- BioNTech SE BNTX announced initial data from the Phase 1 study of mRNA-based individualized neoantigen-specific immunotherapy (iNeST), autogene cevumeran.
- The study assesses cevumeran combined with Tecentriq (atezolizumab) and chemotherapy in patients with resected pancreatic ductal adenocarcinoma (PDAC).
- The preliminary results showed a favorable safety profile and encouraging signs of clinical activity.
- Autogene cevumeran is the lead candidate from BioNTech's iNeST platform, jointly developed with Genentech, a unit of Roche Holdings AG RHHBY, in multiple solid tumor indications.
- 19 PDAC patients underwent surgery and were given Genentech's Tecentriq. Sixteen were then given BioNTech's jab at 9.4 weeks post-surgery.
- The combo treatment was well-tolerated, noting one patient had a Grade 3 fever and hypertension due to the vaccine. There were no other Grade 3, or higher adverse events reported.
- The combo also induced new neoantigen-specific T cell response in eight of the 16 patients, BioNTech reported.
- The companies plan to move toward a randomized study of autogene cevumeran as a post-primary treatment for pancreatic cancer.
- The cancer vaccine is also being tested in a Phase 2 trial as an adjuvant treatment for post-operative circulating tumor DNA-positive, surgically resected colorectal cancer.
- Another Phase 2 study is testing the vaccine in combination with Merck & Co Inc's MRK Keytruda as a first-line treatment for advanced melanoma.
- Price Action: BNTX shares are up 1.24% at $159.65 during the premarket session on the last check Monday.
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