Advaxis and the University of Pennsylvania Reach Agreement

Advaxis, Inc. and the University of Pennsylvania (“UPenn”) signed a patent amendment agreement (the “Second Amendment Agreement”) allowing Advaxis to acquire exclusive licenses for an additional twenty-seven (27) patents related to the company’s proprietary Listeria vaccine technology.

“This second amendment to our current patent licensing agreement is quite important for the development of Advaxis’ platform technology,” commented Advaxis Chairman/CEO Thomas A. Moore. “Although we are currently in a solid position regarding our technology,IP position and exclusive licensee status with UPenn, this second amendment ensures our continued growth. Our patent portfolio is comprehensive and defendable as evidenced in our successful patent defense in European patent court last year.“

About the UPenn-Advaxis Licensing Agreement

This licensing is part of the company’s 20-year exclusive worldwide license agreement with UPenn. It covers patents that expire as late as 2023. As per the terms of the agreement, Advaxis is required to reimburse UPenn a portion of the associated licensing fees and all legal expenses. In addition, Advaxis provides milestone payments upon achievement of Phase III Trials, regulatory approval and commercialization. UPenn also receives a 1.5% royalty fee.

Advaxis' Live Listeria Prostate Cancer Vaccine Heads for Clinic

http://www.marketwatch.com/story/advaxis-live-listeria-prostate-cancer-vaccine-heads-for-clinic-2010-04-30?reflink=MW_news_stmp

Advaxis, the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, is advancing the clinical development of its lead prostate cancer immunotherapeutic toward clinical trials.

The company is collaborating with Dr. Chandan Guha at the Albert Einstein College of Medicine and Montefiore Medical Center to develop ADXS31-142 in human trials. Following the completion of manufacturing trials, the company intends to conduct a Phase 1 study with Dr. Guha.

Regarding Advaxis' prostate initiative, Dr. John Rothman, Executive VP of Science and Operations said, "Prostate cancer is an excellent target for immunotherapy. We believe our approach compares favorably with the recently approved Provenge treatment. Advaxis' vaccine is simple and less expensive, as it is comprised of three (3) vaccinations, which attack all prostate cancer without the need to be patient specific."

Advaxis' prostate cancer vaccine generates a strong immunologic response that attacks and kills cells that secrete prostate specific antigen (PSA), a commonly used clinical indicator of prostate cancer. The company has published preclinical work demonstrating the ability of ADXS31-142, its live Listeria vaccine directed against PSA (Cancer Immunology Immunotherapy. 2008, 57:1301--1313; Clinical & Vaccine Immunology, 2009, 16(1):96--103).

"The approval of Dendreon Corporation's /quotes/comstock/15*!dndn/quotes/nls/dndn (DNDN 52.89, -2.54, -4.58%) Provenge by the Food and Drug Administration (FDA) is an exciting development in the study of cancer immunotherapy. Our collaboration with Dr. Guha, coupled with our recent success in raising funds and some very promising new preclinical research has led us to commit to moving forward immediately on a prostate program with our proprietary live Listeria technology platform," commented Advaxis Chairman/CEO Thomas A. Moore. "If human results approach our animal results, we may be able to offer an immunotherapy that is less expensive, more effective and suitable for use prior to the induction of chemical castration of prostate cancer patients."

About Dr. Chandan Guha

Dr. Guha is Professor of Radiation Oncology and Professor of Pathology at the Albert Einstein College of Medicine and Vice-Chairman of Radio-oncology at the Montefiore Medical Center. He is a member of the National Cancer Institute's Radio-Therapy Oncology Group (RTOG). Dr. Guha has received numerous awards and grants in support of his work.

About Advaxis, Inc.

Advaxis is a biotechnology company developing proprietary, live, attenuated Listeria monocytogenes (Listeria) immunotherapeutics that deliver engineered tumor antigens, which stimulate multiple, simultaneous, immunological mechanisms to fight cancer. Today, the Company has nine (9) distinct, cancer-fighting constructs in various stages of development, directly and through strategic collaborations with such recognized sites of excellence as the City of Hope, the Roswell Park Cancer Institute, the National Cancer Institute, the University of Pittsburgh and Cancer Research -- UK. The Company's technology was developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania and chairperson of Advaxis' scientific advisory board.

Clinical Trials. gov listing

An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+ (ADXS11-001)

This study is currently recruiting participants.

Purpose

Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus which causes cervical cancer. The purpose of the study is to test the safety, tolerability (how the drug makes you feel), immunology (effects on the immune system) and efficacy (disease curing effects) of a vaccine called Lovaxin C against E7. The vaccine is designed to cause the immune system to react against the E7 substance in a manner that is intended to reverse the changes to the cervix and prevent cervical cancer from occurring

http://www.clinicaltrials.gov/ct2/show/NCT01116245?term=advaxis&rank=1

http://www.clinicaltrials.gov/ct2/show/related/NCT01116245?term=advaxis&rank=1

Advaxis Initiates Phase II Cervical Dysplasia (CIN) Trial

04/14/2010 - Advaxis, Inc., the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, initiated the Company’s first clinical trial site in its randomized, single blind, placebo-controlled, Phase 2 clinical trial of ADXS11-001 for the treatment of cervical intraepithelial neoplasia (CIN). The study is designed to assess the safety and efficacy of ADXS11-001 for the treatment of CIN grade 2/3 commonly known as cervical dysplasia.

The Institute for Women’s Health & Body in Wellington, Florida is Advaxis’ first clinical trial site in this multicenter study. The principal investigator at the Institute for the trial is Dr. Keith Aqua, MD – an experienced clinical investigator in the development of new therapies for women’s health. His center has two Florida sites with 84,000 active patients and conducts over 2,000 Pap smears, per month.

Numoda Corporation is Advaxis’ strategic partner in the conduction and execution of this trial. Numoda’s expertise in the administration of all aspects of clinical trials administration from initial data structures and site training to database closure and analysis is extensive and provides Advaxis with high quality clinical trials management.

In regards to the trial, Numoda Corporation CEO Mary Schaheen said, “We are proud to be involved with such innovative drug development. Our combined efforts will help bring effective treatment to women suffering from cervical intraepithelial neoplasia.”

“The initiation of our Phase II CIN program for ADXS11-001 is a major milestone for the development of live, attenuated Listeria vaccines,” commented Advaxis Chairman/CEO Thomas A. Moore. “Our goal is to demonstrate that for millions of American women, CIN can be treated safely and effectively without the pain and risks of surgery. Similarly, we hope to show we can immunize against the return of CIN in the future; something surgery cannot do."

About Cervical Dysplasia (CIN)

CIN is the precursor condition to cervix cancer, which is diagnosed in 450,000 American women annually. Progressive CIN is currently treated with surgery to prevent cancer from occurring; however, this treatment is associated with a number of problems, which include the development of an “incompetent cervix” i.e., a condition that prevents women from carrying a baby to full term. The typical CIN patient is a woman between 25 and 45 years of age. Although surgery is a viable short-term solution for the condition, it does not address the cause of the disease, which is a human papilloma virus (HPV) infection. Women who require surgery once may need it again. Current HPV vaccination products have not demonstrated effectiveness against active HPV infections.

