Base of the enterprise:
Spin-off from the Forschungszentrum Borstel (Research Center Borstel), Leibniz-
Center for Medicine and Biosciences. www.fz-borstel.de
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)
4.) Therapy of local inflammatory processes, e.g. atopic dermatitis
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
- Clinical study of skin and soft tissue infections, starting 2019
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
- Evidence of clinical proof of concept, as of 2019
Cooperation Partners:
Prof. Dr. Uwe Englisch, Fachhochschule Lübeck, Centrum für Industrielle Biotechnologie
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. Volkmar Vill, Universität Hamburg, Organische Chemie
Prof. Dr. Ralf Hoffmann, Universität Leipzig, Biotechnologisch-Biomedizinisches Zentrum
Prof. Dr. Günther Weindl, Freie Universität Berlin, Pharmacology
Prof. Dr. Ralf Hoffmann, Universität Leipzig, Biotechnologisch-Biomedizinisches Zentrum
Prof. Dr. Rolf Müller, Helmholtz-Zentrum Für Infektionsforschung, Saarland.
contact
Founder-Team Brandenburg Antiinfektiva GmbH
- 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. (rer nat.), Universität Lübeck
- Biologist, (Dipl.-Biol)., Universität Hamburg
- Longtime experience in Immunology, drug development, and regulatory affairs
- Prof. Dr., Universität Heidelberg - Radiopharmazeutisches Institut
- Prof. in Pharmaceutical Chemistry, IPMB Heidelberg Department of Nuclear Medicine University Hospital Heidelberg
Scientific Advisory Board
- National Institute of Advanced Industrial Science and Technology (AIST), Takamatsu, Japan
- Universitätsklinikum Aachen, Direktor der Klinik für Operative Intensivmedizin (Critical Care Unit)
- Universidad de Navarra, Pamplona, main Project Manager
- Programmdirektor Forschungszentrum Borstel, Leibniz-Zentrum für Medizin und Biowissenschaften (Research Center Borstel)
- Pharmazeutische Industrie, Pharmazeutische Entwicklung (Pharmaceutical Development)
Shareholder
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).