Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Conference Presentation (November 2024)
15 slides from Syndax Pharmaceuticals's conference presentation, Nov 12, 2024
Slide 1: Revumenib AUGMENT-101 Pivotal Data in R/R mNPM1 AML
Revumenib AUGMENT-101 Pivotal Data in R/R mNPM1 AML November 12, 2024
Slide 2: Forward-looking statements disclosure
Forward-looking statements disclosure This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referenci
Slide 3: Agenda
Agenda Introduction 1 Michael Metzger, Chief Executive Officer, Syndax Topline Pivotal R/R mNPM1 AML Data from AUGMENT-101 Trial 2 Neil Gallagher, MD, PhD, President, Head of R&D, Syndax Clinical Perspective 3 Eytan Stein, MD, Chief, Leukemia Service, Memorial Sloan Kettering Cancer Center Commercia
Slide 4: Revumenib has practice-changing potential in R/R mNPM1 and KMT2Ar acute leukemias
Revumenib xxx has practice-changing potential in R/R mNPM1 and KMT2Ar Response acute leukemias Met the primary endpoint in pivotal AUGMENT-101 cohort enrolling patients with NPM1 mutations MRD-negative Durability • Robust remission rates in heavily pre-treated population Patient • Remissions were no
Slide 5: ~30% of AML patients have NPM1 mutations
There is an urgent need for new treatment options for R/R mNPM1 AML patients mNPM1 AML DISEASE BACKGROUND NPM1 mutations are the most common genetic alterations in AML ~30% of AML patients have NPM1 mutations On average, mNPM1 patients are older, and less fit for HSCT than KMT2Ar patients R/R mNPM1
Slide 6: Revumenib disrupts leukemic transcriptional programs by binding to menin and displacing the KMT2A protein
Revumenib disrupts leukemic transcriptional programs by binding to menin and displacing the KMT2A protein KMT2Ar or mNPM1 acute leukemias Menin inhibition with revumenib Revumenib Menin KMT2A* KMT2A* Menin HOX OFF Menin HOX KMT2A* Leukemia MEIS OFF Differentiation MEIS * KMT2A = KMT2A rearrangement
Slide 7: AUGMENT-101: A Phase 1/2 trial of revumenib monotherapy in R/R mNPM1 and KMT2Ar acute leukemia
AUGMENT-101: A Phase 1/2 trial of revumenib monotherapy in R/R mNPM1 and KMT2Ar acute leukemia Phase 1 Phase 2 Dose Escalation Pivotal Trials KMT2Ar KMT2Ar ALL Data formed the basis for R/R KMT2Ar acute leukemia NDA that is currently under Adult and pediatric KMT2Ar AML review by the FDA patients wi
Slide 8: AUGMENT-101 baseline characteristics in Phase 2 cohort of patients with R/R mNPM1 AML
AUGMENT-101 baseline characteristics in Phase 2 cohort of patients with R/R mNPM1 AML Adult Efficacy Evaluable Safety Population Baseline Characteristics Population N = 84 N = 64 Age, years, median (range) 65 (19, 84) 63 (11, 84) ≥ 18 to <65, n (%) 31 (48) 42 (50) Patients were significantly older t
Slide 9: Revumenib demonstrated compelling efficacy in R/R mNPM1 AML patients in Ph 2 portion of AUGMENT-101
Revumenib demonstrated compelling efficacy in R/R mNPM1 AML patients in Ph 2 portion of AUGMENT-101 Adult Efficacy Evaluable Population Best Response, n (%) N = 64 CR/CRh 15 (23%) (95% Conf. interval); one-sided p-value (14%, 36%); 0.0014 ~50% of patients achieved an CR 12 (19%) overall response in
Slide 10: Safety results from Phase 2 R/R mNPM1 AML cohort in the AUGMENT-101 trial
Safety results from Phase 2 R/R mNPM1 AML cohort in the AUGMENT-101 trial support favorable revumenib safety and tolerability profile Grade ≥3 Treatment-Related Adverse Safety Population Events [TRAEs] (≥5% of patients) N = 84 Patients with Grade ≥3 TRAE 50 (60%) • Safety results in this older, heav
Slide 11: Clinical goals for patients with R/R acute leukemia
Clinical goals for patients with R/R acute leukemia Clinical perspective from Dr. Eytan Stein, MD, Chief, Leukemia Service, Memorial Sloan Kettering Cancer Center Defined by: 1 Eliminate leukemia • Morphologic CR (<5% blasts) may include CR/CRh/CRp/CRi and MLFS Transplant eligible? • MRD negative CR
Slide 12: Revumenib profile supports potential use as backbone therapy across treatment continuum
Revumenib profile supports potential use as backbone therapy across treatment continuum — providing access to >$4B U.S. market opportunity Significant growth potential in earlier lines of treatment ~ $2B market > $4B market Market Opportunity ($ B) ~ $1B market ~ $.75 - $1.25B market ~ $.75B market
Slide 13: Expected upcoming milestones
REVUMENIB Menin-KMT2A inhibition • Present acute leukemia data at ASH 2024 • PDUFA action date of December 26, 2024, in R/R KMT2Ar acute leukemia, followed by immediate launch • Initiate pivotal combination trial with ven/aza in newly diagnosed mNPM1 AML or KMT2Ar acute leukemias by YE24 Expected •
Slide 14: Determined to realize a future in which people with cancer live longer and better
Determined to realize a future in which people with cancer live longer and better than ever before. 14
Slide 15: Slide 15
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