About The Advaxis Phase I Clinical Trial

The Advaxis Phase I clinical trial was conducted in women with advanced cervix cancer who had progressed following cytotoxic therapy. In most cases, these women had been treated with multiple therapeutic modalities including surgery, radiation and chemotherapy. It is accepted that once these patients fail cytotoxic therapy there is little that can be offered to cure their disease or extend life. Historically, the median survival for these patients is approximately 180 days with only about 5% surviving one year. In the Advaxis Phase I clinical trial, the median survival was 347 days with 57% of patients surviving one year. More information on this clinical trial can be found in the published results of this trial (Vaccine 27 2009 3975–3983).

The strong efficacy signal seen in the Phase I trial of ADXS11-001 in advanced cervix cancer patients who had failed cytotoxic treatment, suggests that this agent should be useful in the treatment of CIN as well as cervix cancer, as both indications result from persistent HPV infection.

About Numoda Corporation

Numoda Corporation is a leading provider of clinical trial information and logistics services to promising life sciences companies

. Numoda's services strengthen the business case for new therapies by ensuring efficient deployment of funds and immediate reporting for early assessment of progress to improve conditions for the acquisition of funding, licensing and partnering money for future success. The business offerings include business evaluation, budget projections and oversight, in conjunction with comprehensive management of clinical trials, patented information systems, logistics management and reporting tools with early transparency.

About Advaxis, Inc.

Advaxis is a biotechnology company developing proprietary, live, attenuated Listeria monocytogenes (Listeria) immunotherapeutics that deliver engineered tumor antigens, which stimulate multiple, simultaneous, immunological mechanisms to fight cancer. Today, the Company has nine (9) distinct, cancer-fighting constructs in various stages of development, directly and through strategic collaborations with such recognized sites of excellence as the City of Hope, the Roswell Park Cancer Institute, the National Cancer Institute, the University of Pittsburgh and Cancer Research – UK. The Company’s technology was developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania and chairperson of Advaxis’ scientific advisory board.

NY Times Business Article link

http://topics.nytimes.com/top/news/business/companies/advaxis-inc/index.html

Quick Finacial Data

Advaxis Inc. Form 10k Filed 2010-02-19 link - http://secwatch.com/filings/view.jsp?formid=7039487&source=api

Income Statement Snapshot

View: Annual Data | Quarterly Data

All numbers in thousands

PERIOD ENDING		31-Oct-09	31-Oct-08	31-Oct-07
Total Revenue		30	66	154
Cost of Revenue		-	-	-
Gross Profit		30	66	154
	Operating Expenses
	Research Development	2,316	2,482	2,128
	Selling General and Administrative	2,701	3,036	2,629
	Non Recurring	-	-	-
	Others	-	-	-
	Total Operating Expenses	-	-	-
Operating Income or Loss		(4,987)	(5,452)	(4,603)
	Income from Continuing Operations
	Total Other Income/Expenses Net	5,845	47	2,756
	Earnings Before Interest And Taxes	858	(5,405)	(1,847)
	Interest Expense	851	11	607
	Income Before Tax	7	(5,416)	(2,454)
	Income Tax Expense	(922)	-	-
	Minority Interest	-	-	-
	Net Income From Continuing Ops	929	(5,416)	(2,454)
	Non-recurring Events
	Discontinued Operations	-	-	-
	Extraordinary Items	-	-	-
	Effect Of Accounting Changes	-	-	-
	Other Items	-	-	-
Net Income		929	(5,416)	(2,454)
Preferred Stock And Other Adjustments		-	-	-
Net Income Applicable To Common Shares		$929	($5,416)	($2,454)

Advaxis Develops Room Temperature Formulation of ADXS11-001

03/10/10- News Wire

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company has developing a long-term, room temperature, storage-stable form of its vaccines. This would replace the current requirement to keep the product frozen at -70o C before use.

Advaxis has been investigating other methods for preserving its live vaccines without the need for freezing. Although live Listeria can be freeze dried, this method is associated with a loss of 90% or more of the bacterial activity. A recent test of a different method, called “foam drying” has delivered a product, which is stable at room temperature. Recovery of almost 100% of the product was observed and excellent biological activity was seen.


“This exciting work can make it possible to distribute our products to every physician’s office without special equipment using a low cost process,” commented Advaxis Chairman/CEO Thomas A. Moore. “It will be key to the licensing and commercialization of all our vaccine technologies.”

Advaxis Management Discusses FY2009 on Results Call

For information about the results call: Telephone: Dial-in number: (218) 862-6403 | Access Code: 198209 Playback available until June 25, 2010 until 1800 EST

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, conducted its fiscal year end results conference call yesterday. Following is a summary

• Efforts to maximize shareholder value by demonstrating safety and efficacy of Advaxis’ lead, drug candidate ADXS11-001 – the overall development program for the Company’s proprietary live, attenuated Listeria immunotherapeutic agents for the treatment of cancer and infectious diseases
• Efforts to complete construct licensing post Phase II research, which may result in earlier capital returns
• Lowering corporate risk and maintaining corporate focus through strategic collaborations with recognized sites of excellence such as the City of Hope, the Roswell Park Cancer Institute, the National Cancer Institute (NCI), the University of Pittsburgh and Cancer Research – UK (CRUK)
• Pre-clinical development of ADXS31-142 (prostate cancer construct) and ADXS31-164 (breast cancer construct) is close to completion and identification of academic clinical partners to initiate Phase I studies for both agents has begun
• Currently announced Advaxis clinical trials will have approximately 350 patients receiving in the aggregate with a overall cost to the Company of about $10 million
• Available funding includes more than $3.5 million in cash of the agreed upon $5.0 million funding instrument with Optimus Life Science Capital Partners, announced in June 2009
• The current short-term debt program in its final weeks; whereby, approximately $3.4 million was raised and roughly $900,000 repaid, with interest, to the debt holders.

Advaxis lights up the future for cervical cancer and maybe some head and neck cancers

24th February 2010 17:44

Invasive carcinoma of the cervix is the second most common cancer in women worldwide with over 450,000 new cases and 230,000 deaths annually, most of them occurring in developing countries. Persistent infection with high-oncogenic risk HPV, especially HPV16 and HPV18 are common underlying causes of malignant lesions, accounting for over 70% of Invasive carcinoma of the cervix and over 50% of high-grade precursor lesions.

According to our 2007 feature Gynecological Cancers - Niche opportunities in advanced disease the incidence of cervical cancer is set to fall with the advent of prophylactic HPV vaccines. However cervical cancer will remain a problem for many years for two reasons. Firstly, prophylactic vaccines are unlikely to offer significant benefit to those women already infected with HPV. Consequently cervical cancer will continue to be a problem in women who were sexually active prior to the introduction of the vaccine. Secondly, worldwide implementation of such vaccines remains a challenge.

Given that cervical cancer will continue to be a problem it is particularly disappointing that few advances in this area of oncology have been witnessed over recent years. The best hope for women at risk of cervical cancer is early detection. Prognosis for women with early stage disease is good with cure rates of 60%-80% and fortunately there have been advances in diagnostics. For example DailyUpdates reported news from BD Diagnostics 2008 that the FDA had approved its FocalPoint GS imaging system [press release]. In May 2009 we also reported that Israeli company Zetiq had demonstrated improvements over Pap staining. Pharmacological options remain in a state of relative inertia however.

According NCCN guidelines the first line approach to later stage disease remains radiotherapy with concurrent cisplatin-based chemotherapy. Response rates are quite low (20%-30%) and complete responses rare; overall survival with cisplatin is 6-9 months. Second line treatments are chemotherapeutic and associated with limited efficacy and significant toxicity. There is an obvious need for more targeted therapy that can offer improvements over cisplatin and possibly alternatives/adjuncts to surgery and radiotherapy.

