Moderna, Inc. · NASDAQ:MRNA
Moderna — Technical Presentation (June 2019)
15 slides from Moderna's technical presentation, Jun 3, 2019
Slide 1: Phase 1 Study of mRNA-4157 Alone and With Pembrolizumab (Keynote-603)
A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone in Subjects With Resected Solid Tumors and in Combination With Pembrolizumab in Subjects With Unresectable Solid Tumors (Keynote-603) Saturday 01 June 2019 Slide Exhibit 99.2
Slide 2: Background
Background T-cell targeting of mutation-derived epitopes (neoantigens) has been demonstrated to drive anti-tumor responses Immunizing patients against such neoantigens in combination with a checkpoint inhibitor (CPI) may elicit greater anti-tumor responses than CPI alone Mutations are rarely shared
Slide 3: mRNA-4157 personalized cancer vaccine process
mRNA-4157 is a personalized neoantigen cancer vaccine encoding up to neoantigens: (going forward all patients will receive a vaccine encoding up to neoantigens) Individually designed and manufactured for each patient Encapsulated in a proprietary lipid nanoparticle and delivered intramuscularly Sele
Slide 4: Study design
0.04 mg n=3 0.13 mg n=6 1.0 mg n=1 0.39 mg n=3 0.04 mg n=5 0.13 mg n=5 1.0 mg n=5 0.39 mg n=8 Part A (Adjuvant patients): Monotherapy mRNA-4157 Part B (Metastatic patients): mRNA-4157 + pembrolizumab Dose escalation cohorts Study design Histologies in part A and B: • NSCLC • SCLC • Cutaneous melanom
Slide 5: Study design
Screening period pembrolizumab monotherapy run-in* (Dosing every 21 days for 2 cycles) mRNA-4157 +pembrolizumab (Dosing every 21 days for up to 9 cycles) pembrolizumab monotherapy (Dosing up to 35 cycles) Safety follow-up (100 day post treatment) Study design *Part A patients are adjuvant patients r
Slide 6: Patient demographics
Part A: 13 Part B: 23 Histologies N =36 Part B Prior Therapies N=23 (%) Patient demographics Age(y) Range: 52-85 45-88 Median: Sex Male: Female: Race: Caucasian Black - Asian - Part A Melanoma MSI HIGH/MMR Deficient • Colorectal Carcinoma Non-small Cell Lung Cancer Part B TMB High • Metastatic squam
Slide 7: Safety data
Related Adverse Event* Grade 2 Grade 3 Safety data Related AEs of at least grade 2 highest grade reported once per patient Part A: mRNA-4157 monotherapy LEFT ARM PAIN - COLITIS - FATIGUE - MYALGIAS - Part B: pembrolizumab monotherapy DIARRHEA - AMYLASE INCREASE - LIPASE INCREASE - ELEVATED AST - ANE
Slide 8: Part A: Adjuvant patients receiving mRNA-4157 monotherapy
Part A: Adjuvant patients receiving mRNA-4157 monotherapy adjuvant patients have been treated with mRNA-4157 patients have completed full course of vaccination per protocol patients remain disease free up to weeks on study
Slide 9: Part B: Metastatic patients receiving mRNA-4157/pembrolizumab
Part B: Metastatic patients receiving mRNA- 4157/pembrolizumab combination out of advanced/metastatic patients have been treated with mRNA-4157/pembrolizumab combination patient with MSI-High CRC had a CR on pembrolizumab monotherapy prior to vaccination patients had a PR including patients who have
Slide 10: Responses in patients receiving combination
Responses in patients receiving combinati Best Overall Response Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) onur
Slide 11: Patient 40019 – Small cell lung carcinoma
Patient 40019 – Small cell lung carcinoma
Slide 12: Patient 40031 – Small cell lung carcinoma
Patient 40031 – Small cell lung carcinoma
Slide 13: Patient 40023 – Bladder carcinoma
Baseline Patient 40023 – Bladder carcinoma
Slide 14: Patient 40033 neoantigen specific CD8 T cell response data
Patient was dosed with 1mg of vaccine monotherapy and underwent apheresis at baseline and 7d post 4th dose. Increases in ex vivo (unexpanded) T-cell responses were detected against all neoantigen pulsed DC pools post vaccination (A). Increases in in vitro stimulated (IVS, expanded) T-cell responses
Slide 15: Robust CD8 T cell responses and Conclusions
Robust CD8 T cell responses detected post-vaccine dose 4 to 55% of predicted class I neoantigens CD8 T cell responses to individual neoantigens were measured in in vitro stimulated (IVS, expanded) T cells Flow cytometry plots show increases in % freq. of CD8 cells producing IFN 7d post th vaccine do