Enadenotucirev
Enadenotucirev is an investigational oncolytic virus that is in clinical trials for various cancers.
It is an oncolytic A11/Ad3 Chimeric Group B Adenovirus, previously described as ColoAd1.
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.
Clinical trials
Two clinical trials have been completed with enadenotucirev. The EVOLVE study and the MOA study.
As of June 2019[update], there are two active phase 1 trials: OCTAVE (in ovarian cancer) and SPICE (in multiple solid tumor indications).
Of the T-SIGn viruses, NG-350A has an ongoing clinical study.
See also
References
- ↑ "Enadenotucirev". PsiOxus Therapeutics. Archived from the original on 2019-07-04. 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. Archived from the original on 2019-07-04. 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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