On April 19, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, hosted a Research Reception on Monday, April 18, 2016 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, Louisiana (Press release, Advaxis, APR 19, 2016, View Source [SID:1234511045]).
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The Research Reception featured Rosemarie Krupar, M.D., of Baylor College of Medicine, presenting "Immunogenicity of Axalimogene Filolisbac in Head and Neck Cancer," a review of the late-breaking poster presentation (Abstract #LB-095). The phase 2 trial leveraged a 5-6 week window between diagnosis and trans-oral robotic surgery, administering two doses of treatment with Advaxis’ lead immunotherapy candidate, axalimogene filolisbac (AXAL), two weeks apart to eight patients with late-stage HPV-associated oropharyngeal cancer (HPVOPC). The study observed changes to the tumor immune microenvironment (TME), including cytotoxic T cell infiltration into the post-resection tumor, increased immune activation, a reduction of regulatory T cells, infiltration of cytotoxic T cells, and increased expression of inflammatory activation markers, suggesting that AXAL has the potential to cause positive immunologic responses for patients with HPV+ head and neck cancers.
Nicola Mason, Ph.D., BVetMed, Assistant Professor of Medicine at the University of Pennsylvania, presented "Immune Therapy with ADXS31-164 Prevents Metastatic Disease and Prolongs Overall Survival in Spontaneous Canine Osteosarcoma." In her presentation, Dr. Mason reviewed her experiences with ADXS31-164 in dogs with spontaneous osteosarcoma. In two separate studies, repeat administrations of up to 3.3 x 109 CFUs were well tolerated with transient low-grade side effects. Immune responses to HER2/neu were detected within 6 months in 15 of 18 dogs with minimal residual disease. In these dogs, metastatic disease was delayed or prevented. Radiographic progression of primary osteosarcoma lesions was prevented in a subset of dogs who were treated after palliative radiotherapy. Treated animals had tumor-specific T-cell responses in the tumor site and reduced numbers of Tregs and MDSCs in the tumor microenvironment.
Robert Petit, Ph.D., Chief Scientific Officer and EVP of Advaxis, presented "Effect of Advaxis’ Lm Immunotherapy on the STING Pathway." In his presentation, Dr. Petit discussed the potent triggering of STING (STimulator of Interferon Genes) built into every Advaxis vector and triggered by DNA, including 80-100 copies of DNA plasmids, that code for tumor target antigens. Advaxis Lm-LLO vectors escape into the cytosol of antigen-presenting cells (APCs) where the human STING receptor is triggered preferentially by DNA. Triggering STING results in the secretion of type I interferons and pro-inflammatory cytokines and has been linked to immune sensing of tumors, clinical responses to melanoma, and inflammation of the tumor microenvironment. Experiments in STING knock-out models demonstrate that triggering of STING contributes to part, but not all, of the ability of ADXS11-001 to control HPV+ tumors.
The Research Reception concluded with a final presentation by Robert Petit, "Cancer Neoepitope Immunotherapy: An Update on ADXS-NEO." Advaxis’ Lm Technology is being used to develop novel ADXS-NEO immunotherapies personalized to the specific and unique neo-epitopes found in an individual patient’s tumor. ADXS-NEO is projected to be available for patients in 6-8 weeks from biopsy to infusion. This platform is able to decrease Tregs and myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment and can be used to combine tumor driver targets along with neoepitope targets. Data was presented from a mouse model, demonstrating the ability of ADXS-NEO to express multiple tumor neoantigens which were capable of controlling tumor growth. The data developed in this model confirms that ADXS-NEO can be successfully executed and administered and has the ability to control the tumors that were the source of the neoantigens. Advaxis is currently developing an Investigational New Drug Application for ADXS-NEO and is planning for upcoming clinical trials.
Advaxis is actively building collaborations in academia and industry to drive ADXS-NEO forward, including the MINE (My Immunotherapy Neo-Epitopes) collaboration with Memorial Sloan Kettering Cancer Center, focusing on preclinical and clinical development of neoepitope-based Lm treatments. The goal of MINE is to develop neo-epitope immunotherapies based on the specific and unique neo-epitopes found in an individual patient’s tumor. Advaxis is currently partnering with SGI-DNA for DNA synthesis and bioinformatics.
To view the presentation slides and to listen to the presenters, visit www.advaxis.com.
About Axalimogene Filolisbac
Axalimogene filolisbac (AXAL) is Advaxis’ lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology. Axalimogene filolisbac has Orphan Drug Designation in the U.S. for the treatment of anal cancer.