Advaxis Inc (NASDAQ:ADXS) Announces First Patient in Phase 3 AIM2CERV Trial


Advaxis Inc (NASDAQ:ADXS) shares rose 1.96% to $9.38 on Monday and were unchanged in after-hours trading. Share prices have been trading in a 52-week range of $5.21 to $16.30. The company has a market cap of $385.81 million at 40.15 million shares outstanding.

Advaxis Inc is a clinical-stage biotechnology company that is focused on the discovery, development and commercialization of Lm-LLO cancer immunotherapies. These are based on a platform technology that utilizes live attenuated Listeria monocytogenes bioengineered to secrete antigen/adjuvant fusion proteins. Its immunotherapy candidates include Axalimogene filolisbac, ADXS-PSA and ADXS-HER2.

In this week’s press release, Advaxis Inc announced that the first patient has been enrolled and dosed in its AIM2CERV trial. This stands for Advaxis IMmunotherapy 2 prevent CERVical recurrence, which is a global phase 3 trial enrolling patients with  advanced stage cervical cancer. It involves a randomized, 450-patient study evaluating axalimogene filolisbac as an adjuvant therapy following primary treatment with chemotherapy and radiation in patients with high-risk locally advanced carcinoma of the cervix.

The objective of the trial is to compare disease-free survival (DFS) in patients receiving axalimogene filolisbac to DFS in patients receiving placebo. Its secondary objective is to assess overall survival, safety and tolerability. The trial is being conducted in collaboration with the GOG Foundation, Inc. under a Special Protocol Assessment agreement with U.S. Food and Drug Administration.

While some women with cervical cancer are considered cancer-free after chemotherapy and radiation, a significant number will experience a recurrence of the disease that is often more aggressive and results in a poor prognosis. The global reach of the AIM2CERV study is intended to determine whether treatment with axalimogene filolisbac after chemotherapy and radiation can help prevent or delay such recurrences,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis Inc.

According to the American Cancer Society, approximately 12,000 women in the United States will be diagnosed with cervical cancer in 2017. According to the Surveillance, Epidemiology and End Results Program, approximately 4,900 of these patients will be diagnosed with HRLACC. Only a third of the US population has been vaccinated against the virus and the vaccination rate is lower worldwide.


Following recently published data that revealed cervical cancer mortality rates may be exponentially higher in African American women and significantly underestimated for all women, coupled with research last year showing fewer than half of patients with locally advanced cervical cancer receive standard-of-care therapy, the need for new treatment options is more clear now than ever,” O’Connor continued.

Last year, Advaxis Inc announced a global agreement with Amgen for the development and commercialization of ADXS-NEO, which is apreclinical investigational cancer immunotherapy treatment that is designed to activate a patient’s immune system to respond against the unique mutations, or neoepitopes, contained in and identified from each individual patient’s tumor. This has led to a lot of upside momentum in Advaxis Inc shares since the announcement in August, and further development in the ongoing Phase 3 trial could lead to another push higher for the stock.

DISCLAIMER: There is a substantial risk of loss with any speculative asset, especially small cap stocks. The opinions expressed are those of the author, and do not constitute recommendations to buy or sell a stock. Do your own research before committing capital.