US 12,104,184 B2
PH20 polypeptide variants, formulations and uses thereof
Ge Wei, San Diego, CA (US); H. Michael Shepard, Eugene, OR (US); Qiping Zhao, San Diego, CA (US); and Robert James Connor, Oceanside, CA (US)
Assigned to Halozyme, Inc., San Diego, CA (US)
Filed by HALOZYME, INC., San Diego, CA (US)
Filed on Dec. 19, 2022, as Appl. No. 18/068,443.
Application 18/068,443 is a division of application No. 17/327,568, filed on May 21, 2021.
Application 18/068,443 is a division of application No. 17/327,586, filed on May 21, 2021, granted, now 12,037,618.
Application 15/226,489 is a division of application No. 13/694,731, filed on Dec. 28, 2012, granted, now 9,447,401, issued on Sep. 20, 2016.
Application 16/912,590 is a division of application No. 13/694,731, filed on Dec. 28, 2012, granted, now 9,447,401, issued on Sep. 20, 2016.
Application 15/226,489 is a division of application No. 13/694,731, filed on Dec. 28, 2012, granted, now 9,447,401, issued on Sep. 20, 2016.
Application 16/824,572 is a division of application No. 13/694,731, filed on Dec. 28, 2012, granted, now 9,447,401, issued on Sep. 20, 2016.
Application 15/226,489 is a division of application No. 13/694,731, filed on Dec. 28, 2012, granted, now 9,447,401, issued on Sep. 20, 2016.
Application 17/327,568 is a continuation of application No. 16/912,590, filed on Jun. 25, 2020, granted, now 11,066,656, issued on Jul. 20, 2021.
Application 16/912,590 is a continuation of application No. 15/226,489, filed on Aug. 2, 2016, granted, now 10,865,400, issued on Dec. 15, 2020.
Application 16/912,590 is a continuation of application No. 13/694,731, filed on Dec. 28, 2012, granted, now 9,447,401, issued on Sep. 20, 2016.
Application 17/327,568 is a continuation of application No. 16/824,572, filed on Mar. 19, 2020, granted, now 11,041,149, issued on Jun. 22, 2021.
Application 17/327,568 is a continuation of application No. 15/226,489, filed on Aug. 2, 2016, granted, now 10,865,400, issued on Dec. 15, 2020.
Application 17/327,568 is a continuation of application No. 13/694,731, filed on Dec. 28, 2012, granted, now 9,447,401, issued on Sep. 20, 2016.
Application 17/327,586 is a continuation of application No. 16/912,590, filed on Jun. 25, 2020, granted, now 11,066,656, issued on Jul. 20, 2021.
Application 16/912,590 is a continuation of application No. 15/226,489, filed on Aug. 2, 2016, granted, now 10,865,400, issued on Dec. 15, 2020.
Application 17/327,586 is a continuation of application No. 16/824,572, filed on Mar. 19, 2020, granted, now 11,041,149, issued on Jun. 22, 2021.
Application 16/824,572 is a continuation of application No. 15/226,489, filed on Aug. 2, 2016, granted, now 10,865,400, issued on Dec. 15, 2020.
Application 17/327,586 is a continuation of application No. 15/226,489, filed on Aug. 2, 2016, granted, now 10,865,400, issued on Dec. 15, 2020.
Application 17/327,586 is a continuation of application No. 13/694,731, filed on Dec. 28, 2012, granted, now 9,447,401, issued on Sep. 20, 2016.
Claims priority of provisional application 61/796,208, filed on Nov. 1, 2012.
Claims priority of provisional application 61/631,313, filed on Dec. 30, 2011.
Prior Publication US 2023/0212547 A1, Jul. 6, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. C12N 9/26 (2006.01); A61K 9/00 (2006.01); A61K 38/00 (2006.01); A61K 38/28 (2006.01); A61K 38/47 (2006.01); A61K 45/06 (2006.01); A61K 47/10 (2017.01); A61P 35/00 (2006.01); C07K 14/47 (2006.01); C12Q 1/34 (2006.01)
CPC C12N 9/2474 (2013.01) [A61K 9/0019 (2013.01); A61K 38/28 (2013.01); A61K 38/47 (2013.01); A61K 45/06 (2013.01); A61K 47/10 (2013.01); A61P 35/00 (2018.01); C07K 14/47 (2013.01); C12Q 1/34 (2013.01); C12Y 302/01035 (2013.01); A61K 38/00 (2013.01); C07K 2319/30 (2013.01); G01N 2333/926 (2013.01); G01N 2333/928 (2013.01); Y02A 50/30 (2018.01)] 35 Claims
 
1. A modified PH20 polypeptide, comprising one or more amino acid modifications in an unmodified PH20 polypeptide, wherein:
the unmodified PH20 polypeptide consists of the amino acid sequence selected from the group consisting of SEQ ID NO: 3, 7 and 32-66;
amino acid modifications are selected from the group consisting of amino acid replacements(s), deletion(s), and/or insertion(s);
the modified PH20 polypeptide comprises an amino acid replacement at a position corresponding to residue 328 with reference to amino acid positions set forth in SEQ ID NO: 3;
the replacement at the position corresponding to residue 328 is selected from the group consisting of A, C, G, H, I, K, L, Q, R, S, T, V, and Y;
corresponding amino acid positions are identified by alignment of the PH20 polypeptide with the polypeptide having the amino acid sequence of SEQ ID NO: 3; and
the modified PH20 polypeptide has at least 91% sequence identity to a polypeptide having the amino acid sequence selected from the group consisting of SEQ ID NO: 3, 7 and 32-66.