On July 18, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that its lead Lm immunotherapy candidate, axalimogene filolisbac (AXAL), has been classified as an advanced-therapy medicinal product (ATMP) for the treatment of cervical cancer by the European Medicines Agency’s Committee for Advanced Therapies (CAT) (Press release, Advaxis, JUL 18, 2016, View Source [SID:1234513929]). Schedule your 30 min Free 1stOncology Demo! "Classification of AXAL as an ATMP is reflective of a groundbreaking new opportunity for the treatment of HPV-associated cancers," said Robert Ashworth, PhD, Vice President, Regulatory Affairs. "Building upon the approach endorsed at Advaxis’ meetings with National Competent Authorities earlier this year, it allows us to take advantage of a specific EU regulatory framework, akin to fast-track in the United States, designed to facilitate the review, approval, and access of AXAL in the EU market." In the next phase of this regulatory process, CAT assessment of currently available quality and non-clinical data may help resolve some issues prior to the submission of a marketing-authorization application (MAA).
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The Committee for Advanced Therapies is the committee at the European Medicines Agency that is responsible for classifying and assessing the quality, safety and efficacy of advanced-therapy medicinal products and following scientific developments in the field. It is a multidisciplinary committee, gathering together some of the best available experts in Europe. The ATMP designation is a classification for certain medicines for human use that are gene-, cell-, or tissue-based. The main responsibility of the CAT is to prepare a draft opinion on each ATMP application submitted to the European Medicines Agency, before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on granting a marketing authorization for the product. During drug development, CAT also reviews and certifies the acceptability of quality and non-clinical data.
Advaxis’ immunotherapies, including AXAL, are designed to capitalize on the body’s ability to recognize and attack bacterial infections. Advaxis’ core technology – Lm Technology – alters a live strain of Listeria monocytogenes bacteria to generate cancer fighting T-cells directed against a cancer antigen and neutralizing factors that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. AXAL has Orphan Drug Designation in Europe for treatment of anal cancer.
About Axalimogene Filolisbac
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 2 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 U.S. for the treatment of invasive cervical, head and neck and anal cancers.