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EP About this file: EP3868785

EP3868785 - ANTI-CD28 HUMANIZED ANTIBODIES FORMULATED FOR ADMINISTRATION TO HUMANS [Right-click to bookmark this link]
StatusRequest for examination was made
Status updated on  25.02.2022
Database last updated on 02.09.2024
FormerThe application has been published
Status updated on  23.07.2021
Most recent event   Tooltip15.11.2023New entry: Renewal fee paid 
Applicant(s)For all designated states
OSE Immunotherapeutics
22, boulevard Benoni Goullin
44200 Nantes / FR
[2021/34]
Inventor(s)01 / VANHOVE, Bernard
72bis rue Henri Barbusse
44400 Rézé / FR
 [2021/34]
Representative(s)Carpmaels & Ransford LLP
One Southampton Row
London WC1B 5HA / GB
[N/P]
Former [2021/34]Duffield, Stephen
Carpmaels & Ransford LLP
One Southampton Row
London WC1B 5HA / GB
Application number, filing date21150940.115.12.2016
[2021/34]
Priority number, dateEP2015020028115.12.2015         Original published format: EP 15200281
EP2016030653722.11.2016         Original published format: EP 16306537
[2021/34]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report 
No.:EP3868785
Date:25.08.2021
Language:EN
[2021/34]
Search report(s)(Supplementary) European search report - dispatched on:EP14.07.2021
ClassificationIPC:C07K16/28, A61P37/06
[2021/34]
CPC:
C07K16/2818 (EP,KR,US); A61K38/47 (EP,US); A61K39/3955 (US);
A61K47/60 (US); A61K9/0014 (US); A61K9/0019 (US);
A61P37/06 (EP,US); C12Y302/01035 (EP,US); A61K2039/505 (EP,KR,US);
A61K2039/54 (EP,KR,US); A61K2039/545 (EP,KR,US); C07K2317/24 (EP,KR,US);
C07K2317/33 (EP,KR,US); C07K2317/55 (EP,KR,US); C07K2317/76 (EP,KR,US);
C07K2317/92 (EP,KR,US); C07K2317/94 (EP,KR,US) (-)
Designated contracting statesAL,   AT,   BE,   BG,   CH,   CY,   CZ,   DE,   DK,   EE,   ES,   FI,   FR,   GB,   GR,   HR,   HU,   IE,   IS,   IT,   LI,   LT,   LU,   LV,   MC,   MK,   MT,   NL,   NO,   PL,   PT,   RO,   RS,   SE,   SI,   SK,   SM,   TR [2022/13]
Former [2021/34]AL,  AT,  BE,  BG,  CH,  CY,  CZ,  DE,  DK,  EE,  ES,  FI,  FR,  GB,  GR,  HR,  HU,  IE,  IS,  IT,  LI,  LT,  LU,  LV,  MC,  MK,  MT,  NL,  NO,  PL,  PT,  RO,  RS,  SE,  SI,  SK,  SM,  TR 
TitleGerman:HUMANISIERTE ANTI-CD28-ANTIKÖRPER ZUR VERABREICHUNG AN MENSCHEN[2021/34]
English:ANTI-CD28 HUMANIZED ANTIBODIES FORMULATED FOR ADMINISTRATION TO HUMANS[2021/34]
French:ANTICORPS HUMANISÉS ANTI-CD28 FORMULÉS POUR UNE ADMINISTRATION À DES HUMAINS[2021/34]
Examination procedure22.02.2022Examination requested  [2022/13]
22.02.2022Date on which the examining division has become responsible
23.03.2022Despatch of communication that the application is deemed to be withdrawn, reason: reply to the Extended European Search Report/Written Opinion of the International Searching Authority/International Preliminary Examination Report/Supplementary international search report not received in time
01.06.2022Amendment by applicant (claims and/or description)
Parent application(s)   TooltipEP16822423.6  / EP3390450
Request for further processing for:The application is deemed to be withdrawn due to failure to reply to the Extended European Search Report/Written Opinion of the International Searching Authority/International Preliminary Examination Report/Supplementary international search report/Supplementary European search report
01.06.2022Request for further processing filed
01.06.2022Full payment received (date of receipt of payment)
Request granted
10.06.2022Decision despatched
Fees paidRenewal fee
30.04.2021Renewal fee patent year 03
30.04.2021Renewal fee patent year 04
30.04.2021Renewal fee patent year 05
30.11.2021Renewal fee patent year 06
14.11.2022Renewal fee patent year 07
15.11.2023Renewal fee patent year 08
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Documents cited:Search[AD]WO2011101791  (TCL PHARMA [FR], et al) [AD] 1-15 * the whole document, in particular claims 1-10 and examples 1-6 *;
 [XI]  - Bas-Bernardet Le ET AL, "75 PRECLINICAL EVALUATION OF FR104, AN ANTAGONIST ANTI-CD28 MONOVALENT FAB'ANTIBODY, IN A SKIN INFLAMMATORY DTH PRIMATE MODEL", 11th World Congress On Inflammation, IAIS Abstracts Natal 2013, (20130921), URL: http://static.springer.com/sgw/documents/1427011/application/pdf/IAIS+Abstracts+Natal+2013.pdf, (20160421), XP055267462 [X] 11-13,15 * the whole document * [I] 1-10,14
 [XI]  - N. POIRIER ET AL, "Selective CD28 Antagonist Blunts Memory Immune Responses and Promotes Long-Term Control of Skin Inflammation in Nonhuman Primates", THE JOURNAL OF IMMUNOLOGY, US, (20151123), vol. 196, no. 1, doi:10.4049/jimmunol.1501810, ISSN 0022-1767, pages 274 - 283, XP055266685 [X] 11-13,15 * page 275, column l, paragraphs 2, 3, 5 - page r, paragraph 1 * * discussion; page 276, column r, paragraph 2; figures 2, 6 * [I] 1-10,14

