Kenta Biotech includes first patient in its first-in-human trial of promising monoclonal antibody KBSA301

Zurich-Schlieren 15.06.2012 — Kenta Biotech today announced an important step towards a  more efficient treatment of hospital infections: The first patient was enrolled  in the phase I/II clinical trial with KBSA301, a fully human antibody for the  treatment of severe pneumonia caused by Staphylococcus  aureus (S. aureus).

In this clinical trial, 44 patients suffering from  severe pneumonia caused by S. aureus admitted  in intensive care units around Europe will be administered a single dose of  KBSA301, or placebo, in addition to standard antibiotic therapy. KBSA301 is  developed by Kenta Biotech as a new treatment option to fight severe S. aureus infections, including those  caused by antibiotic resistant strains. Founded six years ago, Swiss biotech  start-up Kenta today is a leader in the field of antibody treatment in nosocomial  infections.

The fully human monoclonal antibody KBSA301 was  identified by using Kenta Biotech’s proprietary MabIgX® technology. In  the field of infectious diseases, this is one of the few therapeutic monoclonal  antibodies that is tested in a first-in-human trial directly in patients. Kenta  Biotech, in this way, can accelerate the clinical development and bringing this  new compound faster to patients.

Novel approach for treatment of infections
KBSA301 binds  to Staphylococcal alpha-toxin, thus preventing the toxin from  damaging the lungs of the patients. Its mode of action is independent from the antibiotic  resistance profile of S. aureus,  therefore covering both MRSA (methicillin-resistant S. aureus) and MSSA (methicillin-sensitive S. aureus). This constitutes a significant progress in the  treatment of severe S. aureus infections. The therapeutic activity of KBSA301 demonstrated in preclinical  animal studies resulted in a significant survival benefit for treated animals.  This, along with an excellent safety profile enabled Kenta Biotech to obtain permission  from health authorities in four major countries to test the antibody on intensive  care unit patients with severe S. aureus pneumonia.

Franco Merckling, CEO said: ”This is a great day for patients, for doctors and for Kenta Biotech.  Thanks to intensive research and the dedication of our outstanding staff, we  are able to bring a human monoclonal antibody with an innovative mode of action  into clinical development in record time. I am confident that this trial will  deliver promising data and pave the way for change in the treatment of severe S. aureus pneumonia.”

Toni Perez, Chief Medical Officer said: ”We are very excited about this clinical trial.  For more than 25 years, I have been developing new anti-infective drugs, and I  have never seen a drug with such tremendous potential. Patients and doctors  have been eagerly waiting for a solution like the one to be expected from KBSA301.“

About the trial KBSA301-001      This first-in human phase  I/II clinical trial is entitled “A Randomized, Double-Blind,  Placebo-Controlled, Single Ascending Dose Group Study to Assess the Safety,  Tolerability, Pharmacokinetics, Efficacy and Pharmacodynamics of a Single  Intravenous Administration of KBSA301 in Severe Pneumonia caused by S. aureus”. With this study, Kenta Biotech  accelerates the clinical development of KBSA301. The trial is already running  in France, where the first patient was included in the trial. This month,  patient enrolment will start in Belgium and Spain, and later this year in the  UK. The trial is registered at Clinicaltrials.gov here (ClinicalTrials.gov  Identifier: NCT01589185).

About KBSA301     KBSA301 is a fully human monoclonal antibody that targets a virulence  factor of S. aureus called alpha-toxin, which  is a highly toxic protein secreted by both MRSA and MSSA strains during the  course of the infection. Using Kenta Biotech’s proprietary MabIgX® technology, a range of human monoclonal antibodies against alpha-toxin has been  generated, from which KBSA301 was selected for clinical development due to its  outstanding toxin neutralisation properties. The mode of action of KBSA301 is  independent from the microbiological sensitivity of S. aureus to antibiotics, and constitutes significant progress in  the treatment of life-threatening S.  aureus infections.

About Kenta Biotech Kenta Biotech is a biopharmaceutical company  headquartered in Zurich-Schlieren, Switzerland, focused on the development of  innovative fully human monoclonal antibodies for the prevention and treatment of  life-threatening infections. Kenta harnesses the power of the human immune  system for the generation of fully human monoclonal antibodies and their transformation  into highly effective therapeutic antibodies. The unique technology in  combination with focused scientific and clinical expertise enables Kenta  Biotech to move innovative antibody therapies rapidly from the bench to high  medical need patients. Kenta Biotech‘s lead-product, Panobacumab (KBPA101) has successfully completed a phase IIa proof-of-concept trial.  Several product candidates are in preclinical development.

Further Information: www.kentabiotech.com www.kentabiotech.com/media.html

Dr. Franco Merckling, CEO     Phone: +41 58 680 52 75     E-Mail: franco.merckling@kentabiotech.com

Michael Wiget, Life Science Communication     Phone: +41 43 266 88 18     E-Mail: michael.wiget@lscom.ch

Kenta  Biotech AG     Wagistrasse  25, 8952 Zurich-Schlieren, Switzerland