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Neogap receives approval to administer full dose in clinical trial – streamlining development of its personalised cell therapy

2025-05-28

PRESS RELEASE. Neogap Therapeutics AB, a Swedish clinical-stage biotechnology company developing personalised immunotherapy for cancer treatment, has received approval from the Swedish Medical Products Agency to administer the full dose to all patients in its ongoing phase I/II clinical trial. The decision introduces a more flexible study design and contributes to a faster and more efficient development of the company’s cell therapy.

According to the revised study protocol, the company is now authorised to treat each patient with the full dose, instead of starting with a low dose and gradually increasing it for subsequent patients. The amendment aligns with recently published data from other cell therapy studies and enables earlier analysis of treatment response.

”Being able to give the full dose from the outset is an important step in the development of our personalised cell therapy. It allows us to collect data earlier that may contribute to the evaluation of both the treatment’s safety and efficacy, while supporting a more efficient and flexible study design – to the benefit of both patients and our continued development efforts,” says Samuel Svensson, CEO of Neogap Therapeutics.

The company has also received approval to extend the shelf life of both the starting material from the patient’s lymph nodes and the final frozen product. This provides greater flexibility in clinical operations, particularly when treatment needs to be scheduled around standard chemotherapy or temporary infections.

The treatment under evaluation is pTTL (personalised Tumour Trained Lymphocytes), Neogap’s personalised, cell-based immunotherapy designed to strengthen the patient’s own T cells to target solid tumours. It is based on Neogap’s patented technologies PIOR® and EpiTCer®, and is currently being investigated in a phase I/II clinical trial for advanced colorectal cancer. Patient recruitment is ongoing at several hospitals in Sweden.

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 neogap.se and follow Neogap on LinkedIn.