DOI:   http://dx.doi.org/10.4049/jimmunol.1501810
 [XI]  - "Project Final Report: TRIAD (Tolerance Restoration in Autoimmune Diseases by selective manipulation of the CD28 costimulatory pathway", (20150410), URL: http://cordis.europa.eu/docs/results/281/281493/final1-triad-report-ce-final-20150410-final.pdf, (20160420), XP055266941 [X] 11-13,15 * page 3, paragraph 5 - page 4, paragraph 2 * * page 5, paragraph 6 - page 6, paragraph 4 * * page 11, paragraph 2 - page 13, paragraph 6 * * page 16, paragraph 6 * * page 20, paragraph 3 - page 21, paragraph 9 * [I] 1-10,14
 [XI]  - K. G. HAANSTRA ET AL, "Selective Blockade of CD28-Mediated T Cell Costimulation Protects Rhesus Monkeys against Acute Fatal Experimental Autoimmune Encephalomyelitis", THE JOURNAL OF IMMUNOLOGY, US, (20150215), vol. 194, no. 4, doi:10.4049/jimmunol.1402563, ISSN 0022-1767, pages 1454 - 1466, XP055266682 [X] 11-13,15 * the whole document, in particular page 1455, left-hand column, fourth paragraph - right-hand column, first paragraph * [I] 1-10,14

DOI:   http://dx.doi.org/10.4049/jimmunol.1402563
 [A]  - POIRIER NICOLAS ET AL, "Advantages of Papio anubis for preclinical testing of immunotoxicity of candidate therapeutic antagonist antibodies targeting CD28", MABS, LANDES BIOSCIENCE, US, (20140501), vol. 6, no. 3, ISSN 1942-0862, pages 697 - 706, XP009189665 [A] 1-15 * the whole document *
 [A]  - SUCHARD SUZANNE J ET AL, "A monovalent anti-human CD28 domain antibody antagonist: preclinical efficacy and safety", THE JOURNAL OF IMMUNOLOGY, AMERICAN ASSOCIATION OF IMMUNOLOGISTS, US, (20131101), vol. 191, no. 9, ISSN 1550-6606, pages 4599 - 4610, XP002765099 [A] 1-15 * the whole document, in particular discussion *
by applicantWO2011101791
 US8785604
    - BOWEN, M.ARMSTRONG, N.MAA, Y.-F., "Investigating high-concentration monoclonal antibody powder suspension in nonaqueous suspension vehicles for subcutaneous injection", J. Pharm. Sci., (20120000), vol. 101, doi:10.1002/jps.23324, pages 4433 - 4443, XP055070252

