Cogent Biosciences, Inc. · NASDAQ:COGT
Cogent Biosciences — American Society of Hematology Annual Meeting 2022
22 slides from Cogent Biosciences's conference presentation, Dec 12, 2022
Slide 1: Updated Clinical Data from Apex Phase 2 Study of Bezuclastinib in Advanced Systemic Mastocytosis
Exhibit 99.2 Updated Clinical Data from Apex Phase 2 Study of Bezuclastinib in Advanced Systemic Mastocytosis Investor Webcast December 12, 2022 Presented at American Society of Hematology Conference December 11, 2022
Slide 2: Forward-looking statements
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 from those expressed or implied by such fo
Slide 3: Presentation Summary
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 Introduction & Corporate Overview Review of Updated APEX Data
Slide 4: Corporate highlights and cash runway
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 2025; $289.1 million as of September 30, 2022 4
Slide 5: Advanced systemic mastocytosis disease overview and unmet need
Neurological Headache, brain fog, Disease Overview: Aggressive and life-threatening cognitive dysfunction, anxiety, depression form of systemic mastocytosis (SM) that is primarily driven by KIT D816V mutation and leads to Systemic 1,2 uncontrolled proliferation of mast cells (MC) Anaphylaxis • Subty
Slide 6: Systemic mastocytosis estimated prevalence
1 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- 1 90% of all cases of SM tolerated treatment options for this patient population AdvSM 1 Coltoff A, Mascarenhas J., 2019. 6
Slide 7: Bezuclastinib kinase inhibition profile
• Oral, selective, and 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 1 • Spares closely related kinases, has minimal brain penetration, and favora
Slide 8: Preliminary Safety and Efficacy from Apex Phase 2 Study of Bezuclastinib
Preliminary Safety and Efficacy from Apex, a Phase 2 Study of Bezuclastinib (CGT9486), a Novel, Highly Selective, Potent KIT D816V Tyrosine Kinase Inhibitor, in Adults with Advanced Systemic Mastocytosis (AdvSM) 1 2 3 Daniel J. DeAngelo , MD, PhD; Vinod Pullarkat , MD, MRCP; Miguel Piris-Villaespesa
Slide 9: Apex study endpoints
Primary Endpoint • Dose Optimization: Incidence of AEs/SAEs, laboratory changes, PK, biomarkers, ORR • Expansion: ORR (confirmed CR, CRh, PR and CI) per mIWG-MRT-ECNM and assessed by Central Response Review Committee Other Endpoints • Safety/Tolerability: Incidence of AEs leading to dose modificatio
Slide 10: Patient demographics and baseline characteristics
• 16 patients enrolled; median age: 69 years; Range: 33-87 Total 50mg BID 100mg BID 200mg BID 400mg QD (N=16) (N=4) (N=3) (N=4) (N=5) Male, n (%) 13 (81) 3 (75) 3 (100) 3 (75) 4 (80) ECOG PS 0-1, n (%) 14 (88) 4 (100) 3 (100) 4 (100) 3 (60) AdvSM Subtype per Central Eligibility Review, n (%) ASM 3 (
Slide 11: Treatment related adverse events
Treatment Related Adverse Events in > 10% Patients and all Related SAEs ‡ TKI Prior ‡ Therapy TKI Total Naïve Exposure 50 mg BID 100 mg BID 200 mg BID 400 mg QD (n=16) (n=13) (n=3) (n=4) (n=3) (n=4) (n=5) Preferred Term All grade Grade ≥3 All grade All grade All grade All grade All grade All grade H
Slide 12: Platelet count requirement and patient data
9 All patients in Apex were required to have platelet count ≥50 x 10 /L for 2 weeks prior to the first dose of study drug *Two patients excluded: (1) due to presence of essential thrombocythemia at baseline; (1) no post-baseline assessment Data as of: 26Oct2022 DeAngelo D,. et al. American Society o
Slide 13: Reductions in serum tryptase, mast cell burden and KIT D816V VAF
– Serum Tryptase • 88% of patients achieved a ≥ 50% reduction • 85% median reduction • 50% achieved levels <20 ng/mL – Bone Marrow MC Burden • 100% of patients with at least 2 cycles of treatment achieved a ≥ 50% reduction a Three patients excluded: no post-baseline assessment available • 77% achiev
Slide 14: Response evaluable populations
Part 1 Dose Optimization (n=16) • Patients inevaluable (n=2) • n=1 no measurable C-finding at baseline • n=1 received confounding concomitant medication mIWG-MRT-ECNM response evaluable population (n=14) • Patients excluded (n=3) • n=2 off study prior to first response timepoint • n=1 ongoing; has n
Slide 15: Response criteria
Response mIWG-MRT-ECNM Response Criteria* Pure Pathological Response Criteria Assessment ✓ Absence of neoplastic MC aggregates in bone ✓ Absence of neoplastic MC aggregates marrow in bone marrow ✓ Serum tryptase ≤ 20 ng/mL✓ Serum tryptase < 20 ng/mL Complete Remission (CR) ✓ Remission of peripheral
Slide 16: Best response per mIWG-MRT-ECNM
mIWG-MRT-ECNM mIWG-MRT-ECNM per CRRC β Best Response, n (%) * Total per CRRC Assessment Assessment ‡ ‡ (confirmed and unconfirmed) (n=11) (TKI Therapy Naïve) (Prior TKI Exposure) (n=9) (n=2) *3 patients pending confirmation Overall response rate of response are included: (2) PR; (1) CR in patients d
Slide 17: Patient response durations and notes
1 a Prior avapritinib and midostaurin. Discontinued due to disease progression b Discontinued after 2 doses of study treatment due to investigator decision (femur fracture) Includes confirmed and unconfirmed responses Data as of: 26Oct2022 17 DeAngelo D,. et al. American Society of Hematology (ASH)
Slide 18: Data as of 26Oct2022
Data as of: 26Oct2022 DeAngelo D,. et al. American Society of Hematology (ASH) 2022 Annual Meeting; New Orleans, LA, 11 Oct 2022: 18 Publication Number: 626
Slide 19: Summary of Apex results
• The highly potent and selective TKI bezuclastinib was generally well-tolerated across all dose levels and continues to demonstrate a differentiated safety profile – No related cognitive effects or bleeding events reported – Limited effect of bezuclastinib on platelet counts in patients, supported
Slide 20: Corporate highlights and cash runway
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 2025; $289.1 million as of September 30, 2022 20
Slide 21: Q&A
Q&A BIOSCIENCES ‘cogent
Slide 22: Thank You
cogent THANK YOU Real Challenges. Real Solutions. Precision therapies for genetically defined diseases
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