Enadenotucirev Explained

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.

The T-SIGn vectors at clinical study stage are:

• 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

Two clinical trials have been completed with enadenotucirev. The EVOLVE study ^[4] and the MOA study.^[5]

, 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

• Oncolytic adenovirus
  • Oncolytic adenovirus#Directed Evolution

Notes and References

1. Web site: Enadenotucirev. PsiOxus Therapeutics. en-GB. 2019-07-04.
2. 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. 10.1186/s40425-019-0510-7. 30691536. 2051-1426. 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. 6348630 . free .
3. Web site: EMA grants positive opinion for orphan drug status for ovarian cancer oncolytic vaccine. 2015-01-13. PsiOxus Therapeutics. en-GB. 2019-07-04.
4. https://clinicaltrials.gov/ct2/show/NCT02028442 Phase I / II Study of Enadenotucirev by Sub-acute Fractionated IV Dosing in Cancer Patients (EVOLVE)
5. https://clinicaltrials.gov/ct2/show/NCT02053220 Mechanism of Action Trial of ColoAd1 (MOA)
6. https://clinicaltrials.gov/ct2/show/NCT02028117 Phase I / II Study Of Enadenotucirev Intraperitoneally in Ovarian Cancer Patients (OCTAVE)
7. Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors (SPICE)
8. First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)