Starpharma Holdings Limited · ASX:SPL
Starpharma — ASCO 2024 Annual Meeting
15 slides from Starpharma's conference presentation, Jun 3, 2024
Slide 1: DEP cabazitaxel presentation at ASCO 2024 Annual Meeting
ASX Announcement DEP® cabazitaxel presentation at ASCO 2024 Annual Meeting Melbourne, Australia; 3 June 2024: Starpharma (ASX: SPL, OTCQX: SPHRY) today provides a copy of the DEP® cabazitaxel presentation that was delivered at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in C
Slide 2: About Starpharma
About Starpharma Starpharma (ASX: SPL, OTCQX: SPHRY) is dedicated to helping patients with significant illnesses, such as cancer, achieve improved health outcomes and quality of life through the application of our unique dendrimer technology. Dendrimers are precise, synthetically manufactured, nanos
Slide 3: Efficacy and safety of dendrimer-enhanced cabazitaxel in advanced solid cancers
For personal use only Efficacy and safety of dendrimer-enhanced cabazitaxel (DEP CTX) in patients with advanced solid cancers; a Phase 1/2 trial James Spicer1, David J. Pinato2, Martin D. Forster3, Anthony M. Joshua4, James Korolewicz5, Karam Aboud6, Cienne Morton1, Jia Liu4, Rasha Cosman4, Nicola J
Slide 4: Dendrimer nanoparticle delivery of cabazitaxel (DEP CTX)
Dendrimer nanoparticle delivery of cabazitaxel (DEP CTX) For personal use only • 3D lysine polymer provides a scaffold for targeting payloads including cytotoxics to tumor microenvironment • Cabazitaxel is a taxane approved for treatment of prostate cancer • We conducted a Phase 1/2 trial of DEP CTX
Slide 5: Dendrimer platform
Dendrimer platform1 DEP CTX designed to improve safety and efficacy of cytotoxic payload For personal use only • Branched poly-lysine polymer DEP dendrimer (1:1 ratio CTX:PEG) • Scalable, precise manufacturing in concentric layers ▪ 5 generations, 64 attachment points per dendrimer Hydrolysable • Co
Slide 6: Preclinical selective delivery and anti-tumor activity
Preclinical selective delivery and anti-tumor activity Size-dependent tumor Tumor accumulation DEP CTX enhanced efficacy: xenograft model For personal use only accumulation1,2 PET-CT image DEP dendrimer-drug conjugate saline S-CTX (9 mg/kg) S-CTX (11 mg/kg) DEP CTX (9 mg/kg) 89Zr-labelled DEP CTX DU
Slide 7: Dendrimer cabazitaxel Phase 1/2 trial
Dendrimer cabazitaxel Phase 1/2 trial • Phase 1 - primary objective: safety profile; MTD & DLTs; secondary objectives: preliminary efficacy, PK • Single patient cohorts, followed by 3+3 escalation1. Expansion cohorts in selected tumor types For personal use only • DEP CTX 3-weekly IV infusion Phase
Slide 8: Phase 2 patient characteristics
Phase 2 patient characteristics HEPATO- PATIENT BASELINE CHARACTERISTICS PROSTATE OVARIAN EGC HNSCC OTHER* TOTAL BILIARY For personal use only Patients enrolled (n, %) 25 (33%) 22 (29%) 15 (20%) 7 (9%) 4 (5%) 2 (3%) 75 (100%) Median 73 62 61 60 65 73 65 Age (years) (range) (57-83) (43-76) (25 – 73)
Slide 9: DEP CTX Phase 2 safety
DEP CTX Phase 2 safety Treatment-related AEs in ≥10% patients, or ≥ Grade 3 (n=75) • G3/4 neutropenia 23% (16% in prostate) Anemia 10.7% 44.0% For personal use only • Febrile neutropenia 1% (none in prostate) Neutropenia 22.7% 37.3% Thrombocytopenia 2.7% 17.3% • G-CSF: Lymphopenia 2.7%8.0% All Grade
Slide 10: DEP CTX Pharmacokinetics
DEP CTX CTX Pharmacokinetics–-Free DEP Pharmacokinetics CTX(mean Free CTX (mean ± SD) ± SD) Pharmacokinetics Cycle 1 (ng/mL) 100 Concentration (ng/mL) Concentration Phase 1 PK: 10 For personal use only Linear PK parameters across dose range (2-25 mg/m2 CTX) 1 No evidence of cycle-to-cycle accumulati
Slide 11: Phase 2 anti-tumor activity
Phase 2 anti-tumor activity Hepato- mCRPC Ovary EGC HNSCC Other† Total (n = 25) (n = 22) (n = 15) (n = 7) biliary (n = 2) (n = 75) For personal use only (n = 4) Evaluable, n 17 18 10 3 1 2 51 RECIST measurable, n 12 17 10 3 1 2 45 ORR % 16.7% 17.6% 30.0% 0.0% 0.0% 50.0% 20.0% [95% CI] [2.1 - 48.4] [
Slide 12: Phase 2 anti-tumor activity – RECIST
Phase 2 anti-tumor activity – RECIST For personal use only Prostate Ovary EGC Other Response rate = 20% (9/45) PRESENTED BY: James Spicer FRCP PhD
Slide 13: Phase 2 prostate cancer
Phase 2 prostate cancer Prostate • PSA reduction in 91% >50% reduction (‘PSA50’) in 52% For personal use only • 62% reduction abdominal LNs • 87% PSA reduction Baseline On treatment • 87% stable or improved bone disease • Durable PRs and SDs up to 55 weeks 1. Scher H et al. J Clin Oncol 2016 PRESENT
Slide 14: Conclusions
Conclusions • Dendrimer cabazitaxel is safe and well tolerated: For personal use only ▪ no pre-medication (due to lack of toxic excipients) ▪ potential for less severe myelosuppression compared with standard CTX - despite little use of G-CSF ▪ no AEs related to dendrimer scaffold • Clinical benefit
Slide 15: Acknowledgements
Acknowledgements For personal use only • All patients participating in the study, and their families • All investigators and research personnel who conducted this trial • Sponsor: Starpharma Pty Ltd PRESENTED BY: James Spicer FRCP PhD