Enadenotucirev

From WikiMD's Wellness Encyclopedia

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[edit | edit source]

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]

See also[edit | edit source]

References[edit | edit source]

  1. "Enadenotucirev". PsiOxus Therapeutics. Retrieved 2019-07-04.
  2. "EMA grants positive opinion for orphan drug status for ovarian cancer oncolytic vaccine". PsiOxus Therapeutics. 2015-01-13. Retrieved 2019-07-04.
  3. Phase I / II Study of Enadenotucirev by Sub-acute Fractionated IV Dosing in Cancer Patients (EVOLVE)
  4. Mechanism of Action Trial of ColoAd1 (MOA)
  5. Phase I / II Study Of Enadenotucirev Intraperitoneally in Ovarian Cancer Patients (OCTAVE)
  6. Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors (SPICE)
  7. First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)



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Contributors: Prab R. Tumpati, MD