(12) International Application Status Report

Received at International Bureau: 10 September 2018 (10.09.2018)

Information valid as of: 28 November 2018 (28.11.2018)

Report generated on: 22 August 2019 (22.08.2019)

(10) Publication number: (43) Publication date: (26) Publication language:
WO 2019/05045814 March 2019 (14.03.2019) English (EN)

(21) Application number: (22) Filing date: (25) Filing language:
PCT/SE2018/05089306 September 2018 (06.09.2018) English (EN)

(31) Priority number(s): (32) Priority date(s): (33) Priority status:
1751091-8 (SE)08 September 2017 (08.09.2017) Priority document received (in compliance with PCT Rule 17.1)
1850017-3 (SE)07 January 2018 (07.01.2018) Priority document received (in compliance with PCT Rule 17.1)

(51) International Patent Classification:
G01N 33/564 (2006.01); A61K 31/592 (2006.01); A61K 31/593 (2006.01); A61K 39/00 (2006.01); A61P 3/10 (2006.01); A61K 38/51 (2006.01); G01N 33/15 (2006.01); G01N 33/569 (2006.01)

(71) Applicant(s):
DIAMYD MEDICAL AB [SE/SE]; Kungsgatan 29 111 56 Stockholm (SE) (for all designated states)

(72) Inventor(s):
LUDVIGSSON, Johnny; c/o Linköpings Universitet 581 83 LINKÖPING (SE)
CASAS, Rosaura; c/o Department of Clinical and Experimental Medicine Linköping University 581 83 LINKÖPING (SE)
HANNELIUS, Ulf; c/o Diamyd Medical AB Kungsgatan 29 111 56 STOCKHOLM (SE)
LINDQVIST, Anton; c/o Diamyd Medical AB Kungsgatan 29 111 56 STOCKHOLM (SE)
ESSEN-MÖLLLER, Anders; Djurgårdsbrunnsvägen 54 115 25 STOCKHOLM (SE)

(74) Agent(s):
ZACCO SWEDEN AB; P.O. Box 5581 Valhallavägen 117N 114 85 Stockholm (SE)

(54) Title (EN): IMPROVED IMMUNOTHERAPY
(54) Title (FR): IMMUNOTHÉRAPIE AMÉLIORÉE

(57) Abstract:
(EN): The invention relates to a method for assessing the efficacy of an immunotherapy comprising administration of GAD to a patient, comprising the following steps: measuring at least one of GADA IgG subclass distribution; GADA levels; distribution of cytokines secreted from lymphocytes; and lymphocyte proliferation in presence of GAD or CD3/CD28 beads; in a first blood, plasma or serum sample obtained from said patient at a first point in time and in a second blood, plasma or serum sample obtained from said patient at a later point in time; and comparing the so obtained measurements. The invention also relates to novel administration regimens of GAD in treatment or prevention of type 1 diabetes, that may include administration by injection into a lymph node, oral administration of vitamin D and/or an assessment of efficacy according to the above methodology followed by an adjustment of dosage and/or administration route based on said assessment.
(FR): La présente invention concerne un procédé d'évaluation de l'efficacité d'une immunothérapie comprenant l'administration de GAD à un patient, comprenant les étapes suivantes : mesure de la distribution d'au moins l'un parmi la sous-classe d'IgG GADA ; des taux de GADA ; de la distribution de cytokines sécrétées par des lymphocytes ; et de la prolifération de lymphocytes en présence de billes de GAD ou CD3/CD28 ; dans un premier échantillon de sang, de plasma ou de sérum obtenu à partir dudit patient à un premier temps et dans un deuxième échantillon de sang, de plasma ou de sérum obtenu à partir dudit patient à un temps ultérieur ; et comparaison des mesures obtenues ainsi. L'invention concerne en outre de nouveaux régimes posologiques de GAD dans le traitement ou la prévention du diabète de type 1, qui peuvent comprendre l'administration par injection dans un ganglion lymphatique, l'administration orale de vitamine D et/ou une évaluation de l'efficacité selon la méthodologie ci-dessus suivie d'un ajustement de la dose et/ou de la voie d'administration sur la base de ladite évaluation.

International search report:
Received at International Bureau: 27 November 2018 (27.11.2018) [SE]

International Report on Patentability (IPRP) Chapter II of the PCT:
Not available

(81) Designated States:
AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, 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, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
European Patent Office (EPO) : 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
African Intellectual Property Organization (OAPI) : BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG
African Regional Intellectual Property Organization (ARIPO) : BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW
Eurasian Patent Organization (EAPO) : AM, AZ, BY, KG, KZ, RU, TJ, TM