With the exception of SRI International's cytotoxin, tirapazamine and PharmaMar's Zalypsis in (Phase 3 and 2 respectively) little development is being seen in the form of small molecules. Instead most activity is from the biologics sector. YM Bioscience is developing EGFR antibody, nimotuzumab, but by far the greatest efforts are currently being focussed on therapeutic vaccines (for background on this field see our 2007 feature, World market for cancer vaccines 2007-2012).

To our knowledge four candidates are currently in the clinic for cervical cancer or the premalignant disease, cervical intraepithelial neoplasias (CIN). Inovio is developing a DNA vaccine targeting E6 and E7 proteins of HPV16 and HPV18, VGX-3100 for the treatment of CIN. This candidate is in Phase 1 development. More advanced is Roche's RG-3484, a modified vaccinia Ankara vaccine expressing E6 and E7 along with IL-2. Phase 2 trials opened last year, again focusing on CIN. A third vaccine is being developed by ISA Pharmaceuticals. In contrast to the Inovio and Roche vaccines this candidate is being developed for both CIN (Phase 2) and cervical cancer (Phase 1).

Today's edition of DailyUpdates features a paper describing a fourth therapeutic vaccine in development for the treatment of cervical cancer, Advaxis' ADXS11-001 (formerly Lovaxin C). The technology being developed by Advaxis differs from other thereapeutic vaccines as it is the only live bacterial vaccine currently in clinical trials. It is based upon attenuated, bioengineered Listeria monocytogenes that provides very strong stimulation of innate immunity as well as both arms of the adaptive immune system, alters the tumor microenvironment to remove regulatory T cells (Tregs) and Myeloid Derived Suppressor Cells (MDSC) that are sources of immune inhibition, increases the pool of mature immune cells, facilitates migration of immune cells into tumors, and other effects.

The paper featured today describes data from a Phase 1 study in which the vaccine was administered safely to women with cervical cancer and who had failed surgical, radiation and/or chemotherapeutic intervention. Patients were inoculated twice, at day 1 and day 22; the protocol required administration of antibiotics five days post-inoculation to attenuate the live vaccine. Adverse events were generally flu-like and transient.

The women recruited to the study would normally be expected to have a median survival of only 6 months with a 1 year survival of 5%. In this study, the median survival was doubled and the 1 year survival increased 10-fold. Remarkably, Advaxis recently reported updated data showing that 2 of 13 patients were alive at 3 years.

The data reported in the present study are fascinating, especially given the advance stage of disease and the fact that responses were seen with just two inoculations. Further studies, perhaps with booster vaccinations built into the protocols are awaited with great interest. In addition the promise shown in the present study suggests that evaluation of the vaccine in earlier stage CIN may be worthwhile. LeadDiscovery understands that further trials are planned for this year - one a Phase 2 study of cervical cancer patients; another a study of CIN patients.

Finally, a paper was published by Maxwell et al last year in the journal head and neck linking HPV to a rare head and neck cancer, nasopharyngeal carcinoma. We understand that a further trial is planned evaluating ADXS11-001 in this disease. This is not only of great clinical importance, it may also be of commercial importance. Advaxis failed to gain orphan drug status from the FDA last year on a cervical cancer indication. The company may be able to refile for an orphan indication on this new indication (for further information on head and neck cancer, including pharyngeal cancers read Stakeholder Opinions: Head and Neck Cancer).

http://leaddiscovery.co.uk/editorials/4/advaxis-lights-up-the-future-for-cervical-cancer-and-maybe-some-head-and-neck-cancers

Cancer Research UK to Fund Clinical Trial of ADXS11-001 for the Treatment of Head and Neck Cancer

Advaxis, Inc., , the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, is pleased to announce that Cancer Research UK (CRUK), the UK philanthropy dedicated to cancer research, has agreed to fund the cost of a clinical trial to investigate the use of ADXS11-001, Advaxis’ lead human papilloma virus (HPV)-directed vaccine candidate, for the treatment of head and neck cancer.

This sponsored-clinical trial will investigate the safety and efficacy of ADXS11-001 in head and neck cancer patients who have previously failed treatment with surgery, radiotherapy and chemotherapy – alone or in combination. Advaxis will provide the vaccines with all other associated costs to be funded by CRUK.

The study is to be conducted at Aintree Hospital at the University of Liverpool, Royal Marsden Hospital in London, and Cardiff Hospital at the University of Wales. Patient enrollment is slated for the latter part 2010. At such time, enrollment officials anticipate recruiting a maximum of forty-five (45) patients.

“Both acceptance by the scientific community and interest in collaborating on live, attenuated Listeria vaccines is accelerating,” said Advaxis Executive VP of Science & Operations John Rothman. “The high caliber of collaborating clinical researchers, such as CRUK and NCI, will result in an excellent development programs. The development of new vaccines, at the pre-clinical level, is being spurred by collaborations with such noteworthy institutions as the City of Hope, the Roswell Cancer Institute and the University of Pittsburgh.”

About Head and Neck Cancer

Oropharyngeal (upper) head and neck cancer, like cervix cancer, is believed to be caused by persistent HPV infection in people whose immune systems fail to clear the virus. According to the National Cancer Institute (NCI), head and neck cancers represent approximately 3 to 5 percent of all cancers in the United States, with these types of cancers being more common in men. Historically, head and neck cancer has been associated with people over the age of 50, and the use of alcohol and tobacco (including smokeless tobacco). Recently, however, this form of cancer is increasing dramatically in younger people with no history of tobacco use.

About Cancer Research UK

Cancer Research UK is the largest single funder of cancer research in the UK and the world’s largest charity dedicated to cancer research. It funds research on all aspects of cancer, from basic cell biology to large clinical studies of entire populations. The organization funds the work of more than 4,500 scientists, doctors and nurses across the UK and runs specialized institutes dedicated to cancer research. Cancer Research UK currently funds more than 180 clinical trials. Since the early 1980’s, Cancer Research UK has taken over 100 new drugs into clinical trials with more than 100,000 patients taking part in trials since 1995. For more information, please visit: cancerresearchuk.org

About the Clinical Sites

The Aintree University Hospitals NHS Foundation Trust was established on August 1, 2006 as a public benefit corporation authorized under the National Health Service Act 2006. It is a large, complex organization providing acute healthcare to a population of 330,000 in North Merseyside and surrounding areas. The immediate catchment covers some 33 square miles, which is largely urban with significant areas of commerce including docklands. The Aintree University Hospitals NHS Foundation Trust provides acute hospital services to the residents of South Sefton, North Liverpool and Kirkby. It is also a teaching hospital for the University of Liverpool and a tertiary centre providing specialist services to a much wider population of around 1.5 million in Merseyside, Cheshire, South Lancashire and North Wales. The population served by Aintree includes some of the most socially deprived communities in the country, with high levels of illness creating a high demand for hospital-based care. For more information, please visit: aintreehospitals.nhs.uk.

