The Henry M. Jackson Foundation for the Advancement of Military Medicine Inc.

The University of Texas System

Other

Slsg Limited LLC

George E Peoples

Sathibalan Ponniah

Constantin G Ioannides

Catherine E Storrer

Michael Flora

Catherine A O'Brian

Martin L Campbell

Ponniah Sathibalan

Angelos M Stergiou

Nicholas J Sarlis

Kathleen Ann Peoples, Legal Representative

The present invention concerns a method for treating triple-negative breast cancer (TNBC) in an individual, and/or for inducing an immune response to HER2/neu in an individual with a triple-negative breast cancer expressing low levels of HER2/neu, the method comprising administering to the individual: (a) an effective amount of trastuzumab, or derivative thereof; and (b) an effective amount of nelipepimut-S, or variant thereof, optionally with an immunological adjuvant. Preferably, the method includes a preparatory or priming phase comprising a frequency and duration of trastuzumab or trastuzumab derivative administration sufficient to substantially increase the major histocompatibility complex (MHC)-mediated presentation of HER2 peptide fragments to the patient immune system. The invention also includes medicaments and kits for treating TNBC in an individual, and/or for inducing an immune response to HER2/neu in an individual with a TNBC expressing HER2/neu.

Combination immunotherapy for treatment of triple-negative breast cancer

The present invention provides methods of preventing or reducing the risk of recurrence of endometrial and ovarian cancers which express low levels of folate binding protein (FBP) by administration of a vaccine containing an E39 peptide.

Vaccine therapy for treatment of endometrial and ovarian cancer

The invention features methods to induce and maintain a protective cytotoxic T-lymphocyte response to a peptide of the HER2/neu oncogene, E75, with the effect of inducing and maintaining protective or therapeutic immunity against breast cancer in a patient in clinical remission. The methods comprise administering to the patient an effective amount of a vaccine composition comprising a pharmaceutically acceptable carrier, an adjuvant such as recombinant human GM-CSF, and the E75 peptide at an optimized dose and schedule. The methods further comprise administering an annual or semi-annual booster vaccine dose due to declining E75-specific T cell immunity. The invention also features vaccine compositions for use in the methods.

Vaccine for the prevention of breast cancer relapse

The invention provides a method for the creation of peptide antigens comprising epitopes with at least a first modification comprising a shortened or lengthened amino acid side chain. By extension or shortening of the side chain with CH3/CH2 groups, for example, made by computer assisted modeling of the tumor antigen (peptide) bound in the MHC-I-groove, immunogenicity can be improved with minimal modification of adjacent tertiary structure, thereby avoiding cross-reactivity. Provided by the invention are methods of creating such antigens, as well as methods for therapeutic or prophylactic treatment of various conditions comprising administration of the antigens.

Controlled modulation of amino acid side chain length of peptide antigens

Provided are methods for inducing and maintaining protective immunity against a tumor expressing FR&#x3b1; in a subject, comprising the administration of one or more peptide vaccines according to a particular dosages or particular dosage regimens.

Peptide vaccine therapy for treatment of FR&#x3b1;-expressing tumors

Provided are methods to induce and maintain a protective cytotoxic T-lymphocyte response to a peptide of the HER2/neu oncogene, GP2, with the effect of inducing and maintaining protective or therapeutic immunity against breast cancer in a patient in clinical remission, including patients having low to intermediate levels of HER2/neu expression. The methods comprise administering to the patient an effective amount of a vaccine composition comprising a pharmaceutically acceptable carrier, an adjuvant such as GM-CSF, and the GP2 peptide. The methods may further comprise administering a periodic booster vaccine dose as needed due to declining GP2-specific T cell immunity. Also provided are vaccine compositions for use in the methods.

Vaccine for the prevention of breast cancer recurrence

This invention relates generally to identifying peptide sequences involved in antibody binding to any protein for synthesis of vaccine treatments. This novel method allows for a more manageable vaccine peptide discovery and specific generation of unique immunogenic peptides from self-tumor associated proteins and/or foreign proteins from infectious organisms for specific and/or enhanced expression only in the presence of the antibody.

Targeted identification of immunogenic peptides

The present invention is directed to variants of antigens comprising folate binding protein epitopes as a composition associated with providing immunity against a tumor in an individual. The variant is effective in inducing cytotoxic T-lymphocytes but preferably not to the extent that they become sensitive to silencing by elimination, such as by apoptosis, or by anergy, as in unresponsiveness.

Induction of tumor immunity by variants of folate binding protein

Provided are methods to induce and maintain a protective cytotoxic T-lymphocyte response to a peptide of the HER/neu oncogene, GP2, with the effect of inducing and maintaining protective or therapeutic immunity against breast cancer in a patient in clinical remission, including patients having low to intermediate levels of HER2/neu expression. The methods comprise administering to the patient an effective amount of a vaccine composition comprising a pharmaceutically acceptable carrier, an adjuvant such as GM-CSF, and the GP2 peptide. The methods may further comprise administering a periodic booster vaccine dose as needed due to declining GP2-specific T cell immunity. Also provided are vaccine compositions for use in the methods.

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Fulton, MD, United States of America

George E Peoples