Onkure Therapeutics, Inc. · NASDAQ:OKUR
Onkure Therapeutics — San Antonio Breast Cancer Symposium 2024
14 slides from Onkure Therapeutics's conference presentation, Dec 10, 2024
Slide 1: San Antonio Breast Cancer Symposium Investor Call
San Antionio Breast Cancer Symposium Investor Call December 10, 2024 1
Slide 2: Forward-Looking Statements
Legends Forward-Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties of OnKure Therapeutics, Inc. (“OnKure” or the “Company”). All statements other than statements of historical facts contained in this presentation, including state
Slide 3: OKI-219 Clinical Update – PIKture-01
OKI-219 Clinical Update – PIKture-01 • Preliminary safety, tolerability, and pharmacokinetic data from the FIH Trial of OKI-219 − OKI-219 was well tolerated across all doses with no hyperglycemia and only Grade 1 TRAEs reported − No dose interruptions, delays, reductions, or discontinuations were re
Slide 4: Pipeline Updates
Pipeline Updates The aim of OnKure’s discovery engine is to deliver highly selective drug candidates that preserve wild-type PI3Kα while effectively targeting the majority of PI3Kα-mutated cancers • Pan-Mutant Program − Broadened expectations of the next-generation program beyond PI3KαH1047 to targe
Slide 5: Preliminary results from PIKture-01, a First-in-Human Study of OKI-219
Preliminary results from PIKture-01, a First-in-Human Study of OKI-219, a mutant selective inhibitor of PI3KαH1047R, in mutant selected solid tumors including breast cancer Alexander Spira1, Andreas Varkaris2, Seock-Ah Im3, Peter Kabos4, Ramon Yarza5, Yeon Hee Park6, Kevin Litwiler7, Guy Gammon7, Am
Slide 6: PI3K and OKI-219
PI3K and OKI-219 • PI3Kα is one of the most commonly mutated oncogenes, found in approximately 13% of human cancers and 29% of breast cancer • Currently approved PI3Kα inhibitors target both wild-type and mutant forms, leading to significant on-target toxicities, including hyperglycemia, rash, fati
Slide 7: PIKture-01 Study Design
PIKture-01 Study Design • PIKture-01 (OKI-219-101): Phase 1a/b, open-label, multicenter, dose-escalation and expansion study • Evaluate the safety, tolerability, PK, PDx, and efficacy of OKI-219 as monotherapy in advanced PI3KαH1047R-mutated solid tumors and in combination with fulvestrant or trastu
Slide 8: PIKture-01 Study Design
PIKture-01 Study Design As of October 28, 2024 OKI-219 Monotherapy Dose Escalation Metastatic HR+HER2-Breast Dose Optimization Part B Advanced Solid Tumors Cancer 1500 mg* PI3K𝑎H1047R mutation OKI-219 PAD 1 + Fulvestrant PI3KαH1047R mutation (N=20) BOIN Design 1200 mg* OKI-219 + Fulvestrant N = 24…
Slide 9: Demographics
Demographics 300 mg BID 600 mg BID 900 mg BID Total Demographic n=3 n=8 n=6 n = 17 Age, med(range), yr 69(53,69) 67(52,81) 59(46,77) 61(46,81) Female, n(%) 1 (33%) 7 (88%) 6 (100%) 14 (82%) Male, n(%) 2 (67%) 1 (13%) 0 (0%) 3 (18%) ECOG 0, n(%) 0 (0%) 3 (38%) 4 (67%) 7 (41%) ECOG 1, n(%) 3 (100%) 5
Slide 10: Pharmacokinetics: Highly Developable Candidate Profile
Pharmacokinetics: Highly Developable Candidate Profile Steady-State OKI-219 Concentrations Dose Proportionality 30 (Day 15) (Single Dose) • Steady-state OKI-219 Plasma Concentration (µg/mL) AUC 10.0 exposures (900 mg AUClast (hr*µg/mL) 20 BID) show near- 900 mg (n=4) continuous 10 1.0 EC80 coverage
Slide 11: Only Grade 1 TRAEs Observed Across All Dose Levels
Only Grade 1 TRAEs Observed Across All Dose Levels No Hyperglycemia, Stomatitis, or Rash Observed at Any Dose • OKI-219 is well tolerated 300 mg BID 600 mg BID 900 mg BID ALL Pts n=3 n=8 n=6 n=17 across all doses Preferred Term Grade 1 Grade 1 Grade 1 Grade 1 • Adverse events were Diarrhoea 0 (0%) 3
Slide 12: Time on Treatment
Time on Treatment As of October 28, 2024 300 m g 600 m g 900 m g BR HR+/HER2- Patient 1 • 13/14 patients at doses Patient 2 BR HR+/HER2- BR HR+/HER2- ≥600 mg BID remain BR HR+/HER2- on study BR HR+/HER2- Colon BR HR+/HER2- • 2/3 patients at 300 mg Cancer Type BR HR±/HER2+ Colon showed prolonged BR H
Slide 13: Summary
Summary • Data to date supports the continued development of OKI-219 • The fulvestrant combination arm has been initiated (OKI-219 | 600 mg BID) • Mature single agent and initial fulvestrant data expected in 2H-2025 13
Slide 14: San Antonio Breast Cancer Symposium Investor Call
San Antionio Breast Cancer Symposium Investor Call December 10, 2024 14
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