• Bacterial infections are the largest health care challenge of the 21st century

  • Aspidasept® is our hope for people with life-threatening infections
    Prof. Dr. Klaus Brandenburg & Team

  • We should love what is old to the extent that it is worth while, but we should really live for what is new
    Theodor Fontane (1819-1898)

    To know is not enough, one must apply...
    Johann Wolfgang von Goethe (1749-1832)

Base of the enterprise:

Spin-off from the Forschungszentrum Borstel (Research Center Borstel), Leibniz-
Center for Medicine and Biosciences. www.fz-borstel.de

Development of antiiinfective drugs:

1.) For therapy of systemic bacterial infections (Sepsis, "Blood Poisoning"), against local bacterial infections, also against antibiotic-resistant germs.

2.) For diagnosis of bacterial contaminations in body- and other liquids (Bacteria or their inflammation - indusing products)

3.) For therapy of some viral infections (HIV, Herpes Simplex I + II, Human Papilliom-Virus, Hepatitis B)

Planned Investitions:

  • Finalization of preclinical development and investigational new drug ( IND),  2017-2018
  • GMP-Production, 2015
  • Early clinical development (Phases I/II, clinical proof of concept cPOC), from 2018

Highlights / Milestones:

  • Design and Testing of anti-infective peptides (Platform), since 1997
  • In vitro, ex vivo and in vivo Validation, since 2000
  • Preclinical development & Scientific Advice Meeting (BfArM), since 2010
  • Establishment GMP-Production, 2012

Cooperation Partners:

Prof. Dr. Uwe Englisch, Fachhochschule Lübeck, Centrum für Industrielle Biotechnologie

Prof. Dr. Gülsah Gabriel, Heinrich-Pette-Institut für Virologie, Hamburg

Prof. Dr. Thomas Gutsmann, Forschungszentrum Borstel, Biophysik

Prof. Dr. Mathias Hornef, Medizinische Hochschule Hannover, Immunologie

Dr. Dirk Kuhlmeier, Fraunhofer-Institut für Zelltherapie und Immunologie (IZI) Leipzig

Prof. Dr. Christoph Thiemermann, Queens Mary University, London

Dr. Karl Mauss, Asklepios Klinik Hamburg Altona

Prof. Dr. Guillermo Martinez de Tejada, Universidad de Navarra, Pamplona, Dep. de Microbiologia

Prof. Dr. Walter Mier, Universitätskrankenhaus Heidelberg, Nuklearmedizin

Prof. Dr. Tobias Schürholz, Universitätsmedizin Rostock

Prof. Dr. Volkmar Vill, Universität Hamburg, Organische Chemie

Prof. Dr. Sunil David, Dep. of Medicinal Chemistry, University of Kansas, Lawrence

Prof. Dr. Günther Weindl, Freie Universität Berlin, Pharmacology

Founder-Team Brandenburg Antiinfektiva GmbH

Prof. Dr. Klaus Brandenburg – Chief Scientific Officer (CSO)
Prof. Dr. Klaus Brandenburg
  • Prof. i.R. (apl.), Universität Kiel
  • Visiting Lecturer (Lehrbeauftragter) Fachhochschule Lübeck (University of Applied Science)
  • Scientific advisor of the CIB (Centrum für industrielle Biotechnologie, c/o Fachhochschule Lübeck).
  • Longtime scientist at Forschungszentrum Borstel (Borstel Research Center)
  • Receipt of several grants (DFG, EU, BMBF, Clinique La Prairie, Leibniz-Gemeinschaft)
  • Mitglied im redaktionellen Beirat von: BMC Biochemistry, Open Glycoscience, Anti-Infective Agents in Medicinal Chemistry, International Journal of Antibiotics, World Journal of Biological Chemistry, Envilen, Scientific Reports
  • Award: Deutscher Innovationspreis der Bioregionen 2013: (www.biodeutschland.org/innovationspreis.html)
  • Nominated for "Springer Galenus von Pergamon Preis 2016"
Dr. Michael Ruppert – Chief Executive Officer (CEO)
Master of Business Administration (MBA) Business development and project management.
  • Prof. Dr., Universität Heidelberg - Radiopharmazeutisches Institut
Prof. Dr. Tobias Schürholz – Chief Medical Officer (CMO)
Prof. Dr. Tobias Schürholz
  • Prof. Dr. Tobias Schürholz, Universitätsmedizin Rostock
Dr. Lena Heinbockel – Biologie / Regulatorien
Dr. Lena Heinbockel
  • Dr. (rer nat.), Universität Lübeck
  • Biologist, (Dipl.-Biol)., Universität Hamburg
  • Longtime experience in Immunology, drug development, and regulatory affairs
Prof. Dr. Walter Mier – Pharmakologe
Prof. Dr. Walter Mier
  • Prof. Dr., Universität Heidelberg - Radiopharmazeutisches Institut
  • Prof. in Pharmaceutical Chemistry, IPMB Heidelberg Department of Nuclear Medicine University Hospital Heidelberg


