Annual Report_Bookmarked_Web_Proof 4.17.19 FINAL
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Annual Report_Bookmarked_Web_Proof 4.17.19 FINAL
u R AONCOLOGYDeveloping Precision Medicines for the Treatment of CancerADVANCING OUR PIPELINE2018 Annual ReportIVe are advancing a pipeline of precisi Annual Report_Bookmarked_Web_Proof 4.17.19 FINALion medicines for the treatment of cancer. Our pipeline consists of small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Our most advance Annual Report_Bookmarked_Web_Proof 4.17.19 FINALd drug candidate is tipifarnib, a farnesyl transferase inhibitor currently in a registration-directed clinical trial in patients with HR AS mutant heaAnnual Report_Bookmarked_Web_Proof 4.17.19 FINAL
d and neck squamous cell carcinoma.ProgramPreclinicalPhase 1Phase 2PivotalKO-947 ERK InhibitorMAPK Pathway TumorsSolid TumorsKO-539 Menin Ml L Inhibitu R AONCOLOGYDeveloping Precision Medicines for the Treatment of CancerADVANCING OUR PIPELINE2018 Annual ReportIVe are advancing a pipeline of precisi Annual Report_Bookmarked_Web_Proof 4.17.19 FINALquamous Cell Carcinomas (LSCC). Spanish Lung Cancer GroupTo Our ShareholdersAt Kura, we're committed to realizing the promise of precision medicines for the treatment of cancer. Approximately one year ago. we took another stop toward achieving that goal with a successful ond-of-Phaso 2 mooting with Annual Report_Bookmarked_Web_Proof 4.17.19 FINALthe U.S. Food & Drug Administration (FDA). Now. a year later. I am very pleased to report that the first registration-directed trial of our lead drugAnnual Report_Bookmarked_Web_Proof 4.17.19 FINAL
candidate, tipifarnib, in patients with HRAS mutant head and neck squamous cell carcinoma (HNSCC) is underway.Our registration-directed trial is desigu R AONCOLOGYDeveloping Precision Medicines for the Treatment of CancerADVANCING OUR PIPELINE2018 Annual ReportIVe are advancing a pipeline of precisi Annual Report_Bookmarked_Web_Proof 4.17.19 FINALke approximately two years to fully enroll. However, according to the statistical assumptions, the trial could be positive as soon as 15 confirmed responses are observed. Based on feedback from the FDA. we believe that the trial, if positive, may be adequate to support a new drug application (NDA) s Annual Report_Bookmarked_Web_Proof 4.17.19 FINALeeking accelerated approval.Meanwhile, we continue to enroll patients in our ongoing Phase 2 trial in HRAS mutant solid tumors, including HNSCC patienAnnual Report_Bookmarked_Web_Proof 4.17.19 FINAL
ts at clinical sites that have yet to open in our registration-directed trial, as well as patients with other squamous cell carcinomas. We look forwaru R AONCOLOGYDeveloping Precision Medicines for the Treatment of CancerADVANCING OUR PIPELINE2018 Annual ReportIVe are advancing a pipeline of precisi Annual Report_Bookmarked_Web_Proof 4.17.19 FINALutant solid tumors, we also made considerable strides over the past year to broaden the potential for tipifarnib, including the validation of CXCL12 as a therapeutic target of tipifamib in peripheral T-cell lymphoma (PTCL) and clinical proof-of-concept in angioimmunoblastic T-cell lymphoma (AITL). a Annual Report_Bookmarked_Web_Proof 4.17.19 FINALn aggressive form of PTCL often characterized by high levels of CXCL12 expression.We continue to bo encouraged by our emerging clinical data in AITL aAnnual Report_Bookmarked_Web_Proof 4.17.19 FINAL
nd CXCL12 high PTCL. and wo believe this represents another potential registrational opportunity for tipifarnib. Wc anticipate providing an update frou R AONCOLOGYDeveloping Precision Medicines for the Treatment of CancerADVANCING OUR PIPELINE2018 Annual ReportIVe are advancing a pipeline of precisi Annual Report_Bookmarked_Web_Proof 4.17.19 FINALin chronic myolomonocytic leukemia (CMML). If successful, wo believe this approach may allow US to extend the potential use of tipifarnib to other myeloid indications, including previously untreated, poor-risk and elderly patients with acute myeloid leukemia (AMI ) as well as other lymphoid indicati Annual Report_Bookmarked_Web_Proof 4.17.19 FINALons such as DI RCl. and CTCI.. In April 2019, woTroy E. Wilson. Ph.D.. J.D.President &■ Chief Executive OfficerIn addition to our efforts in I IRAS muAnnual Report_Bookmarked_Web_Proof 4.17.19 FINAL
tant solid tumors, we also made considerable strides over rhe past year to broaden rhe potential for ripifarnib, including the validation of CXCL12 asu R AONCOLOGYDeveloping Precision Medicines for the Treatment of CancerADVANCING OUR PIPELINE2018 Annual ReportIVe are advancing a pipeline of precisi Annual Report_Bookmarked_Web_Proof 4.17.19 FINALURA ONCOLOGY »01« ANNUAL REPORTMultiple Proof-of-Concept StudiesReinforce Our Precision Medicine ApproachWe have now demonstrated clinical proof-of-concept in multiple indications using biomarker strategies to select for patients most likely to benefit from treatment. In addition to our efforts in r Annual Report_Bookmarked_Web_Proof 4.17.19 FINALelapsed/refractory (R/R) HR AS mutant HNSCC and CXCLI2+ AITL/PTCL, we are working to validate the utility of CXCL12 pathway biomarkers as a strategy fAnnual Report_Bookmarked_Web_Proof 4.17.19 FINAL
or patient enrichment in R/R myeloid tumor indications, such as AML and CMML, other lymphoid malignancies, such as DLBCL and CTCL, and solid tumor indu R AONCOLOGYDeveloping Precision Medicines for the Treatment of CancerADVANCING OUR PIPELINE2018 Annual ReportIVe are advancing a pipeline of precisi Annual Report_Bookmarked_Web_Proof 4.17.19 FINALM KCCQ3CCM -5* KCCCjHR AS MutantHNSCC••••••••••TttittflWu R AONCOLOGYDeveloping Precision Medicines for the Treatment of CancerADVANCING OUR PIPELINE2018 Annual ReportIVe are advancing a pipeline of precisiGọi ngay
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