Cullinan Therapeutics, Inc. · NASDAQ:CGEM
Cullinan Therapeutics — Technical Presentation (September 2025)
14 slides from Cullinan Therapeutics's technical presentation, September 2025
Slide 1: Phase 1/2a Study of CLN-081 in NSCLC Patients with EGFR Exon 20 Insertion Mutations
Phase1/2a Study of CLN-081 in NSCLC Patients with EGFR Exon 20 Insertion (ex20ins) Mutations Helena Yu1, Daniel Shao-Weng Tan2, Egbert F. Smit3, Alexander I. Spira4, Ross A. Soo5, Danny Nguyen6, Victor Ho-FunLee7, James Chih-Hsin Yang8, Vamsidhar Velcheti9, John M. Wrangle10, Mark A. Socinski11, Mar
Slide 2: EGFR exon 20 insertion (ex20ins) mutations in NSCLC
EGFR exon 20 insertion (ex20ins) mutations in NSCLC ~2-3% of all non-small cell Patients with ex20ins have Agents targeting EGFR Toxicities related to lung cancer (NSCLC) poorer outcomes than those ex20ins mutations have inhibition of wild-type cases harbor EGFR ex20ins with more common EGFR been re
Slide 3: CLN-081: A selective EGFR inhibitor for NSCLC patients with exon 20 insertion mutations
CLN-081: A selective EGFR inhibitor for NSCLC patients with exon 20 insertion mutations Select CLN-081 pre-clinical data CLN-081 CLN-081 LXF2478 PDX model for lung cancer harboring EGFR V769_D770INSASV • CLN-081 (TAS6417) is a novel, irreversible, oral EGFR inhibitor with a unique pyrrolopyrimidine
Slide 4: Phase 1/2a Study Design (NCT04036682)
CLN-081-001: Phase 1/2a Study Design (NCT04036682) KEY ELIGIBILITY STUDY SCHEMA • Confirmed recurrent or metastatic NSCLC with documented EGFR ex20ins mutation demonstrated by local laboratory • Prior treatment in the recurrent/metastatic setting including a platinum-based chemotherapy regimen unles
Slide 5: CLN-081-001: Patient Disposition
CLN-081-001: Patient Disposition P AT I E N T E N R O L L M E N T ( To t a l N = 7 3 ) • Data cut-off 9 May 2022 Dose (BID) Accelerated Titration Rolling 6 Phase 1 Expansion Phase 2a Expansion • 73 patients enrolled across doses 30 mg N=2 N=6 ranging from 30 to 150 mg BID • Enrollment at 150 mg BID
Slide 6: Baseline characteristics of enrolled patients
Baseline characteristics of enrolled patients CHARACTERISTIC ALL PATIENTS (N=73) Median age (range) 64 (36-82) • Heavily pre-treated patients Female 41 (56%) • 66% of patients with ≥2 ECOG PS (0, 1) 22 (30%), 51(70%) prior lines of treatment Number of prior systemic anticancer regimens1 • Prior EGFR
Slide 7: Treatment-Related Adverse Events Occurring in ≥10% of Patients
Treatment-Related Adverse Events Occurring in ≥10% of Patients Dose BID ≤65 mg (N = 23) 100 mg (N = 39) 150 mg (N = 11) Overall (N = 73) • Most AEs Grade 1/2 AE Term, n (%) All grade1 Grade ≥ 𝟑𝟑 All grade Grade ≥ 𝟑𝟑 All grade Grade ≥ 𝟑𝟑 All grade Grade ≥3 Rash 19 (83) 0 32 (82) 0 7 (64) 1 (9)…
Slide 8: Pharmacokinetic (PK) profile consistent with clinical observations
Pharmacokinetic (PK) profile consistent with clinical observations AV E R A G E U N B O U N D P L A S M A C O N C E N T R AT I O N O V E R T I M E * • Sustained PK exposure over 1000 GI50 for ex20ins EGFR for 8h post dose GI50 -WT EGFR • Limited time of exposure over GI50 for WT EGFR 100 at doses <
Slide 9: Best percentage change from baseline in target lesion dimensions and confirmed response by dose level
CLN-081-001: Best percentage change from baseline in target lesion dimensions and confirmed response by dose level ≤65 mg BID 100 mg BID 150 mg BID Overall N (%) N = 23 N = 39 N = 11 N = 73 1Confirmed PR, n (%) 8 (35%) 16 (41%) 4 (36.4%) 28 (38.4%) SD 14 (60.9%) 22 (56.4%) 6 (54.5%) 42 (57.5%) PD 1
Slide 10: Time on treatment and activity, all patients by dose level
CLN-081-001: Time on treatment and activity, all patients by dose level Median time on study = 11 months 150 mg Median time to response = 1.5 months RECIST Response Stable Disease Confirmed Partial Response (PR) Progressive Disease (PD) 100 mg Time to PR (Confirmed) Time to PD Ongoing Treatment 65 m
Slide 11: Progression-Free Survival (PFS) by dose level
CLN-081-001: Progression-Free Survival (PFS) by dose level Kaplan-Meier Estimates of Progression-Free Survival ≤65 mg BID 100 mg BID 150 mg BID Overall N = 23 N = 39 N = 11 N = 73 Dose Level mPFS, months [95% CI] 8 [5-13] 12 [5, NC] 8 [1,10] 10 [6,12] mPFS = median progression-free survival; CI = co
Slide 12: Intracranial response observed in a patient with CNS target lesion at baseline
Intracranial response observed in a patient with CNS target lesion at baseline • 3 patients entered the study with CNS target lesions at baseline:1 • Patient #1 achieved both an intracranial and systemic response at cycle 6 and remains in PR at cycle 16 (images at left) • Patient #2 continues on tre
Slide 13: Conclusions
Conclusions Safety Efficacy Summary Safety profile amenable for long-term Objective responses observed in Enrollment to the phase 2b portion treatment at doses <150 mg BID heavily pre-treated patients, of the study is planned for 2H 2022 • Most adverse events Grade 1/2 including patients who progres
Slide 14: Acknowledgements
Acknowledgements • The Sponsor wishes to thanks all the patients and their families for participation in this study, as well as investigators and staff at participating institutions for their support in executing this study • This trial was sponsored by Cullinan Pearl Corporation, a Cullinan Oncolog
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