Biomed Valley Discoveries, Inc.

National Institutes of Health, a Component of the US Dept. of Health & Human Services

The Johns Hopkins University

Synlogic Operating Company, Inc.

Novartis Ag

The United States of America As Represented by the Department of Health

Saurabh Saha

Xiaoyan Michelle Zhang

Dimiter Stanchev Dimitrov

Zhongyu Zhu

Dean Welsch

Gary DeCrescenzo

Brad St Croix

Enrique Zudaire

Jeffrey James Roix

Bert Vogelstein

Kenneth W Kinzler

Bradley St Croix

Shibin Zhou

Linping Zhang

Rimas J Orentas

Crystal L Mackall

Jonathan W Kotula

Vincent M Isabella

Dean Falb

Paul F Miller

Yves Millet

Adam B Fisher

Suman Machinani

Steven Seaman

Ning Li

Tony Fleming

Alberto Bardelli

Gary A Decrescenzo

KiBem Kim

Reza Halse

Amit Chaudhary

Rou-fun Kwong

Mary Beth Hilton

Jose M Lora

Kibem Kim

Kenneth Kinzler

The present invention provides, inter alia, methods for treating or ameliorating an effect of a solid tumor present in a non-human animal. These methods include administering intratumorally to the non-human animal a unit dose of, preferablyNT, colony forming units (CFUs), which contains about 1×106-1×1010 CFUs suspended in a pharmaceutically acceptable carrier or solution. Methods for debulking a solid tumor present in a non-human animal, a method for microscopically precise excision of tumor cells in a non-human animal, methods for treating or ameliorating an effect of a solid tumor that has metastasized to one or more sites in a non-human animal, methods for ablating a solid tumor present in a non-human animal, unit doses of, preferablyNT, CFUs, and kits for treating or ameliorating an effect of a solid tumor present in a non-human animal are also provided.

C. novyi for the treatment of solid tumors in non-human animals

The presently disclosed subject matter provides methods and kits for treating solid tumors in a subject by using a combination of anti-CTLA-4 and/or anti-PD-1 antibodies with at least one member of the group consisting of a bacterium, bacterial product, and an immunoregulatory entity. In particular embodiments, the bacteria are toxin-depleted, anaerobic bacteria, such as-NT.

Use of bacteria, bacterial products, and other immunoregulatory entities in combination with anti-CTLA-4 and/or anti-PD-1 antibodies to treat solid tumor malignancies

The present invention provides, inter alia, methods, kits, and pharmaceutical compositions for treating or ameliorating the effects of a cancer in a subject in need thereof. The method comprises administering to the subject an effective amount of (i) a first anti-cancer agent, which is BVD-523 or a pharmaceutically acceptable salt thereof and (ii) a second anti-cancer agent, which is a CDK inhibitor or a pharmaceutically acceptable salt thereof, to treat or ameliorate the effects of the cancer. Additional methods for effecting cancer cell death are also provided.

Cancer treatments using combinations of CDK and ERK inhibitors

Polypeptides and proteins that specifically bind to and immunologically recognize CD276 are disclosed. Chimeric antigen receptors (CARs), anti-CD276 binding moieties, nucleic acids, recombinant expression vectors, host cells, populations of cells, pharmaceutical compositions, and conjugates relating to the polypeptides and proteins are also disclosed. Methods of detecting the presence of (a) cancer or (b) tumor vasculature in a mammal and methods of (a) treating or preventing cancer or (b) reducing tumor vasculature in a mammal are also disclosed.

Anti-CD276 antibodies (B7H3)

Genetically programmed microorganisms, such as bacteria or virus, pharmaceutical compositions thereof, and methods of modulating and treating cancers are disclosed.

Microorganisms programmed to produce immune modulators and anti-cancer therapeutics in tumor cells

Polypeptides and proteins that specifically bind to and immunologically recognize CD276 are disclosed. Chimeric antigen receptors (CARs), anti-CD276 binding moieties, nucleic acids, recombinant expression vectors, host cells, populations of cells, and pharmaceutical compositions relating to the polypeptides and proteins are also disclosed. Methods of detecting the presence of cancer in a mammal and methods of treating or preventing cancer in a mammal are also disclosed.

