Search the database for deliberate release of GM medicinal products
Displaying 1 - 6 of 6
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
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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. |
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. |
B/BE/18/BVW6 | Global study of a recombinant adeno-associated virus designed to address the monogenic root cause of Spinal Muscular Atrophy | AveXis | Humans | Recombinant adeno-associated virus serotype 9 (AAV9) containing the cDNA of the human SMN (Survival Motor Neuron) gene |
Only notified under the "contained use" procedure. Dossier submitted on 04/10/2018. | A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy | Immune Design | Humans | Replication deficient lentiviral vector encoding NY-ESO-1 cancer testis antigen |
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 |
B/BE/09/BVW1 | A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 | N.V. Roche S.A. | Humans | E6 and E7 genes of the HPV16 virus and gene of the human Interleukin-2 (hIL2) |