Neogap receives approval to administer full dose in cell therapy trial for colorectal cancer
Ella Day | May 28, 2025 | News story | Research and Development | Neogap, Oncology, Swedish Medical Products Agency, colorectal cancer
Neogap Therapeutics has received regulatory approval from the Swedish Medical Products Agency to administer the full dose of its investigational cell therapy to all patients in its ongoing phase 1 and 2 trial for advanced colorectal cancer.
The approval allows for a revised study protocol that removes the initial dose-escalation step, allowing all participants to receive the full treatment dose from the outset. According to Neogap, the change is expected to streamline data collection on safety and preliminary efficacy and is consistent with emerging data from other cell therapy studies.
“This is an important step in our clinical development, allowing for a more flexible trial design and earlier assessment of treatment outcomes,” said Samuel Svensson, CEO of Neogap Therapeutics.
The company has also been granted approval to extend the shelf life of both the lymph node-derived starting material and the final frozen product. This is expected to offer greater scheduling flexibility for patients undergoing concurrent treatments such as chemotherapy.
The prospective therapy, personalised tumour trained lymphocytes, is based on Neogap’s PIOR and EpiTCer platforms. It uses machine learning and patient-specific sequencing data to expand T-cells targeting tumour-specific mutations.
Patient recruitment is ongoing at multiple sites across Sweden.
Ella Day
28/5/25
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