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FDA accepts Advaxis' IND for personalized neoepitope immunotherapy ADXS-NEO

Published 07 March 2017

The US Food and Drug Administration (FDA) has accepted Advaxis’ Investigational New Drug (IND) application for ADXS-NEO, a personalized neoantigen-targeted approach to cancer immunotherapy that is being developed in partnership with Amgen.

This ground-breaking IND paves the way for bringing a new precision immunotherapy for the treatment of cancers into the clinic this year.

ADXS-NEO employs Advaxis’ proprietary Listeria monocytogenes (Lm)-based antigen delivery technology, its Lm Technology, to target multiple patient-specific neoantigens in each individual patient’s tumor that are not present in normal cells.

ADXS-NEO is designed to stimulate both the innate and adaptive arms of the immune system.

Advaxis bioengineers ADXS-NEO constructs by programming its Lm-based antigen delivery technology to present the unique protein fragments or neoantigens associated with mutations found in a patient’s own cancer cells. These cancer-specific mutations are identified by comparing the DNA sequences of cancer cells with normal cells.

ADXS-NEO works by presenting a large payload of neoantigens directly into dendritic cells within the patient’s immune system to generate new cancer-fighting white blood cells. These T cells hunt down cancer cells bearing these neoantigens while at the same time broadly stimulating the immune system and reducing the ability of the cancer to resist.

ADXS-NEO constructs can present multiple neoantigens that can be targeted by a patient’s immune system simultaneously. Tumors may accumulate up to 100 or more mutations that can generate neoantigens, and each patient has a set of mutations that are unique to his or her own tumors.

ADXS-NEO is designed to hit multiple targets at once to improve the likelihood of a benefit.

ADXS-NEO will be manufactured in Advaxis’ newly constructed facility in Princeton, N.J., utilizing a process that minimizes the time required to develop the patient-specific immunotherapy. A single manufacturing run can provide sufficient product to treat each patient repeatedly for more than one year.

Advaxis chief scientific officer Robert Petit said: “The IND acceptance is a landmark step towards escaping the one-size-fits-all approach to cancer treatments by building innovative, patient-specific immunotherapies. This highly personalized approach has the potential to transform the treatment of care across multiple types of cancers.

“This enables us to employ Lm Technology to focus the attention of a patient’s immune system against the very mutations within their cancer that turned their cells malignant in the first place.”

ADXS-NEO is under development through a collaboration between Amgen and Advaxis, bringing together Amgen’s expertise in immuno-oncology development and commercialization and Advaxis’ proprietary Lm-based antigen delivery technology and it’s My Immunotherapy Neo-Epitopes or MINE platform. Advaxis plans to initiate a phase 1 trial evaluating ADXS-NEO in multiple tumor types later this year.

Amgen translational sciences senior vice president David Reese said: “Over the past several years, the field of cancer immunotherapy has brought promising new treatments with meaningful benefits to cancer patients. Amgen remains committed to a multi-modality approach in immunotherapy, and our collaboration with Advaxis adds to the toolkit of cancer-fighting options available for patients.

“We look forward to our continued work with Advaxis to explore the potential of ADXS-NEO in the clinic and across multiple tumor types.”



Source: Company Press Release