Early Data Shows BioNTech's Personalized Therapy Safe In Pancreatic Cancer Patients

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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