On March 23, 2017 Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, reported the European Medicines Agency (EMA) issued an advanced therapy medicinal product certificate for manufacturing quality and non-clinical data (Press release, Advaxis, MAR 23, 2017, View Source [SID1234518243]). Schedule your 30 min Free 1stOncology Demo! The certification procedure involved a thorough scientific evaluation over several months of the quality (CMC) data and non-clinical data by the EMA’s Committee for Advanced Therapies (CAT). After a positive opinion from CAT, EMA issued a certificate confirming that the CMC and non-clinical data comply with the standards that apply for evaluating the Marketing Authorization Application (MAA) of axalimogene filolisbac for the treatment of metastatic cervical cancer. Advaxis is now positioned to file the complete MAA in the second half of 2017.
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"EMA’s issuance of this certification is a major milestone for Advaxis," said Daniel J. O’Connor, President and CEO. "With a significant portion of the MAA now reviewed and certified, we are preparing to file the complete MAA as we work to bring this innovative immunotherapy to patients with metastatic cervical cancer who have limited treatment options."
About Axalimogene Filolisbac
Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. In a phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), the drug candidate showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This is a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.
Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.