimens. This includes prospective and standardized collection of pre-, intra- and post-surgical patient data and biospecimen data by specially trained research associates, extracting clinical data from existing clinical systems, developing an enhanced collaborative relationship with the MedStar Health system, which owns and operates Georgetown University Hospital through a clinical partnership agreement with the university, and eventually developing partnerships with national health systems to establish a network of biobanking partnerships for specimen collection.

“Indivumed’s approach to standardized and high-quality biobanking and data management as a foundation for individualized medical treatment aligns well with GUMC’s approach to a database of cancer,” says Hartmut Juhl, MD, CEO of Indivumed and former GUMC faculty member.

The collaboration is a key step in the future development of the Georgetown Database of Cancer (G-DOC) at Lombardi Comprehensive Cancer Center at Georgetown. The G-DOC will be designed to marry clinical information from patients in clinical trials with molecular characteristics of their cancer. This effort will define the molecular features that underlie prognosis and responsiveness to therapy in patients, providing a basis for personalized medicine and a tool for target discovery and drug development.

“Georgetown—and its Lombardi Comprehensive Cancer Center—is committed to reducing the burden of human cancer through the discovery and early adoption of cutting-edge systems biology-based tools,” says Louis M. Weiner, MD, director, Lombardi Comprehensive Cancer Center. Lombardi is one of only 41 comprehensive cancer centers in the country and the only one in the Washington area. “Collaborating with a company with an established, successful research strategy such as Indivumed brings together the strengths of both institutions in order to achieve this goal.”

Indivumed is a privately owned company started by former Georgetown faculty member Hartmut Juhl (Dr. Juhl continues to hold an adjunct faculty appointment at the university but is not compensated by Georgetown). Indivumed also has partnerships with eight clinical cancer centers in Hamburg, Germany, to collect similar specimens. Indivumed also has offices in Kensington, Md.

About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO), home to 60 percent of the university’s sponsored research funding.

About Lombardi Comprehensive Cancer Center
The Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center and Georgetown University Hospital, seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Lombardi is one of only 39 comprehensive cancer centers in the nation, as designated by the National Cancer Institute, and the only one in the Washington, DC, area. For more information, go to http://lombardi.georgetown.edu.

15 January 2008
Indivumed appoints Harald Eistetter as Chief Business Officer and Managing Director

Hamburg, Germany, 15 January 2008 – INDIVUMED GmbH, the leading provider of products and services enabling the individualized diagnosis and therapy of cancer, today announces the appointment of Harald R Eistetter, PhD, as Managing Director and to the newly created position of Chief Business Officer.

Dr Eistetter, who has more than two decades of leadership experience in the pharmaceutical and biotech industry, will be responsible in particular for further developing and implementing INDIVUMED's corporate strategy and commercial potential. He joins from The Genetics Company Inc., a Zürich, Switzerland, based drug and diagnostics discovery company, where he served as Chief Executive Officer for the past six years. Dr. Eistetter started his professional career with Altana Pharma and subsequently held several senior and international management positions within Glaxo and BASF Pharma. His interests are in the fields of oncology and neuroscience and he received his PhD in Genetics from the University of Tuebingen, Germany in 1985.

"We are very pleased to welcome Harald to INDIVUMED, as he brings to the company an extensive network and a breadth of know-how in the life science industries" says Prof. Hartmut Juhl, Chief Executive Officer and Founder of INDIVUMED. “This will prove to be very helpful in our efforts to increasingly leverage our unique biospecimen platform-based products and services in the creation of high-value business relationships with leading pharmaceutical and diagnostic companies."

Dr. Eistetter said, "INDIVUMED has developed an impressive and demonstrable track record of accomplishments within a very short period of time. The company´s concepts towards fighting cancer based on individualized diagnosis and therapy are worldwide unique and have convinced me of its outstanding potential. I look forward to playing a leading role in further developing INDIVUMED into a major and worldwide player in the field of personalized cancer medicine."

