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.

Posted In: BiotechLarge CapNewsHealth CareGeneralBriefsPancreatic CancerPhase 1 Trial