Enadenotucirev
| Enadenotucirev | |
|---|---|
Virus classification 
| |
| (unranked): | Virus |
| Realm: | Varidnaviria |
| Kingdom: | Bamfordvirae |
| Phylum: | Preplasmiviricota |
| Class: | Tectiliviricetes |
| Order: | Rowavirales |
| Family: | Adenoviridae |
| Genus: | Mastadenovirus |
| Species: | Human mastadenovirus B
|
Enadenotucirev is an investigational oncolytic virus that is in clinical trials for various cancers.[1]
It is an oncolytic A11/Ad3 Chimeric Group B Adenovirus, previously described as ColoAd1.[2]
Enadenotucirev has also been modified with additional genes using the tumor-specific immuno-gene therapy (T-SIGn) platform to develop novel cancer gene therapy agents.[citation needed]
The T-SIGn vectors at clinical study stage are:[citation needed]
- NG-350A: This vector contains two transgenes expressing the heavy and light chains for a secreted CD40 agonist monoclonal antibody.
- NG-641: This vector contains four transgenes expressing secreted Interferon alpha, the chemokines CXCL9, CXCL10 and an anti-FAP/anti-CD3 bispecific T-cell activator
In Jan 2015 the European Medicines Agency's (EMA) Committee for Orphan Medical Products (COMP) designated enadenotucirev as an orphan medicinal product for the treatment of ovarian cancer.[3]
Clinical trials
[edit]Two clinical trials have been completed with enadenotucirev. The EVOLVE study [4] and the MOA study.[5]
As of June 2019[update], there are two active phase 1 trials: OCTAVE (in ovarian cancer)[6] and SPICE (in multiple solid tumor indications) [7]
Of the T-SIGn viruses, NG-350A has an ongoing clinical study.[8]
See also
[edit]References
[edit]- ^ "Enadenotucirev". PsiOxus Therapeutics. Retrieved 2019-07-04.
- ^ Machiels, Jean-Pascal; Salazar, Ramon; Rottey, Sylvie; Duran, Ignacio; Dirix, Luc; Geboes, Karen; Wilkinson-Blanc, Christine; Pover, Gillian; Alvis, Simon; Champion, Brian; Fisher, Kerry; McElwaine-Johnn, Hilary; Beadle, John; Calvo, Emiliano (2019-01-28). "A phase 1 dose escalation study of the oncolytic adenovirus enadenotucirev, administered intravenously to patients with epithelial solid tumors (EVOLVE)". Journal for Immunotherapy of Cancer. 7 (1): 20. doi:10.1186/s40425-019-0510-7. ISSN 2051-1426. PMC 6348630. PMID 30691536.
- ^ "EMA grants positive opinion for orphan drug status for ovarian cancer oncolytic vaccine". PsiOxus Therapeutics. 2015-01-13. Retrieved 2019-07-04.
- ^ Phase I / II Study of Enadenotucirev by Sub-acute Fractionated IV Dosing in Cancer Patients (EVOLVE)
- ^ Mechanism of Action Trial of ColoAd1 (MOA)
- ^ Phase I / II Study Of Enadenotucirev Intraperitoneally in Ovarian Cancer Patients (OCTAVE)
- ^ Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors (SPICE)
- ^ First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)
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