Extract from the Register of European Patents

EP About this file: EP4259149

EP4259149 - EGANELISIB FOR USE IN THE TREATMENT OF PD-L1 NEGATIVE CANCER [Right-click to bookmark this link]
StatusExamination is in progress
Status updated on  24.01.2025
Database last updated on 09.04.2026
FormerRequest for examination was made
Status updated on  15.09.2023
FormerThe international publication has been made
Status updated on  17.06.2022
Formerunknown
Status updated on  10.01.2022
Most recent event   Tooltip26.02.2026New entry: Despatch of examination report + time limit 
Applicant(s)For all designated states
Twelve Therapeutics, Inc.
345 Park Avenue South, 12th Floor
New York, NY 10010 / US
[2025/48]
Former [2023/42]For all designated states
Infinity Pharmaceuticals, Inc.
1100 Massachusetts Avenue, 4th Floor
Cambridge, MA 02138 / US
Inventor(s)01 / O'CONNELL, Brenda Carol
Brighton, MA 02135 / US
 [2023/42]
Representative(s)Jones Day
Gewürzmühlstr. 11
80538 München / DE
[N/P]
Former [2023/42]Jones Day
Rechtsanwälte, Attorneys-at-Law, Patentanwälte
Prinzregentenstrasse 11
80538 München / DE
Application number, filing date21835092.407.12.2021
[2023/42]
WO2021US62127
Priority number, dateUS202063122892P08.12.2020         Original published format: US 202063122892 P
US202163146470P05.02.2021         Original published format: US 202163146470 P
US202163168123P30.03.2021         Original published format: US 202163168123 P
US202163203515P26.07.2021         Original published format: US 202163203515 P
[2023/42]
Filing languageEN
Procedural languageEN
PublicationType: A1 Application with search report
No.:WO2022125497
Date:16.06.2022
Language:EN
[2022/24]
Type: A1 Application with search report 
No.:EP4259149
Date:18.10.2023
Language:EN
The application published by WIPO in one of the EPO official languages on 16.06.2022 takes the place of the publication of the European patent application.
[2023/42]
Search report(s)International search report - published on:EP16.06.2022
ClassificationIPC:A61K31/519, A61K39/395, A61K31/337, A61P35/00
[2023/42]
CPC:
A61K31/519 (EP,US); A61K31/337 (EP,US); A61K39/3955 (EP,US);
A61P35/00 (EP,US); A61P35/04 (US); C07K16/2818 (US);
C07K16/2827 (US); A61K2039/505 (US); C07K2317/21 (US);
C07K2317/24 (US) (-)
C-Set:
A61K31/519, A61K39/395, A61K2300/00 (EP,US);
A61K39/3955, A61K2300/00 (EP)
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 [2023/42]
TitleGerman:EGANELISIB ZUR VERWENDUNG BEI DER BEHANDLUNG VON PD-L1-NEGATIVEM KREBS[2023/42]
English:EGANELISIB FOR USE IN THE TREATMENT OF PD-L1 NEGATIVE CANCER[2023/42]
French:ÉGANÉLISIB DESTINÉ À ÊTRE UTILISÉ DANS LE TRAITEMENT D'UN CANCER PD-L1 NÉGATIF[2023/42]
Entry into regional phase06.06.2023National basic fee paid 
06.06.2023Designation fee(s) paid 
06.06.2023Examination fee paid 
Examination procedure06.06.2023Examination requested  [2023/42]
06.06.2023Date on which the examining division has become responsible
20.02.2024Despatch 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
20.02.2024Despatch of communication of loss of particular rights: Claims {1}
19.04.2024Amendment by applicant (claims and/or description)
28.01.2025Despatch of a communication from the examining division (Time limit: M06)
25.07.2025Reply to a communication from the examining division
25.02.2026Despatch of a communication from the examining division (Time limit: M04)
Request for further processing for:19.04.2024Request for further processing filed
19.04.2024Full payment received (date of receipt of payment)
Request granted
25.04.2024Decision despatched
19.04.2024Request for further processing filed
19.04.2024Full payment received (date of receipt of payment)
Request granted
25.04.2024Decision despatched
Fees paidRenewal fee
27.12.2023Renewal fee patent year 03
27.12.2024Renewal fee patent year 04
29.12.2025Renewal fee patent year 05
Opt-out from the exclusive  Tooltip
competence of the Unified
Patent Court
See the Register of the Unified Patent Court for opt-out data
Responsibility for the accuracy, completeness or quality of the data displayed under the link provided lies entirely with the Unified Patent Court.
Cited inInternational search[YP] WO2021004421  (ZHEJIANG HISUN PHARM CO LTD et al.)
