Syndax Pharmaceuticals, Inc. · NASDAQ:SNDX
Syndax Pharmaceuticals — Investor Presentation (October 2019)
25 slides from Syndax Pharmaceuticals's investor presentation, Oct 7, 2019
Slide 1: Corporate presentation | October 2019
Corporate presentation | October 2019 Determined to realize a future in which people with cancer live longer and better than ever before
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: Syndax Current Pipeline
Syndax Current Pipeline Entinostat Class I HDAC inhibitor Preclin. Phase I Phase II Phase III Indication(s) Sponsor HR+, HER2- mBC NCI/Syndax NSCLC Syndax Melanoma Syndax SNDX-6352 CSF-1R mAB Preclin. Phase I Phase II Phase III Indication(s) Sponsor Chronic GVHD Syndax SNDX-5613 Menin inhibitor Prec
Slide 4: 2019: Portfolio prioritization to drive value
Oral, Class I HDAC in HR+ mBC Positive OS data possible 2Q20 NDA filing anticipated 2H20 Efficacy in CDK4,6 treated patients Blockbuster potential 2019: Portfolio prioritization to drive value HR+ mBC – hormone receptor positive metastatic breast cancer; MLL – mixed lineage leukemia; AML – acute mye
Slide 5: Entinostat Breast Cancer
SNDX-5613 Menin inhibitor Leukemias Entinostat Breast Cancer Immuno- oncology New molecules Oncology SNDX-6352 anti-CSF1R Ab Immuno- oncology GvHD Immuno- oncology
Slide 6: Entinostat re-sensitizes cancer cells
Entinostat re-sensitizes cancer cells ERα+ Breast Cancer Acquires Hormone Resistance estrogen dependent estrogen drives tumor growth sensitive to hormone therapy acquired resistance to hormone therapy ERa+ breast cancer cell + entinostat estrogen independent growth factors drive tumor growth resista
Slide 7: Phase 2 trial resulted in breakthrough therapy designation
Phase 2 trial resulted in breakthrough therapy designation Overall Survival EE = exemestane plus entinostat EP = exemestane plus placebo Placebo 0/0 1/3 5/18 8/35 12/47 13/60 4/66 Entinostat 0/1 2/9 3/21 9/43 4/49 5/55 4/64 EE: median OS 28.1 months EP: median OS 19.8 months Hazard Ratio 0.59 (95% C
Slide 8: Phase 3 E2112: Focused on overall survival
Phase 3 E2112: Focused on overall survival 4Q18: Accrual completed (n=608), PFS and interim OS analyses shared 4Q19: Passed final interim OS futility 2Q20: Final OS analysis Expect to file NDA ~6 months after positive OS data E2112 Trial Milestones E2112: Exemestane +/- entinostat Randomized, blinde
Slide 9: Blockbuster potential as 2nd/3rd line agent
Source: DataMonitor 2016 Breast cancer: HR+/HER2- Disease Coverage Report Blockbuster potential as 2nd/3rd line agent Anastrozole or letrazole +/- CDK4,6 inhibitor Capecitabine, gemcitabine, eribulin Leading treatment options – HR+, HER2- advanced breast cancer 1st line hormone Tx Anastrazole, Faslo
Slide 10: SNDX-5613 Menin inhibitor Leukemias
SNDX-5613 Menin inhibitor Leukemias Entinostat Breast Cancer Immuno- oncology New molecules Oncology SNDX-6352 anti-CSF1R Ab Immuno- oncology GvHD
Slide 11: SNDX-5613 targets novel fusion protein
Strong target validation Precise patient selection Big effect in small studies Molecular markers of disease status Rapid regulatory path Advantages SNDX-5613 targets novel fusion protein: fusion proteins proven to be good candidates for targeted therapies BCR-ABL NTRK Fusions EML4-ALK RET Fusions LO
Slide 12: Menin is a scaffold protein involved in gene transcription
MLL1 fusion partner recruits oncogenic factors to transcription site1 Menin is a scaffold protein involved in gene transcription MLL1 N-terminus binds w/in conserved pocket on Menin MLL1 Transformations Menin In MLLr, leukemic transformation is highly dependent on the Menin-MLL interaction Inhibitor
Slide 13: Binding of Menin to MLL1 leads to HOX upregulation and leukemia
Binding of Menin to MLL1 leads to upregulation of HOX gene transcription and leukemia in MLLr AML and MLLr ALL Adopted from: Uckelmann HJ, et al. Presented at ASH Annual Meeting, 2018. MLLr AML or MLLr ALL Inhibition with SNDX-5613 Menin ON Leukemia Differentiation OFF SNDX-5613 HOX MLL1 Fusion Meni