The Royal Marsden NHS Foundation Trust was the first hospital in the world dedicated to the study and treatment of cancer. It was founded as the Free Cancer Hospital in 1851 by Dr. William Marsden to classify tumors, research the causes of cancer, and to find new treatments. In 1991 the Royal Marsden became the first NHS hospital to be awarded the Queen’s Award for Technology for its work on drug development. The hospital achieved the international quality standard ISO 9001 for radiotherapy in 1996 and for chemotherapy in 2003. It was recognized as one of six (6) centers of excellence in the Government’s NHS Plan and has achieved four national Charter Marks for all its services, the most recent awarded in 2005. In April 2004, the hospital became one of the country’s first NHS Foundation Trusts. This new status has provided the financial freedom and greater flexibility to focus on allowing more patients to access the hospital's expertise. For more information, please visit: royalmarsden.nhs.uk.

Cardiff Hospital (University of Wales) is part of the Cardiff and Vale NHS Trust and provides day-to-day health services to a population of around 500,000 people living in Cardiff and the Vale of Glamorgan who need hospital treatment, mental health care, care for elderly people and children as well as a growing range of community-based services, including specialist dental services, and new therapies as alternatives to hospital admission. Patients also attend from across Wales for a range of specialist services, for which the Cardiff and Vale NHS Trust is regarded as a centre of excellence, including pediatric, renal, cardiac, neurological services and bone marrow transplantation. For more information, please visit: cardiffandvale.wales.nhs.uk.

Yvonne J. Paterson video interview from 2007

This is an older video interview ( 2007) of Dr. Yvonne Patterson in which she explains her personal experience and subsequent involvement in seeking relief for many stricken with cancer.

http://wbztv.com/video/?id=27635@wbz.dayport.com

The following is the article associated with the interview.

Doctor Works Toward A Breast Cancer Vaccine

The Vaccine May Stop Breast Cancer From Happening Again To Survivors

Jan 9, 2007

It's a constant worry for breast cancer survivors -- will the disease return?

Now, there is new research into a breast cancer vaccine and one doctor has made it her life's work.

Yvonne Paterson, a mother and medical researcher, was only 42 when she got the devastating diagnosis -- breast cancer. "I said, 'what do you mean?' I just wanted to have the comfort in my mind that it had gone and I had gotten rid of it… So I opted to have a mastectomy."

Now 20 years later, Paterson is more than a survivor, she's on the cutting edge of breast cancer research -- trying to develop a vaccine. "We've shown that we can either eliminate, eradicate all together or stop the growth of breast tumors in mice."

The vaccine would not prevent women from getting the disease. It's designed to prevent a recurrence in patients who have undergone treatments like radiation and chemotherapy.

"The idea is that it will promote survival by decreasing the risk of recurrence -- eliminating all of the residual tumor cells that conventional therapy hasn't managed to kill," said Paterson.

"Vaccines for the large part have been used to treat infectious diseases," said Dr. Eric Winer of the Dana Farber Cancer Institute.

Winer, head of Dana Farber's Breast Oncology Center, says scientists in general have been pessimistic about cancer vaccines, but now there is a renewed interest in this research.

"With some of the new technologies it's hoped that we can apply some of what's been done in the infectious disease setting to cancer," said Winer.

The next step for Dr. Paterson is human clinical trials. If successful? "This can give them peace of mind, like the peace of mind I didn't have 20 years ago," said Paterson.

The vaccine is called Lovaxin B and is currently in pre-trial testing. The company making the vaccine is seeking FDA approval for a clinical trial.

Both Dr. Paterson and Dr. Winer admit it will take years for a breast cancer vaccine to be approved for patients -- if it is approved at all.

Yvonne J. Paterson, Ph.D.-Description of Research Expertise

http://www.med.upenn.edu/apps/faculty/index.php/g20000320/p19034

Description of Research Expertise

Last updated: 06/05/2009
The Trustees of the University of Pennsylvania

Research Interests
Rational approaches to immune intervention in neoplastic and infectious disease.

Key words: Immune regulation, antigen design, vaccine development, cancer immunotherapy, HIV, HPV.

Description of Research
The research performed in the Paterson laboratory is dedicated to harnessing the immune system to provide cures for, or protection against, neoplastic and infectious disease. There have been enormous advances made in the last few years in our understanding of the molecular and cellular machinery that renders proteins immunogenic. In our laboratory, we are applying this knowledge to the development of strategies to enhance the immune response in the design of more effective vaccines against viral diseases, such as HIV, and against tumor cells. To do this we are using a facultative intracellular bacterium, Listeria monocytogenes, which has the unusual ability to live and grow in the cytoplasm of the cell. Our laboratory was the first to show that this bacterium could be used to target antigens to the MHC class I pathway for antigen processing with the induction of cytotoxic T cells and has pioneered the application of this organism in vaccine development over the past 15 years. We have shown that recombinant forms of this organism which have been transformed to express viral antigens from influenza, HIV and SIV are excellent vectors for inducing cell mediated immune responses both parenterally and at mucosal surfaces. We have also applied this technology in the development of cancer vaccines that result in the induction of potent cell mediated immunity that can eliminate established macroscopic tumors even in the face of profound immune tolerance to the tumor-associated antigen. In other studies, we have discovered that fusing an antigen to some bacterial proteins enhances its immunogenicity. This finding opens up novel, and perhaps safer, avenues to cancer immunotherapy. We are currently looking at a number of different approaches to carry these fusion proteins to the immune system for cancer immunotherapy. Cancers to which we are directing our various technologies currently include cervical cancer, breast cancer, lung cancer, melanoma and lymphoma.

USPTO issues new patent for Advaxis' intellectual property portfolio

22. January 2010

The U.S. Patent and Trademark Office (USPTO) issued today patent 7,635,479, "Compositions and Methods for Enhancing the Immunogenicity of Antigens,” by Dr. Yvonne Paterson, et al, which is assigned to the Trustees of the University of Pennsylvania and licensed to Advaxis, Incorporated

“As we develop the intellectual property portfolio associated with our technology, this patent integrates nicely with our LLO- and ActA-antigen patents”

Research, originating in the laboratory of Dr. Yvonne Paterson and continued at Advaxis and elsewhere, has shown that the unique protein pattern called PEST (Proline, Glutamic Acid , Serine, Threonine) is associated with therapeutic efficacy in live Listeria monocytogenes (Lm)vaccines that are engineered to secrete antigen-adjuvant fusion proteins when either LLO (listeriolysin O) or ActA are used as the adjuvant.

“As we develop the intellectual property portfolio associated with our technology, this patent integrates nicely with our LLO- and ActA-antigen patents,” said Executive VP of Science and Operations Dr. John Rothman. “Our portfolio includes patents for three different attenuated vaccine strains of Listeria and two different families of fusion proteins.”

The Company’s flagship Lm strain is currently in clinical testing for human papilloma virus (HPV)-induced disease, including cancer of the cervix.

.................................................................................

Excerpt about PEST from Advaxis.........

("LLO"), a protein that generates a hole in the membrane of the phagolysosome and allows the bacteria to escape into the relatively safe cytoplasm. Once in the cytoplasm, however, LLO still retains some activity and is also capable of creating a hole in the cell membrane. This would destroy the host cell, and spill the bacteria back out into the intercellular space where it would be exposed to more immune cell attacks and destruction. To prevent this, a sequence of approximately 30 amino acids is present in the LLO protein, called the PEST sequence (for the predominant amino acids it contains). This PEST sequence is recognized by the host cells and targets the LLO protein for rapid digestion, thus giving LLO a very short life span.

