WO 2014/ A3. 23 October 2014 ( ) P O P C T
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1 (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2014/ A3 23 October 2014 ( ) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C07K 16/32 ( ) A61P 35/04 ( ) kind of national protection available): AE, AG, AL, AM, G01N 33/53 ( ) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, (21) International Application Number: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/US20 14/ HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (22) International Filing Date: KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, 15 April 2014 ( ) MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (25) Filing Language: English SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (26) Publication Language: English TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 61/812, April 2013 ( ) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except AL, AT, BE, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, BG, CH, CN, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IN, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, P T RO, RS, SE, SI, SK, SM, TR) : GENENTECH, INC. [US/US]; 1 Dna Way, South San Francisco, Califor nia (US). UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). (71) Applicant (for AL, AT, BE, BG, CH, CN, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IN, IS, IT, LT, LU, Published: LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR only): F. HOFFMANN-LA ROCHE AG with international search report (Art. 21(3)) [CH/CH]; Grenzacherstrasse 124, CH-4070 Basel (CH). before the expiration of the time limit for amending the claims and to be republished in the event of receipt of (72) Inventors: GENNARO, Lynn A.; c/o Genentech Inc., 1 amendments (Rule 48.2(h)) DNA Way, South San Francisco, California (US). KAO, Yung-Hsiang; c/o Genentech, Inc., 1 DNA Way, with sequence listing part of description (Rule 5.2(a)) South San Francisco, California (US). ZHANG, (88) Date of publication of the international search report: Yonghua; c/o Genentech, Inc., 1 DNA Way, South San 8 January 2015 Francisco, California (US). (74) Agents: LEE, Wendy M. et al; Genentech, Inc., Mail Stop 49, South San Francisco, California (US). < l l - (54) Title: PERTUZUMAB VARIANTS AND EVALUATION THEREOF (57) Abstract: The present application discloses variants of Pertuzumab. In particular, it discloses: an unpaired cysteine variant comprising Cys23/Cys88 unpaired cysteines in one or both variable light domains of Pertuzumab, an afucosylated variant of Pertu - zumab, a low-molecular-weight-species (LMWS) of Pertuzumab, and a high-molecular-weight-species (HMWS) or Pertuzumab. The application further discloses the isolated variants, compositions, pharmaceutical compositions, and articles of manufacture comprising the variants, as well as methods of making and characterizing the variants and compositions thereof.
2 A. CLASSIFICATION O F SUBJECT MATTER INV. C07K16/32 G01N33/53 A61P35/04 ADD. According to International Patent Classification (IPC) or to both national classification and IPC B. FIELDS SEARCHED Minimum documentation searched (classification system followed by classification symbols) C07K G01N A61K Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched Electronic data base consulted during the international search (name of data base and, where practicable, search terms used) EPO-Internal, BIOSIS, WPI Data C. DOCUMENTS CONSIDERED TO B E RELEVANT Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. US 2006/ Al (KAO YUNG-HSIANG [US] ET 1-13, AL) 26 January 2006 ( ) page 3, l eft-hand col umn ; f i gure 3; 26,27 sequences 15, 16 page 26, paragraph page 28, paragraph 0289 ; f i gure 9 page 29, paragraph 300; f i gures 13-14; tabl e 5 -/- X Further documents are listed in the continuation of Box C. See patent family annex. * Special categories of cited documents : "A" document defining the general state of the art which is not considered to be of particular relevance "T" later document published after the international filing date or priority date and not in conflict with the application but cited to understand the principle or theory underlying the invention "E" earlier application or patent but published o n or after the international "X" document of particular relevance; the claimed invention cannot be filing date considered novel or cannot be considered to involve an inventive "L" documentwhich may throw doubts on priority claim(s) orwhich is step when the document is taken alone cited to establish the publication date of another citation or other "Y" document of particular relevance; the claimed invention cannot be special reason (as specified) considered to involve an inventive step when the document is "O" document referring to an oral disclosure, use, exhibition or other combined with one o r more other such documents, such combination means being obvious to a person skilled in the art "P" document published prior to the international filing date but later than the priority date claimed "&" document member of the same patent family Date of the actual completion of the international search Date of mailing of the international search report 17 November /11/2014 Name and mailing address of the ISA/ Authorized officer European Patent Office, P.B Patentlaan 2 NL HV Rijswijk Tel. (+31-70) , Fax: (+31-70) Le Fl ao, Katel l
