Biotech Values

[DewDiligence]

AMGN’s webpage about ADXS-NEO:

https://www.amgenscience.com/immuno-oncology-research/ [scan down]

Listeria monocytogenes is a species of bacteria with attributes that give it great potential as an immunotherapy vector. Amgen and Advaxis are working to realize this potential through a novel technology platform called ADXS-NEO. This investigational therapy is a personalized Listeria-based vaccine. It’s designed to meet the needs of individual cancer patients by producing an immune response to multiple, specific mutations found only in their tumor cells.

Targeting a key cell in the immune system

The collaboration aims to leverage Amgen’s deep and broad experience in immuno-oncology with two novel platforms pioneered by Advaxis:

• A technology called MINE™ (My Immunotherapy Neo-Epitopes) uses in-depth DNA sequencing to identify a wide range of tumor neoantigens—mutated protein fragments—that are found in a patient’s tumor cells but not healthy cells.

• The Advaxis Lm Technology™ employs a weakened strain of Listeria as a vehicle to smuggle the genes for apatient’s tumor-specific mutations into antigen-presenting cells (APCs).

Listeria make an ideal vector for a vaccine because these bacteria have evolved to target and live inside APCs. Once inside the cell, the engineered bacteria secrete tumor-associated proteins, which are processed by the APCs and presented to T cells (see illustration). This stimulates the T cells to recognize cancer cells with these same mutations and attack them.

A large payload

ADXS-NEO can be engineered to carry a payload of numerous tumor antigens—up to 100 or more if needed. This feature of the vaccine is designed to address the genetic diversity found in tumors. “The cancer cells in a patient’s body don’t all express the same number or kinds of antigens,” said Roger Sidhu, a global product general manager at Amgen who chairs the Amgen-Advaxis Joint Steering Committee. “This new approach could generate antitumor T cells that target a broad spectrum of the cells present in a tumor. We see that as an exciting potential advantage.”

Into the clinic

An Investigational New Drug application for ADXS-NEO was accepted by the FDA in March 2017, paving the way for the start of phase 1 studies. “We look forward to our continued work with Advaxis to explore the ground-breaking potential of ADXS-NEO in the clinic and across multiple tumor types,” said David Reese, Amgen’s senior vice president for Translational Sciences.

Emphasis added.