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BioNTech begins Phase 2 trial of mRNA-based vaccine against cancer

Christian Fernsby |
The second phase trial of an mRNA-based cancer vaccine developed by BioNTech has started, the German biopharmaceutical company announced on Friday.

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The trial has been initiated in the United States, Germany, Spain and Belgium. It is planned to enroll about 200 patients to evaluate the efficacy of RO7198457 (BNT122) compared to watchful waiting after surgery and chemotherapy, the current standard of care for these high-risk patients. As the second deadliest cancer worldwide, the medical need for novel therapies to treat colorectal cancer remains high.

The open-label Phase 2 trial (NCT04486378) is investigating autogene cevumeran in stage II/III colorectal cancer patients after surgical resection of their tumor and completion of adjuvant chemotherapy.

The current standard of care in this indication is watchful waiting to see if tumors recur after removal of the primary tumor and adjuvant chemotherapy. A proportion of these patients are expected to have a recurrence of their tumor within 2-3 years after their surgery: in the clinical trial, patients at high risk for recurrence will be identified early on with a highly sensitive blood test detecting circulating tumor DNA (ctDNA).

The Phase 2 trial will investigate the efficacy of autogene cevumeran as a single agent compared to standard of care watchful waiting in this high-risk patient population. The primary endpoint for the study is disease-free survival (DFS). Secondary objectives include relapse-free survival (RFS), overall survival (OS) and safety. The first patient in the trial has been treated at a clinical site in Europe.

The Phase 2 trial is based on previous results from the Phase 1a/1b basket trial evaluating autogene cevumeran as a single agent and in combination with atezolizumab, an anti-PD-L1 antibody, in patients with solid tumors (NCT03289962).

The data show the induction of neoantigen-specific T cell responses, a manageable safety profile and objective responses as indication of clinical activity. In parallel to the ongoing Phase 2 study, BioNTech has initiated an epidemiological study (NCT04813627) to investigate ctDNA status in patients with stage II/III colorectal cancer following resection or prior to adjuvant chemotherapy to identify patients who might be potential candidates for the Phase 2 trial.

In Germany, trial screening is supported by the molecular registry Colopredict Plus 2.0 (AIO-KRK-0413/ass) of the Association for Internal Oncology (AIO), a working group of the German Cancer Society, and the Ruhr University Bochum.

Autogene cevumeran is an individualized neoantigen specific immunotherapy (iNeST) and the lead candidate from BioNTech’s mRNA-based cancer vaccine platform.

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