Advaxis, Inc. (NASDAQ:ADXS) has revealed that the Food and Drug Administration of the United States has given the go-ahead for an application filed to try out ADXS-NEO. Development of the treatment is being done in partnership with Amgen, Inc. (NASDAQ:AMGN).
“The IND acceptance is a landmark step towards escaping the one-size-fits-all approach to cancer treatments by building innovative, patient-specific immunotherapies,” Advaxis Scientific chief, Robert Petit, said.
ADXS-NEO allows cancer patients to get immunotherapy that is more precise and highly targeted. By employing a technology for antigen delivery known as Listeria monocytogenes, ADXS-NEO is able to isolate and target neoantigens that are specific to a patient and which are different from normal cells. Both the immune system’s adaptive and the innate arms are able to be stimulated this way.
To be able to isolate the cancerous cells from the normal ones, the Listeria monocytogenes method of antigen delivery works by identifying the cancer cells’ DNA sequences and then comparing them with the normal cells. ADXS-NEO then presents a huge neoantigens payload into the dendritic cells which are located in the immune system of the patient. This helps in the generation of new white blood cells which are then used to fight cancer. And as the T cells take on the cancer cells which contain the neoantigens, they also help to stimulate the body’s immune system as well as lessening the ability and the capacity of cancer to fight back.
With ADXS-NEO, its constructs are able to present a variety of neoantigens and thereby making it possible to target the immune system of a patient simultaneously. This is important because tumors have the capacity to accumulate mutations numbering one hundred or even more and thus there is need for the ability to hit more than one target in order to enhance the effectiveness of the treatment.
The manufacture of ADXS-NEO will take place in Princeton, New Jersey using a technique that reduces the amount of time needed in the development of a patient-specific immunotherapy as much as possible.
On Tuesday shares of Advaxis Inc fell sharply by 8.65% to close the day at $8.77.