Advaxis Announces Dosing of First Patient with ADXS-NEO, an Investigational Customized Immunotherapy Approach Targeting Personal Neoantigens

-ADXS-NEO is being evaluated in a Phase 1 clinical trial in various cancers

-First patient dosed is being treated for NSCLC

PRINCETON, NJ, USA I June 11, 2018 I Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announced it has commenced a Phase 1 trial with the dosing of the first patient with ADXS-NEO, an investigational personalized immunotherapy approach targeting personal neoantigens found by sequencing a patient’s own cancer cells. ADXS-NEO is being evaluated in an open-label, dose-escalation, multicenter Phase 1 clinical trial in the United States. The study is open to patients with metastatic non-small cell lung cancer (NSCLC), metastatic microsatellite stable colon cancer and metastatic squamous head and neck cancer. The first patient dosed is being treated for non-small cell lung cancer. ADXS-NEO is being developed in collaboration with Amgen. Advaxis is leading clinical development through proof-of-concept.

Pre-clinical findings for ADXS-NEO were presented at the 2018 American Association for Cancer Research (AACR) Annual Meeting. The company presented data in mouse models showing 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. Additionally, data were presented highlighting the capacity of the Advaxis Lm vector and its ability to target frameshift mutations of greater than 90 amino acids, and to generate T cells to multiple neoantigens per frameshift in tumor mouse models.

“We are extremely pleased to advance ADXS-NEO into the clinic. This program brings our clinically-validated Lm Technology to the cutting-edge area of neoantigen immuno-oncology,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “We are committed to realizing the potential of ADXS-NEO to mobilize patients’ immune systems against mutations that accumulate within and contribute to the development of their cancer, and to bring the potential benefits of our technology to more patients and their families.”

Enrolled patients will undergo a biopsy, and Advaxis will then manufacture an investigational personalized treatment for each patient based on an analysis of their tumor neoantigen mutations, which will be ready to dose within 8 weeks of the initial biopsy. More information about the trial is available at www.clinicaltrials.gov.

About ADXS-NEO

ADXS-NEO is an investigational personalized Listeria monocytogenes (Lm)-based immunotherapy designed to generate immune response against mutation-derived tumor-specific neoantigens identified through DNA sequencing of a patient’s own tumors. The program focuses on creating a customized treatment for each patient targeting multiple neoantigens found in a biopsy of the patient’s tumor. ADXS-NEO is being developed in partnership 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 product candidates in various stages of clinical and preclinical development in the following areas: HPV-associated cancers, neoantigen therapy, hotspot/cancer antigens and prostate cancer.

SOURCE: Advaxis

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