SG11201808630WA - Humanized anti-pacap antibodies and uses thereof - Google Patents

Humanized anti-pacap antibodies and uses thereof

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Publication number
SG11201808630WA
SG11201808630WA SG11201808630WA SG11201808630WA SG11201808630WA SG 11201808630W A SG11201808630W A SG 11201808630WA SG 11201808630W A SG11201808630W A SG 11201808630WA SG 11201808630W A SG11201808630W A SG 11201808630WA SG 11201808630W A SG11201808630W A SG 11201808630WA
Authority
SG
Singapore
Prior art keywords
wvrqapgkglewig
washington
syymt
pacap
fidaggdayyaswakg
Prior art date
Application number
SG11201808630WA
Inventor
Maria-Cristina Loomis
Leon Garcia-Martinez
Benjamin Dutzar
Daniel Allison
Katherine Hendrix
Ethan Ojala
Pei Fan
Jeffrey Smith
John Latham
Charlie Karasek
Jenny Mulligan
Michelle Scalley-Kim
Erica Stewart
Vanessa Lisbeth Rubin
Jens J Billgren
Original Assignee
Alder Biopharmaceuticals Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alder Biopharmaceuticals Inc filed Critical Alder Biopharmaceuticals Inc
Publication of SG11201808630WA publication Critical patent/SG11201808630WA/en

