Cogent Biosciences, Inc. · NASDAQ:COGT
Cogent Biosciences — European Hematology Association Congress 2022
24 slides from Cogent Biosciences's conference presentation, Jun 10, 2022
Slide 1: Initial Data from APEX Phase 2 Study of Bezuclastinib in Advanced Systemic Mastocytosis
Exhibit 99.2 Initial Data from APEX Phase 2 Study of Bezuclastinib in Advanced Systemic Mastocytosis Investor Webcast Presented at the European Hematology Association Congress June 10, 2022
Slide 2: Forward Looking Statement and Risk Factors
Forward Looking Statement and Risk Factors This presentation and the accompanying oral commentary contain forward-looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ materially
Slide 3: Webcast Agenda and Speakers
Webcast Agenda and Speakers Andrew Robbins Daniel J. DeAngelo, M.D., Ph.D. Jessica Sachs, M.D. President and Chief Executive Officer Chief of the Division of Leukemia Chief Medical Officer Dana-Farber Cancer Institute Introduction & Corporate Overview Andrew Robbins Review of Initial APEX Data with
Slide 4: Cogent Biosciences: Emerging Leader in Precision Medicines for Genetically Defined Diseases
Cogent Biosciences: Emerging Leader in Precision Medicines for Genetically Defined Diseases Demonstrating differentiated profile as potential best-in-class selective KIT mutant inhibitor Building exciting portfolio of next-generation potent, selective kinase inhibitors Cash runway into 2024; $191.0
Slide 5: Significant Unmet Need Remains for Advanced Systemic Mastocytosis Patients
Significant Unmet Need Remains for Advanced Systemic Mastocytosis Patients Neurological Disease Overview: Aggressive and life-threatening form of Headache, brain fog, cognitive dysfunction, anxiety, depression systemic mastocytosis (SM) that is primarily driven by mutations in KIT D816V and leads to
Slide 6: Large, Yet Not Well Understood Population of SM Patients
Large, Yet Not Well Understood Population of SM Patients 16 Systemic Mastocytosis: Estimated prevalence in the U.S. is 20,000–30,000 patients NonAdvSM Significant unmet medical need Comprises upwards of for clinically active, well-tolerated 1 90% of all cases of SM treatment options for this patient
Slide 7: Bezuclastinib: Highly Selective and Potent KIT D816V Inhibitor
Bezuclastinib: Highly Selective and Potent KIT D816V Inhibitor • Oral, selective, and potent type I tyrosine kinase inhibitor (TKI) with potent activity against KIT D816V, an activation loop mutation • Preclinically, highly active with specificity for mutations in KIT exons 9, 11, 17, and 18, includ
Slide 8: Summary of mIWG-MRT-ECNM Response Thresholds
Summary of mIWG-MRT-ECNM Response Thresholds Response duration Serum Tryptase Mast Cell Peripheral Blood C-Findings Improvement Improvement* Counts must be ≥12 weeks 9 • ANC ≥1×10 /L with Resolution of normal differential No presence of mast palpable CR • Platelet count <20 ng/mL hepatosplenomegaly
Slide 9: A Phase 2 Study of Bezuclastinib in Adults with Advanced Systemic Mastocytosis (APEX)
A Phase 2 Study of Bezuclastinib (CGT9486), A Novel, Highly Selective, Potent KIT D816V Inhibitor, in Adults with Advanced Systemic Mastocytosis (Apex): Methods, Baseline Data, and Early Insights ABSTRACT CODE: P1049 EHA2022 HYBRID CONGRESS | VIENNA, AUSTRIA 10 JUNE 2022
Slide 10: APEX: A Phase 2 Open-Label, Multicenter Clinical Study of Bezuclastinib in AdvSM
APEX: A Phase 2 Open-Label, Multicenter Clinical Study of Bezuclastinib in Patients with Advanced Systemic Mastocytosis PART 2: EXPANSION** KEY ENTRY CRITERIA PART 1: DOSE OPTIMIZATION* N=80 N=60 • Diagnosed with ASM, SM-AHN, or MCL per 50 mg BID AdvSM IWG evaluable (N=60) WHO 2016 100 mg BID Classi
Slide 11: Demography and Baseline Characteristics
Demography and Baseline Characteristics Baseline Characteristics: 11 mIWG-evaluable patients enrolled as of 24-May-2022; median age 70 years (range: 48-87) 50mg BID 100mg BID 200mg BID 400mg QD Total Baseline Characteristics (N=3) (N=3) (N=3) (N=2) (N=11) Male, n (%) 2 (67) 3 (100) 2 (67) 2 (100) 9
Slide 12: Summary of Safety and Tolerability
