BioNTech has reported positive data from a first-in-human Phase I trial of autogene cevumeran (BNT122, RO7198457) together with anti-PD-L1 immune checkpoint inhibitor atezolizumab, and chemotherapy in resected pancreatic ductal adenocarcinoma (PDAC) patients.

Autogene Cevumeran is a mRNA-based individualised neoantigen specific immunotherapy (iNeST). It is jointly developed with Roche Group member Genentech in multiple solid tumour indications.

The therapy is said to be the lead candidate from BioNTech’s iNeST platform.

The single-centre, investigator-initiated study is assessing the tolerability and safety of the combination therapy as an add-on to the standard-of-care regimen along with chemotherapy mFOLFIRINOX in resected PDAC patients.

BioNTech noted that the preliminary data from the study, which is conducted at Memorial Sloan Kettering Cancer Center, New York in the US, demonstrated a favourable safety profile and encouraging signs of clinical activity.

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In the trial, about 19 PDAC patients who underwent surgery were given atezolizumab and 16 out of these received autogene cevumeran at 9.4 weeks post-surgery.

The findings showed that the combination therapy was well-tolerated, and one patient had a Grade 3 fever and hypertension due to the vaccine.

Evaluation of safety is the trial’s primary objective, and the efficacy of the treatment measured as the 18-month RFS, the feasibility of the treatment regimen and the immunogenicity are included as secondary objectives.

BioNTech co-founder and chief medical officer Özlem Türeci said: “With only under 5% of patients responding to current treatment options, PDAC is one of the highest unmet medical need cancers.

“We are committed to take up this challenge by leveraging our long-standing research in cancer vaccinology and are trying to break new ground in the treatment of such hard-to-treat tumours.”

The companies are planning for a randomised study to further assess the therapy’s safety and efficacy along with atezolizumab and chemotherapy in resected PDAC patients.

Last month, BioNTech and Pfizer reported topline findings from a Phase II/III clinical trial, where a third 3µg dose of their Covid-19 vaccine induced a robust immune response in children aged six months to below five years.