Are genetically modified protozoa eligible for ATMP status? Concerning the legal categorization of an oncolytic protozoan drug candidate

Bjerkas I, Mohn SF, Presthus J. Unidentified cyst-forming sporozoon causing encephalomyelitis and myositis in dogs. Z Parasitenkd. 1984;70:271–4.

Article  CAS  PubMed  Google Scholar 

Dubey JP, Carpenter JL, Speer CA, Topper MJ, Uggla A. Newly recognized fatal protozoan disease of dogs. J Am Vet Med Assoc. 1988;192:1269–85.

CAS  PubMed  Google Scholar 

Dubey JP, Lindsay DS. A review of Neospora caninum and neosporosis. Veterinary Parasitol. 1996;67:1–59.

Article  CAS  Google Scholar 

Lantier L, Poupée-Beaugé A, di Tommaso A, Ducournau C, Epardaud M, Lakhrif Z, et al. Neospora caninum: a new class of biopharmaceuticals in the therapeutic arsenal against cancer. J Immunother Cancer. 2020;8:e001242.

Article  PubMed  PubMed Central  Google Scholar 

Li X, Qi M, He K, Liu H, Yan W, Zhao L, et al. Neospora caninum inhibits tumor development by activating the immune response and destroying tumor cells in a B16F10 melanoma model. Parasit Vectors. 2022;15:332.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Battistoni A, Lantier L, Tommaso AD, Ducournau C, Lajoie L, Samimi M, et al. Nasal administration of recombinant Neospora caninum secreting IL-15/IL-15Rα inhibits metastatic melanoma development in lung. J ImmunoTher Cancer. 2023;11:e006683.

Article  PubMed  PubMed Central  Google Scholar 

Lantier L, Poupee-Beauge A, Lantier L, Ducournau C, Tommaso AD, Germon S, et al. 846 Neospora caninum – an immunotherapeutic protozoan against solid cancers. J ImmunoTher Cancer. 2020;8:A504–A505.

Google Scholar 

Lantier L, Poupée-Beaugé A, Tommaso AD, Ducournau C, Germon S, Lee GS, et al. Abstract 1712: Neospora caninum: An immunotherapeutic protozoan against cancer. Cancer Res. 2021;81:1712–1712.

Article  Google Scholar 

Ding H, Wu S, Jin Z, Zheng B, Hu Y, He K, et al. Anti-Tumor Effect of Parasitic Protozoans. Bioengineering (Basel). 2022;9:395.

Article  CAS  PubMed  Google Scholar 

European Medicines Agency. Imligyc Assessment report - EMA/734400/2015/ corr. 1. In: Committee for Medicinal Products for Human Use, (ed). London, 2015.

European Union. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. 2001.

European Union. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. 2007.

Guerriaud M. Les Médicaments de Thérapie Innovante - statut juridique In: LexisNexis (ed) JurisClasseur Droit Pharmaceutique, vol. Fascicule 61–70, 2022.

Guerriaud M, Kohli E. RNA-based drugs and regulation: Toward a necessary evolution of the definitions issued from the European union legislation. Front Med. 2022;9:1012497.

Article  Google Scholar 

European Union. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. 2004.

European Medicines Agency. Reflection paper on classification of Advanced Therapy Medicinal Products EMA/CAT/600280/2010 rev.1. 2015.

Yaeger RG. Protozoa: Structure, Classification, Growth, and Development. In: Baron S (ed) Medical Microbiology, 4th edn: Galveston (TX), 1996.

Verma AK. Protozoans: Animals or Protists? Int J Life Sci. 2021;9:41-44.

European Medicines Agency. Scientific recommendation on classification of advanced therapy medicinal products. EMA/348841/2012. In, 2012.

Bonini C, Ferrari G, Verzeletti S, Servida P, Zappone E, Ruggieri L, et al. HSV-TK Gene Transfer into Donor Lymphocytes for Control of Allogeneic Graft-Versus-Leukemia. Science. 1997;276:1719–24.

Article  CAS  PubMed  Google Scholar 

Tiberghien P, Ferrand C, Lioure B, Milpied NL, Angonin RG, Deconinck E, et al. Administration of herpes simplex–thymidine kinase–expressing donor T cells with a T-cell–depleted allogeneic marrow graft. Blood. 2001;97:63–72.

Article  CAS  PubMed  Google Scholar 

Jones BS, Lamb LS, Goldman F, Di Stasi A. Improving the safety of cell therapy products by suicide gene transfer. Front Pharmacol. 2014;5:254.

Article  PubMed  PubMed Central  Google Scholar 

Yagyu S, Hoyos V, Del Bufalo F, Brenner MK. An Inducible Caspase-9 Suicide Gene to Improve the Safety of Therapy Using Human Induced Pluripotent Stem Cells. Mol Ther. 2015;23:1475–85.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Guercio M, Manni S, Boffa I, Caruso S, Di Cecca S, Sinibaldi M, et al. Inclusion of the Inducible Caspase 9 Suicide Gene in CAR Construct Increases Safety of CAR.CD19 T Cell Therapy in B-Cell Malignancies. Front Immunol. 2021;12:755639.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Stavrou M, Philip B, Traynor-White C, Davis CG, Onuoha S, Cordoba S, et al. A Rapamycin-Activated Caspase 9-Based Suicide Gene. Mol Ther. 2018;26:1266–76.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Radke JR, White MW. Expression of herpes simplex virus thymidine kinase in Toxoplasma gondii attenuates tachyzoite virulence in mice. Infect Immun. 1999;67:5292–7.

