Enadenotucirev

Enadenotucirev is an investigational oncolytic virus that is in clinical trials for various cancers.<ref name="SPICE2015">

Enadenotucirev(link). PsiOxus Therapeutics.

Accessed 2019-07-04.

</ref>

It is an oncolytic A11/Ad3 Chimeric Group B Adenovirus, previously described as ColoAd1.<ref name="EVOLVE-pos-2014">,

 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, 
 
 Vol. 7(Issue: 1),
 pp. 20,
 DOI: 10.1186/s40425-019-0510-7,
 
 PMC: 6348630,</ref>

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.<ref>

EMA grants positive opinion for orphan drug status for ovarian cancer oncolytic vaccine(link). PsiOxus Therapeutics.

2015-01-13.

Accessed 2019-07-04.

</ref>

Clinical trials

Two clinical trials have been completed with enadenotucirev. The EVOLVE study <ref name="CT-octave2">Phase I / II Study of Enadenotucirev by Sub-acute Fractionated IV Dosing in Cancer Patients (EVOLVE)</ref> and the MOA study.<ref name="CT-octave3">Mechanism of Action Trial of ColoAd1 (MOA)</ref>

As of  2019[[Category:Articles containing potentially dated statements from ]], there are two active phase 1 trials: OCTAVE (in ovarian cancer)<ref name="CT-octave">Phase I / II Study Of Enadenotucirev Intraperitoneally in Ovarian Cancer Patients (OCTAVE)</ref> and SPICE (in multiple solid tumor indications) <ref name="CT-evolve2">Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors (SPICE)</ref>

Of the T-SIGn viruses, NG-350A has an ongoing clinical study.<ref>First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)</ref>

See also

• Oncolytic adenovirus
  • Oncolytic adenovirus#Directed Evolution

References

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