Cervical Health Awareness Month Know The Facts To Prevent And Detect Cancer

Some facts and information regarding the focus of ADXS11-011.

Article Date: 17 Jan 2010


In observance of National Cervical Health Awareness Month, The American College of Obstetricians and Gynecologists (the College) has an important message for women: All women should have an annual well-woman exam, but not all women need annual Pap tests. For many women, the College now advises Pap testing at regular intervals instead of every year, based on their age, risk factors, and previous cervical screening test results.

In 2009, an estimated 11,270 new cases of cervical cancer were diagnosed in the US, and the disease caused over 4,000 deaths. The Pap test is a highly effective tool in detecting cervical cancer at its earliest and most treatable stages. In fact, regular cervical screening tests can actually find precancerous changes before they become dangerous and turn into cancer.

Getting regular, but less frequent, Pap tests is a safe option for many women, according to new evidence-based guidelines issued in December 2009 by The American College of Obstetricians and Gynecologists. The College now recommends that Pap testing start at age 21 and that women ages 21-29 be screened every two years; women age 30 and older can be screened every three years. However, women with certain risk factors and health issues may need more frequent screening.

The College acknowledges that reducing the frequency of Pap tests may be met with resistance by many women, but the bottom line is that research has shown less frequent cervical screening to be just as effective in preventing cancer as annual screening. Consequently, overscreening for cervical cancer may actually do more harm than good and can lead to unnecessary treatment and future childbearing implications.

Click here to get the facts on cervical and other women's cancers, including information about who is most at risk, how cancer can be prevented, available screenings and their recommended frequency, warning signs and symptoms, and how the cancer is treated.

Source
American College of Obstetricians and Gynecologists

'Bugs provoke the immune system into fiighting cancer'

Published in 'New Scientist' 2008.

Disease-causing bugs could play a valuable role in the treatment of cancer. Deliberately infecting people with the bacteria that cause listeriosis could increase their ability to destroy tumours. The goal is to kick-start the body's immune system by "provoking" it with the bacteria, which are modified to trigger an attack on the cancer.

US vaccine company Advaxis chose Listeria monocytogenes because of its ability to stow away in immune cells called antigen-presenting cells (APCs). These cells prime the rest of the immune system to attack a given strain of microbe, say, by showing fragments of antigen from that microbe to the appropriate cells.

Advaxis modified the bacterium so it was no longer harmful, and so that once inside the APC it would secrete fragments of HPV-E7, a molecule found on the surface of cervical cancer cells. By presenting HPV-E7 to other immune cells, the APCs would then prime them to attack the cancer.

In a preliminary trial on 13 women with advanced cervical cancer, four of those injected with the bacteria responded. One is tumour-free more than two years after the treatment, and tumours in the other three shrank by 20 per cent. Seven of the women have died from the cancer. Advaxis hopes to begin a trial on 180 patients with less advanced cervical cancer.

John Stanford of University College London, whose team has had recent success treating cancer patients with dead Mycobacterium vaccae, says that Advaxis may need to give booster doses to sustain the therapeutic effect.

Executive Clinical Officer Dr. Christine Chansky Brings Seasoned Expertise In FDA Procedures and Drug Development

Christine Chansky, MD, JD, FCLM ,is a veteran clinician, pharmaceutical industry Medical Director, and Food & Drug Administration (“FDA”) procedural specialist.

Dr. Chansky has over fifteen years of professional expertise in health care compliance and FDA regulations with comprehensive experience in drug development, pharmaceutical promotional regulations, and patient compliance within the guidelines provided by the Health Insurance Portability and Accountability Act (“HIPAA”). She has been integrally involved in every stage of FDA clinical protocols from pre-IND submission through drug commercialization in the global arena and has been involved with blockbuster drugs such as Johnson & Johnson’s (NYSE: JNJ) Procrit/Eprex and Sanofi-Aventis SA’s (NYSE: SNY), formerly Aventis Pharmaceuticals, Lovenox.

“We welcome Dr. Chansky to the company with open arms,” commented Advaxis Chairman and CEO Tom Moore. “Her expertise and impressive background in the execution of clinical trials and her deep knowledge of FDA procedures will be a key addition to our team in the furtherance of our flagship drug candidate, Lovaxin C, and the future development of our drug pipeline. With her knowledge, we are confident in being able to successfully navigate the FDA’s procedural landscape in short order and avoid the common pitfalls facing biotechnology companies.”

About Dr. Christine Chansky, MD, JD, FCLM

Before coming to Advaxis, Dr. Chansky was a Senior Director and Medical Monitor for Bayer HealthCare Pharmaceuticals. In that capacity, she was the Global Clinical Project Director of six (6) separate Women’s Health Care protocols. The focus of her responsibilities was the medical review of patient profile listings, adverse event reviews, comprehensive FDA communications, and safety reports. Contemporaneously, she was the clinical lead of various project managers, study monitors, clinical research associates (“CRAs”) and statisticians; oversaw data management, clinical operations, and medical writings; and was involved in pharmacovigilance and strategic collaboration with the regulatory and marketing departments.

Prior to that, Dr. Chansky was the Global Lead and Director of Medical Operations for Cordis Corporation, a Johnson & Johnson Company (NYSE: JNJ). In this capacity, she was responsible for establishing and leading the Global Protocol Review Committee for all Cordis marketed products involving the cross-functional creation of internal relationships to document spending of departmental funds. Her managerial influence and leadership catalyzed and provided medical leadership to the internal and external CROs for all clinical studies and registries. Similarly, she oversaw the Healthcare Compliance teams with respect to writing and maintaining policies and procedures as required by U.S. and ex-U.S. regulatory health authorities.

As part of her earlier accomplishments and roles, Dr. Chansky held senior positions orchestrating regulatory affairs, global development, medical affairs, medical marketing, and clinical research for The Medicines Company (NASDAQ: MDCO), Sanofi-Aventis (NYSE: SNY), formerly Aventis Pharmaceuticals, Johnson & Johnson Company (NYSE: JNJ), GlaxoSmithKline (NYSE:GSK), formerly Glaxo Wellcome, and Roche Pharmaceuticals (PINK: RHHBF). Her U.S. and ex-U.S. regulatory affairs experience includes the submissions of Investigational New Drug Applications (“INDs”), New Drug Applications (“NDAs”), Supplemental New Drug Applications (“sNDAs”), CTDs, and Marketing Authorization Applications (“MAAs”). She has worked as an industry expert in a variety of therapeutic areas that include oncology, the human immunodeficiency virus (“HIV”), anemia, pain management, women’s health care, and interventional cardiology.

Dr. Chansky holds a Doctor of Medicine degree from The Georgetown University School of Medicine and a Juris Doctor degree from Seton Hall University School of Law, with a concentration in pharmaceutical, regulatory, and health law. She trained as a surgeon in New York and Delaware, and currently maintains her Delaware medical license.

Advaxis US Patent information.

Advaxis owns 23 issued patents issued within its licenses portfolio and 22 pending patent applications. There are an additional 27 pending patent applications that the Company is currently negotiating the rights to with the University of Pennsylvania, the owner of these patents. There is no assurance that the parties will enter into this agreement, and that the Company will gain the rights to these additional 27 patents.

A Penny For Your Thoughts: Advaxis, Inc. (ADXS)

by Jack Williams

Advaxis, Inc. engages in the research and development of live cancer vaccines targeting cervical, head and neck, breast, prostate, and other cancers using a bio engineered bacterium, Listeria monocytogenes to activate the immune system. Results are very promising. The stock trades at 14 cents a share… I’ve heard this one before.

