Clinical Status 2006 -

Avantogen Oncology Inc. (AVTO), Los Angeles, Calif.

Bioaccelerate Holdings Inc. (BACL), New York, N.Y.

RESprotect GmbH, Dresden, Germany

• Product: RP101
• Business: Cancer
• Molecular target: STAT3 mRNA; Apex gene
• Description: Inhibits induced chemoresistance and enhances chemosensitivity
• Indication: Treat advanced pancreatic cancer
• Endpoint: NA
• Status: Interim Phase I data
• Milestone: Submit IND (4Q06); start Phase II (early 2007)

• Product: RP101
• Business: Cancer
• Molecular target: STAT3 mRNA; Apex gene
• Description: Inhibits induced chemoresistance and enhances chemosensitivity
• Indication: Treat advanced pancreatic cancer
• Endpoint: NA
• Status: Phase II start
• Milestone: Start Phase II (early 2007)

  8th Guide to German Biotech Companies 2006: German Biotechs 2006

Combating Chemoresistance –

Chemogenomics Joins the Battleground

Drugs that prevent or inhibit induction of chemoresistance are beset
by limitations. Rudolf Fahrig at RESprotect GmbH investigates a new approach

Rudolf Fahrig is Professor at the University of Hamburg, Germany, and CEO of RESprotect GmbH. He served for many years in several national and international scientific committees and on the editorial boards of scientific journals. His work, resulting in a drug that prevents induction of chemoresistance, received the ‘Central German Innovation Prize’ in 2005. Rudolf studied Biology at the University of Hamburg, the Free University, Berlin, the University of Vienna, Austria and the Justus-Liebig-University.

In cancer model systems, chemoresistance is often mediated by a single gene, and therefore may in theory be inhibited by any drug that targets the product of that gene. All these drugs possess potency and specificity for only one of the several reasons for chemoresistance. In this respect, the chemogenomics approach focuses on small molecules, causing favourable phenotypic changes, and inhibiting or preventing the induction of chemoresistance. The drugs have to counteract the over-expression of apoptosis-antagonising genes and to enhance immune responses. By influencing not only one but a number of different validated targets, a new class of effective anticancer drugs will be developed. These compounds have to be given in addition to standard chemotherapy. RP101 (BVDU) is the first drug that shows these effects in vitro and significantly extended patient survival rate in a clinical pilot study. Similar tendencies are observed in a second study that has started recently.

Living science - Biotechnology in Dresden

Prof. Dr. Rudolf Fahrig
Managing Director, RESprotect GmbH

BioMet Mail 1|2006

42 Vereins- und Netzwerkmitglieder waren neugierig und fanden am 23. Januar trotz Eiseskälte den Weg nach Hellerau.

Nach der Begrüßung wurden zunächst die schon etwas länger in Dresden ansässigen Unternehmen RESprotect GmbH und Qualitype AG und dann die 2005 angesiedelte InnoTERE BioMaterials GmbH vorgestellt.

Herr Prof. Dr. Rudolf Fahrig, Geschäftsführer der RESprotect GmbH, stellte die Entwicklung seines Unternehmens seit der Gründung im Jahr 2000 und seine international verknüpften Forschungsarbeiten zur Verhinderung von Chemoresistenz am Beispiel des Bauchspeicheldrüsenkrebses dar. Die RESprotect GmbH erhielt für ihre herausragenden Leistungen als einer von 5 Preisträgern den Innovationspreis Mitteldeutschland 2005.

Die Qualitype AG, ein florierendes Bioinformatik-Unternehmen, gegründet 2001 in Hellerau, wurde von Herrn Dr. Frank Götz vorgestellt. Das Unternehmen bietet informationstechnische Leistungen für die Bereiche der biologischen, pharmazeutischen und medizinischen Forschung an. Zu den Erfolgen des Unternehmens zählt Qualiproof , eine Datenbank zum Salmonellenmonitoring in der Schweine-fleischerzeugung, die von der Qualitype AG entwickelt wurde und gepflegt wird. Daran beteiligen sich mehr als 25.000 Unternehmen mit über 100.000 Datensätzen. Als weiteres Geschäftsfeld entwickelt Qualitype AG Lösungen im Bereich der elektronischen Datenerfassung (EDC) für human- und veterinärmedizinische Studien. Außerdem werden die Unternehmen zu Fragen der Datenverwaltung, der Prozessanalyse, der Workflow-Optimierung oder der Validierung beraten.

Eines der Geschäftsfelder der InnoTERE GmbH wird die Herstellung von bioaktivem Knochenzement zur Behandlung und Aussteifung ostheoporotischer Knochen sein.

Wir bedanken uns ganz herzlich bei den drei Referenten, die uns auch die Abbildungen auf dieser Seite zur Verfügung stellten.

Im Labor der RESprotect GmbH. Vorn links Herr Professor Fahrig, Geschäftsführer des Unternehmens.

If there's one thing guaranteed to excite attention in the biotech investment field, it's the result of a clinical trial. This analyst could talk until he was blue in the face about in vitro data, findings from animal model work, and even anecdotal evidence that a therapeutic approach works in people. However until a company is ready to report the outcome of a properly designed clinical study, only the aficionados will really be listening, and they generally aren't people who buy much biotech stock. That's why a company called Avantogen, ASX Code ACU, is of some interest to this analyst at the moment.

If the name Avantogen doesn't ring a bell, you may know it by its pre-May 2005 name of Australian Cancer Technology, which also had the ACU ticker. When this analyst first looked at AustCancer around three years ago it was a more or less obscure developer of peptide-based cancer vaccines. Things began to change for the company in 2003 when Paul Hopper, a former private hospital executive turned technology entrepreneur, introduced a second project and helped recapitalise the company before being named CEO in August 2003, at the height of that year's biotech bull market.

Hopper had no background in biotech but he took seriously the task of going up the learning curve, and was able to do so fairly swiftly. He was also a good dealmaker, and over the next year and a half managed to bring into AustCancer a number of projects which both spread the project risk and moved the company closer to a point where marketable products would be in sight. For a while in 2003 and 2004 the market was pretty impressed. At its high point in May 2004 AustCancer stock was up fivefold on its level of twelve months before.

One of the projects that Hopper and his colleagues got hold of in 2004, and the chief reason to be looking at Avantogen right now, involves a small molecule drug that has been given the codename RP101. The compound has been showing promise as the next big thing in treating pancreatic cancer, and a Phase I/IIa clinical trial is currently being completed, with results expected in the next few months.

Sure, cancer of the pancreas isn't all that common in the Western world - there are only around 30,000 cases a year in the US - but uncommon medical conditions are often the most lucrative to target. A drug company can and often does charge the earth for drugs specific to a rare disease, and in the case of pancreatic cancer Avantogen has previously speculated that the U.S. market for RP101 is worth perhaps US$200m a year. Moreover if there's nothing out there that really works for the patients - and that seems to be the case with pancreatic cancer - the regulatory folks will generally accelerate approval of the drug.

And don't forget the tax breaks an  other benefits out there for people who develop so-called 'Orphan Drugs' where the patient population is less that 200,000. All of this suggests that the pay-off from a successful clinical trial of RP101 could be both swift and lucrative from the perspective of a small company like Avantogen. Given RP101's performance to date, we think it's reasonable to expect the data from the trial to be favourable. But to understand why it's necessary to go back and look at all that early stage science. So bear with us for a moment while we explain why Avantogen thinks it is on to something good...