Genocea Biosciences Inc · OTC:GNCAQ
Genocea Biosciences — Technical Presentation (November 2020)
17 slides from Genocea Biosciences's technical presentation, Nov 9, 2020
Slide 1: GEN-009 Part B SITC data presentation
GEN-009 Part B SITC data presentation November 9, 2020
Slide 2: Disclaimer
This presentation contains “forward-looking” statements that are within the meaning of federal securities laws and are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include information concerning our possible or ass
Slide 3: Today's summary
Today’s summary Compelling early signal persists with longer follow-up Clear anti-tumor activity “Targets matter” Highly differentiated immunogenicity results Powerful readthrough to GEN-011 ATLAS enables unique breadth and specificity 3
Slide 4: Clinical trial design (Part B)
Clinical trial design (Part B) • Combination of GEN-009 and standard-of-care PD-1-based regimens in patients with advanced disease • Tumor types: Melanoma, NSCLC, SCCHN, Urothelial, RCC • Objectives: safety, immunogenicity, efficacy • Vaccination contribution to be determined after CPI response esta
Slide 5: Simple, scalable production and delivery
Simple, scalable production and delivery 5
Slide 6: GEN-009 is being studied in two distinct patient groups
GEN-009 is being studied in two distinct patient groups 1. Checkpoint-sensitive / controlled GEN-009 dosing +/- prior therapy SOC and GEN-009 manufacture Biopsy Enroll Progression and GEN-009 dosing salvage treatment 2. Checkpoint-resistant SOC Therapy Melanoma: nivo monotherapy or nivo + ipi RCC: n
Slide 7: GEN-009 safety profile
GEN-009 safety profile GEN-009 is exceptionally well tolerated for a cancer therapeutic Grade 1 or 2 Grades 3-5 All TEAE (N=16) 12 (75%) 0 Injection site reactions 12 (75%) 0 • Redness • 6 (37.5%) • Swelling • 3 (18.8%) • Pain • 7 (43.8%) • Tenderness • 7 (43.8%) Fatigue 2 (12.5%) 0 Myalgia 1 (6.3%)
Slide 8: Historical CPI data define expected outcome over 3-4 months
#2 genocea Historical CPI data define expected outcome over 3-4 months Each patient can serve as own control A Patients with Melanoma Change in Target Lesions from Baseline (%) 1005 A First occurrence of new lesion @ Patient off study 0 10 2 30 40 SO 60 70 80 90 Weeks since Treatment Initiation 100
Slide 9: Part B trial design enables assessment of vaccine specific contribution
Part B trial design enables assessment of vaccine specific contribution to clinical responses Each patient can serve as own control , Pre-Vaccination Post-Vaccine Dose 1 PD (+20%) @Scan Baseline PR (-30%) -60 Steretyceess : Effect attributable to vaccine % Change in Target Lesion Sum b 6 Vaccine Dos
Slide 10: Compelling signal of response in checkpoint-sensitive patients
Compelling signal of response in checkpoint-sensitive patients GEN-009 responses 1 CR and 2 PR of 7 evaluable Overall responses 2/9 (22%) with CR 4/9 (67%) with PR 2/9 (22%) with SD 7/9 (78%) progression-free 10
Slide 11: Early evidence of stabilization in checkpoint-resistant patients
Early evidence of stabilization in checkpoint-resistant patients Investigator iRECIST read after GEN-009 5/7 disease control 1 patient with possible pseudo-progression 11
Slide 12: Preliminary ctDNA analyses corroborate GEN-009 impact on clinical disease
Preliminary ctDNA analyses corroborate GEN-009 impact on clinical disease Both GEN-009 vaccine neoantigens and non-vaccine mutations disappear post-treatment -001 (UC, Responsive, GEN-009 CR) -106 (SCCHN, Refractory, GEN-009 SD) 80 40 60 30 Non-antigenic mutations Vaccine Neoantigens 40 20 Neoantige
Slide 13: Peak ex vivo T cell responses occur at D92
Peak ex vivo T cell responses occur at D92 Interim analysis of nine subjects in Part B N=9 300 1000 N=9 250 800 SEM SEM 200 ± ± 600 SFC per γ 150 N=8 400 100 N=7 N=7 Mean GrB SFC per GrBMean SFC Mean IFN Mean million PBMC million N=8 PBMC million 200 50 N=8 N=8 N=3 N=3 0 0 Day 1 Day 29 Day 50 Day 92
Slide 14: Summary D50 immunogenicity across Part B cohort
Summary D50 immunogenicity across Part B cohort + + 900 PBMC 900 CD4 350 CD8 ~35,000/million ~30,000/million ~10,000/million 800 IFN-gamma 800 IFN-gamma IFN-gamma 300 TNF-alpha TNF-alpha TNF-alpha 700 cells T 700 cells T + + 250 600 600 500 500 200 400 400 150 300 300 100 200 200 Cytokine SFU/20,000
Slide 15: Emerging evidence of epitope spread in CPI-sensitive patients
Emerging evidence of epitope spread in CPI-sensitive patients CPI-sensitive N=5 CPI-resistant N=2 Screening Screening D50 D50 CD4 Inhibigen CD8 Inhibigen CD4 Neoantigen CD8 Neoantigen Comprehensive ATLAS mutanome screens were performed at the screening timepoint and again at D50 post- initiation of
Slide 16: Immune responses continue to be best-in-class
Immune responses continue to be best-in-class Properties Genocea Neon BioNTech Moderna Gritstone Vaccibody NEO-PV-01 (NT- GEN-009 iNeST mRNA-4157 GRANITE-001 VB N-01 Study 001) part B n=16 n=108 n=23 n=8 N=14 n=60 % of patients with vaccine 100% 100% 100% 73% 100% immune (of nine reported) response
Slide 17: GEN-009: Delivering on the promise of neoantigen therapies
GEN-009: Delivering on the promise of neoantigen therapies Compelling early signal persists with longer follow-up Clear anti-tumor activity “Targets matter” Highly differentiated immunogenicity results Powerful readthrough to GEN-011 ATLAS enables unique breadth and specificity 17
Genocea Biosciences — Technical Presentation (November 2020) on 6ix