 [XPY]   PORTMAN N ET AL: "Mario-3 phase II study safety run-inevaluating a novel triplet combination of eganelisib(formerly IPI-549), atezolizumab (atezo), and nab-paclitaxel (nab-pac) as first-line (1L) therapy for locallyadvanced or metastatic triple-negative breast cancer(TNBC)", CANCER RESEARCH 20210201 AMERICAN ASSOCIATION FOR CANCER RESEARCH INC. NLD, vol. 81, no. 4 SUPPL, 8 December 2020 (2020-12-08), & 2020 San Antonio Breast Cancer Symposium, 08 - 11 Dec 2020, XP002805808, ISSN: 1538-7445
 [XPY]   TOMCZAK P ET AL: "Preliminary analysis of a phase II, multicenter, randomized, activecontrol study to evaluate the efficacy and safety of eganelisib (IPI 549) in combination with nivolumab compared to nivolumab monotherapy in patients with advanced urothelial carcinoma", JOURNAL OF CLINICAL ONCOLOGY 20210201 AMERICAN SOCIETY OF CLINICAL ONCOLOGY NLD, vol. 39, no. 6 SUPPL, 1 February 2021 (2021-02-01), & 2021 Genitourinary Cancers Symposium 11 - 13 Jan 2021, XP002805809, ISSN: 1527-7755
 [Y]   SULLIVAN R J ET AL: "Initial results from first-in-human study of IPI-549, a tumor macrophage-targeting agent, combined with nivolumab in advanced solid tumors", JOURNAL OF CLINICAL ONCOLOGY 20180501 AMERICAN SOCIETY OF CLINICAL ONCOLOGY NLD, vol. 36, no. 15, Supplement 1, 1 May 2018 (2018-05-01), & 2018 Annual Meeting of the American Society of Clinical Oncology, ASCO 01 - 05 Jun 2018, XP002805821, ISSN: 1527-7755
 [Y]   TOLCHER A: "IPI-549-01 - A Phase 1/1b, first-in-human study of IPI-549, a PI3K-[gamma] inhibitor, as monotherapy and in combination with nivolumab in patients with advanced solid tumors", CANCER RESEARCH 20170701 AMERICAN ASSOCIATION FOR CANCER RESEARCH INC. NLD, vol. 77, no. 13, Supplement 1, 1 July 2017 (2017-07-01), & American Association for Cancer Research Annual Meeting, Washington DC 01 - 05 Apr 2017, XP002805822, ISSN: 1538-7445
ExaminationUS2018055852
   DE HENAU OLIVIER ET AL: "Overcoming resistance to checkpoint blockade therapy by targeting PI3K[gamma] in myeloid cells", NATURE, vol. 539, no. 7629, 1 November 2016 (2016-11-01), pages 443 - 447, XP055773634, Retrieved from the Internet DOI: 10.1038/nature20554

DOI:   http://dx.doi.org/10.1038/nature20554
by applicantUS2013295102
 WO2015051244
 WO2015143012
 WO2017048702
 WO2011041399
 US2010029693
 US2010305096
 US2010305084
 US8008449
 WO2006121168
 WO2009114335
 US8354509
 WO2009101611
 US8609089
 US2010028330
 US2012114649
 WO2007005874
 WO2010077634
 US7943743
 US2012039906
 WO2010027827
 WO2011066342
 US2011150892
 WO2010019570
 WO2014008218
 US6111090
 EP0090505
 US8586023
 WO2010003118
 WO2011090754
 US7025962
 EP1947183
 US7812135
 US8388967
 US8591886
 EP1866339
 WO2011028683
 WO2013039954
 WO2005007190
 WO2007133822
 WO2005055808
 WO9940196
 WO0103720
 WO9920758
 WO2006083289
 WO2005115451
 US7618632
 WO2011051726
   GAESTEL ET AL., CURRENT MEDICINAL CHEMISTRY, vol. 14, 2007, pages 2214 - 2234
   CHOU ET AL., ADV ENZYME REGUL, vol. 22, 1984, pages 27 - 55
   VANHAESEBROECK, B. ET AL., ANNU REV BIOCHEM., vol. 70, 2001, pages 535 - 602
   BERGE ET AL., J. PHARMACEUTICAL SCIENCES, vol. 66, 1977, pages 1 - 19
