The Princeton, New Jersey-based company is focused on the discovery, development and commercialization of treatments that boosts the body's natural defenses to fight cancer.
Phase 1 clinical trials are about to begin on its primary neoantigen, or tumor-directed therapy, ADXS-NEO. In preliminary data, the treatment demonstrated anti-tumor immune activation within one week after the first dose.
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CEO Kenneth Berlin said in a statement that the results fuel Advaxis’s belief that neoantigen-directed immunotherapies can become an important addition to the cancer treatment paradigm due to the unique presentation of neoantigens in cancer cells.
“The results from our ADXS-NEO program have shown the ability to have an impact within the tumor microenvironment in metastatic colorectal cancer, which historically has been a tumor type that is refractory to immunotherapy,” he said. “We look forward to starting Part B of the study with ADXS-NEO in combination with a checkpoint inhibitor in the third quarter of this year.”
During fiscal 2Q ending April 30, 2019, the biotechnology company reported total revenue of $1.2 million compared to the $1.7 million in 2Q 2018. Advaxis said the decrease was due to the termination of a collaboration with biopharmaceutical company Amgen.
Net loss for the second quarter of 2Q 2019 was $9.4 million or $1.59 per share, compared with a loss of $13.4 million or $4.03 per share during the year-ago quarter.
The company said it is in discussions with a leading academic institution to finalize an investigator-sponsored trial evaluating ADXS-HOT in patients with prostate cancer and anticipate filing an Investigational New Drug application with the US Food and Drug Administration later this year.
Shares of Advanxis lost 10.7% in aftermarket trading to sit at $2.50.
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