The street is littered with penny biotech companies promising the cure to cancer and delivering only a capital loss. The set up was fairly simple. Purchase controlling shares of a shell company (or start your own), create a good story, pump out a constant stream of press releases, sell your shares, and get out before having to deal with the FDA. I heard stories of a “scientist” and pitch man doing this on three different occasions.

But what about the exceptions? A rocket like Human Genome Systems (NASDAQ: HGSI) that would turn a $15,000 investment into a new social class? The answer is threefold: A legitimate company, a promising product the street questions could work, and a management team better suited for science than hyping stock. Turn that same microscope on Advaxis and this is what you get:

Company Legitimacy:

•Advaxis is based on technology developed by Dr. Yvonne Paterson, professor of microbiology at the University of Pennsylvania and chairperson of Advaxis’ scientific advisory board. The University of Pennsylvania remains a large shareholder of the company.
•In December the company announced its collaboration with the National Cancer Institute in beginning a Phase II clinical trial of the Company’s lead drug candidate, ADXS11-001 in the treatment of advanced cervix cancer in women. This trial will be conducted by the Gynecologic Oncology Group investigators and largely underwritten by the National Cancer Institute (NCI).
•In October the company completed funding sufficient enough to get through Phase II trials for ADXS11-001. The company will run two trials with the NCI the third. Total shares outstanding including dilution for warrants is approximately 150 million.

Determining penny stocks legitimacy can be a daunting task at times. But can you name one pump and dump that had an Ivy League professor as a head scientist and a phase II trial administered and funded by the NCI?

A Promising Product:

Although the Phase I trial for ADXS11-001 was designed to assess safety, not efficacy or survival of women with advanced, recurrent, metastatic cervix cancer, Advaxis noted the following facts (published in the medical journal Vaccine):

•Four of thirteen evaluable patients,experienced tumor reductions.
•Two patients had their lesions disappear.
•Fifty-three percent survived more than one year; a median survival rate of 347 days versus the NCI median survival rate of 115 to 185 days. One year historic survival rate is five percent.
•Three of the thirteen patients were still alive at over 1,000 days, post-dosing with the drug, as of September 29, 2009.

Even strong results like these are overshadowed on Wall Street by the past failures of “cancer vaccine companies”. The sentiment among biotech investors seems to be that cancer vaccines won’t work. We have our promise and our doubt.

Good Scientists, Bad Promoters:

This is where the management of Advaxis shines. If news is not buried somewhere in an 8-K, it’s often placed with a small wire service and barley acknowledged. Don’t expect daily news in an attempt to inflate the stock price like with some small biotech companies. The attitude here seems to be “if the product works the stock will go up in due time.” Throw in a late 10-Q filing slapping the dread E at the end of the company’s symbol for exactly one day earlier this year and you start questioning if these guys should be allowed out of the lab.

But as always it comes down to risk and reward. A small biotech does not fall to 14 cents without doubt, and it does not shoot to $30 without a viable product. Advaxis has the promise and the doubt. It’s your job as an investor to weight both sides and place your bet. Or you can continue searching for that next rocket.

(Disclosure: JR Williams owns Advaxis in his personal account)

Optimus Life Science Partners buys Series A preferred stock

On January 11, 2010, the Company issued and sold 145.0 shares of non-convertible, redeemable Series A preferred stock to Optimus Life Sciences Capital Partners LLC ("Optimus") pursuant to the terms of a Preferred Stock Purchase Agreement between the Company and Optimus dated September 24, 2009 (the "Purchase Agreement"). The aggregate purchase price for the Series A preferred stock was $1.45 million (less $130,000 representing an administrative fee and the balance of a commitment fee due and owing to Optimus under the Purchase Agreement). Under the terms of the Purchase Agreement, Optimus remains obligated, from time to time until September 24, 2012, to purchase up to an additional 355.0 shares of Series A preferred stock at a purchase price of $10,000 per share upon notice from the Company to Optimus, and subject to the satisfaction of certain conditions, as set forth in the Purchase Agreement.

In connection with the foregoing transaction, an affiliate of Optimus exercised warrants to purchase 11,563,000 shares of common stock at an adjusted exercise price of $0.17 per share. The Company and Optimus agreed to waive certain terms and conditions in the Purchase Agreement and the warrant in order to permit the affiliate of Optimus to exercise the warrants at such adjusted exercise price prior to the closing of the purchase of the Preferred Stock and acquire beneficial ownership of more than 4.99% of the Company's common stock on the date of exercise. As permitted by the terms of such warrants, the aggregate exercise price of $1,965,710 received by the Company is payable pursuant to a 4 year full recourse promissory note bearing interest at the rate of 2% per year.

As a result of anti-dilution protection provisions contained in certain of the Company's outstanding warrants, the Company has (i) reduced the exercise price from $0.20 per share to $0.17 per share with respect to an aggregate of approximately 62.0 million warrant shares to purchase the Company's Common Stock and (ii) correspondingly adjusted the amount of warrant shares issuable pursuant to certain warrants such that approximately 11.0 million additional warrant shares are issuable at $0.17 per share.

Original filing and agreement link

http://biz.yahoo.com/e/090925/adxs.ob8-k.html

Advaxis Awarded European Patent for New Listeria Vector

Advaxis, Inc has received notification from the European Patent Office (EPO) that Advaxis patent application 98957980.0 titled “Bacterial Vaccines Comprising Auxotrophic, Attenuated Strains of Listeria Expressing Heterologous Antigens,” has been granted and will be issued as patent #1032417. This application complements the already obtained US and Japan approvals for this technology and extends Advaxis’ intellectual property protection.

This novel form of bioengineered Lm was designed to be an improved vaccine strain of the bacterium with a lower level of virulence and a higher level of immunogenicity; resulting in a potentially safer and more effective therapeutic agent. Both the breast cancer and prostate cancer vaccines planned for clinical development use the new Lm strain.

Advaxis’ intellectual property portfolio contains compositions of matter, uses and methods that go to the manufacture and use of live, attenuated Lm vaccines that secrete antigen-adjuvant fusion proteins; and, for the manufacture and use of the fusion proteins independent of Lm. Currently, Advaxis has patents, either issued or in process, for three (3) different bioengineered strains of Lm with different properties for use as human vaccines, as well as patents covering two (2) separate families of adjuvant fusions based on the molecules LLO (listeriolysin O) and ActA.

The EPO provides a uniform application procedure for individual inventors and companies seeking patent protection in up to thirty-eight (38) European countries. It is the executive arm of the EPO and is supervised by the Administrative Council.

A New Star in Cancer Therapy

Biotechs are fascinating. They have such great promise, yet very few of them actually turn those promises into money — Advaxis (OTC BB:ADXS) is a beginner in the biotech oncology world, but has recently shown some reason to think they stand out from the pack. ADXS might be one of these hidden gems, following DNDN or ONTY. The Oncology sector has been a good investment so far and has provided huge reward this year. There is no doubt that Cancer therapy companies should again be in the Spotlight for the next years.

Advaxis is using Listeria monocytogenes bacteria as a vector to destroy solid tumors in patients. There is no other biotech company that is using this modality to treat cancer patients. It is not some newly discovered drug, but based on a biological entity that has been studied for over a hundred years and whose actions have been well documented if not totally understood. The Listeria platform will also have applications in the fields of infectious disease and autoimmune disorders.

