On May 28, 2025 Neogap Therapeutics AB, a Swedish clinical-stage biotechnology company developing personalised immunotherapy for cancer treatment, reported to have received approval from the Swedish Medical Products Agency to administer the full dose to all patients in its ongoing phase I/II clinical trial (Press release, Neogap Therapeutics, MAY 28, 2025, View Source;streamlining-development-of-its,c4156253 [SID1234653443]). The decision introduces a more flexible study design and contributes to a faster and more efficient development of the company’s cell therapy.
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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.