Cervical Cancer

Cervical cancer, which is characterized by cancerous malignancies in the tissue of the cervix, is the most common HPV-associated cancer in women. Nearly all instances of invasive cervical cancer are caused by HPV. According to the World Health Organization, cervical cancer is the fourth most common cancer in women globally, and the second most common cancer in women in less developed regions, accounting for 84 percent of new cases annually. While 5-year survival rates are slowly improving, cervical cancer remains a concerning issue, globally affecting 500,000 women each year. Despite such a need for therapeutic options, there has been little drug development to treat the disease. And that’s why we’re here.

Americans currently infected with HPV
Global patients diagnosed with cervical cancer
Estimated U.S. cases of cervical cancer in 2017

There has been only one new treatment option approved for patients with cervical cancer in the last 30 years. That’s why Advaxis is working to address this significant need for additional treatments, as the only biopharmaceutical company sponsoring a global phase 3 trial in high-risk, locally advanced cervical cancer (HRLACC). AIM2CERV is evaluating immunotherapy candidate, axalimogene filolisbac in patients with late-stage cervical cancer who have an increased chance of recurrence, progression and death.

Late-stage cervical cancer includes HRLACC and metastatic cervical cancer. HRLACC is a high-risk form of cervical cancer that, in later stages, can spread to the surrounding area, including the uterus and cervix. According to internal market research, approximately 6,800 women are expected to have HRLACC in 2016. Patients with HRLACC have typically undergone chemotherapy, radiation and sometimes surgery, but still have roughly a 50 percent chance of disease recurrence or death within four years of diagnosis.

Patients are diagnosed with metastatic cervical cancer when their cancer has spread beyond the pelvic wall, infecting organs such as the liver, intestinal track or lungs. This is classified as a stage IVB cancer. It’s estimated that there were 1,000 women living with this stage IVB cancer in 2016. Patients with this diagnosis do not have any additional treatment options; once they have undergone chemotherapy, radiation and bevacizumab, there are no other options aside from continuing with treatments that have been ineffective.

At Advaxis, we believe that we can make a difference by preventing recurrence, and if we can prevent cervical cancer from becoming metastatic, we can decrease the chances of patients facing death. Advaxis is addressing this by developing axalimogene filolisbac as an adjuvant treatment for HRLACC patients, which has the potential to prevent recurrence and metastatic cervical cancer. Should a patient’s cancer recur, we are looking toward drug development for metastatic disease, which will be evaluated in an upcoming phase 3 trial this year.

In recent studies, axalimogene filolisbac has shown a consistent safety profile and to be well-tolerated. Advaxis is currently screening and enrolling in its global Phase 3 AIM2CERV trial.