"Neoantigen prioritization for use in a Listeria monocytogenes cancer vaccine"

PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc.  (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announces that two presentations highlighting the potential of Advaxis vectors to generate T cell responses to a large percentage of neoantigens and to promote antigen spreading and potentially slow progression of prostate cancer, were presented at the 2019 Keystone Symposia on Cancer Vaccines, held January 19-24 in Vancouver.

The first presentation, “Neoantigen prioritization for use in a Listeria monocytogenes cancer vaccine” delivered by Brandon Coder, Ph.D., Associate Director Research & Development at Advaxis, shows the impact of CD8+ T cell responses generated to a large proportion of neoantigens, including those that were not immunogenic as peptide vaccines as well as large frameshift mutations (FSMs) that generated tumor-infiltrating lymphocytes that controlled tumor growth in preclinical CT-26 and MC-38 mouse models. The data presented support the potential of Advaxis vectors to be among the most efficient and effective at generating CD8+ T cell responses to neoantigens, including some that are not immunogenic by alternative methods of vaccination.

The second presentation, “Magnitude of anti-PSA T cell response is associated with antigen spreading and slowing in PSA and PAP velocity in ADXS-PSA treated mCRPC patients,” was delivered by Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. These data are from 13 patients treated in the ADXS-PSA monotherapy arm of Advaxis’ Phase 1/2 clinical trial of men with metastatic, castration-resistant prostate cancer (mCRPC). The presentation focused on the 56% of ADXS-PSA monotherapy patients (5/9) who exhibited a greater than three-fold increase above baseline in the magnitude of their PSA-specific T cell responses. All nine ADXS-PSA patients who received three or more treatments showed T cell responses against one or more prostate cancer antigens not included in ADXS-PSA, providing evidence of antigen spreading. Additionally, a greater magnitude of the PSA-specific T cell responses in ADXS-PSA-treated mCRPC patients was associated with more antigen spreading than those with a less than three-fold increase. Similarly, those patients with a greater than three-fold increase in PSA-specific T cells also exhibited a significant slowing in PSA and PAP velocities, which could support the potential for delaying progression and improving survival in larger studies. As previously reported, ADXS-PSA monotherapy showed a manageable safety profile with Grades 1–2 chills/rigors and fever in all patients and Grade 3 and Serious Adverse Events in five and two patients, respectively.

“These presentations highlight some of the potential benefits of the drug constructs from our proprietary Lm platform, namely the efficient generation of CD8+ T cell responses against neoantigens as well as the potential improvement of clinical endpoints due to the magnitude of these T cell responses and antigen spreading. The data directly support our ongoing investigations of the ADXS-NEO and ADXS-PSA constructs as well as future studies of the various drug constructs from our ADXS-HOT program,” said Dr. Petit.

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.

To learn more about Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook and YouTube.

Advaxis Forward-Looking Statement

Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The factors that could cause our actual results to differ materially include: the success and timing of our clinical trials, including subject accrual; our ability to avoid any clinical holds; our ability to obtain and maintain regulatory approval and/or reimbursement of our product candidates for marketing; our ability to obtain the appropriate labeling of our products under any regulatory approval; our plans to develop and commercialize our products; the successful development and implementation of our sales and marketing campaigns; the size and growth of the potential markets for our product candidates and our ability to serve those markets; our ability to successfully compete in the potential markets for our product candidates, if commercialized; regulatory developments in the United States and other countries; the rate and degree of market acceptance of any of our product candidates; new products, product candidates or new uses for existing products or technologies introduced or announced by our competitors and the timing of these introductions or announcements; market conditions in the pharmaceutical and biotechnology sectors; our available cash; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; our ability to obtain additional funding; our ability to obtain and maintain intellectual property protection for our product candidates; the success and timing of our preclinical studies including IND-enabling studies; the timing of our IND submissions, the ability to resolve FDA’s partial clinical hold, the ability to get FDA approval for study amendments, the timing of data read-outs, the ability of our product candidates to successfully perform in clinical trials; our ability to initiate, enroll, and execute pilots and clinical trials; our ability to maintain collaborations; ; our ability to manufacture and the performance of third-party manufacturers; the performance of our clinical research organizations, clinical trial sponsors and clinical trial investigators; our ability to successfully implement our strategy; and other risk factors identified from time to time in our reports filed with the SEC. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

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