1. nouscom srl
  2. merck sharp & dohme corp
  3. institut de recherches internationales servier
  4. t-knife gmbh
  5. flugen inc.
  6. Search the database for deliberate release of GM medicinal products

Search the database for deliberate release of GM medicinal products

Displaying 1 - 5 of 5
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/22/BVW4 A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors Nouscom Srl Humans The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the FSP neoantigens; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the same neoantigens.
Only notified under the "contained use" procedure. Dossier submitted on 28/10/2021. A Phase I/II, First-in-human, open-label, accelerated-titration, two-part clinical trial of TK-8001 in patients with HLA-A*02:01 genotype and advanced-stage/metastatic, MAGE-A1 + solid tumors that either have no further approved therapeutic alternative(s) T-Knife GmbH Humans chimere MAGE-A1 TCRs
B/BE/20/BVW5 Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Nous-PEV, with pembrolizumab, in Patients with Unresectable Stage III / IV Cutaneous Melanoma and with Stage IV NSCLC Nouscom Srl Humans The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the PEV neoantigens gene; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the neoantigens gene.
Only notified under the "contained use" procedure. Dossier submitted on 04/05/2018. Phase IIa clinical trial for the evaluation of a vaccin against influenza virus H3N2 FluGen Inc. Humans recombinant H3N2 influenza virus: 6 intern genes of the replication defective A/Puerto Rico/8/34 (PR8) strain with hemagglutinine and neuraminidase from A/Brismane/10/2007 (H3N2) strain
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2017. A Phase 1, Open Label, Non-comparative Study to Evaluate the Safety and the Ability of UCART19 to Induce Molecular Remission in Paediatric Patients With Relapsed/Refractory B Acute Lymphoblastic Leukaemia Institut de Recherches Internationales Servier Humans chimeric antigen receptor and suicide-ligand (RQR8)