US 12,435,138 B2
Immunotoxins, formulations thereof and their use in medicine
Henricus Gerardus Van Hooren, Nijmegen (NL); Maarten Jaap Frijlink, Nijmegen (NL); and Ypke Vincentius Johannes Maria Van Oosterhout, Nijmegen (NL)
Assigned to Philikos B.V., Nijmegan (NL)
Filed by Philikos B.V., Nijmegen (NL)
Filed on Aug. 1, 2022, as Appl. No. 17/816,550.
Application 17/816,550 is a continuation of application No. 16/759,952, granted, now 11,447,548, previously published as PCT/EP2018/079860, filed on Oct. 31, 2018.
Claims priority of application No. 1717966 (GB), filed on Oct. 31, 2017.
Prior Publication US 2024/0150463 A1, May 9, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. C07K 16/28 (2006.01); A61K 9/08 (2006.01); A61K 9/19 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61K 47/68 (2017.01); A61P 37/06 (2006.01)
CPC C07K 16/2809 (2013.01) [A61K 9/08 (2013.01); A61K 9/19 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); A61K 47/6827 (2017.08); A61K 47/6849 (2017.08); A61P 37/06 (2018.01)] 8 Claims
 
1. A pharmaceutical composition comprising:
(i) 0.05 to 0.5 mg/mL, optionally 0.2 mg/mL, of a monoclonal antibody molecule that specifically recognises CD3 and which is conjugated to at least one ricin toxin A (RTA), and/or
0.05 to 0.5 mg/mL, optionally 0.2 mg/mL, of a monoclonal antibody molecule that specifically recognises CD7 and which is conjugated to at least one RTA;
(ii) 5 to 20 mM, optionally 10 mM, of a citrate buffer;
(iii) 50 to 300 mM, optionally: a) 75 to 200 mM; or b) 125 mM, of L-arginine or a pharmaceutically acceptable salt thereof;
(vi) 0.01 to 0.1% (w/v), optionally 0.05% (w/v), of a polysorbate,
wherein the composition is in water and has a pH in the range 6 to 7.5, optionally 6.5.