Human Monoclonal Antibody To Treat P. aeruginosa Infections in Cystic Fibrosis

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$2,922,383.00
Award Year:
2011
Program:
STTR
Phase:
Phase II
Contract:
2R42AI072866-03
Award Id:
n/a
Agency Tracking Number:
R42AI072866
Solicitation Year:
2011
Solicitation Topic Code:
NIAID
Solicitation Number:
PA10-124
Small Business Information
5941 Optical Court, SAN JOSE, CA, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
141088463
Principal Investigator:
ERIC PATZER
(408) 385-1742
patzere@aridispharma.com
Business Contact:
ERIC PATXER
(408) 385-1742
patzere@aridispharma.com
Research Institute:
WAISMAN BIOMANUFACTURING FACILITY, UNIVERSITY OF WISCONSIN

UNIVERSITY OF WISCONSIN SYSTEM
1220 LINDEN DR MADISON, WI 53706
MADISON, WI, 53706-
() -
Nonprofit college or university
Abstract
DESCRIPTION (provided by applicant): Over the past two decades, the number of new antimicrobials being developed has experienced a greater than 60% decline, while the number of antibiotic resistant microorganisms has been steadily increasing. Only one newantibacterial drug with a novel mechanism of action (linezolid) has been introduced during this period making the long term outlook for sustained infection control increasingly precarious. One particularly concerning example is a Gram negative bacterium called Pseudomonas aeruginosa in which 30% of clinical isolates from ICU (intensive care unit) or nursing home patients were reported to be resistant to 3 or more drugs. The Infectious Diseases Society of America (IDSA) also identified P. aeruginosa as one of six superbugs on the top priority hit list of dangerous pathogens that are becoming increasingly drug resistant. P. aeruginosa poses a particularly deadly threat for lung infections in hospital acquired pneumonia (HAP), particularly ventilator associated pneumonia (VAP) cases and in cystic fibrosis (CF) patients. The major hypothesis to be tested in this application is whether a human monoclonal antibody (mAb) targeted against a prevalent cell surface carbohydrate (alginate) on P. aeruginosa can be used clinically to treat P. aeruginosa lung infections resulting in improvement in lung function and a reduction in morbidity and mortality. Preliminary data indicate that these human mAbs recognize an epitope on alginate that is expressed on a broad arrayof P. aeruginosa clinical isolates. The mAb kills these isolates through an immune mediated process called opsono-phagocytosis and can be used therapeutically to protect animals from lethal lung infections. In this application, we propose to scale-up themanufacturing process for the mAb and produce clinical material for future clinical trials. We propose to test the clinical material in toxicity studies in animals according to Good Laboratory Procedures (GLP) to demonstrate that the mAb is safe to administer to people in human clinical testing. Finally, we propose to schedule a pre-IND (investigational new drug) meeting with the FDA to present and discuss the Mab preclinical data and our proposed clinical plan. Incorporating feedback from the FDA, we willthen file an IND application. PUBLIC HEALTH RELEVANCE: The proposed studies will result in further development of a human monoclonal antibody for the treatment of severe bacterial lung infections due to Pseudomonas aeruginosa in patients with hospital acquired pneumonia and cystic fibrosis. Clinical material will be produced, safety data in animals will be generated and an IND will be filed with the FDA.

* information listed above is at the time of submission.

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