Kenta Biotech Reports Phase IIa Data with Lead Candidate Panobacumab in Hospital-Acquired Pneumonia.

Results presented at ICAAC suggest first-in-class drug could revolutionise treatment of life-threatening infections

BERNE, Switzerland -- Kenta Biotech has presented positive Phase IIa results of its lead drug candidate, panobacumab (KBPA101), showing it is safe and well tolerated in patients with hospital-acquired pneumonia caused by Pseudomonas aeruginosa. The compound, a fully human IgM monoclonal antibody, has the potential to reduce mortality rates. The Phase IIa data were presented yesterday in a poster session at the 49th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco.

The open-label Phase IIa study evaluated the safety, pharmacokinetics and potential efficacy of three separate infusions of panobacumab every third day in high-risk patients with ventilator-associated and hospital-acquired pneumonia caused by Pseudomonas aeruginosa serotype O11. A total of 18-patients were treated. Thirteen patients received three doses of panobacumab and five patients received one dose. In addition to the positive safety and tolerability data, panobacumab also showed a better than expected survival rate. All patients receiving the full treatment cycle survived despite a predicted mortality of 24% according to the severity of disease classification (APACHE II).

Kenta's CEO Violetta Georgescu-Kyburz commented on the data: "We are extremely pleased with these results. They indicate that panobacumab is safe and well tolerated in critically ill patients, as well as showing efficacy with a direct impact on patient survival. With this approach Kenta Biotech is pioneering the use of fully human IgM antibodies to develop treatments that are desperately needed for severe hospital-acquired infections."

Lead study investigator Professor Doctor Michael Tamm of University Hospital Basel in Switzerland said: "This study shows that panobacumab is paving the way for the development of innovative treatments in the fight against life-threatening nosocomial pneumonia in intensive care, an area of high unmet medical need."

Kenta's proprietary MabIgX([R]) technology generates fully human antibodies that have been optimised by the human immune system. Fully human monoclonal antibodies, rather than antibodies partially derived from other species (e.g. rodents), provide a highly effective, clinically relevant response and reduce dramatically the risk of immunogenicity. Kenta's MabIgX([R]) antibodies effectively target bacterial pathogens independently of resistance to antimicrobial agents.

Kenta is seeking a licensing partner for panobacumab and three complementary antibodies in earlier stages of development.

About nosocomial infections

In the US and Europe, an estimated 5 to 10% of patients are expected to develop an infection during their hospital stay caused by bacteria such as MRSA (gram-positive) and P. aeruginosa (gram-negative). P. aeruginosa is the most prevalent gram-negative bacterium amongst ventilated patients([1][2]). It is estimated that around 20-25% of the pneumonia infections in intensive care are caused by P. aeruginosa. In ventilated patients, P. aeruginosa has an attributable mortality of between 33 and 50% ([3][4]).

About Kenta Biotech

Kenta Biotech is pioneering the use of fully human antibodies to fight life-threatening hospital infections. Kenta's pipeline includes a series of human antibodies to target the most difficult to treat bacteria, such as Pseudomonas aeruginosa, Acinetobacter baumannii and Staphylococcus aureus.

The company's fully human antibodies are generated from Kenta's proprietary MAbIgX([R]) technology, which enables the company to test therapeutically promising antibodies against a variety of targets within a short period of time. The resulting monoclonal antibodies are expected to enhance the efficacy of current treatment options and have a superior safety profile in the management of highly resistant bacteria.

Kenta Biotech was founded in 2006 and is headquartered in Berne, Switzerland. The company is financed by independent private investors and management who together hold the company share capital. For more information, visit www.kentabiotech.com

References

1. NNIS, National Nosocomial Infect. Surveill. System Report, Am J Infect Control 2004; 32:470-85

2. Fridkin et al, Clinics in Chest Medicine, 1999, 20, 2:303ff

3. Guidelines for the management of adults with hospital-acquired ventilator-associated, and healthcare-associated pneumonia, Am J Respir Crit Care Med, Vol 171.pp 388-416, 2005

4. Wisplinghoff, Clin.Infect Dis, 2004; 39:309ff