Search the database for deliberate release of GM medicinal products

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EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/26/BVW4	A Phase 1/2/3, Open-Label, Dose Escalation, Dose Expansion, and Randomized, Controlled Study to Evaluate the Safety and Efficacy of ATSN-201 Gene Therapy in Subjects with RS1-Associated X-linked Retinoschisis (LIGHTHOUSE)	ASTENA Therapeutics	Humans	Non-replicating recombinant vector derived from adeno-associated virus AAV44.9 carrying functional copies of the human retinoschisin (hRS1) gene.
B/BE/21/BVW2	Phase I study to assess safety, tolerability and immunogenicity of the hRVFV-4s vaccine in healthy subjects	Wageningen Bioveterinary Research (Larissa Consortium)	Humans	hRVFV-4s is a four segments human Rift Valley fever virus vaccine, which derives from a natural clone (Clone 13) that lacks 69% of the gene NSs, a major virulence determinant of the virus. The hRVFV-4s vaccine is further attenuated by splitting the M genome segment into two M-type segments.
B/BE/18/BVW2	A phase 2 vaccine study in healthy adults and adolescents to evaluate the safety and immunogenicity of two oral polio type 2 vaccine candidates	University of Antwerp	Humans	The nOPV2 candidate strains include different combinations of 5 distinct modified regions of the Sabin-2 genome, including changes to the RNA sequence in the 5’ untranslated region of polio genome (5’ UTR), the capsid protein coding region (P1), the non-structural protein 2C, and the polymerase 3D. Of these modifications, only the changes to polymerase 3D result in a change in the amino acid sequence. The rest of the modifications aim to stabilize the genetic sequence against reversion in either the 5’ UTR or capsid regions.