Neogap Therapeutics has received approval from the Swedish Medical Products Agency to start a clinical trial of its personalised cell therapy against colorectal cancer. The phase I/IIa trial is planned to be initiated during the first half of 2023.
Neogap's cell therapy product pTTL (personalised Tumor Trained Lymphocytes) is a unique immunotherapy that aims to treat solid tumours by training the immune system to recognise neoantigens and thereby attack the cancer. A neoantigen is an altered protein only found in the tumour after a mutation has occurred in a gene.
The study, which includes up to 16 patients with advanced colorectal cancer, will be conducted at Karolinska University Hospital in Stockholm and Västmanland Hospital in Västerås. The primary objective of the phase I/IIa trial is to determine the tolerability and safety of Neogap's therapy. The trial is conducted as a dose escalation study, starting with a low dose that is gradually increased.
"The approval and the prompt initiation of the clinical trial represent significant milestones for Neogap. We have demonstrated that we can take an advanced cell therapy product from preclinical to clinical development. I am very proud of our skilled and committed team who, together with experienced partners, have brought us to this important point. As a result, we are now taking a big step towards our goal of curing cancer patients who would otherwise not survive," says Samuel Svensson, CEO of Neogap.
The cell therapy pTTL (personalised Tumor Trained Lymphocytes) is based on Neogap's proprietary technologies PIOR and EpiTCer. PIOR is a software utilising algorithms and machine learning. It is applied to select the most suitable neoantigens for each patient. EpiTCer is a method for proliferating the T cells that recognise the selected tumour-specific target structures to attack the cancer while leaving healthy tissue untouched.
Neogap's cell therapy can theoretically treat several different types of cancer, but the company will initially focus on advanced colorectal cancer.