September 2007
Indivumed supports Roche Diagnostics with immunohistochemistry services and clinical specimens for biomarker discovery and drug development
September 13th, 2007, Hamburg - Indivumed announces today that a service agreement with Roche Diagnostics GmbH was signed. Within this agreement Indivumed will apply its automated immunohistochemistry service platform for analyzing various biomarkers and drug targets in the area of oncology. Indivumed will provide for this project a selection of tumor tissue sections from its tumor biobank as well as specifically collected clinical samples. The analysis of specific biomarkers and drug targets should enable Roche to efficiently develop novel targeted therapies for cancer.

Indivumed is a privately held biotech company focused on the generation, characterization and analysis of highly standardized biological samples from human cancer. Founded in 2002 and headquartered in Hamburg, Germany with a subsidiary in Kensington, Maryland, USA, Indivumed has cooperation agreements with all major oncological hospitals in the Hamburg metropolitan area. Indivumed’s current tumor biobank of over 6500 patient-cases, collected with a mean cold ischemia time of less than eight minutes, serves as a resource for Indivumed’s internal cancer research in biomarkers and primary cell drug screening as well as for the use of pharmaceutical and biopharma partners through tumor biobank access and IHC services.

January 2007
Indivumed and Marien Hospital Cooperate in the Fight against Cancer
January 30, 2007, Hamburg, Germany – Marien Hospital and Indivumed agreed on a close cooperation to accelerate the development of new cancer therapies. The cooperation focuses on a comprehensive sample and data collection of cancer patients, in particular, lung and colon cancer. The Marien Hospital represents one of the best cancer therapy centers in Hamburg while Indivumed GmbH has developed a special technique for collecting tissue samples. Together with Indivumed´s unique database, this cooporation improves discovery opportunities for the development of new therapies.

Prof. Hartmut Juhl, founder and CEO of Indivumed GmbH is very happy that “ we can significantly expand our unique tumor biobank and database through the cooperation with the Marien Hospital and by doing so put our research and the research of our industrial and academic partners on a stronger, more broadly based foundation.” The Marien Hospital hopes for an improvement of cancer therapy in a not too distant future. Prof. Christian Müller, head of Visceral, Thorax and Vascular Surgery: “The special clinical data collection of Indivumed during clinical treatment and aftercare enhances the inclusion of individual differences of patients in cancer research that we know is necessary to develop more effective therapy.”

Indivumed has now cooperation agreements with eight hospitals including all major oncological hospitals in the Hamburg metropolitan area with overall 13 different departments.

August 2006
Cooperation with Tumor Center of Albertinen Hospital in Hamburg
August 15, 2006, Hamburg, Germany—Albertinen Hospital and Indivumed GmbH agreed on a close cooperation for an intensified search for new individualized treatment methods for cancer therapy. The target of this cooperation is sample and data acquisition for gynecological cancers (e.g. breast cancer), gastrointestinal tumors (e.g. colon cancer) and urological cancer (e.g. prostate carcinoma).

Dr. Hartmut Juhl, founder and CEO of Indivumed GmbH is glad that "We could win Albertinen Hospital, which is one of Hamburgs most famous hospitals, for our unique tumor and database. Thereby, we can clearly broaden the base of our research but also improve our capability to support research programs of our industrial and academic partners."

The leadership of the Albertinen Hospitel has great expectations. Dr. Angres, Medical Director at Albertinen Hospital, stated that "With this data researchers are able to find out, which changes in the diseased tissue are actually connected to the cancer and which are attributed to other factors."

Now the clinic network of Indivumed GmbH includes 10 surgical departments—one for internal medicine—at 7 hospitals (Albertinen Hospital, University Hospital Hamburg Eppendorf, University Hospital Göttingen, Israelitic Hospital, Alten Eichen Hospital, Elim Hospital and also the General Hospital Harburg).