DOI:   http://dx.doi.org/10.1002/jps.23324
    - FINDLAY LEASTWOOD DSTEBBINGS RSHARP GMISTRY YBALL C et al., "Improved in vitro methods to predict the in vivo toxicity in man of therapeutic monoclonal antibodies including TGN1412", J Immunol Methods, (20100000), vol. 352, pages 1 - 12, XP026808302
    - HAANSTRA KG.DIJKMAN K.BASHIR N. et al., "Selective Blockade of CD28-Mediated T Cell Costimulation Protects Rhesus Monkeys against Acute Fatal Experimental Autoimmune Encephalomyelitis", J Immunol, (20150114), page 1402563
    - HALEY PJ, "Small molecule immunomodulatory drugs: challenges and approaches for balancing efficacy with toxicity", Toxicol Pathol, (20120000), vol. 40, no. 2, pages 261 - 266
    - JACKISCH, C.MIILLER, V.MAINTZ, C.HELL, S.ATASEVEN, B., "Subcutaneous Administration of Monoclonal Antibodies in Oncology", Geburtshilfe Frauenheilkd, (20140000), vol. 74, doi:10.1055/s-0034-1368173, pages 343 - 349, XP055344155

DOI:   http://dx.doi.org/10.1055/s-0034-1368173
    - MELICHAR, B.STUDENTOVA, H.KALABOVA, H.VITASKOVA, D., "Role of subcutaneous formulation of trastuzumab in the treatment of patients with HER2-positive breast cancer", Immunotherapy, (20140000), vol. 6, pages 811 - 819
    - OHRESSER MOLIVE DVANHOVE BWATIER H, "Risk in drug trials", Lancet, (20060000), vol. 368, no. 9554, doi:10.1016/S0140-6736(06)69883-8, pages 2205 - 6, XP025093799

DOI:   http://dx.doi.org/10.1016/S0140-6736(06)69883-8
    - POIRIER, N.DILEK, N.MARY, C. et al., "FR104, an Antagonist Anti-CD28 Monovalent Fab' Antibody, Prevents Alloimmunization and Allows Calcineurin Inhibitor Minimization in Nonhuman Primate Renal Allograft", Am J Transplant, (20150000), no. 1, pages 88 - 100
    - POIRIER, N.MARY, C.DILEK, N. et al., "Preclinical efficacy and immunological safety of FR104, an antagonist anti-CD28 monovalent Fab' antibody", Am J Transplant, (20120000), no. 10, doi:10.1111/j.1600-6143.2012.04164.x, pages 2630 - 40, XP055110877

DOI:   http://dx.doi.org/10.1111/j.1600-6143.2012.04164.x
    - POIRIER, N.MARY, C.LE BAS-BERNADET, S., N. et al., "Advantages of Papio anubis for preclinical testing of immunotoxicity of candidate therapeutic antagonist antibodies targeting CD28", MAbs, (20140000), no. 3, pages 697 - 707
    - SHIAO SLMCNIFF JMMASUNAGA TTAMURA KKUBO KPOBER JS, "Immunomodulatory properties of FK734, a humanized anti-CD28 monoclonal antibody with agonistic and antagonistic activities", Transplantation, (20070000), vol. 83, no. 3, pages 304 - 13
    - SHPILBERG, O.JACKISCH, C., "Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase", Br. J. Cancer, (20130000), vol. 109, doi:10.1038/bjc.2013.371, pages 1556 - 1561, XP002782443

DOI:   http://dx.doi.org/10.1038/bjc.2013.371
    - STEBBINGS RFINDLAY LEDWARDS CEASTWOOD DBIRD CNORTH D et al., "Cytokine storm' in the phase I trial of monoclonal antibody TGN1412: better understanding the causes to improve pre-clinical testing of immunotherapeutics", J Immunol., (20070000), vol. 179, pages 3325 - 3331
    - SUNTHARALINGAM GPERRY MRWARD SBRETT SJCASTELLO-CORTES ABRUNNER MDPANOSKALTSIS N, "Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412", N Engl J Med, (20060000), vol. 355, no. 10, doi:10.1056/NEJMoa063842, pages 1018 - 28, XP002559375

DOI:   http://dx.doi.org/10.1056/NEJMoa063842
    - WEINBLATT, M.E.SCHIFF, M.VALENTE, R.VAN DERHEIJDE, D.CITERA, G.ZHAO, C.MALDONADO, M.FLEISCHMANN, R., "Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study", Arthritis Rheum, (20130000), vol. 65, pages 28 - 38
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