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    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
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    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • C07K—PEPTIDES
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    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
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    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575—Hormones
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
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    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property -, Organization 11111111011110111010101111101011111011101111111101011111001101111101111011111 International Bureau ... .... ..Yjd ..... ....!;,,,' (10) International Publication Number (43) International Publication Date WO 2017/181039 Al 19 October 2017(19.10.2017) WIPO I PCT (51) International Patent Classification: (US). SMITH, Jeffrey, T.L.; 42 Abington, Malahide, C07K 16/26 (2006.01) C07K 19/00 (2006.01) Dublin, 13 (IE). LATHAM, John, A.; 2409 10th Avenue C07K 16/18 (2006.01) A61K 39/00 (2006.01) W., Seattle, Washington 98119 (US). KARASEK, Charlie; 1221 Minor Avenue, Apt. 709, Seattle, Washing- (21) International Application Number: PCT/US2017/027669 ton 98101 (US). MULLIGAN, Jenny; 9512 53rd Avenue N.E., Lake Forest Park, Washington 98155 (US). SCAL- (22) International Filing Date: LEY-KIM, Michelle; 3002 19th Avenue S., Seattle, 14 April 2017 (14.04.2017) Washington 98144 (US). STEWART, Erica; 1030 NE (25) Filing Language: English 103rd Street, Seattle, Washington 98125 (US). RUBIN, Vanessa Lisbeth; 2230 N. 106th Street, Apt. 205, Seattle, (26) Publication Language: English Washington 98133 (US). BILLGREN, Jens J.; 7309 Sand Point Way N.E., #B948, Seattle, Washington 98115 (US). (30) Priority Data: 62/322,939 15 April 2016 (15.04.2016) US (74) Agents: TESKIN, Robin, L. et al.; Leclair Ryan, P.C., In- 62/322,957 15 April 2016 (15.04.2016) US tellectual Property Department, 2318 Mill Road, Suite 62/323,495 15 April 2016 (15.04.2016) US 1100, Alexandria, Virginia 22314 (US). 62/323,573 15 April 2016 (15.04.2016) US (81) Designated States (unless otherwise indicated, for every 62/366,902 26 July 2016 (26.07.2016) US kind of national protection available): AE, AG, AL, AM, 62/408,347 14 October 2016 (14.10.2016) US AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (71) Applicant: ALDER BIOPHARMACEUTICALS, INC. BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, [US/US]; 11804 North Creek Parkway South, Bothell, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, Washington 98011 (US). HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, _ (72) Inventors: LOOMIS, Maria-Cristina; 4807 196th Street MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, Bothell, SE, Washington 98012 (US). GAR- NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, CIA-MARTINEZ, Leon, F.; 4926 214th Street SE, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, Woodinville, Washington 98072 (US). DUTZAR, Ben- TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, = jamin, H.; 511 NE 81st Street, Seattle, Washington 98115 ZA, ZM, ZW. (US). ALLISON, Daniel, S.; 19223 55th Avenue N.E., Lake Forest Park, Washington 98155 HENDRIX, (84) Designated States (unless otherwise indicated, for every (US). Katherine, Lee; 11804 North Creek Parkway South, kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, Bothell, Washington 98011 (US). OJALA, Ethan; 14310 Nevers Road, Snohomish, Washington 98290 FAN, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, (US). Pei; 9815 NE 158th Street, Bothell, Washington 98011 TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, [Continued on next page] (54) Title: HUMANIZED ANTI-PACAP ANTIBODIES AND USES THEREOF Antibody Heavy chain Protein features Sequence Name FR1 CDR1 FR2 CDR2 AWN QSVEESGGRLVTPGTPLTLICTVSGIDLN SYYMT WVRQAPGKGLEWIG FIDAGGDAYYASWAKG Ab20 QSVEESGGRLVTPGTPLTLICTVSGIDLS SYYMS WVRQAPGKGLEWIG FIDIDGSAYYATWAKG Ab21 QSVEESGGRLVTPGTPLTLTCTVSGIDLS SYYMT WVRQAPGKGLEWVG FIDAGGSAYYATWAKG Ab22 QEQLVESGGGLVQPEGSLTLTCTASGFDFS SNAMC WVRQAPGKGLEWIG SIYNADGKNYYAIWAKG Ab23 QSVEESGGRLVTPGTPLTLTCTVSGFSLN NYAMS WVRQAPGKGLEWIG IMGVNDITYYASWAKG AblO.H EVQLVESGGGLVQPGGSLRLSCAASGIDLN SYYMT WVRQAPGKGLEWIG FIDAGGDAYYASWAKG Ab21.H EVQLVESGGGLVQPGGSLRLSCAASGIDLS SYYMT WVRQAPGKGLEWIG FIDAGGSAYIATWAKG Ab1O.H2 EVQLVESGGGLVQPGGSLRLSCAASGIDLN SYYMT WVRQAPGKGLEWIG FIDAGGDAYYASWAKG AblO.H3 EVQLVESGGGLVQPGGSLRLSCAASGIDLN SYYMT WVRQAPGKGLEWIG FIDAGGDAYYASWAKG AblO.H4 EVQLVESGGGLVQPGGSLRLSCAASGIDLN SYYMT WVRQAPGKGLEWIG FIDAGGDAYYASWAKG AblO.H5 EVQLVESGGGLVQPGGSLRLSCAASGIDLN SYYMT WVRQAPGKGLEWIG FIDAGGDAYYASWAKG AblO.H6 EVQLVESGGGLVQPGGSLRLSCAASGIDLN SYYMT WVRQAPGKGLEWIG FIDAGGDAYYASWAKG 11 Ab21.H2 EVQLVESGGGLVQPGGSLRLSCAASGIDLS SYYMT WVRQAPGKGLEWIG FIDAGGSAYYATWAKG Ab21.H3 EVQLVESGGGLVQPGGSLRLSCAASGIDLS SYYMT WVRQAPGKGLEWIG FIDAGGSAYYATWAKG Ab21. H4 EVQLVESGGGLVQPGGSLRLSCAASGIDLS SYYMT WVRQAPGKGLEWIG FIDAGGSAYYATWAKG C:r M Figure lA © - (57) : The present invention is directed to antibodies and antigen binding fragments thereof having binding specificity for w w PACAP. The antibodies and antigen binding fragments thereof comprise the sequences of the VH, VL, and CDR polypeptides de- I-1 ---- scribed herein, and the polynucleotides encoding them. Antibodies and antigen binding fragments described herein bind to and/or IN compete for binding to the same linear or conformational epitope(s) on human PACAP as an anti-PACAP antibody. The invention C contemplates conjugates of anti-PACAP antibodies and binding fragments thereof conjugated to one or more functional or detect - el able moieties. Methods of making said anti-PACAP antibodies and antigen binding fragments thereof are also contemplated. Other O embodiments of the invention contemplate using anti-PACAP antibodies, and binding fragments thereof, for the diagnosis, assess - ,.1 ment, and treatment of diseases and disorders associated with PACAP and conditions where antagonism of PACAP-related activit- ies, such as vasodilation, photophobia, mast cell degranulation, and/or neuronal activation, would be therapeutically beneficial. WO 2017/181039 Al MIDEDIMOMOIDEIRMEMOMMUMINOCIONVOIS DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, Published: LU, LV, MC, MK, MT, NL, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, NO, PL, PT, RO, RS, SE, w i t h international search report (Art. 21(3)) GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: — before the expiration of the time limit for amending claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) the — as to applicant's entitlement a patent (Rule 4.17(11)) to apply for and be granted with sequence listing part of description (Rule 5.2(a))
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