The Swedish Medical Products Agency has granted approval for Neogap Therapeutics’ application to commence a Phase I/IIa clinical trial with its advanced cell therapy against colorectal cancer.

The Phase I/IIa clinical trial includes up to 16 advanced colorectal cancer patients and will be carried out at Karolinska University Hospital in Stockholm, and Västmanland Hospital in Västerås.

Its primary objective is to determine the safety and tolerability of Neogap’s cell therapy product personalised Tumor Trained Lymphocytes (pTTL).

The trial will be conducted as a dose escalation study, beginning with a low dose and will be gradually increased.

It is anticipated to commence in the first half of this year.

Neogap Therapeutics CEO Samuel Svensson said: “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.

“As a result, we are now taking a big step towards our goal of curing cancer patients who would otherwise not survive.”

The company’s pTTL offers a unique personalised cell therapy that is designed for precisely targeting and eliminating cancer in a personalised setting.

It has been developed based on the company’s technologies, EpiTCer, and the software PIOR, which are together capable of identifying optimal neoantigens for targeting, activating, and multiplying T-lymphocytes.

The cell therapy aims to treat solid tumours by training the patient’s immune system to recognise the neoantigens and then attack the cancer.

In June last year, Neogap Therapeutics announced that its patented method opened for new individualised treatment of multiple sclerosis (MS).

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