IP Library Granted Patent US 11,213,588
Granted Patent B2
US 11,213,588 · App. 16/235,936 · Granted Jan 4, 2022

Multifunctional forms of polyoxazoline copolymers and drug compositions comprising the same

Inventors: J Milton Harris (Huntsville, AL); Kunsang Yoon (Madison, AL); Michael David Bentley (Huntsville, AL); Zhihao Fang (Madison, AL); Tacey Viegas (Madison, AL)
Assignee: Serina Therapeutics, Inc.
A61K47/59A61K38/09A61P35/00C08G73/0233
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Quick Facts
Patent No.
US 11,213,588
App. No.
16/235,936
Granted
Jan 4, 2022
Kind
B2
Abstract

The present disclosure provides copolymers of 2-substituted-2-oxazolines possessing two or three reactive functional groups which are also chemically orthogonal. The copolymers described may be random copolymers, block copolymers or a mixture of random and block copolymer configurations. Furthermore, the present disclosure provides novel methods for synthesizing the above polymers and for conjugating to molecules such as targeting, diagnostic and therapeutic agents.

Claims (50)

1. A method of treating cancer in a subject, the method comprising the step of administering a heterofunctional polyoxazoline derivative of the general structure I to the subject:

R 1 —{[N(COX)CH 2 CH 2 ] o —[N(COR 2 )CH 2 —CH 2 )] n —[N(COY)CH 2 —CH 2 )] m } a —Z  I

wherein:

R 1 is an initiating group;

R 2 is independently selected for each repeating unit from an unsubstituted or substituted alkyl, an unsubstituted or substituted alkenyl, an unsubstituted or substituted aralkyl or an unsubstituted or substituted heterocyclylalkyl group;

X is a pendent moiety containing a first functional group and the first functional group is selected from the group consisting of: an alkyne, an amine, an oxyamine, an aldehyde, a ketone, an acetal, a ketal, an ester, a carboxylic acid, an activated carboxylic acid, an active carbonate, a chloroformate, an alcohol, an azide, a vinyl sulfone, a maleimide and orthopyridyl disulfide;

Y is a pendent moiety containing a second functional group and the second functional group is selected from the group consisting of: an alkyne, an amine, an oxyamine, an aldehyde, a ketone, an acetal, a ketal, an ester, a carboxylic acid, an activated carboxylic acid, an active carbonate, a chloroformate, an alcohol, an azide, a vinyl sulfone, a maleimide and orthopyridyl disulfide;

Z is a terminating nucleophile;

a is ran which indicates a random copolymer or block which indicates a block copolymer;

o and m are each an integer independently selected from 1-50; and

n is an integer selected from 0-1000;

wherein the heterofunctional polyoxazoline derivative is linked to at least one target molecule, through at least one of the first or second functional groups.

2. The method of claim 1 , wherein R 1 is a hydrogen, substituted or unsubstituted alkyl or substituted or unsubstituted aralkyl group.

3. The method of claim 1 , wherein R 2 is an unsubstituted alkyl.

4. The method of claim 1 , wherein Z is —S—U—W, wherein U is a linking group and W is a third functional group selected from the group consisting of an alkyne, an amine, an oxyamine, an aldehyde, a ketone, an acetal, a ketal, an ester, a carboxylic acid, an activated carboxylic acid, an active carbonate, a chloroformate, an alcohol, an azide, a vinyl sulfone, a maleimide, and orthopyridyl disulfide.

5. The method of claim 4 , wherein W is a carboxylic acid, a protected carboxylic acid, an active ester, an amine or a protected amine and U is an alkylene linking portion.

6. The method of claim 4 , wherein the heterofunctional polyoxazoline derivative has the structure:

R 1 —{[N(COX)CH 2 CH 2 ] o —[N(COR 2 )CH 2 —CH 2 )] n [N(COY)CH 2 —CH 2 )] m } a —S—(CH 2 ) p —W,

R 1 —{[N(COX)CH 2 CH 2 ] o [N(COR 2 )CH 2 —CH 2 )] n —[N(COY)CH 2 —CH 2 )] m } a —S—(CH 2 ) p —NH 2 or

R 1 —{[N(COX)CH 2 CH 2 ] o —[N(COR 2 )CH 2 —CH 2 )] n —[N(COY)CH 2 —CH 2 )] m } a —S—(CH 2 ) p —CO 2 H,

wherein p is an integer from 1 to 10.

7. The method of claim 1 , wherein the at least one target molecule is a therapeutic agent.

8. The method of claim 1 , wherein the heterofunctional polyoxazoline derivative is linked to a therapeutic agent and optionally a targeting agent, a diagnostic agent, or a targeting agent and a diagnostic agent.

9. The method of claim 7 , wherein the therapeutic agent is an organic molecule, a peptide, a protein, an antibody, an antibody fragment, a carbohydrate, or an oligonucleotide.