Slide 14: SNDX-469 shows single agent treatment benefit in multiple models
SNDX-469 shows profound, single agent treatment benefit in multiple models Menin-MLL inhibition significantly prolongs survival in MLLr xenograft models MLLr Cell Line Xenograft (MV4;11) (SNDX-469) Patient Derived Xenograft (PDX) MLL-AF4 (SNDX-469) 28d Tx (28d) 0 20 40 60 0 20 40 60 80 100 Treatment
Slide 15: SNDX-5613 potentially effective in MLLr ALL
SNDX-5613 potentially effective in MLLr – ALL; distinct molecular subtype of ALL conferring a worse prognosis Pediatric ALL: 75%-90% MLLr ALL: ~50% for infants and ~60% >1 yr Adopted from: Shah, B. and Nasello, D. Jan 2019; NCCN conference and meetings: Update on Management of Acute Lymphoblastic Le
Slide 16: SNDX-5613 poised to target MLLr and NPM1 classes of AML
SNDX-5613 poised to target MLLr and NPM1 classes of AML; distinct subsets representing ~34% of AML Adopted from: Dohner, H. et al. Blood, 2017; 129(4):424-447 MLLr AML (4 - 10% AML) ~3,000 patients / year NPM1 AML (30% AML) ~20,000 patients / year WW Incidence AML 5 yr survival 5% - 55%
Slide 17: NPM1 mice showed survival benefit with SNDX-469 in PDX models
NPM1 transfected mice showed profound single agent survival benefit with SNDX-469 in multiple PDX models NPM1c; FLT3 ITD; PHF6 mice (treated with SNDX-469 or vehicle) Preclinical models of NPM1 AML reveal profound single agent activity of Menin inhibition NPM1 mutation is the most frequent molecular
Slide 18: SNDX-5613: potential best-in-class, targeted, oral agent
PEDS ADULTS SNDX-5613: potential best-in-class, targeted, oral agent with single agent activity and fast to market potential MLLr ALL NPM1 AML MLLr AML Phase 1/2 trial population: MLLr adult, MLLr peds, NPM1 mut AML IND cleared; AUGMENT program init. Initial data expected in 2020 MLLr and NPM1 ident
Slide 19: AUGMENT clinical program
AUGMENT clinical program: testing oral Menin inhibitor, SNDX-5613, in patients with acute leukemia Adult NPM1 mut AML Adult MLL-r ALL Adult MLL-r AML Enrolling R/R acute leukemias* Accel. titration into 3+3 design 28 day cycle Primary endpoint: CR Rate (CR + CRh^) * Unselected population; ^ CR = Com
Slide 20: SNDX-6352 anti-CSF1R Ab
SNDX-5613 Menin inhibitor Leukemias Entinostat Breast Cancer Immuno- oncology New molecules Oncology SNDX-6352 anti-CSF1R Ab Immuno- oncology GvHD
Slide 21: Update on SNDX-6352: pursuing novel indication
Update on SNDX-6352: pursuing novel indication High affinity, IgG4 (KD = 4-8 pM) Chronic graft versus host disease (cGVHD) study initiated Expect phase 1 dose escalation results in 2H20 Ascending dose trials: Identified RP2D in combo with IMFINZI® (durvalumab, AZ) Monotherapy (solid tumors) ongoing
Slide 22: 2Q 2019 financial highlights and 3Q, full-year 2019 guidance
Ticker SNDX (NASDAQ) As of June 30, 2019 Cash and short-term investments $98.4 million $80.5 million Shares Outstanding* 22.7 million 31.6 million 2019 3Q and full year Operating Expense Guidance 3Q 2019 2019 Research and Development $11 – 12 M $45 - 47 M Total Operating Expenses^ $15 – 16 M $60 – 6
Slide 23: Key upcoming milestones
ENTINOSTAT (Class 1 specific HDAC inhibitor) 4Q19 1Q20 2Q20 2H20 E2112 – Final OS analysis expected Key upcoming milestones SNDX-6352 (anti-CSF-1R mAB) 4Q19 1Q20 2Q20 2H20 Results from Phase 1 chronic GVHD trial SNDX-5613 (Menin inhibitor) 4Q19 1Q20 2Q20 2H20 Results from phase 1 portion of AUGMENT
Slide 24: 2019: Portfolio prioritization to drive value
Oral, Class I HDAC in HR+ mBC Positive OS data possible 2Q20 NDA filing anticipated 2H20 Efficacy in CDK4,6 treated patients Blockbuster potential 2019: Portfolio prioritization to drive value HR+ mBC – hormone receptor positive metastatic breast cancer; MLL – mixed lineage leukemia; AML – acute mye
Slide 25: Thank you. Questions?
Thank you. Questions?
Syndax Pharmaceuticals — Investor Presentation (October 2019) on 6ix