INTRODUCING MINE™

Making Personalized Cancer Care a Reality

My Immunotherapy Neo-Epitopes

WORKING WITH AMGEN TO MAKE PERSONALIZED MEDICINE A REALITY

Advaxis’ Lm Technology™ has proven to be an extremely versatile platform and is being investigated for use in treating a broad range of cancers by targeting tumor-specific mutations known as neoepitopes.  This approach has led to Advaxis’ MINE™ (My Immunotherapy Neo-Epitopes) program, with ADXS-NEO as the program’s lead product candidate.

“Personalized Medicine” has long been a popular catch-phrase for pharmaceutical companies, but to date no company has delivered on the promise of a truly personalized therapy.  ADXS-NEO creates a customized treatment with neoantigens specifically selected based on a biopsy of the patient’s tumor.  Working in partnership with Amgen, we are proud to be developing a truly personalized solution for oncology patients. 

This development strategy eliminates the need for predictive algorithms, enabling the development of truly tailored immunotherapies.

LEADING DRUG CANDIDATES

ADXS-NEO

The first immunotherapy candidate leveraging the MINE™ technology, ADXS-NEO, is a customized cancer treatment with promising implications across several cancers. Through a parallel manufacturing system, the production of ADXS-NEO is designed to be easily scalable, cost-effective, and timely for patients. Further details on the potential of ADXS-NEO can be found in new white paper.

Developing the ADXS-NEO immunotherapy begins with a biopsy of the primary tumor and/or metastases, along with the patient’s normal cells, to identify non-synonymous mutations, or neoepitopes. These are then sent for exome sequencing, where a mutational map of the tumor is developed that can be used to select a set of neoepitopes most likely to be immunogenic.

Advaxis uses its Lm Technology™ to integrate coding sequences for these tumor-associated neoepitopes into a plasmid-based system that expresses them in the context of a fusion protein sequence including a fragment of the LLO molecule. The Lm vector is taken up by the antigen-presenting cells. Within the vector, large quantities of proteins with the mutated neoepitope are generated and secreted into the cytosol of the antigen-presenting cells, wherein they are processed and used to activate tumor-specific T cells, which can then find the cancer cells and destroy them. ADXS-NEO constructs also are designed to neutralize tumor protecting mechanisms by reducing the immune-suppressive activities of Tregs and myeloid-derived suppressor cells in the tumor microenvironment. Because the immune response is activated only against the mutated neoepitopes, little-to-no systemic blockade of tolerance and no off-target toxicity is expected.

The MINE program is expected to enter the clinic in 2017 using ADXS-NEO vectors to target patients’ unique, tumor-specific neoepitopes, in collaboration with Amgen.

ADXS-HOT

Advaxis’ other neoantigen program using MINE technology , ADXS-HOT, leverages public so-called “hotspot” neoantigen mutations to create off-the-shelf targeted cancer immunotherapies.  These therapies will address the most commonly appearing mutations in many different types of cancer.  DNA sequencing is not required for ADXS-HOT, and the presence of the “hotspot” target can usually be determined by a rapid biomarker test, allowing treatment to begin quickly.

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