Scientific Advisory Board

Dr. Satoshi Fukuoka
Dr. Satoshi Fukuoka
  • National Institute of Advanced Industrial Science and Technology (AIST), Takamatsu, Japan
Prof. Dr. Gernot Marx

  • Universitätsklinikum Aachen, Direktor der Klinik für Operative Intensivmedizin (Critical Care Unit)
Prof. Dr. Guillermo Martinez de Tejada
Prof. Dr. Guillermo Martinez de Tejada
  • Universidad de Navarra, Pamplona, main Project Manager
Prof. Dr. Ulrich Schaible

  • Programmdirektor Forschungszentrum Borstel, Leibniz-Zentrum für Medizin und Biowissenschaften (Research Center Borstel)
Prof. Dr. Patrick Garidel
Prof. Dr. Patrick Garidel
  • Pharmazeutische Industrie, Pharmazeutische Entwicklung (Pharmaceutical Development)

Details

The enterprise has a platform technology for the development of new synthetic peptides for treatment of systemic bacterial and viral diseases.

Problem

  • Severe infections are a latent and increasing threatening of human health care.
  • Sepsis represents globally one of the most frequent causes of death in critical care units.
  • Existing  therapies aim at killing the germs, modulate the immune response, or suppress selected inflammation pathways.
  • Main cause of sepsis is the release of pathogenicity factors (PF), affording a specially designed therapy.
  • Thus, there is a great need of new drugs, which may be directed against the germs, but more importantly, neutralize the released PFs.

Solution

  • Design and development of novel PF-neutralizing polypeptides.
  • Preclinical validation of new polypeptides, in particular of the primary development candidate Aspidasept®, in vitro, ex vivo and in vivo.
  • Proof of efficiency and tolerance in vivo-mouse- and rat models.
  • Proof of efficiency and tolerance in in vivo-swine models (Endotoxemia, Bacteremia; Data are presently generated).
  • Proof of antibacterial activity against multiresistent germs (MRSA).
  • Proof of antiviral activity among others against Herpes simplex I and II, Hepatitis B, Papillomavirus, HIV, Influenza (Flu) and Swine fever.
  • The primary development candidate is in a late, preclinical development. The results of a Scientific Advice Meetings (BfArM, 2011) imply only the toxicology test in the non-rodent model.

Business Model

  • Bb-A develops proprietary drugs until the clinical proof of concept (cPOC), which gives highest increase in value, and license this for further development/marketing for Biotech/Pharma companies.
  • Bb-A participates by market-usual acquisition, milestone- and royalty-payments.
  • Out-licensing takes place for a given drug and a specific indication (for example,  Sepsis vs. Pneumonia vs. Severe dermal Infections).
  • Based on preclinical and clinical data the primary development candidate (Aspidasept®) will be out-licensed soon for second and third indications.
  • Advantage of the concept: (i) Rapid generation of turnover, (ii) Focusing (iii) Securing of resources and (iv) Reduction of development time, -costs and -risks.

Technology / Intellectual Property

  • In the name of the Forschungszentrum Borstel a priority EP-application and an international PCT-application (PCT/EP2009/002565), which was granted 2014 in EP, CH, US and JP.
  • The international search report was positive and the test certificate confirmed that the granting will be done soon.
  • Founding team and FZB negotiate a term-sheet for an exclusive license.

Market

  • Primary or initially scheduled market for Aspidasept® is the treatment of sepsis.
  • In the USA annually appr. 750.000 sepsis patients are treated, with costs lying around 14 billion Euro.
  • According to ‚Deutsches Expertennetzwerk für Sepsis‘ and the ‚Deutsche Sepsis-Stiftung‘ in Germany annually more than 200.000 persons are concerned (costs around  2 billion Euro). The real number are probably much higher.
  • The market for soft tissue / skin infections can not be estinated but should be larger than that for sepsis.

Competition

  • There are several anti-infectives in development, but none against sepsis.
  • Biotech/Pharma companies in the past have done much effort to develop an anti-sepsis medicament, which, however, failed in clinical phases II/III at the latest.
  • Former approaches in most cases aimed at modulation of the immune response, the coagulation system or the signal transduction, but not on a neutralization of the PFs with sufficient cross-reactivity (against Gram-negative and Gram-positive bacteria).