Advaxis Seeks FDA Approval to Begin Phase 1 Trial of its ADXS-504 Immunotherapy for Prostate Cancer

Advaxis Seeks FDA Approval to Begin Phase 1 Trial of its ADXS-504 Immunotherapy for Prostate Cancer
Advaxis is seeking permission from the U.S. Food and Drug Administration (FDA) to start the first Phase 1 clinical trial of ADXS-504, a potential immunotherapy for prostate cancer. Cancer cells carry multiple mutations in tumor driver genes, some of which originate mutated proteins that are less recognized by the immune system than the original, non-mutated molecules. Under its ADXS-HOT program, Advaxis is developing immunotherapies targeting sets of mutated proteins, called hotspot antigens, which are often shared by multiple patients with a similar cancer. ADXS-504, for example, is developed specifically for prostate cancer patients. These immunotherapies make use of a weakened bacteria called Listeria monocytogenes (Lm) which is engineered to produce the mutated proteins. When the bacteria are injected into patients, they are seen as a threat by the immune system, which then mounts an immune response against all substances found within these bacteria, including the cancer proteins. Because they can include more than 30 different targets, ADXS-HOT candidates are suitable for all patients with a given tumor type, with the potential of being offered as off-the-shelf products, according to Advaxis. In addition to ADXS-504 for prostate cancer, Advaxis is conducting a Phase 1/2 clinical trial (NCT03847519) of ADXS-503 in lung cancer, and has seve
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