"These preliminary data suggest our approach may be among the best-in-class for CD8+ T cell response which we believe is important for successful clinical outcomes."

PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (NASDAQ:ADXS), (the Company) a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announces the presentation of the progression of its Lm platform from discovery to clinical application, and the unique opportunity the platform affords Advaxis in its pursuit of innovative new cancer therapeutics.

The presentation is being made today by Robert G. Petit, Ph.D., the Company’s Chief Scientific Officer and Executive Vice President and Andres A. Gutierrez, M.D., Ph.D., the Company’s Chief Medical Officer and Executive Vice President, during a plenary session at the Immuno-Oncology 360° Conference at the Crowne Plaza Times Square in New York City. The session begins at 4:00 p.m. ET and the Company’s presentation begins at 4:55 p.m. ET.

Drs. Petit and Gutierrez will provide an overview of the Company’s proprietary Lm platform, including the following features that have been observed:

• Ability to generate CD8+ T cells rapidly and against large percentage of peptides/neoantigens targets;
• Excellent priming without adding adjuvant, systemic pro-inflammatory immune “macroenvironment”;
• Antigen spreading demonstrated in clinical trials including our neoantigen-directed drug constructs;
• No neutralizing antibodies allowing for repeat boosting;
• Efficacy signals include single agent complete responses in late stage cancer and improved survival; and
• Manageable safety profile – nearly 500 patients treated to date, mostly grade 1 or grade 2 treatment related adverse events.

Drs. Petit and Gutierrez will also present an overview of the Company’s neoantigen-directed therapy programs, ADXS-NEO (customized, personalized neoantigens) and ADXS-HOT (off-the-shelf, hotspot or shared neoantigens and other antigens). The presentation will be available on the Company’s website, www.advaxis.com.

“We are looking forward to presenting an overview of our proprietary Lm platform which, over the last several years, has accumulated a large amount of data supporting immune response, clinical activity and safety in the treatment of multiple cancers. Leveraging the knowledge gained from our single-antigen targeting constructs, we have further optimized our Lm vector in the development of our multiple-antigen targeting constructs. Our discussion today will provide insight into immunological activity that we’ve observed in our ADXS-NEO clinical trial,” said Dr. Petit. He concluded, “These preliminary data suggest our approach may be among the best-in-class for CD8+ T cell response which we believe is important for successful clinical outcomes.”

“We have a broad pipeline of drug candidates being evaluated for multiple cancer types at various stages of development. We anticipate our first drug construct from our ADXS-HOT program, ADXS-503 for non-small cell lung cancer, to enter the clinic later this quarter.” said Dr. Gutierrez. He added, “We believe that our neoantigen-directed drug candidates will likely be used in combination with checkpoint inhibitors and have the potential to significantly impact the cancer treatment paradigm.” He concluded, “The preliminary clinical data from our ADXS-NEO Phase 1 study demonstrate broad and rapid anti-tumor immunity. We are looking forward to providing clinical data read-outs from several studies throughout 2019.”

ADXS-NEO, the Company’s personalized neoantigen program, is in an ongoing Phase 1 dose-escalation study to treat a variety of cancers. ADXS-HOT is the Company’s off-the-shelf program and consists of several different drug constructs that target hotspot or shared neoantigens, and other antigens. We expect the first drug construct from this program, ADXS-503, or HOT-Lung, will enter the clinic this quarter.

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, personalized neoantigen-directed immunotherapy, off-the-shelf, hotspot/cancer antigens neoantigen-directed immunotherapy 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.

CONTACT:

Investors:
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Miriam Weber Miller, (212) 838-3777
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