PRINCETON, NJ, USA I May 11, 2018 I Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, provides an update on recently presented preclinical data demonstrating the anti-cancer potential of their Lm vector that presents tumor neoantigens, and is being evaluated in the ADXS-NEO program. ADXS-NEO is derived from the Company’s proprietary Lm Technology and is being developed in partnership with Amgen.

These preclinical findings were discussed in poster presentations at the recent American Association for Cancer Research (AACR) Annual Meeting. Additionally, portions of these data were presented by Amgen at a podium presentation during the European Neoantigen Summit 2018.

The first study, as discussed in a poster presentation at AACR entitled “Neoantigens that fail to elicit measurable T cell responses following peptide immunization can control tumor growth when delivered using a Listeria-based immunotherapy platform,” showed that ADXS-NEO generates T cell responses against neoantigen peptides that control tumor growth, even when they were identified as “non-immunogenic” using a conventional peptide-adjuvant immunization. The poster is available here: https://www.advaxis.com/wp-content/uploads/2018/05/ADXS-NEO-Lm-immunogenicity-AACR-poster_Final.pdf.

In the second study, discussed in a poster presentation at AACR entitled “Targeting frameshift mutations with a Listeria monocytogenes immunotherapy drives neoantigen-specific antitumor immunity in MC38 and CT26 mouse tumor models,” Advaxis’ Lm platform was shown to target frameshift mutations and generate T cells to multiple neoantigens per frameshift in MC38 and CT26 mouse tumor models. The poster is available here: https://www.advaxis.com/wp-content/uploads/2018/05/ADXS-NEO-Lm-Frameshift-muations-AACR-poster_Final.pdf.

“The results of these studies highlight the therapeutic potential of targeting neoantigens and suggest that ADXS-NEO could impact the way we approach treatment across a range of cancers,” said Ken Berlin, President and CEO of Advaxis. “We look forward to our continued collaboration with Amgen, and to moving into the clinic with this product candidate.”

“These preclinical findings provide foundational rationale suggesting that ADXS-NEO has the potential to generate immune responses against multiple neoantigens with the ability to control tumor growth. This is a personalized approach that uses a patient’s own immune system to recognize and eliminate cancer cells harboring multiple mutations that caused their malignancy,” said Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. “We also saw potent immune responses targeting frameshift mutations and control of tumor growth via multiple complementary mechanisms. This is important because frameshift mutations are observed to generate up to nine times more neoantigens per mutation than in-frame mutations” according to Turajlic, et al.

About ADXS-NEO

ADXS-NEO is a personalized Listeria monocytogenes (Lm)-based immunotherapy designed to generate immune response against mutation-derived tumor-specific neoantigens. The program focuses on creating a customized treatment with neoantigens specifically selected based on a biopsy of the patient’s tumor. The approach enables the development of tailored immune-therapies. ADXS-NEO is being evaluated in collaboration with Amgen.

About Advaxis, Inc.

Advaxis, Inc. is a late-stage biotechnology company focused on the discovery, development and commercialization of proprietary Lm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuated Listeria monocytogenes (Lm) bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy and are designed to access and direct antigen presenting cells to stimulate anti-tumor T cell immunity, activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the tumor microenvironment to enable the T cells to eliminate tumors. Advaxis has four franchises in various stages of clinical and preclinical development: HPV-associated cancers, neoantigen therapy, hotspot/ cancer antigens and prostate cancer.

SOURCE: Advaxis