On May 18, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported that an abstract describing data from a clinical study of its IDO pathway inhibitor, indoximod, in combination with chemotherapeutic agents for patients with newly diagnosed acute myelogenous leukemia (AML), is now available on the website of the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress (Press release, NewLink Genetics, MAY 18, 2017, View Source [SID1234519222]). Schedule your 30 min Free 1stOncology Demo! An infographic accompanying this announcement is available at View Source
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"These data to be presented at the EHA (Free EHA Whitepaper) Congress further highlight clinical results presented at AACR (Free AACR Whitepaper) in April and to be presented at ASCO (Free ASCO Whitepaper) in June, supporting the hypothesis that the IDO pathway is central to immune suppression in cancer," said Charles J. Link, Jr., M.D., Chief Executive Officer and Chief Scientific Officer. "NewLink Genetics has two separate and distinct types of IDO pathway inhibitors in clinical development. Indoximod, which is wholly owned by NewLink Genetics, has a proposed differentiated mechanism within the IDO pathway and acts as a tryptophan mimetic having a direct effect on immune cells to reverse immune suppression used by cancer to protect itself."
Indoximod in combination with chemotherapeutic agents
Initial results from the Phase 1b portion of a Phase 1b/randomized Phase 2a trial of indoximod in combination with chemotherapeutic agents, idarubicin and cytarabine, for patients with newly diagnosed AML will be presented as an e-poster (Abstract number E-912) by Ashkan Emadi, M.D., Ph.D., Associate Professor of the University of Maryland Greenebaum Comprehensive Cancer Center, at EHA (Free EHA Whitepaper) in Madrid on Friday, June 23, 2017, 9:30 AM to Saturday, June 24, 7:00 PM CET and is titled: Indoximod in Combination with Idarubicin and Cytarabine for Upfront Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia (AML): Phase 1 Report.
This study uses a conventional remission induction and consolidation protocol for patients with newly diagnosed AML. Indoximod is given orally starting on day 8 of induction onward. The Phase 1 portion evaluated three dose levels of indoximod (600 mg, 1000 mg, 1200 mg) in combination with the standard of care 7+3 chemotherapy. Twelve patients were enrolled, as of March 1, 2017. The results indicate indoximod does not appear to add significant toxicity to standard remission induction and consolidation therapy for patients with newly diagnosed AML. Initial data suggest a low rate of minimal residual disease (MRD-neg) after one cycle of induction chemotherapy.
Nicholas N. Vahanian, M.D., President and Chief Medical Officer added, "Importantly, these data support further clinical investigation of our IDO pathway inhibitors in combination with currently available therapies, such as chemotherapy for patients with newly diagnosed Acute Myeloid Leukemia (AML)."
Key findings presented from the study include:
Combination treatment with indoximod and conventional remission induction and consolidation therapy was well tolerated without adding significant toxicity
Five of 6 (83%) evaluable patients treated with indoximod (600 mg or 1000 mg) achieved complete remission, with no evidence of minimal residual disease
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape.
NewLink Genetics is currently evaluating indoximod in multiple combination studies for patients with various types of cancer including melanoma, acute myeloid leukemia, pancreatic cancer and prostate cancer.