10. The method of claim 1 , wherein the heterofunctional polyoxazoline derivative is administered in a therapeutically effective amount.

11. A method of preventing cancer in a subject, the method comprising the step of administering a therapeutically effective amount of a heterofunctional polyoxazoline derivative of the general structure I to the subject:

R 1 —{[N(COX)CH 2 CH 2 ] o —[N(COR 2 )CH 2 —CH 2 )] n —[N(COY)CH 2 —CH 2 )] m } a —ZI

wherein:

R 1 is an initiating group;

R 2 is independently selected for each repeating unit from an unsubstituted or substituted alkyl, an unsubstituted or substituted alkenyl, an unsubstituted or substituted aralkyl or an unsubstituted or substituted heterocyclylalkyl group;

X is a pendent moiety containing a first functional group and the first functional group is selected from the group consisting of: an alkyne, an amine, an oxyamine, an aldehyde, a ketone, an acetal, a ketal, an ester, a carboxylic acid, an activated carboxylic acid, an active carbonate, a chloroformate, an alcohol, an azide, a vinyl sulfone, a maleimide and orthopyridyl disulfide;

Y is a pendent moiety containing a second functional group and the second functional group is selected from the group consisting of: an alkyne, an amine, an oxyamine, an aldehyde, a ketone, an acetal, a ketal, an ester, a carboxylic acid, an activated carboxylic acid, an active carbonate, a chloroformate, an alcohol, an azide, a vinyl sulfone, a maleimide and orthopyridyl disulfide;

Z is a terminating nucleophile;

a is ran which indicates a random copolymer or block which indicates a block copolymer;

o and m are each an integer independently selected from 1-50; and

n is an integer selected from 0-1000;

wherein the heterofunctional polyoxazoline derivative is linked to at least one target molecule, through at least one of the first or second functional groups.

12. The method of claim 11 , wherein R 1 is a hydrogen, substituted or unsubstituted alkyl or substituted or unsubstituted aralkyl group.

13. The method of claim 11 , wherein R 2 is an unsubstituted alkyl.

14. The method of claim 11 , wherein Z is —S—U—W, wherein U is a linking group and W is a third functional group selected from the group consisting of an alkyne, an amine, an oxyamine, an aldehyde, a ketone, an acetal, a ketal, an ester, a carboxylic acid, an activated carboxylic acid, an active carbonate, a chloroformate, an alcohol, an azide, a vinyl sulfone, a maleimide, and orthopyridyl disulfide.

15. The method of claim 14 , wherein W is a carboxylic acid, a protected carboxylic acid, an active ester, an amine or a protected amine and U is an alkylene linking portion.

16. The method of claim 14 , wherein the heterofunctional polyoxazoline derivative has the structure:

R 1 —{[N(COX)CH 2 CH 2 ] o —[N(COR 2 )CH 2 —CH 2 )] n —[N(COY)CH 2 —CH 2 )] m } a —S—(CH 2 ) p —W,

R 1 —{[N(COX)CH 2 CH 2 ] o [N(COR 2 )CH 2 —CH 2 )] n —[N(COY)CH 2 —CH 2 )] m } a —S—(CH 2 ) p —NH 2 or

R 1 —{[N(COX)CH 2 CH 2 ] o —[N(COR 2 )CH 2 —CH 2 )] n —[N(COY)CH 2 —CH 2 )] m } a —S—(CH 2 ) p —CO 2 H,

wherein p is an integer from 1 to 10.

17. The method of claim 11 , wherein the at least one target molecule is a therapeutic agent.

18. The method of claim 17 , wherein the therapeutic agent is an organic molecule, a peptide, a protein, an antibody, an antibody fragment, a carbohydrate, or an oligonucleotide.

19. The method of claim 17 , wherein the heterofunctional polyoxazoline derivative is further linked to a targeting agent, a diagnostic agent, or a targeting agent and a diagnostic agent.

20. The method of claim 11 , wherein the heterofunctional polyoxazoline derivative is linked to a plurality of target molecules.

Assignments (2)
CHANGE OF NAME Recorded Apr 9, 2024
From: SERINA THERAPEUTICS, INC.
To: SERINA THERAPEUTICS (AL), INC.
Reel/Frame 067050/0622 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 11, 2019
From: HARRIS, J. MILTON; BENTLEY, MICHAEL DAVID; YOON, KUNSANG; FANG, ZHIHAO; VIEGAS, TACEY
To: SERINA THERAPEUTICS, INC
Reel/Frame 047968/0540 →
Continuity (9)
Continuation 15205671 · Jul 8, 2016
Continuation 14627555 · Feb 20, 2015
Continuation 13957989 · Aug 2, 2013
Continuation 13356552 · Jan 23, 2012
Division 12787241 · May 25, 2010
Continuation In Part 12744472
Provisional Application 61029337 · Feb 16, 2008
Provisional Application 61020684 · Jan 11, 2008
Related Publication 20190134208A1 · May 9, 2019