Advaxis

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Advaxis Inc.

Company type	Public
Traded as	OTCQX: ADXS
Industry	Biotechnology Healthcare
Predecessor	Great Expectations, Inc.
Founded	March 1, 2002; 22 years ago (2002-03-01), in the United States
Headquarters	Princeton, New Jersey , United States
Key people	Ken Berlin (CEO) Dr. Robert Petit (CSO) Molly Henderson (CFO) Dr. Andres Gutierrez (CMO)
Products	Immunotherapies for cancer
Website	www.advaxis.com

Advaxis Immunotherapies Inc. was an American company that focused on the discovery, development, and commercialization of immunotherapies based on a technology platform that uses engineered Listeria monocytogenes (aka Lm).^[1] The company merged with Ayala Pharmaceuticals, with the newly formed company beginning operations under the name Ayala Pharmaceuticals in January 2023.^[2]

The Lm-based platform on which the company's products were based involves the use of attenuated Lm, which secretes antigen/adjuvant fusion proteins and stimulates a patient's immune system (specifically their T cells) to mount an immune response to the secreted antigen. If the antigen is specifically found on cancerous cells, the result is an effective immune response targeting and eliminating the cancer.^[1] Treatments developed using this paradigm are referred to as Lm-LLO immunotherapies.^[1]

The company had 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 had a veterinary medicine program that was evaluating an Lm-LLO-based immunotherapy in a Phase 1 study in canine osteosarcoma. Source: [1]

Advaxis was a Delaware corporation when it was acquired by a shell corporation (in the official SEC sense)^[3] in November 2004.^[1]: 1 The acquiring company was Great Expectations, which was incorporated in Colorado in June 1987.^[1]: 1 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.^[1]: 1 The official 'date of inception' for the company is 1 March 2002.^[1]: 1

In 2014, Advaxis entered a co-development and commercialization agreement with India's Biocon for the ADXS-HPV therapeutic in the Indian market, addressing HPV-associated cancers, including cervical cancer.^{[1]: 2 ,[4]}

Advaxis immunotherapies are based on a novel platform technology using live attenuated Listeria monocytogenes (Lm) that are bioengineered 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%.^[5]

• The company's novel platform technology is based on over twenty years of preclinical research by Yvonne Paterson, Professor of Microbiology, University of Pennsylvania, and Fellow of the American Academy for the Advancement of Science.

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.

• 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.^[6][7]
• Advaxis has begun a Phase 1 study with the University of Pennsylvania School of Veterinary Medicine to evaluate an Lm-LLO-based immunotherapy in a Phase 1 study in canine osteosarcoma.^[8][9]