Article  CAS  PubMed  PubMed Central  Google Scholar 

European Medicines Agency. Zalmoxis Assessment report - EMA/CHMP/589978/2016. In: Committee for Medicinal Products for Human Use, (ed). London, 2016.

Lobato J, Silva Deise AO, Mineo Tiago WP, Amaral Jodi DHF, Segundo Gesmar RS, Costa-Cruz Julia M, et al. Detection of Immunoglobulin G Antibodies to Neospora caninum in Humans: High Seropositivity Rates in Patients Who Are Infected by Human Immunodeficiency Virus or Have Neurological Disorders. Clin Vaccine Immunol. 2006;13:84–89.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ibrahim HM, Huang P, Salem TA, Talaat RM, Nasr MI, Xuan X, et al. Short report: prevalence of Neospora caninum and Toxoplasma gondii antibodies in northern Egypt. Am J Trop Med Hyg. 2009;80:263–7.

Article  PubMed  Google Scholar 

Tranas J, Heinzen RA, Weiss LM, McAllister MM. Serological evidence of human infection with the protozoan Neospora caninum. Clin Diagn Lab Immunol. 1999;6:765–7.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Oshiro LM, Motta-Castro AR, Freitas SZ, Cunha RC, Dittrich RL, Meirelles AC, et al. Neospora caninum and Toxoplasma gondii serodiagnosis in human immunodeficiency virus carriers. Rev Soc Bras Med Trop. 2015;48:568–72.

Article  PubMed  Google Scholar 

Duarte PO, Oshiro LM, Zimmermann NP, Csordas BG, Dourado DM, Barros JC, et al. Serological and molecular detection of Neospora caninum and Toxoplasma gondii in human umbilical cord blood and placental tissue samples. Sci Rep. 2020;10:9043.

Article  ADS  CAS  PubMed  PubMed Central  Google Scholar 

Dubey JP, Schares G, Ortega-Mora LM. Epidemiology and control of neosporosis and Neospora caninum. Clin Microbiol Rev. 2007;20:323–67.

Article  CAS  PubMed  PubMed Central  Google Scholar 

English ED, Adomako-Ankomah Y, Boyle JP. Secreted effectors in Toxoplasma gondii and related species: determinants of host range and pathogenesis? Parasite Immunol. 2015;37:127–40.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Irwin CR, Hitt MM, Evans DH. Targeting Nucleotide Biosynthesis: A Strategy for Improving the Oncolytic Potential of DNA Viruses. Front Oncol. 2017;7:229.

Article  PubMed  PubMed Central  Google Scholar 

Munro JB, Silva JC. Ribonucleotide reductase as a target to control apicomplexan diseases. Curr Issues Mol Biol. 2012;14:9–26.

CAS  PubMed  Google Scholar 

Arranz-Solis D, Regidor-Cerrillo J, Lourido S, Ortega-Mora LM, Saeij JPJ. Toxoplasma CRISPR/Cas9 constructs are functional for gene disruption in Neospora caninum. Int J Parasitol. 2018;48:597–600.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Mineo TWP, Chern JH, Thind AC, Mota CM, Nadipuram SM, Torres JA, et al. Efficient Gene Knockout and Knockdown Systems in Neospora caninum Enable Rapid Discovery and Functional Assessment of Novel Proteins. mSphere. 2022;7:e0089621.

Article  PubMed  Google Scholar 

Zhou Y, Husman T, Cen X, Tsao T, Brown J, Bajpai A, et al. Interleukin 15 in Cell-Based Cancer Immunotherapy. Int J Mol Sci. 2022;23:7311.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kowalsky SJ, Liu Z, Feist M, Berkey SE, Ma C, Ravindranathan R, et al. Superagonist IL-15-Armed Oncolytic Virus Elicits Potent Antitumor Immunity and Therapy That Are Enhanced with PD-1 Blockade. Mol Ther. 2018;26:2476–86.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Isvoranu G, Surcel M, Munteanu AN, Bratu OG, Ionita-Radu F, Neagu MT, et al. Therapeutic potential of interleukin-15 in cancer (Review). Exp Ther Med. 2021;22:675.

Article  CAS  PubMed  PubMed Central  Google Scholar 

European Medicines Agency. Guideline on xenogeneic cell-based medicinal products (EMEA/CHMP/CPWP/83508/2009). In. London, 2009.

European Medicines Agency. Guideline on Human Cell-Based Medicinal Products (EMEA/CHMP/410869/2006). In. London, 2008.

European Medicines Agency. Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products (EMA/CAT/80183/2014). In. London, 2018.

European Medicines Agency. Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (EMA/CAT/GTWP/671639/2008 Rev. 1 - corr). In. Amsterdam, 2020.

European Medicines Agency. Guideline on the risk-based approach according to annex I part IV of Directive 2001/83/EC applied to Advanced therapy medicinal products (EMA/CAT/CPWP/686637/2011). In. London, 2013.

Nolan SJ, Romano JD, Luechtefeld T, Coppens I. Neospora caninum Recruits Host Cell Structures to Its Parasitophorous Vacuole and Salvages Lipids from Organelles. Eukaryot Cell. 2015;14:454–73.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ungerechts G, Bossow S, Leuchs B, Holm PS, Rommelaere J, Coffey M, et al. Moving oncolytic viruses into the clinic: clinical-grade production, purification, and characterization of diverse oncolytic viruses. Mol Ther Methods Clin Dev. 2016;3:16018.

Article  PubMed  PubMed Central 

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