On May 13, 2020 OncoSec Medical Incorporated (Nasdaq:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported the European Medicines Agency (EMA) issued an advanced therapy medicinal product (ATMP) certificate for chemistry manufacturing controls (CMC) data covering its lead product candidate, TAVO (interleukin-12 or "IL-12" plasmid), for the treatment of metastatic melanoma (Press release, OncoSec Medical, MAY 13, 2020, View Source [SID1234557968]). Following TAVO’s classification as an ATMP last year, the certification procedure involved a thorough scientific evaluation over several months of CMC data for TAVO by the EMA’s Committee for Advanced Therapies (CAT). The CAT assessment of the TAVO CMC data provides valuable regulatory feedback to help ensure a successful marketing authorization application prior to submission. After a positive opinion from CAT, EMA issued a certificate confirming that the CMC data comply with the standards that apply for evaluating the Marketing Authorization Application (MAA).
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"Certification of TAVO as an ATMP allows us to leverage a specific EU regulatory framework, akin to fast-track in the United States, designed to facilitate the review, approval, and access of TAVO in the EU market," said Robert Ashworth, PhD, Senior Vice President, Regulatory, Quality and CMC at OncoSec. "With the CMC portion of the MAA now reviewed and certified, we are preparing to commence process validation activities for TAVO as we work to bring this innovative immunotherapy to patients with metastatic melanoma who have limited treatment options."
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.
OncoSec has expanded its pivotal KEYNOTE-695 study of TAVO to Europe, laying the foundation for a MAA submission within the EU. The KEYNOTE-695 study is a pivotal, global, open-label trial evaluating TAVO in combination with the checkpoint inhibitor, KEYTRUDA (pembrolizumab) in patients with anti-PD-1 checkpoint resistant metastatic melanoma. TAVO currently has orphan drug designation and fast track status in the United States.