Neogap Therapeutics receives EMA's ATMP classification for its personalised cancer cell therapy
Neogap Therapeutics AB, a Swedish clinical-stage biotechnology company, announces that the European Medicines Agency (EMA) has granted Advanced Therapy Medicinal Product (ATMP) classification to its cell therapy, pTTL (personalised Tumour Trained Lymphocytes). This classification confirms that pTTL meets the regulatory criteria for a somatic cell therapy product, providing a clear regulatory pathway for its further development.
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."
About Neogap's cell therapy, pTTL
pTTL is a cell therapy that combines advanced DNA analysis with T-cell expansion, providing personalised precision therapy for the treatment of solid tumours. The treatment is based on Neogap's patented technologies, PIOR® and EpiTCer®. The goal is to provide patients with a tailored and innovative therapy that meets their specific needs.
Project reference number: 190185439 - NEOpTTL. Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or EISMEA. Neither the European Union nor the granting authority can be held responsible for them.
For more information, please contact:
Samuel Svensson, CEO
Email: samuel.svensson@neogap.se
Phone: +46 733 54 21 94
About Neogap Therapeutics
Neogap Therapeutics is a Swedish clinical-stage biotechnology company focused on developing personalised cancer immunotherapy using the patient's own cells. The therapy is based on the company's two technologies PIOR® and EpiTCer®. PIOR® is sophisticated software that uses DNA sequencing data from the patient and machine learning algorithms to select tumour-specific mutations. Then, EpiTCer® is used to multiply T cells that can recognize and attack the selected tumor-specific targets. Neogap is located at Cancer Center Karolinska in Stockholm. To learn more about Neogap and its cutting-edge research, please visit the company's website at neogap.se and follow Neogap on LinkedIn.
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