US Government As Represented by the Secretary of the Army

Novavax, Inc.

Paul V Lemley, Jr

Arthur E Frankel

D Craig Wright

Donald A Creasia

A method for treating a tumor is provided, which comprises the steps of preliminarily immunizing a patient in need of antitumor treatment with a toxin or toxin surrogate vaccine in an amount which is effective to generate an immune response to the toxin in the patient, thereby providing systemic protection from the toxin to the patient, and subsequently administering the toxin to the patient in an amount which is effective to kill tumor cells. The toxin may be any suitable toxin, for example ricin, abrin, gelonin or diphtheria.

Method for treating tumors with a toxin

Monoclonal antibodies against the A chain of ricin have been found to be ective in protecting mammals from morbidity arising from exposure to ricin toxin. The neutralizing action of the antibodies does not appear to be mediated by complement or by immunoprecipitation. The antibodies of the invention are characterized as of isotype IgG1 having the binding characteristics which include: a) binding specifically to the neutralizing epitope of the ricin A chain and b) providing in vitro protection of at least 95% of EL-4 cells from 100 .eta.g/mL ricin challenge when said antibody is present in the tissue culture at a level of at least 1000 .eta.g/mL.

Monoclonal antibody against ricin A chain

It is now possible to immunize susceptible mammals against the pathological effect of exposure to rice, including inhalation of ricin, by administration of an immunogenic effective amount of ricin toxin sub-units, including subunits of both the A chain and the B chain of the ricin toxin given separately to provide safe, efficacious protection.

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Gettysburg, PA, United States of America

Paul V Lemley, Jr