Page 1

Syndax >> Syndax Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Clinical and Business Update August 9 , 2021 - Intermediate doses selected for Phase 2 portion of AUGMENT - 101 trial of SNDX - 5613 in patients with genetically - defined acute leukemias ; updated results from Phase 1 portion anticipated in 4Q21 - - - Syndax initiating frontline combination of SNDX - 5613 with venetoclax and azacitidine in the BeatⓇ AML Master Clinical Trial - - Enrollment ongoing in global pivotal AGAVE - 201 trial of axatilimab in cGVHD ; updated results from Phase 1/2 trial anticipated in 4Q21 - - Company to host conference call today at 4:30 p.m. ET - WALTHAM , Mass . , Aug. 9 , 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 second quarter ended June 30 , 2021. In addition , the Company provided a clinical and business update . " The second quarter of 2021 was marked by significant progress advancing our pipeline of innovative therapeutics , and we are pleased to share that we have selected a go - forward dose for the pivotal Phase 2 portion of AUGMENT - 101 based on favorable findings from the intermediate dose cohort , " said Briggs W. Morrison , M.D. , Chief Executive Officer of Syndax . " Enrollment in the trial continues , with recently enrolled patients expected to count towards the Phase 2 expansion portion , subject to endorsement of the Phase 2 dose by the U.S. Food and Drug Administration ( FDA ) . We are also excited to announce an important step in our plans to expand development of SNDX - 5613 into earlier lines of therapy with the initiation of the first frontline combination trial of a menin inhibitor in the Leukemia & Lymphoma Society's BeatⓇ AML Master Clinical Trial . " " Beyond SNDX - 5613 , enrollment remains on track in the ongoing global pivotal AGAVE - 201 trial of axatilimab in patients with chronic graft versus host disease ( cGVHD ) , and we continue to expect topline data from the trial in 2023. In addition , as previously announced , we anticipate sharing updated results from the recently completed Phase 1/2 trial of axatilimab in cGVHD later this year and remain committed to unlocking the full potential of axatilimab in the growing number of cGVHD patients lacking effective interventions . " Recent Progress and Anticipated Milestones SNDX - 5613 • In May 2021 , the Company reported updated data from the ongoing Phase 1 dose escalation portion of the Phase 1/2 AUGMENT - 101 trial of SNDX - 5613 , a highly selective oral menin inhibitor , in patients with mixed lineage leukemia rearranged ( MLLr ) and nucleophosmin ( NPM1c ) mutant relapsed / refractory ( R / R ) acute leukemias . The updated May data showed that a total of 7/31 patients ( 23 % ) have achieved CR / CRh . Based on positive findings from the intermediate dose cohort , in which no dose limiting toxicities were observed , the Company has selected 276 mg of SNDX - 5613 every 12 hours in patients who are not receiving a concomitant strong CYP3A4 inhibitor ( Arm A ) and 163 mg every 12 hours for patients who are receiving a concomitant strong CYP3A4 inhibitor ( Arm B ) , for Phase 2. Enrollment in the trial remains ongoing , with recently enrolled patients expected to count towards the Phase 2 expansion portion , subject to endorsement of the Phase 2 dose by the U.S. FDA . • The Company today announced it will initiate a frontline trial of SNDX - 5613 in combination with venetoclax and azacytidine in newly diagnosed acute myeloid leukemia ( AML ) patients unable to tolerate induction chemotherapy . The trial will be conducted as part of the Leukemia & Lymphoma Society's Beat® AML Master Clinical Trial , a collaborative clinical trial that aims to change the paradigm of AML treatment through a precision medicine approach . SNDX - 5613 is the first menin inhibitor to be included in the Beat AML Master Clinical Trial . • The Company also announced today that it plans to initiate a new trial to assess the safety , tolerability , and preliminary anti - leukemic efficacy of SNDX - 5613 in combination with chemotherapy in patients with R / R MLLr or NPM1 acute leukemias . The Phase 1b trial , which will be referred to as AUGMENT - 102 , is expected to enroll up to 27 patients . • In June 2021 , the Company announced that the U.S. FDA granted Fast Track Designation ( FTD ) to SNDX - 5613 for the treatment of adult and pediatric patients with R / R acute leukemias harboring an MLLr or NPM1 mutation . FTD is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need , enabling drugs to reach patients earlier . Axatilimab • In May 2021 , Syndax announced that enrollment is complete in the Phase 2 expansion portion of the Phase 1/2 trial of