On December 10, 2024 Neogap Therapeutics AB, a Swedish clinical-stage biotechnology company, reported that the European Medicines Agency (EMA) has granted Advanced Therapy Medicinal Product (ATMP) classification to its cell therapy, pTTL (personalised Tumour Trained Lymphocytes) (Press release, Neogap Therapeutics, DEC 10, 2024, View Source,c4079677 [SID1234648989]). This classification confirms that pTTL meets the regulatory criteria for a somatic cell therapy product, providing a clear regulatory pathway for its further development.
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The ATMP classification is a key milestone for companies developing advanced therapies. It signifies that the EMA formally recognises the product as an advanced therapy under EU regulations. This designation offers access to the EMA’s tailored scientific advice, ensuring that the therapy’s safety, quality, and efficacy meet stringent regulatory standards. For Neogap, the classification sets a clear direction for preparing upcoming clinical trials and advancing towards future market authorisation.
Neogap’s personalised cell therapy is currently being evaluated in a Phase I/II clinical trial focused on assessing its safety and tolerability in patients with advanced colorectal cancer. This study is a critical step in Neogap’s mission to provide curative treatments for cancer patients with limited remaining treatment options.
"The ATMP classification is a strong validation of our innovative approach and pTTL’s potential as a breakthrough cancer therapy," says Samuel Svensson, CEO of Neogap Therapeutics. "It provides regulatory clarity and invaluable guidance from the EMA, enabling us to advance development efficiently and effectively. We are now well-positioned to continue our work towards delivering transformative treatments to cancer patients."