Group B adenovirus-containing formulation
The present disclosure relates to formulations suitable for the storage of group B adenoviruses, such as Enadenotucirev (EnAd), processes for making the formulations, and use of the formulations in methods of treatment.
1 . A liquid formulation suitable for a group B adenovirus, comprising:
a) a group B adenovirus;
b) 15 to 25% v/v glycerol;
c) methionine or arginine; and
d) buffer,
wherein the pH of the formulation is in the range of 8.0 to 9.6 and wherein the formulation does not comprise a divalent cation.
2 . The formulation of claim 1 , wherein the formulation does not comprise a sugar.
3 . The formulation of claim 1 , wherein the formulation is for intravenous administration.
4 . The formulation of claim 3 , wherein the formulation is for administration by slow injection or by infusion.
5 . The formulation of claim 1 , wherein the formulation further comprises a surfactant.
6 . The formulation of claim 5 , wherein the surfactant is polysorbate, optionally wherein the polysorbate is polysorbate 80.
7 . The formulation of claim 6 , wherein the formulation comprises 0.05-0.15% polysorbate.
8 . The formulation of claim 1 , wherein the formulation comprises 0.01-0.3 mM methionine.
9 . The formulation of claim 1 , wherein the formulation comprises 5-20 mM arginine.
10 . The formulation of claim 1 , wherein the buffer is selected from meglumine, glycine, TRIS, and combinations thereof.
11 . The formulation of claim 1 , wherein the formulation does not comprise HEPES buffer.
12 . The formulation of claim 1 , wherein the formulation comprises:
a) 15 to 20% v/v glycerol;
b) 1 to 1.5% v/v ethanol;
c) 0.1 to 0.2% v/v polysorbate 80;
d) 0.2 to 0.3 mM methionine; and
e) 10 to 20 mM arginine.
13 . The formulation of claim 1 , wherein the group B adenovirus is replication competent.
14 . The formulation of claim 1 , wherein the group B adenovirus is Ad11 or Enadenotucirev (EnAd).
15 . The formulation of claim 1 , wherein the formulation further comprises 0.1 to 1.5% v/v ethanol.