Anti-CD276 polypeptides, proteins, and chimeric antigen receptors

The present invention provides, inter alia, methods for treating or ameliorating an effect of a solid tumor present in a human. These methods include administering intratumorally to the human a unit dose of, preferablyNT, colony forming units (CFUs), which contains about 1&#xd7;10-1&#xd7;10CFUs suspended in a pharmaceutically acceptable carrier or solution. Methods for debulking a solid tumor present in a human, methods for ablating a solid tumor present in a human, a method for microscopically precise excision of tumor cells in a human, methods for treating or ameliorating an effect of a solid tumor that has metastasized to one or more sites in a human, unit doses of, preferablyNT, CFUs, and kits for treating or ameliorating an effect of a solid tumor present in a human are also provided.

C. novyi for the treatment of solid tumors in humans

The present invention provides, inter alia, methods, pharmaceutical compositions, and kits for treating or ameliorating the effects of a cancer in a subject, which cancer is refractory or resistant to non-ERK MAPK pathway inhibitor therapy. Also provided are methods for identifying a subject having cancer who would benefit from therapy with an ERK inhibitor and methods for inhibiting phosphorylation of RSK in a cancer cell that is refractory or resistant to a non-ERK MAPK pathway inhibitor.

Methods and compositions for treating non-ERK MAPK pathway inhibitor-resistant cancers

The present invention provides, inter alia, methods for treating or ameliorating the effects of a disease, such as cancer, in a subject. The methods include: administering to a subject in need thereof (a) a therapeutically effective amount of an agent selected from the group consisting of an anti-angiogenic agent, a vascular disrupting agent (VDA), and combinations thereof; and (b) a therapeutically effective amount of a monoclonal antibody or antigen binding fragment thereof, wherein the monoclonal antibody contains: (i) a heavy chain variable region (VH), which includes an amino acid sequence selected from SEQ ID NO:1, SEQ ID NO:3, SEQ ID NO:5, and SEQ ID NO:7; and (ii) a light chain variable region (VL), which includes an amino acid sequence selected from SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6, and SEQ ID NO:8. Compositions, including pharmaceutical compositions, and kits for treating diseases, such as cancer, are also provided.

Combination therapies targeting tumor-associated stroma or tumor cells

The present invention provides, inter alia, methods for treating or ameliorating the effects of a disease, such as cancer, in a subject. The methods include: administering to a subject in need thereof (a) a therapeutically effective amount of a microtubule inhibitor; and (b) a therapeutically effective amount of a monoclonal antibody or antigen binding fragment thereof, wherein the monoclonal antibody contains: (i) a heavy chain variable region (VH), which includes an amino acid sequence selected from SEQ ID NO:1, SEQ ID NO:3, SEQ ID NO:5, and SEQ ID NO:7; and (ii) a light chain variable region (VL), which includes an amino acid sequence selected from SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6, and SEQ ID NO:8. Compositions, including pharmaceutical compositions, and kits for treating diseases, such as cancer, are also provided herein.

Combination therapies targeting tumor-associated stroma or tumor cells and microtubules

The present invention provides, inter alia, methods for treating or ameliorating the effects of a disease, such as cancer, in a subject. The methods include: administering to a subject in need thereof (a) a therapeutically effective amount of a monoclonal antibody or antigen binding fragment of the present invention, and (b) a therapeutically effective amount of a combination therapy including bevacizumab and at least one additional therapeutic agent; or a therapeutically effective amount of at least one additional therapeutic agent selected from the group consisting of a COX-2 inhibitor (COXIB), a non-steroidal anti-inflammatory drug (NSAID), a prostaglandin E2 (PGE2) synthase inhibitor, and combinations thereof. Compositions, including pharmaceutical compositions, and kits for treating diseases, such as cancer, are also provided herein.

Combination therapies using agents that target tumor-associated stroma or tumor cells and tumor vasculature

The present invention provides, inter alia, a composition containing a compound of formula (I): or a pharmaceutically acceptable salt thereof, optionally, in combination with at least one immune checkpoint inhibitor compound. Kits containing the composition, and methods of using the composition for ameliorating or treating the effects of a disease such as a cancer, in a subject, are also provided herein.

LPT-723 and immune checkpoint inhibitor combinations and methods of treatment

Growing community of inventors

Wellesley Hills, MA, United States of America

Saurabh Saha