Individualized mRNA vaccine shows promise in pancreatic cancer patients
BioNTech has announced initial data from an ongoing investigator-initiated first-in-human Phase I study evaluating the safety and tolerability of the mRNA-based individualised neoantigen specific immunotherapy (iNeST) autogene cevumeran (also known as BNT122, RO7198457) in combination with anti-PD-L1 immune checkpoint inhibitor atezolizumab and chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC).
Feasibility of the process of profiling each patient’s tumour to inform individualised vaccine design and on-demand manufacturing of iNeST in a clinically relevant timeframe was confirmed. The preliminary results showed a favourable safety profile, as well as encouraging signs of clinical activity.
Autogene cevumeran is the lead candidate from BioNTech’s iNeST platform, which is jointly developed together with Genentech, a member of the Roche Group, in multiple solid tumour indications.
The data include a total of 19 patients who underwent surgery and received atezolizumab. Of these patients, 16 (84 percent) received autogene cevumeran at 9.4 weeks after surgery. The preliminary data readout from these 16 vaccinated patients revealed that autogene cevumeran in combination with atezolizumab was well-tolerated. Only one of 16 patients (six percent) developed a vaccine-related Grade 3 fever and hypertension, no other Grade 3 or higher adverse events were observed.
Based on these data, BioNTech and Genentech are planning a randomised study to further evaluate the efficacy and safety of autogene cevumeran in combination with atezolizumab and chemotherapy in patients with resected PDAC.
https://www.europeanpharmaceuticalreview.com/news/172008/biontech-results-inest-pdac-treatment/
ارسال به دوستان