Advaxis

Advaxis

Type	Public
Traded as	OTCBB: ADXS
Industry	Biotechnology Healthcare
Headquarters	Princeton, New Jersey, United States
Key people	Thomas A. Moore, Dr. John Rothman, Mark Rosenblum, Yvonne Paterson
Products	Immunotherapies for cancer and infectious diseases
Website	http://www.advaxis.com

Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Their novel platform technology generates a comprehensive immune response by serving as its own adjuvant, directing antigen presentation, increasing tumor infiltrating killer T-cells, and decreasing Tregs/MDSCs in the tumor.

Today, the Company has over fifteen distinct constructs in various stages of development, directly developed by the Company and through strategic collaborations with recognized centers of excellence 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

Contents 1 History 2 Advaxis Technology 3 Clinical Development Program 4 Veterinary Medicine Program 5 Intellectual Property 6 References

History

• Advaxis is a leader in developing the next generation of immunotherapies that harness the body’s intrinsic immune ability to fight cancer and infectious diseases.

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

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%.^[1]

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, recurent 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.^[2]

• 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.^[3]

Intellectual Property

Advaxis’ intellectual property includes over 70 pending and issued patents. On May 18, 2010, Advaxis and the University of Pennsylvania signed an agreement granting Advaxis exclusive rights to 27 remaining patents held by the University of Pennsylvania.

References