Advaxis is using Listeria monocytogenes bacteria as a vector to destroy solid tumors in patients. There is no other biotech
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
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.
