Advaxis Combination Trial With MedImmune Completes First Dose-Escalation Cohort

Advaxis, Inc. recently announced its combination study with MedImmune, the global biologics research and development arm of AstraZeneca, has completed the first dose-escalation cohort in a study evaluating axalimogene filolisbac (AXAL) in combination with durvalumab and has commenced the second dose-escalation cohort.

The study is evaluating the safety and efficacy of AXAL, Advaxis’ lead immunotherapy candidate, in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab, for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.

“I am proud that we have reached this stage because combination therapies hold great potential for cancer patients,” said Daniel J. O’Connor, President and Chief Executive Officer at Advaxis. “This trial is exploring how we can harness the power of immuno-oncology to block anti-tumor T-cell immunity and simultaneously target HPV-associated cancers. It is these kinds of combination therapies that may dramatically change the course of how we treat cancer.”

The first dose-escalation cohort evaluated AXAL at 1×10⁹ cfu with 3 mg/kg durvalumab and the second dose-escalation cohort will now examine AXAL at 1×10⁹ cfu in combination with 10 mg/kg durvalumab. Upon completion of dose escalation, the Phase II study will randomize 90 patients to receive AXAL in combination with durvalumab vs. durvalumab alone. The primary efficacy endpoints include objective response rate and progression-free survival.

The companies plan to submit an abstract to a major medical meeting on the dose-escalation portion of the study in the second half of the year. Further information about the Phase I/II study can be found on ClinicalTrials.gov, using Identifier NCT02291055.

Cervical cancer is the fourth most common cancer in women worldwide. In the US, nearly 13,000 new cases are diagnosed annually and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9% of women in the US are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7% of invasive cervical cancers are attributed to high-risk HPV strains.

Axalimogene filolisbac (AXAL) is Advaxis’ lead Lm Technology™ immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase II study in recurrent/refractory cervical cancer, AXAL showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology. AXAL has Orphan Drug Designation in the US for the treatment of invasive cervical cancer, head and neck, and anal cancer.

Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). PD-L1 can be expressed by tumors to evade detection by the immune system through binding to PD-1 on cytotoxic T lymphocytes. Durvalumab blocks the PD-L1 interaction with PD-1, countering the tumor’s immune-evading tactics. Durvalumab is being developed, alongside other immunotherapies, to empower the patient’s immune system and attack the cancer. Durvalumab is being investigated in an extensive clinical trial program, as monotherapy or in combination with tremelimumab, in NSCLC, head and neck, bladder, gastric, pancreatic, HCC and blood cancers.

Located in Princeton, NJ, Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology. The Lm Technology, using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against cancer antigens and neutralize Tregs and myeloid-derived suppressor cells (MDSCs) that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’ lead Lm Technology immunotherapy, axalimogene filolisbac, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase II in invasive cervical cancer, Phase I/II in head and neck cancer, and Phase I/II in anal cancer. The US Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development.

For additional information on Advaxis, visit www.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.