Advaxis Inc. is an American company devoted to the discovery, development and commercialization of

immunotherapies Immunotherapy or biological therapy is the treatment of disease by activating or suppressing the immune system. Immunotherapies designed to elicit or amplify an immune response are classified as ''activation immunotherapies,'' while immunotherap ...

based on a technology platform which uses

engineered Engineering is the use of scientific principles to design and build machines, structures, and other items, including bridges, tunnels, roads, vehicles, and buildings. The discipline of engineering encompasses a broad range of more specializ ...

'' Listeria monocytogenes'' (''aka'' ''Lm''). The company is headquartered in

Princeton, New Jersey Princeton is a municipality with a borough form of government in Mercer County, in the U.S. state of New Jersey. It was established on January 1, 2013, through the consolidation of the Borough of Princeton and Princeton Township, both of whi ...

and was incorporated in

Delaware Delaware ( ) is a state in the Mid-Atlantic region of the United States, bordering Maryland to its south and west; Pennsylvania to its north; and New Jersey and the Atlantic Ocean to its east. The state takes its name from the adjacent Del ...

in 2006. The ''Lm''-based platform on which the company's products are based involves the use of attenuated ''Lm'' which secrete

antigen In immunology, an antigen (Ag) is a molecule or molecular structure or any foreign particulate matter or a pollen grain that can bind to a specific antibody or T-cell receptor. The presence of antigens in the body may trigger an immune response. ...

adjuvant In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs. Specifically, the term can refer to: * Adjuvant therapy in cancer management * Analgesic ...

fusion proteins Fusion proteins or chimeric (kī-ˈmir-ik) proteins (literally, made of parts from different sources) are proteins created through the joining of two or more genes that originally coded for separate proteins. Translation of this ''fusion gene'' r ...

and stimulate a patient's

immune system The immune system is a network of biological processes that protects an organism from diseases. It detects and responds to a wide variety of pathogens, from viruses to parasitic worms, as well as cancer cells and objects such as wood splinte ...

(specifically their

T cell A T cell is a type of lymphocyte. T cells are one of the important white blood cells of the immune system and play a central role in the adaptive immune response. T cells can be distinguished from other lymphocytes by the presence of a T-cell r ...

s) to mount an immune response to the secreted antigen; if the antigen is specifically found on cancerous cells, then the result aims to be an effective immune response targeting and eliminating the cancer. Treatments developed using this paradigm are referred to as ''Lm''-LLO immunotherapies. Today, the Company has over fifteen distinct constructs in various stages of development, directly developed by the Company and through strategic collaborations with centers　such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, and the Department of Homeland Security among others. The Company also has a veterinary medicine program that is evaluating an Lm-LLO based immunotherapy in a Phase 1 study in canine osteosarcoma. Source
www.advaxis.com

Corporate history and governance

Beginnings

Advaxis was a Delaware corporation when it was acquired by a shell corporation (in the official SEC sense) in November 2004. The acquiring company was Great Expectations, which was incorporated in Colorado in June 1987. The only operating company owned by Great Expectations was Advaxis and in 2004, a month after the acquisition, it changed its name to Advaxis, and 18 months after that it reincorporated as a Delaware corporation. The official 'date of inception' for the company is 1 March 2002.

Partnerships

In 2014, Advaxis entered a co-development and commercialization agreement with India's

Biocon Biocon Limited is an Indian biopharmaceutical company based in Bangalore. It was founded by Kiran Mazumdar-Shaw in 1978. The company manufactures generic active pharmaceutical ingredients (APIs) that are sold in approximately 120 countries, ...

for the ADXS-HPV therapeutic in the Indian market, addressing HPV-associated cancers, including

cervical cancer Cervical cancer is a cancer arising from the cervix. It is due to the abnormal growth of cells that have the ability to invade or spread to other parts of the body. Early on, typically no symptoms are seen. Later symptoms may include abnormal ...

.^,

Advaxis Technology

Advaxis immunotherapies are based on a novel platform technology using live attenuated ''Listeria monocytogenes'' (''Lm'') that are bio-engineered to secrete an antigen/adjuvant fusion protein. The vectors infect the key elements of the immune system and the secreted antigen/adjuvant fusion protein redirects the powerful immune response all human beings inherit to ''Lm'' against the cancer, itself. The adjuvant also reduces the cancer's defense against this immune attack by 80%. * The Company's novel platform technology is based on over twenty years of pre-clinical research by Yvonne Paterson, Professor of Microbiology,

University of Pennsylvania The University of Pennsylvania (also known as Penn or UPenn) is a private research university in Philadelphia. It is the fourth-oldest institution of higher education in the United States and is ranked among the highest-regarded universitie ...

, and Fellow of the American Academy for the Advancement of Science.

Clinical Development Program

ADXS-HPV is in Phase 2 trials for HPV-associated diseases (cervical intraepithelial neoplasia (CIN), cervical cancer and HPV-associated head and neck cancer). In 2009 Advaxis published the results of the first Phase 1 trial with the first Lm-LLO based immunotherapy, ADXS-HPV in Vaccine (19 June 2009 / Volume 27, Issue 30). This study assessed side effects associated with increasing doses of ADXS-HPV in patients with metastatic, refractory, recurrent cervical cancer
Vaccine (19 June 2009 / Volume 27, Issue 30)
* This study demonstrated for the first time that a live-attenuated Lm-LLO based immunotherapy could be administered to human subjects. * ADXS-HPV was well tolerated, and a maximum tolerated dose was established. * 4/13 evaluable patients experienced increased survival and tumor shrinkage that merited further investigation.

Veterinary Medicine Program

* Advaxis signed a CRADA (Cooperative Research And Development Agreement) with the Department of Homeland Security. The DHS will initially conduct a pilot “proof-of-concept” study in cattle investigating the safety of proprietary/patented Advaxis immunotherapies. * Advaxis has begun a Phase 1 study with the

University of Pennsylvania School of Veterinary Medicine The University of Pennsylvania School of Veterinary Medicine, commonly referred to as Penn Vet was founded in 1884. It has two campuses; the main campus is located in Philadelphia, and a second campus is located in Kennett Square, Pennsylvania. A ...

to evaluate an ''Lm''-LLO based immunotherapy in a Phase 1 study in canine osteosarcoma.

References

{{Reflist, 30em Biotechnology companies of the United States Companies based in Princeton, New Jersey Companies formerly listed on the Nasdaq Companies traded over-the-counter in the United States 2002 establishments in New Jersey Biotechnology companies established in 2002 Immunotherapy