   "Enantiomers, Racemates and Resolutions", 1981, WILEY INTERSCIENCE
   WILEN ET AL., TETRAHEDRON, vol. 33, 1977, pages 2725
   "Stereochemistry of Carbon Compounds", 1962, MCGRAW-HILL
   "Tables of Resolving Agents and Optical Resolutions", 1972, UNIV. OF NOTRE DAME PRESS, pages: 268
   FUNG-LEUNG WP., CELL SIGNAL., vol. 23, no. 4, 2011, pages 603 - 8
   VANHAESEBROECK, B. ET AL., CURRENT TOPICS IN MICROBIOLOGY AND IMMUNOLOGY, DOI 10.1007/82 2010 65, 2010
   HARRIS, SJ ET AL., CURR OPIN INVESTIG DRUGS, vol. 10, no. 11, 2009, pages 1151 - 62
   ROMMEL C. ET AL., NAT REV IMMUNOL, vol. 7, no. 3, 2007, pages 191 - 201
   DURAND CA ET AL., J IMMUNOL., vol. 183, no. 9, 2009, pages 5673 - 84
   DIL NMARSHALL AJ., MOL IMMUNOL., vol. 46, no. 10, 2009, pages 1970 - 8
   AL-ALWAN MM ET AL., J IMMUNOL., vol. 178, no. 4, 2007, pages 2328 - 35
   ZHANG TT ET AL., J ALLERGY CLIN IMMUNOL., vol. 122, no. 4, 2008, pages 811 - 819
   SRINIVASAN L ET AL., CELL, vol. 139, no. 3, 2009, pages 573 - 86
   HIRSCH ET AL.: "Central Role for G Protein-Coupled Phosphoinositide 3-Kinase y in Inflammation", SCIENCE, vol. 287, 2000, pages 1049 - 1053
   SASAKI ET AL.: "Function of PI3Ky in Thymocyte Development, T Cell Activation, and Neutrophil Migration", SCIENCE, vol. 287, 2000, pages 1040 - 1046, XP002214938, DOI: 10.1126/science.287.5455.1040

DOI:   http://dx.doi.org/10.1126/science.287.5455.1040
   LI ET AL.: "Roles of PLC-p2 and -(33 and PI3Ky in Chemoattractant-Mediated Signal Transduction", SCIENCE, vol. 287, 2000, pages 1046 - 1049
   RANDIS ET AL., EUR. J. IMMUNOL., vol. 38, no. 5, 2008, pages 1215 - 24
   TAKEDA ET AL., J. ALLERGY CLIN. IMMUNOL., vol. 123, 2009, pages 805 - 12
   SASAKI ET AL., SCIENCE, vol. 287, 2000, pages 1040 - 46
   ROLLER ET AL.: "Blockade of Phosphatidylinositol 3-Kinase (PI3K) or PI3Ky Reduces IL-17 and Ameliorates Imiquimod-Induced Psoriasis-like Dermatitis", J. IMMUNOL., vol. 189, 2012, pages 4612 - 4620, XP055065662, DOI: 10.4049/jimmunol.1103173

DOI:   http://dx.doi.org/10.4049/jimmunol.1103173
   SCHMID ET AL., CANCER CELL, vol. 19, 2011, pages 715 - 727
   HARDAMON: "Proceedings: AACR 103rd Annual Meeting 2012", CANCER RESEARCH, vol. 72, 15 April 2012 (2012-04-15)
   SUBRAMANIAM ET AL., CANCER CELL, vol. 21, 2012, pages 459 - 472
   BURGER: "Inhibiting B-Cell Receptor Signaling Pathways in Chronic Lymphocytic Leukemia", CURR. MEMATOL. MALIG. REP., vol. 7, 2012, pages 26 - 33, XP035015776, DOI: 10.1007/s11899-011-0104-z

DOI:   http://dx.doi.org/10.1007/s11899-011-0104-z
   RUCKLE ET AL., NATURE REV., DRUG DISCOVERY, vol. 5, 2006, pages 903 - 18
   SCHMID ET AL.: "Myeloid cells in tumor inflammation", VASCULAR CELL, 2012
   EDLING ET AL., HUMAN CANCER BIOLOGY, vol. 16, no. 2, 2010, pages 4928 - 37
   VOGT, PK ET AL., CURR TOP MICROBIOL IMMUNOL., vol. 347, 2010, pages 169 - 104
   FRESNO VARA, JA ET AL., CANCER TREAT REV, vol. 30, no. 2, 2004, pages 193 - 204
   ZHAO, LVOGT, PK, ONCOGENE, vol. 27, no. 41, 2008, pages 5486 - 96
   COURTNEY, KD ET AL., J CLIN ONCOL., vol. 28, no. 6, 2010, pages 1075 - 1083
   MARKMAN, B ET AL., ANN ONCOL., vol. 21, no. 4, 2010, pages 683 - 91
   KONG, DYAMORI, T, CURR MED CHEM., vol. 16, no. 22, 2009, pages 2839 - 54
