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Biotechnology company Amphera has reported data from the Phase II Reactive trial and the Phase II/III DENIM trial of MesoPher cell therapy.

During the Phase II Reactive study, resected pancreatic cancer patients who had previously completed standard-of-care chemotherapy received three bi-weekly injections of the company’s MesoPher dendritic cell therapy, along with booster injections at four- and seven-month intervals.

Findings showed that MesoPher demonstrated a statistically significant two-year Recurrence Free Survival of 60% and a strong safety profile.

The trial met the primary endpoint with efficacy and safety data from two cohorts of a study of 38 patients.

Following this, the second cohort of 28 participants were fully enrolled in the trial.

Reactive trial principal investigator Casper van Eijck said: “These results exceed expectations for this group of patients, compared to the best current treatments.

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“A 60% two-year recurrence free survival after surgical resection truly is an exceptional outcome. Further randomised clinical research with MesoPher in pancreatic cancer is a likely next step.

“In addition, we have seen that MesoPher induces a T cell response against the tumour of patients, which could explain the efficacy, although pancreatic cancer is known as a cold tumour.”

Mesothelioma patients with stable disease were given either MesoPher maintenance treatment or best supportive care (BSC) in the DENIM trial.

The study confirmed the safety profile of MesoPher, as well as its ability to induce a robust T-cell response.

Despite this, the immune response did not translate into clinical benefit and therefore the primary endpoint of improved overall survival (OS) was not met.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

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