Advaxis is the exclusive licensee of a patented broadly enabling Listeria platform technology that can elicit effective anti-tumor responses. The leading Advaxis Listeria vaccine candidate, Lovaxin C, targets cervical cancer, head cancer and neck cancers. Other Listeria vaccines in development target breast cancer, ovarian cancer and lung cancers.

Advaxis is developing multiple platform approaches to the treatment of several cancers which represent a market potential in excess of $10 billion.

Advaxis’ Phase I/II clinical cervix cancer study in their lead candidate ADXS11-001 showed an impressive overall survival rate of 53% in those patients who fail first line cytotoxic therapy (current survival rate is 5% at one year).

According to statistics provided by the GOG* (Gynaecologic Oncology Group); the median survival rate in months is increased by 88% to 200%. In addition, 3 of the 13 evaluable patients have now survived more than 3 YEARS. That is remarkable; other cancer vaccines have nowhere near the potential that the Advaxis’ vaccine platform has so far.

It is important to understand that Advaxis is developing vaccines for treating patients who have already contracted the target disease, such as cervical or breast cancer. In animal models of breast cancer, the data show that the Advaxis Lovaxin B vaccine, composed of the Listeria with the Her2/neu antigen, was able to successfully stop tumor growth.

Dr. John Rothman, Vice President of Clinical Development for Advaxis said, “The GOG* is an extremely competent and experienced group of clinical researchers. Their interest in collaborating with Advaxis is very encouraging. The GOG* has a thirty-year history of facilitating the development of many therapeutic agents that were once novel and today are well accepted as effective drugs. Our collaboration with this excellent research group will enable us to objectively demonstrate the therapeutic efficacy of our Lovaxin C vaccine for the treatment of women with cervical cancer. ”

Based on over a decade of work in the laboratory of Dr. Yvonne Paterson at the University of Pennsylvania, the Company’s broadly enabling Listeria technology platform uses modified Listeria monocytogenes to deliver a tumor-specific antigen fusion protein. Listeria has the ability to generate a robust immune response and produce an unusually strong and effective therapeutic immune response to existing cancers and other diseases affecting many related immune mechanisms simultaneously and in an integrated fashion. Advaxis’ Listeria-based technology not only generates an unusually profound cytotoxic immune response capable of killing cancer cells, but the Company’s proprietary antigen fusion protein technology minimizes the suppressive effects of regulatory T cells that appear to inhibit many vaccines, and also creates a local tumor environment conducive to the therapeutic effects of the activated tumor killing cells.

Advaxis is now getting ready for 2 Phase II clinical trial which starts in January.

One Phase II trial will be conducted by GOG investigators and largely underwritten by the NCI. The study’s patient population – a very sick and rapidly progressive patient population for whom no therapy has been found to be effective – will be the same patient population that was treated in Advaxis Phase I trial of ADXS11-001.

Portfolio Early Development

Vaccines in early development include treatments for other cancers, including: Ovarian, Glioma, Lymphoma, Leukemia, Prostate and others.

“Advaxis now has 9 distinct cancer fighting constructs under various stages of development, four through academic collaborations,” commented Advaxis CEO Thomas A. Moore. “As scientific excitement around Listeria technology grows, we believe many more opportunities will develop. These collaborations add to our overall understanding of Listerial vaccines, generate further scientific standing and accelerate the development of our pipeline. This new opportunity expands our potential pipeline beyond solid tumors. ”

ADXS31-164

Her/2-neu is over expressed in various cancers such as breast (40%), melanoma (30%), pancreatic (20%), ovarian (30%) & gastric (19%). Advaxis proven the efficacy of using a live Listeria vaccine for the treatment of HER2 related diseased by constructing multiple vectors that express overlapping fragments of the rat version of this molecule (about 1,000 residues). Following this work the company developed a novel vaccine based on an entirely new vaccine strain of Listeria that is more attenuated and more immunogenic than the strain currently in the clinic with ADXS11-001. By identifying and isolating the immunogenic portions of the multiple vaccines tested the company was able to create a chimeric antigen comprised of these immunogenic epitopes and fuse it to LLO to create an extremely powerful vaccine.

We have published, or publications are currently in press, that show not only does this vaccine eliminate existing tumors, but prevents metastases, can treat tumors within the brain (a difficult immune site frequently not amenable to treatment), and has even prevented the occurrence of spontaneous tumors in a year long study of transgenic animals who have had tumor causing oncogenes inserted into their DNA, and who thus get tumors spontaneously.

ADXS31-142

Prostate Specific Antigen (PSA) is the basis of the common blood test used to indicate the presence of prostate cancer. It is an antigen that is currently being used by many companies in the development of prostate specific therapies. A Listeria construct containing a PSA-LLO fusion protein has been developed using our newest strain of Listeria, and has been shown to be stable and very effective in animal models of prostate cancer.

Intellectual Property

Advaxis is the exclusive licensee of a portfolio of patents based on the work of Dr. Yvonne Paterson whose research at the University of Pennsylvania has resulted in a substantial base of intellectual property protecting the use of Listeria and listerial products as vaccine vehicles, in the form of several broad patents and applications that were filed both in the US and internationally. This includes 23 approved and over 41 pending patent applications. These patents are filed in the US as well as in Japan, Canada, Australia and Europe.

Financial situation

In October 2009, $1.3 million was raised in a convertible note.

Earlier in September, Advaxis announced the receipt of a $210,000 grant from the National Institutes of Health to support their research and has also entered into a definitive agreement for a $5 million investment commitment with an investment fund.

“This financing, combined with our current debt offering, will allow us to move from preparation to patient recruitment for our two, Company-sponsored Phase II clinical trials in cervical intraepithelial neoplasia and invasive cervical cancer,” commented Advaxis Chairman & CEO Thomas A. Moore.

Conclusion

Oncology biotechs companies were a very good investment this year and it’s only the beginning as many of them are showing very strong studies result and efficacy. DNDN, ONTY, NVLT were all a more than 500% return investment in 2009. Advaxis has shown so far that it can be the next big mover, and the next rising star in the Oncology sector. With a market cap of just around $15M, it is surely a good bet and a clever investment opportunity. You can be sure that with a good Phase II result in the coming months, the market cap will be well above $100M.

* About GOG

the GOG is one of the NCI’s funded cooperative cancer research groups and the only group which focuses its research on women with pelvic malignancies, such as cancer of the ovary, uterus, and cervix. The GOG’s main objective is to test new ideas for prevention of female pelvic malignancies and management of patients with such malignancies. Currently over 3,300 patients are registered each year to GOG research trials. To date, GOG has completed over 300 clinical trials and contributed over 550 manuscripts to the peer reviewed medical literature.

ADXS11-001 Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) and Head and Neck Cancer

The first-in-man use of attenuated live Listeria as a cancer vaccine vector was conducted by Advaxis in end-stage (IVb) cervical cancer. The trial demonstrated the safety of this approach, with the side effects being comprised of a flu-like syndrome (fever, chills, headache, etc.) frequently associated with strong innate immune activation. Adverse events responded to over the counter treatments and did not require antibiotics to resolve, further indicating the non-infectious, immune nature of the response. No bacteria were shed in urine or feces and the agent was well tolerated. The patient population tested had advanced metastatic disease and had failed prior cytotoxic therapy. The historical prognosis for this group as determined by the National Cancer Institute is a median survival of 6 months with a one year survival of 5%. As this was the first time this agent was tested in humans, only 2 doses were administered, rather than the 3 dose regimen used to for therapy. Although efficacy was assessed this study, like all phase 1 studies, was not designed or powered to assess efficacy. Nonetheless, in 13 evaluable patients 4 (30%) experienced reductions in their tumor burdens and 3 (23%) are still alive at 3 years post dosing. The one year survival in this study was 53%.

