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Syndax >>> Syndax Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Clinical and Business Update November 15 , 2021 - - Initiated pivotal Phase 2 portion of SNDX - 5613 AUGMENT - 101 trial in patients with NPM1 and MLLr acute leukemias - Entered global collaboration with Incyte to develop and commercialize axatilimab for cGVHD and other fibrotic diseases · Updated data from SNDX - 5613 and axatilimab clinical programs to be presented during oral sessions at 63rd ASH Annual Meeting - - Company to host conference call today at 4:30 p.m. ET - WALTHAM , Mass . , Nov. 15 , 2021 / PRNewswire / -- Syndax Pharmaceuticals , Inc. ( " Syndax , " the " Company " or " we " ) ( Nasdaq : SNDX ) , a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies , today reported its financial results for the third quarter ended September 30 , 2021. In addition , the Company provided a clinical and business update . " We are thrilled to announce that the pivotal Phase 2 portion of AUGMENT - 101 , examining SNDX - 5613 across three distinct patient populations , is open and enrolling following a productive meeting with the U.S. Food and Drug Administration ( FDA ) , " said Briggs W. Morrison , M.D. , Chief Executive Officer of Syndax . " Supported by a growing body of data , we firmly believe that SNDX - 5613 is ideally positioned to be first to market and serve as a meaningful intervention for patients with mutant nucleophosmin ( NPM1c ) and mixed lineage leukemia rearranged ( MLLr ) acute leukemias who are deeply in need of effective therapies . We look forward to presenting updated data from the Phase 1 portion of the AUGMENT - 101 trial , including updated durability of CR / CRh responses , during an oral session at the upcoming 63rd American Society of Hematology ( ASH ) Annual Meeting . " " We were also pleased to recently announce our partnership with Incyte for the development and commercialization of axatilimab . This agreement represents a key step forward in our strategy to expand and maximize the program across multiple lines of treatment in chronic graft - versus - host disease ( cGVHD ) as well as additional fibrotic diseases , such as idiopathic pulmonary fibrosis ( IPF ) , where the monocyte - macrophage lineage plays a vital role . As we continue to execute on advancing the program , we look forward to sharing updated data from our Phase 1/2 trial of axatilimab in CGVHD during an oral session at the ASH Annual Meeting next month . " Recent Pipeline Progress and Anticipated Milestones SNDX - 5613 • The Phase 2 portion of AUGMENT - 101 is currently enrolling patients with NPM1c mutant and MLLr relapsed / refractory ( R / R ) acute leukemias . A total of 64 adult and up to 10 pediatric patients will be enrolled across each of the following three distinct trial populations : patients with NPM1 mutant acute myeloid leukemia ( AML ) , patients with MLLr AML , and patients with MLLr acute lymphocytic leukemia . Discussions with the FDA have confirmed that AUGMENT - 101 may potentially serve as the basis for regulatory filings in each of the three distinct trials . The primary endpoint for each of the three trials will be efficacy as measured by complete remission rate ( complete response [ CR ] + CR with partial hematologic recovery rate [ CRh ] ) , with key secondary endpoints including duration of response and overall survival . • In November 2021 , the Company announced that updated data from the Phase 1 portion of the ongoing AUGMENT - 101 trial will be featured during an oral session at the 63rd ASH Annual Meeting being held December 11-14 , 2021. Data included in the abstract demonstrated robust clinical activity with durable responses and no discontinuations due to treatment - related adverse events . The oral presentation will include updated Phase 1 data from additional patients as of a more recent cutoff date , as well as further details on durability and CR / CRh rate by mutational status . • The Company today announced plans to initiate a new trial to assess the anti - leukemic efficacy of SNDX - 5613 in NPM1 or MLLr patients with measurable residual disease ( MRD ) progression following initial treatment . The trial will be conducted as part of the Australian Leukemia and Lymphoma Group ( ALLG ) INTERCEPT Master Clinical Trial , a collaborative clinical trial investigating novel therapies to target early relapse and clonal evolution as pre - emptive therapy in AML . SNDX - 5613 is the first menin inhibitor to be included in the INTERCEPT AML Master Clinical Trial . The Company expects ALLG to initiate the trial in the first half of 2022 . In August 2021 , the Company announced plans to initiate two additional trials to assess the safety , tolerability , and preliminary anti - leukemic efficacy of SNDX - 5613 in combination with venetoclax and azacitidine as part of the Leukemia & Lymphoma Society's BeatⓇ AML Master Clinical Trial , and in combination with chemotherapy in patients with R / R NPM1 or MLLr acute leukemias in the AUGMENT - 102 trial . The Company expects both trials to initiate in the first half of 2022 . Axatilimab • In November 2021 , the Company announced that updated data from its Phase 1/2 trial of axatilimab in patients with CGVHD will be featured during an oral session at the 63rd ASH Annual Meeting . Data included in the abstract demonstrated broad efficacy and tolerability for axatilimab in patients with relapsed or refractory cGVHD . The oral presentation will include additional follow up on all patients enrolled .