Advaxis, Inc. (ADXS) is “One to Watch”

Advaxis is currently advancing three primary candidates through clinical trials for the treatment of various cancers, with over 15 key immunotherapies in various stages of development. The company utilizes a technology platform based on the power of an attenuated live Listeria vaccine (under license from partner/collaborator, the University of Pennsylvania) to jump-start natural immune system functionality using a secreted antigen that is tumor-specific. This is a sweeping method of action that allows the company’s tech platform to potentially strike far and wide across the entire oncology spectrum because of how it re-wires the body’s own immune response, allowing the individual’s immune system to correctly identify and attack cancer cells via the highly-targeted antigen mechanism.

We are talking live, bioengineered Listeria monocytogenes as a framework for encoding a fusion protein sequence that includes a piece of the Lm-LLO (listeriolysin O) molecule. The bacteria and the body’s own powerful immune response to it are used as a vector for leveling the tumor’s defense mechanisms, while strongly promoting the innate and adaptive arms of the immune system via the secreted antigen/adjuvant fusion protein. Shutting down T-regulatory cell and immature dendritic cell mechanisms (Treg and MDSC), both vital for tumor defense, while supercharging the background innate/adaptive arms of the immune system, is a wining approach that has already shown empirical fruits through clinical and preclinical testing.

This kind of buckshot approach using the body’s response to strains of Listeria is ingenious to say the least and it is also one main reason why ADXS has been invited to present two key abstracts on some of their most compelling R&D at the upcoming 27th Annual Meeting (October 26-28) of the Society for Immunotherapy of Cancer (SITC). One abstract will include the company’s most recent Phase II clinical data (110 patients, India) on this revolutionary Lm-LLO immunotherapy technology’s use in treating recurrent/refractory and advanced cervical cancer via targeting the HPV E7 gene (Human Papilloma Virus-related expression of the gene is a primary, identified catalyst for malignancy, dysplasia, and/or other abnormal cell growth). The other abstract to be presented will look at the company’s preclinical development work using a novel strain of Listeria for a bivalent Lm-LLO immunotherapy delivering a dual, antigen-adjuvant fusion protein punch (one for the tumor, one for the tumor’s blood supply – angiogenesis) via a single bacterial vector.

This is great coverage for the company’s leading ADXS-HPV piepline, which also includes Phase II work in the U.S. on Cervical Intraepithelial Neoplasia (Grade 2/3, CIN or Cervical Dysplasia, 120 patients) using a vaccine called Lovaxin C that shows real promise for preventing cervical cancer from occurring; work on locally advanced cervical cancer with GOG here in the U.S. (National Cancer Institute Gynecologic Oncology Group, 67 patients); as well as work in the UK (27 patients) on HPV-associated head and neck cancers. This research firmly reinforces the technology’s other traction through preclinical work in prostate cancer (ADXS-PSA) targeting the PDA antigen, as well as in canine osteosarcoma of large breed dogs (ADXS-HER2) currently in Phase I veterinary trials and targeting HER2 over-expressing cells, which is being carried out at ADXS partner, the University of Pennsylvania’s School of Veterinary Medicine.

The company’s development pipeline takes advantage of the tech design marvelously, using both LLO-fused triggering directly inside antigen presenting cells and general inhibition of Treg/MDSC cells in target tumors to circumvent cancer formation and lifecycles. HER2 (human epidermal growth factor receptor 2) also shows broad over-expression in breast/brain, bladder, gastric, ovarian, and pancreatic cancers. This conceptually offers a route whereby ADXS-HER2 could be used to eliminate respective HER2 positive cancer cells (especially those exhibiting/promoting cellular immunity and resistance to treatment), also helping to find and eliminate potential metastases in the brain’s of breast cancer patients, while preventing the development of resistance that can occur with antibody treatment.

No one needs to see the metrics on cancer anymore. The clinical pipeline ADXS is advancing could help countless people across the world, and the company has fully engaged a robust array of important partners in the oncology field to help speed things along, including the National Cancer Institute Gynecologic Oncology Group (ADXS-HPV multi-center Phase 2 clinical trials), Cancer Research UK (ADXS-HPV) and the Albert Einstein College of Medicine and Montefiore Medical Center (ADXS-PSA). With the leading ADXS-HPV candidate in four Phase II clinical trials and having received the Best Therapeutic Vaccine (approved/in development) award in April this year at the 5th Annual Vaccine Industry Excellence Awards (hosted by the industry and by the Expert Reviews of Vaccines journal, sponsored by Novartis Vaccines and Diagnostics), Advaxis has the kind of forward momentum needed to break out with some impressive shareholder returns in coming years. The warm reception by both media and industry should prove very useful as the company moves towards commercialization of the technology.

Thus far clinical data has shown the pipeline to be very safe, with transient, non-cumulative flu-like symptoms and good survival benefit response from tumors, both standalone and in conjunction with cytotoxic therapy. Preclinical evidence shows reduced immune suppression capability in tumors, a seriously pumped up immune stimulus/response, and what looks to be effectively a more complete and robust therapeutic solution, precisely as predicted. Advaxis has some 80 and growing patents worldwide covering their huge IP portfolio, nailing down everything from composition of matter, to methods, and usage.

For more information on Advaxis, Inc., investors are encouraged to visit the company’s website at: www.Advaxis.com

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