   WAGNER, AJ ET AL., J CLIN ONCOL., vol. 27, 2009, pages 146s
   VOGT, PK ET AL., VIROLOGY, vol. 344, no. 1, 2006, pages 131 - 8
   WARD, S ET AL., CHEM BIOL., vol. 10, no. 3, 2003, pages 207 - 13
   SALMENA, L ET AL., CELL, vol. 133, 2008, pages 403 - 414
   CHAPUIS, N ET AL., CLIN CANCER RES., vol. 16, no. 22, 2010, pages 5424 - 35
   HERRERA, VA ET AL., ANTICANCER RES., vol. 31, no. 3, 2011, pages 849 - 54
   HALUSKA, F ET AL., SEMIN ONCOL., vol. 34, no. 6, 2007, pages 546 - 54
   SARKER, D ET AL., CLIN CANCER RES., vol. 15, no. 15, 2009, pages 4799 - 805
   CHEN J.S. ET AL., MOL CANCER THER., vol. 7, no. 4, 2008, pages 841 - 850
   BANSAL, N ET AL., CANCER CONTROL., vol. 16, no. 1, 2009, pages 8 - 13
   FURUKAWA, T, J GASTROENTEROL., vol. 43, no. 12, 2008, pages 905 - 11
   PORTA, CFIGLIN, RA, J UROL., vol. 182, no. 6, 2009, pages 2569 - 77
   SAIF, MWCHU, E, CANCER J., vol. 16, no. 3, 2010, pages 196 - 201
   TORBETT, NE ET AL., BIOCHEM J., vol. 415, 2008, pages 97 - 100
   BRZEZIANSKA, EPASTUSZAK-LEWANDOSKA, D, FRONT BIOSCI., vol. 16, 2011, pages 422 - 39
   MAZZOLETTI, MBROGGINI, M, CURR MED CHEM., vol. 17, no. 36, 2010, pages 4433 - 47
   HERMAN SE ET AL., BLOOD, vol. 116, no. 12, 2010, pages 2078 - 88
   BILLOTTET C ET AL., ONCOGENE, vol. 25, no. 50, 2006, pages 6648 - 59
   BILLOTTET C ET AL., CANCER RES., vol. 69, no. 3, 2009, pages 1027 - 36
   HOELLENRIEGEL, J ET AL., 52ND ANNUAL ASH MEETING AND EXPOSITION, 4 December 2010 (2010-12-04)
   HERMAN SE ET AL., BLOOD, vol. 117, no. 16, 2011, pages 4323 - 7
   PROCEEDINGS OF THE 105TH ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH, 5 April 2014 (2014-04-05)
   CANCER RES, vol. 74, 2014
   CLAIRE E. LEWIS: "Imaging immune cell infiltrating tumors in zebrafish", AACR ANNUAL MEETING, 5 April 2014 (2014-04-05)
   LEWISPOLLARD, CANCER RES., vol. 66, no. 2, 15 January 2006 (2006-01-15)
   COUSSENS LM. ET AL., CANCER DISCOV., June 2011 (2011-06-01), pages 54 - 67
   HAMID, O. ET AL., NEW ENGLAND JOURNAL OF MEDICINE, vol. 369, no. 2, 2013, pages 134 - 44
   CANCER RES, vol. 73, no. 12, 15 June 2013 (2013-06-15)
   CURRAN M A ET AL., PNAS, vol. 107, 2010, pages 4275 - 4280
   TOPALIAN ET AL., N ENGL J MED, vol. 366, 2012, pages 2443 - 2454
   WOLCHOK ET AL., NEJM, 2013, pages 369
   CAS , no. 477202-00-9
   CANCER CELL, vol. 25, 16 June 2014 (2014-06-16), pages 1 - 14
   SCHMID ET AL.: "Proceedings: AACR 103rd Annual Meeting", CANCER RESEARCH, vol. 72, 15 April 2012 (2012-04-15)
   CHEUNG ET AL., APPL. IMMUNOHISTOCHEM. MOL. MORPHOL., vol. 27, no. 10, 2019, pages 699 - 714
   DAVIS ET AL., JOURNAL FOR IMMUNOTHERAPY OF CANCER, vol. 7, 2019
   KIM ET AL., J THORAC. ONCOL., vol. 13, no. 5, 2018, pages 636 - 648
   POWLES ET AL., LANCET, 2020
   PATEL ET AL., LANCET, 2018
   BELLMUNT ET AL., NEJM, 2017
   ROSENBERG ET AL., LANCET, 2016
   ZAJAC, PLOS ONE, 2020
   GALSKY ET AL., CLIN CAN RES, 2020
   VUKY ET AL., JCO, 2020
   BALAR ET AL., LANCET, 2017
The EPO accepts no responsibility for the accuracy of data originating from other authorities; in particular, it does not guarantee that it is complete, up to date or fit for specific purposes.