Summary of Safety and Tolerability • Majority of treatment emergent adverse events (TEAE) were of low-grade with one serious adverse event (SAE) and no Grade 4 events • No periorbital/peripheral edema, cognitive effects or intracranial bleeding reported • No treatment discontinuations; all patients
Slide 13: Bezuclastinib Demonstrated Substantial Serum Tryptase Reductions
Bezuclastinib Demonstrated Substantial Serum Tryptase Reductions Maximum Percent Change in Serum Tryptase from Baseline Summary of Clinical Activity • 11/11 patients experienced a ≥50% reduction in serum tryptase • 89% median reduction in serum tryptase • 6/11 patients achieved a serum tryptase leve
Slide 14: Bezuclastinib Demonstrated Rapid Serum Tryptase Reductions
Bezuclastinib Demonstrated Rapid Serum Tryptase Reductions Time to Serum Tryptase Reduction and Duration on Treatment Summary of Clinical Activity • 10/11 patients achieved ≥50% serum tryptase reduction within first week of treatment • 4 patients achieved <20 ng/mL serum tryptase level during first
Slide 15: Bezuclastinib Demonstrated Impressive Bone Marrow MC Reductions
Bezuclastinib Demonstrated Impressive Bone Marrow MC Reductions Percent Change in Bone Marrow Mast Cell at C3D1 Summary of Clinical Activity • 8/8 patients with ≥2 cycles of treatment and available Cycle 3, Day 1 (C3D1) data achieved ≥50% reduction in bone marrow mast cells • 6/8 patients (C3D1) ach
Slide 16: Bezuclastinib Demonstrated Impressive KIT D816V VAF Reductions
Bezuclastinib Demonstrated Impressive KIT D816V VAF Reductions Percent Change in KIT D816V VAF at C3D1 Summary of Clinical Activity • 8/8 patients (C3D1) demonstrated decreases in KIT D816V variant allele fraction (VAF) by ddPCR A, prior Avapritinib; M, prior midostaurin **Patient discontinued Avapr
Slide 17: Case 1: Robust Clinical Activity in Avapritinib-Intolerant Patient
Case 1: Robust Clinical Activity in Avapritinib-Intolerant Patient Serum Bone Marrow KIT D816V Tryptase Mast Cell VAF • Background: Patient with SM-AHN, prior treatment with midostaurin (progression) and avapritinib (toxicity: Grade 3 thrombocytopenia and anemia) • Baseline labs: serum tryptase 1578
Slide 18: Case 2: Rapid and Durable Clinical Activity for ASM Patient
Case 2: Rapid and Durable Clinical Activity for ASM Patient >4 months • Background: Patient with ASM, no prior TKI exposure • Baseline tryptase 370 ng/mL, baseline MC burden 80%, C-finding: spleen >5 cm below left coastal margin • Randomized to 400 mg QD • Safety: Hypersensitivity (mediator flare) o
Slide 19: Bezuclastinib has Potential to Provide Meaningful Clinical Benefit
Bezuclastinib has Potential to Provide Meaningful Clinical Benefit • Bezuclastinib is a highly potent and selective tyrosine kinase inhibitor that targets the KIT D816V mutation, the primary driver of systemic mastocytosis • Bezuclastinib was generally well-tolerated across all dose levels o Majorit
Slide 20: Investor Webcast Summary
Investor Webcast Summary CogentBio.com Cogent Biosciences, Inc. | 200 Cambridge Park Drive Suite 2500 | Cambridge, MA 02140 USA
Slide 21: Cogent Biosciences: Emerging Leader in Precision Medicines for Genetically Defined Diseases
Cogent Biosciences: Emerging Leader in Precision Medicines for Genetically Defined Diseases Demonstrating Demonstrating differentiated profile as differentiated profile as potential best-in-class potential best-in-class selective KIT mutant selective KIT mutant inhibitor inhibitor Building exciting
Slide 22: Questions & Answers
Questions & Answers CogentBio.com Cogent Biosciences, Inc. | 200 Cambridge Park Drive Suite 2500 | Cambridge, MA 02140 USA
Slide 23: Appendix
Appendix CogentBio.com Cogent Biosciences, Inc. | 200 Cambridge Park Drive Suite 2500 | Cambridge, MA 02140 USA
Slide 24: References + Disclosures
References + Disclosures References: 1. Garcia-Montero AC, et al. Blood. 2006;108(7):2366-72 2. Jara-Acevedo M, et al. Mod Pathol. 2015;28(8):1138-49 3. Vaes M, et al. Front Med (Lausanne). 2017;4:110 4. Pardanani A. Am J Hematol. 2019;94(3):363-77 5. Gotlib J, et al. J Natl Compr Canc Netw. 2018;16
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