Granted Patent
B2
US 12,577,296 · App. 16/736,207 · Granted Mar 17, 2026
Compositions and methods for growth factor modulation
Inventors:
Thomas Schurpf (Cambridge, MA); Nagesh K. Mahanthappa (Cambridge, MA); Michelle Marie Straub (Yarmouth, ME)
Assignee:
Scholar Rock, Inc.
C07K16/22A61K39/001134A61K39/3955C07K14/495C07K16/005C07K16/28C07K16/2863C12N15/1037A61K38/00C07K2317/21C07K2317/24C07K2317/31C07K2317/32C07K2317/55C07K2317/565C07K2317/76C07K2317/92C07K2317/94G01N2333/495G01N2333/71
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Abstract
Provided herein are proteins, antibodies, assays and methods useful for modulating growth factor levels and/or activities. In some embodiments, such growth factors are members of the TGF-β superfamily of proteins.
Claims (39)
1 . A method for manufacturing a pharmaceutical composition that comprises an antibody, or an antigen-binding portion thereof, that inhibits transforming growth factor beta 1 (TGF-β1) signaling, the method comprising the steps of:
(i) screening an antibody display library or hybridoma cell lines for an antibody, or an antigen-binding portion thereof, capable of binding an antigen comprising a transforming growth factor beta 1 prodomain complex (TGF-β1 GPC), that comprises:
a) a latency associated peptide (LAP) dimer, wherein each polypeptide of the dimer has an amino acid sequence comprising SEQ ID NO: 38 or SEQ ID NO: 99; and
b) a growth factor dimer, wherein each polypeptide of the dimer has an amino acid sequence comprising SEQ ID NO: 44; and
selecting an antibody, or antigen-binding portion thereof, that binds to the TGF-β1 GPC;
(ii) providing a growth factor activity assay to measure inhibition of TGF-β1 signaling comprising:
a) contacting the TGF-β1 GPC with the antibody, or antigen-binding portion thereof, selected in step (i), a cell expressing αvβ6 integrin and/or αvβ8 integrin, and a responsive cell comprising a reporter gene comprising a TGF-β1 growth factor responsive promoter operably linked to a sequence encoding a detectable gene product;
b) obtaining TGF-β1 signaling activity data by detecting expression of the detectable gene product, and
c) selecting an antibody, or an antigen-binding portion thereof, that inhibits TGF-β1 signaling;
(iii) preparing expression vectors comprising the coding sequences of the antibody, or the antigen-binding portions thereof, selected in step (ii);
(iv) transfecting the vectors prepared in step (iii) into a cell in culture medium for expression of the antibody, or antigen-binding portion thereof;
(v) purifying the antibody, or the antigen-binding portion thereof, expressed in step (iv) from the culture medium; and
(vi) formulating the antibody, or the antigen-binding portion thereof, purified in step (v) into a pharmaceutical composition.
2 . The method of claim 1 , wherein the antibody display library is an antibody fragment display library.
3 . The method of claim 2 , wherein the antibody fragment display library comprises Fab fragments or single-chain variable fragments (scFvs).
4 . The method of claim 1 , wherein the antibody display library is expressed in a host selected from the group consisting of yeast, bacteriophage, bacteria and retroviruses.
5 . The method of claim 1 , wherein the antibody display library screened in step (i) comprises human antibodies or antigen-binding portions thereof.
6 . A method for manufacturing a pharmaceutical composition that comprises an antibody, or an antigen-binding portion thereof, that inhibits transforming growth factor beta 1 (TGF-β1) signaling, the method comprising the steps of:
(i) screening an antibody display library or hybridoma cell lines for an antibody, or an antigen-binding portion thereof, capable of binding an antigen comprising a transforming growth factor beta 1 prodomain complex (TGF-β1 GPC), that comprises:
a) a latency associated peptide (LAP) dimer, wherein each polypeptide of the dimer has an amino acid sequence comprising SEQ ID NO: 38 or SEQ ID NO: 99; and
b) a growth factor dimer, wherein each polypeptide of the dimer has an amino acid sequence comprising SEQ ID NO: 44; and
selecting an antibody, or antigen-binding portion thereof, that binds to the TGF-β1 GPC;
(ii) providing a growth factor activity assay to measure inhibition of TGF-β1 signaling comprising:
a) contacting the TGF-β1 GPC with the antibody, or antigen-binding portion thereof, selected in step (i), a cell expressing αvβ6 integrin and/or αvβ8 integrin, and a responsive cell comprising a reporter gene comprising a TGF-β1 growth factor responsive promoter operably linked to a sequence encoding a detectable gene product;
b) obtaining TGF-β1 signaling activity data by detecting expression of the detectable gene product, and
c) selecting an antibody, or an antigen-binding portion thereof, that inhibits TGF-β1 signaling;
d) carrying out affinity maturation and/or optimization of the antibody, or antigen-binding portion thereof selected in step (ii) c); or
humanizing the antibody, or the antigen-binding portion thereof selected in step (ii) c); or
selecting an antibody, or antigen-binding portion thereof, from step (ii) c) that cross-reacts with human or mouse forms of the antigen; or
performing an in vitro binding assay for the antibody, or antigen-binding portion thereof, selected in step (ii) c), and selecting an antibody, or antigen-binding portion thereof, that does not bind mature TGF-β1 growth factor or empty LAP dimer;
(iii) preparing expression vectors comprising the coding sequences of the antibody, or the antigen-binding portions thereof, of step (ii) d);
(iv) transfecting the vectors prepared in step (iii) into a cell in culture medium for expression of the antibody, or antigen-binding portion thereof;
(v) purifying the antibody, or the antigen-binding portion thereof, expressed in step (iv) from the culture medium; and
(vi) formulating the antibody, or the antigen-binding portion thereof, purified in step (v) into a pharmaceutical composition.
7 . The method of claim 6 , wherein step (ii) d) is carrying out affinity maturation and/or optimization of the antibody, or antigen-binding portion thereof selected in step (ii) c).
8 . The method of claim 6 , wherein step (ii) d) is humanizing the antibody, or the antigen-binding portion thereof selected in step (ii) c).
9 . The method of claim 6 , wherein step (ii) d) is selecting an antibody, or antigen-binding portion thereof, from step (ii) c) that cross-reacts with human or mouse forms of the antigen.
10 . The method of claim 6 , wherein step (ii) d) is performing an in vitro binding assay for the antibody, or antigen-binding portion thereof, selected in step (ii) c), and selecting an antibody, or antigen-binding portion thereof, that does not bind mature TGF-β1 growth factor or empty LAP dimer.
11 . The method of claim 10 , wherein the in vitro binding assay is an Enzyme-Linked Immunosorbent Assay (ELISA), Surface Plasmon Resonance assay and/or a Fluorescence-Associated Cell Sorting (FACS) assay.
Assignments (2)
SECURITY INTEREST
Recorded Mar 3, 2026
From: SCHOLAR ROCK, INC.
To: LSI FINANCING LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 075015/0854 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jan 10, 2020
From: SCHURPF, THOMAS; MAHANTHAPPA, NAGESH K.; STRAUB, MICHELLE MARIE
To: SCHOLAR ROCK, INC.
Reel/Frame 051476/0551 →
Continuity (7)
Continuation
PCTUS2014036933
· May 6, 2014
Provisional Application
61900438
· Nov 6, 2013
Provisional Application
61823552
· May 15, 2013
Provisional Application
61819840
· May 6, 2013
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