Advaxis, City of Hope to Develop Listeria-Based Cancer Vaccine

Advaxis entered into a collaboration with investigators at City of Hope for the development of a vaccine based on the company’s live, attenuated Listeria monocytogenes (Lm) platform to treat certain forms of leukemia and lymphoma.

The City of Hope team will study one of Advaxis’ vaccines directed against the tumor associated antigen WT-1. This molecule is observed to be overexpressed in certain cancers of the blood as well as some solid tumors such as breast, pancreas, and brain cancers, the researchers point out.

Advaxis’ lead vaccine candidate, Lovaxin C, is in Phase I trials as a treatment for metastatic cancer of the cervix, and resulting data has found it to be safe. Lovaxin C is also in late preclinical development in head and neck cancers. Earlier in preclinical development are candidates for breast, ovarian, and prostate cancers.

City of Hope is recognized worldwide for its compassionate patient care, innovative science and translational research, which rapidly turns laboratory breakthroughs into promising new therapies.

We are one of only 40 National Cancer Institute-designated Comprehensive Cancer Centers nationwide and a founding member of the National Comprehensive Cancer Network. An independent biomedical research, treatment and education institution, we are a leader in the fight to conquer cancer, diabetes, HIV/AIDS and other life-threatening diseases.

Advaxis to Present at the Sidoti Microcap 2010 Investor Conference

Sidoti & Company, LLC is the largest and fastest-growing small-cap, equity research provider on Wall Street. The company’s analysts provide institutional-quality research on nearly 600 equities across more than 30 industries, focusing on undiscovered, profitable companies at a market capitalization below $3 billion. Sidoti research is exclusive to institutional investors; the company’s sales and trading staff serve hundreds of clients in the U.S. and Canada.

The Grand Hyatt Hotel, New York City / Monday, January 11, 2010, 11:50 AM EST

Webcast Bio-Investor Forum 10/29

CEO Tom Moore very simply and concisely explains what ADXS is about and how it works, as well as updates efficacy and timelines.

http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=ADXS&item_id=2478420

Yvonne Paterson, Ph.D. Professor of Microbiology

The research performed in the Paterson laboratory is dedicated to harnessing the immune system to provide cures for, or protection against, neoplastic and infectious disease. There have been enormous advances made in the last few years in our understanding of the molecular and cellular machinery that renders proteins immunogenic. In our laboratory, we are applying this knowledge to the development of strategies to enhance the immune response in the design of more effective vaccines against viral diseases, such as HIV, and against tumor cells. To do this we are using a facultative intracellular bacterium, Listeria monocytogenes, which has the unusual ability to live and grow in the cytoplasm of the cell. Our laboratory was the first to show that this bacterium could be used to target antigens to the MHC class I pathway for antigen processing with the induction of cytotoxic T cells and has pioneered the application of this organism in vaccine development over the past 15 years. We have shown that recombinant forms of this organism which have been transformed to express viral antigens from influenza, HIV and SIV are excellent vectors for inducing cell mediated immune responses both parenterally and at mucosal surfaces. We have also applied this technology in the development of cancer vaccines that result in the induction of potent cell mediated immunity that can eliminate established macroscopic tumors even in the face of profound immune tolerance to the tumor-associated antigen. In other studies, we have discovered that fusing an antigen to some bacterial proteins enhances its immunogenicity. This finding opens up novel, and perhaps safer, avenues to cancer immunotherapy. We are currently looking at a number of different approaches to carry these fusion proteins to the immune system for cancer immunotherapy. Cancers to which we are directing our various technologies currently include cervical cancer, breast cancer, lung cancer, melanoma and lymphoma.

http://www.med.upenn.edu/micro/faculty/paterson.html

Fifteen Percent of ADXS11-001 Treated Cervix Cancer Patients Still Alive Three Years after Initial Dosing These mortality figures substantially excee

The Phase I trial of ADXS11-001, the lead vaccine candidate of Advaxis, Incthe company that pioneered the live, attenuated Listeria monocytogenes (Lm) vaccine, has shown thirty-six (36) month survival in two (2) of the thirteen (13) evaluable patients treated with Advaxis’ therapeutic cancer vaccine, indicating the possibility of persistent immune protection, from only a two (2) dose initial regimen.

The patients had participated in the first human trial of a live Listeria vaccine for the treatment of advanced, recurrent, metastatic cervix cancer in women who have failed prior cytotoxic treatment. Advaxis is tracking the survival of these patients at three (3) month intervals.

These mortality figures substantially exceed the median survival rate established by the National Cancer Institute's Gynecologic Oncology Group (GOG), which varies between 3.8 and 6.2 months in studies of patients who have failed prior cytotoxic treatment including chemotherapy with various agents (GOG Protocol #127).

Earlier this year, Advaxis published in the medical journal Vaccine the fact that four (4) of thirteen (13) evaluable patients, treated with ADXS11-001, experienced tumor reductions, two (2) patients had lesions disappear and fifty-three percent (53%) survived more than one (1) year; thus, posting a median survival rate of 347 days. Although this trial was designed to assess safety – not efficacy or survival – two (2) of the thirteen (13) patients or fifteen percent (15%) evaluable for efficacy are still alive, at over 1,000 days post-dosing with the study drug, as of December 10, 2009. One patient, who had been the longest surviving patient, passed away since the previous 90-day update.

Advaxis Announces Phase II Trial Collaboration with the National Cancer Institute Gynecologic Oncology Group to Study ADXS11-001 in Sixty-Patient Stu

Advaxis, Inc the live, attenuated Listeria monocytogenes (Lm) vaccine company, will collaborate with the Gynecologic Oncology Group (GOG), a collaborative research group of the National Cancer Institute (NCI), in a multicenter, Phase II clinical trial of the Company’s lead drug candidate, ADXS11-001 in the treatment of advanced cervix cancer in women who have failed prior cytotoxic therapy.

This Phase II trial will be conducted by GOG investigators and largely underwritten by the NCI. The study’s patient population – a very sick and rapidly progressive patient population for whom no therapy has been found to be effective – will be the same patient population that was treated in Advaxis Phase I trial of ADXS11-001.

Advaxis will contribute the study drug and some funds to the cost of the trial, including the translational clinical immunology research. Advaxis will update its IND and file the final protocol with FDA before the study begins.

In an Advaxis Phase I clinical trial, it was found that multiple doses of the agent were safely administered to this patient population at two (2) different dose levels and that the side effect profile, comprised of a flu-like syndrome, was consistent with strong immune stimulation. Although this first-in-human trial was not powered for efficacy, it was observed that the response rate and survival data compared favorably with historical controls. The new study will investigate this response with greater statistical power. The Phase I trial results were published earlier this year in Vaccine (Vaccine. 2009, 27 3975–3983).

Advaxis has separately announced its plans of Phase II studies of cervical cancer and cervical intraepithelial neoplasia (CIN), which are anticipated to begin dosing shortly.