Enadenotucirev

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]

As of June 2019, 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]

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See also

References
  1. "Enadenotucirev". PsiOxus Therapeutics. Retrieved 2019-07-04.
  2. 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.
  3. "EMA grants positive opinion for orphan drug status for ovarian cancer oncolytic vaccine". PsiOxus Therapeutics. 2015-01-13. Retrieved 2019-07-04.
  4. Phase I / II Study of Enadenotucirev by Sub-acute Fractionated IV Dosing in Cancer Patients (EVOLVE)
  5. Mechanism of Action Trial of ColoAd1 (MOA)
  6. 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)


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