3 C(Continuation). DOCUMENTS CONSIDERED TO BE RELEVANT Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. A ZHANG TAYLOR ET AL: " Identi f i cati on and 1-10 characteri zati on of buri ed unpai red cystei nes i n a recombi nant monocl onal IgGl anti body. ", ANALYTICAL CHEMISTRY 2 1 AUG 2012, vol. 84, no. 16, 2 1 August 2012 ( ), pages , XP , ISSN : page 7112, l eft-hand col umn X US 2004/ Al (KELSEY STEPHEN M [US] 1-10, ET AL) 22 January 2004 ( ) page 28, paragraph page 35, paragraph 371 ; c l aims 1-12 X / A2 (GENENTECH INC [US] ; 1-10 HOFFMANN LA ROCHE [CH] ; K0LL HANS [DE] ; BOSSENMAI E) 22 January 2004 ( ) exampl e s 1-7 A T. T. JUNTTI LA ET AL: "Superi or I n v i vo 11, 12, Effi cacy of Afucosyl ated Trastuzumab i n 2 1,22 the Treatment of HER2-Ampl i f i ed Breast Cancer", CANCER RESEARCH, vol. 70, no. 11, 1 June 2010 ( ), pages , XP , ISSN : , D0I : / CAN page 4483 ; tabl e 1 A HARRIS R J : "Heterogenei t y of recombi nant 11-13, anti bodi e s : l i nki ng structure t o 2 1,22 functi on", DEVELOPMENTS I N BI0L0GICALS, KARGER, BASEL, vol. 122, 1 January 2005 ( ), pages , XP , ISSN : abstract; f i gures 1-5 -/--
4 C(Continuation). DOCUMENTS CONSIDERED TO BE RELEVANT Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. PATRICK DI EDERICH ET AL: " A sub-two 13 mi nutes method for monocl onal anti body-aggregate quanti f i cati on usi ng paral l e l i nterl aced s i ze excl usi on hi gh performance l i qui d chromatography", JOURNAL OF CHROMATOGRAPHY, ELSEVI ER SCI ENCE PUBLISHERS B.V, NL, vol. 1218, no. 50, 16 September 2011 ( ), pages , XP , ISSN : , D0I : /J. CHROMA [retri eved on ] abstract NICOLE STACKH0USE ET AL: " A 26,27 hi gh-throughput UPLC method for the characteri zati on of chemi cal modi f i cati ons i n monocl onal anti body mol ecul es", JOURNAL OF PHARMACEUTICAL SCI ENCES, vol. 100, no. 12, 24 December 2011 ( ), pages , XP , ISSN : , D0I : /jps abstract; f i gures 3, 4 14
5 INTERNATIONAL SEARCH REPORT Box No. II Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet) This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons: Claims Nos.: because they relate to subject matter not required to be searched by this Authority, namely: Claims Nos.: because they relate to parts of the international application that do not comply with the prescribed requirements to such an extent that no meaningful international search can be carried out, specifically: 3. I I Claims Nos.: because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a). Box No. Ill Observations where unity of invention is lacking (Continuation of item 3 of first sheet) This International Searching Authority found multiple inventions in this international application, as follows: see addi t i onal sheet As all required additional search fees were timely paid by the applicant, this international search report covers all searchable claims. As all searchable claims could be searched without effort justifying an additional fees, this Authority did not invite payment of additional fees. As only some of the required additional search fees were timely paid by the applicant, this international search report covers ' ' only those claims for which fees were paid, specifically claims Nos. : 4. I I No required additional search fees were timely paid by the applicant. Consequently, this international search report is restricted to the invention first mentioned in the claims; it is covered by claims Nos. : Remark on Protest ' ' The additional search fees were accompanied by the applicant's protest and, where applicable, the ' payment of a protest fee. The additional search fees were accompanied by the applicant's protest but the applicable protest ' fee was not paid within the time limit specified in the invitation. IX I No protest accompanied the payment of additional search fees. Form PCT/ISA/21 0 (continuation of first sheet (2)) (April 2005)
6 International Application No. PCT/ US2014/ FURTHER INFORMATION CONTINUED FROM PCT/ISA/ 210 Thi s Internati onal Searchi ng Authori t y found mul t i p l e (groups of) i nventi ons i n thi s i nternati onal appl i cati on, a s fol l ows : 1. c l aims : l-lo(compl etely) ; 15-20, (parti a l ly) A composi t i on compri s i ng Pertuzumab and unpai red cystei n vari ant thereof, wherei n the unpai red cystei ne vari ant compri ses Cys23/Cys88 unpai red cystei nes i n one or both vari abl e l i ght domai n s or Pertuzumab. 2. c l aims : 11, 12, 2 1, 22 (compl etely) ; 15-20, (parti a l ly) A composi t i on compri s i ng Pertuzumab and an afucosyl ated vari ant of Pertuzumab, wherei n the amount of the afucosyl ated vari ant i s from 0.9 t o 4. 1 % of the composi t i on. 3. c l aims : 13 (compl etely) ; 15-20, (parti a l ly) A composi t i on compri s i ng a mi xture of Pertuzumab, l ow-mol ecul ar-wei ght speci e s ( LM S ) of Pertuzumab, and hi gh-mol ecul ar-wei ght-speci e s (HMWS) of Pertuzumab, wherei n the amount of LMWS i s < 1. 6 % and the amount of HMWS i s < 1. 7 % a s determi ned by s i ze excl usi on hi gh performance l i qui d chromatography (SE-HPLC). 4. c l aims : 14, 26, 27 A composi t i on compri s i ng a mi xture of Pertuzumab, Peak 1, and Peak 2, wherei n the amount of Peak 1 i s < 0.5% and the amount of Peak 2 i s < 1.0% a s measured by reduced capi l l i ary e l ectrophoresi s sodi um dodecyl sul phate (R-CE-SDS) assay.
7 Patent document Publication Patent family Publication cited in search report date member(s) date US A l A R A l AU A l BR PI A CA A l CN A CO A l CR 8932 A DK T EC SP A EP A ES T GT A HK A l P A P A KR A KR A KR A KR A KR A KR A MA B l NZ A PA A l PE A l RU C SV A UA C US A l US A l US A l O A ZA A US A l US A l US A l A AT T AU A l AU A l BR A CA A l CN A CN A DK T DK T EP A EP A l ES T ES T HK A l IL A P B P A J P A MX PA A NZ A PL B l page 1 of 2
8 Patent document Publication Patent family Publication cited in search report date member(s) date PT E PT E RU A US Al US Al A page 2 of 2
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