December 2005
Indivumed among the "365 Places in the Land of Ideas" competition winners
The German government sponsored initiative names Indivumed a special place in the land of ideas. Next year's World Cup will provide Germany with a unique opportunity to present a fascinating, multifaceted picture of itself to the world. The "365 Places in the Land of Ideas"—one for each day of the year—will be unveiled internationally at that time. Look for Indivumed's name among the winners.

Indivumed will hold an open house on Wednesday, April 5th, 2006 to showcase its facilities to the general public.

http://www.land-of-ideas.org

October 2005
Johns Hopkins scientists develop a new colon cancer blood test using Indivumed's biobank
October 28, 2005, Hamburg, Germany and Silver Spring, MD - Bert Vogelstein and colleagues at the Johns Hopkins Kimmel Cancer Center and Howard Hughes Medical Institute, in a collaborative study with Indivumed, have developed a test that reliably quantifies mutations in cancer genes in the blood of colorectal cancer patients (F. Diehl et al.: Detection and Quantification of Mutations in the Plasma of Patients with Colorectal Tumors. Proc Natl Acad Sci 102(45):16368-16373, 2005).

Using Indivumed's highly standardized biobank, the researchers found elevated levels of mutated adenomatous polyposis coli (APC) gene in the plasma of patients with advanced stage colorectal cancer. They also detected mutant genes in more than 60 percent of patients with early stage cancers. While many cancers, including those of the colon, are curable if detected early, the lack of sensitive, non-invasive screening tools for early stage cancers has limited progress in this area. Their results provide the foundation for a new type of screening tool for presymptomatic, at-risk populations.

August 2005
Press Release
Indivumed expands U.S. Market Focus, Names Director of Sales and Marketing
August 16, 2005, Hamburg, Germany - Indivumed has appointed Kevin Sullivan Director of Sales and Marketing for the United States. Mr. Sullivan's appointment accelerates Indivumed's market expansion in the USA. Mr. Sullivan spent the previous six years in business development with Automated Cell, a therapeutic antibody discovery company in cancer, and has more than 20 years of sales and marketing experience in the life sciences. Mr. Sullivan will begin work immediately from the newly established Indivumed, Inc. office in Silver Spring, Maryland. He will market Indivumed products and services to pharmaceutical and biotechnology companies to support the discovery of new cancer diagnostics and new cancer drugs.

June 21st 2005
Indivumed: Awarded Best German Company
In the presence of Wolfgang Clement, the Federal Minister of the Economy, and representatives from economics, media and culture, Indivumed was named Germany's Best Company in the Visionary category. The deciding factor for the jury was Indivumed's concept to accelerate the development of individualized cancer therapies with a unique BioBank and database of cancer patients.

The German Founder Award is an initiative of ZDF (German Public TV-channel 2), McKinnsey, German Savings Bank Association and Stern Magazine and is supported by the German Federal Department of Economy.

May 2005
Indivumed: Recognized as one of the top three German companies
The Start-Up partners German TV2, McKinsey, German Savings Bank Association, Stern Magazine and German Federal Department of Economy recognized Indivumed as one of the top three companies in Germany and nominated it for the 2005 German Company Founder Award.

The jury noted Indivumed's contribution to the business environment of Germany and its visionary concept to promote the development of individualized cancer therapies for the benefit of humanity.

January 2005
Cooperation between Indivumed and the University Clinic Hamburg-Eppendorf
The University Clinic Hamburg-Eppendorf and Indivumed have signed a research agreement in which Indivumed will be responsible for the biobanking and data collection. This collaboration will allow Indivumed to expand its activities to additional tumor entities. It provides researchers at the University Hospital with a highest standard of biospecimen and data collection and, thus, helps to improve their research. The cooperation has started with the Clinic for Hepatobiliary Surgery and Visceral Transplantation and the Clinic for Urology and includes joint research projects on malignant tumors in the liver and prostate.

2004-2002

©2008 INDIVUMED GmbH