Agenus Inc. · NASDAQ:AGEN
Agenus — Agenus Corporate Event at ESMO 2023
34 slides from Agenus's conference presentation, Oct 22, 2023
Slide 1: Immunotherapy Revolution 2.0: Agenus Corporate Event @ ESMO 2023
Immunotherapy Revolution 2.0 Agenus Corporate Event @ ESMO 2023 October 22, 2023
Slide 2: BOT/BAL Potential: $48B IO Market
BOT/BAL Potential $48B 2022 IO market size 1 PD-(L)1 HOT TUMOR Melanoma 1st gen CTLA-4 NSCLC Pancreatic CRC COLD TUMOR BOT/BAL Sarcomas EARLY-STAGE LATE-STAGE 2 1. Global Data IO Market Report
Slide 3: BOT/BAL and Standard of Care Clinical Readouts by Treatment Setting
BOT/BAL and Standard of Care Clinical Readouts by Treatment Setting Target Population Overall Response Rate (ORR%) Survival Treatment Setting (current Standard of SOC median Overall Care, or SOC) SOC or Comparator BOT or BOT/BAL BOT or BOT/BAL Survival (mOS) MSS CRC Non-active 74% 12-month OS* 2/3L+
Slide 4: Potential BLA Filings
Potential BLA Filings Based on promising clinical signal across treatment settings Treatment US + EU5 BOT/BAL Highlights Development Plan Patients1 Setting 2/3L+ MSS CRC Data in >300 Patients • U.S. and EU regulatory interactions ongoing 13,000 NLM Fast Track Designation Granted • Planned BLA filing
Slide 5: CRC
Immunotherapy Revolution 2.0 CRC
Slide 6: Colorectal Cancer (CRC): Growing Prevalence, High Unmet Need
Colorectal Cancer (CRC): Growing Prevalence, High Unmet Neet CRC is the 3rd most common cause of cancer mortality globally1 Despite advances in treatment of CRC, long term survival remains dismal2,3 • 3-year relative OS for patients with metastatic CRC is ~30-35% • 5-year relative OS for patients wi
Slide 7: Updated Clinical Data in Refractory MSS CRC
Updated Clinical Data in Refractory MSS CRC 100 Change in Sum of Target Lesions (%) 90 80 70 2/3L+ MSS CRC with No Active Liver Mets 60 50 Efficacy Evaluable Population (n=70) 40 30 20 10 Confirmed ORR, % (95% CI) 24% (15%, 36%) 0 -10 -20 BOR, n (%) -30 -40 -50 -60 CR 1 (1%) -70 -80 -90 PR 16 (23%)
Slide 8: Updated Clinical Data in Refractory MSS CRC: Overall Survival
Updated Clinical Data in Refractory MSS CRC Median OS, 12-month OS, % Median F/U, Months (95% CI) (95% CI) Months (Range) 100 No Active Liver Mets ITT (n=77) NR (16.5 , NR) 71% (58%, 81%) 11.1 (0.6, 40.5) No Active Liver Mets EE (n=70) NR (16.5 , NR) 74% (61%, 83%) 12.3 (1.4 40.5) 90 Overall Surviva
Slide 9: Expansion into Earlier Treatment Lines in MSS CRC
Expansion into Earlier Treatment Lines in MSS CRC Investigator sponsored studies support ongoing development and registrational strategy IST / Disease Setting Anticipated Data Readout 1L MSS CRC • 1H 2024 BOT/BAL + Bev + FOLFOX vs. Bev + FOLFOX Marwan Fakih, MD Neoadjuvant MSS & MSI-H CRC • 4Q 2023
Slide 10: "Window of Opportunity" Neoadjuvant CRC Study Shows Promising Results
“Window of Opportunity” Neoadjuvant CRC Study Shows Promising Results Treatment with BOT/BAL led to significant tumor reduction within four weeks; well tolerated • BOT/BAL treatment with Standard of Care surgery Topline results: • Major tumor reductions observed within four weeks • No safety signals
Slide 11: "Window of Opportunity" - Neoadjuvant CRC Study Shows Promising Results
“Window of Opportunity” - Neoadjuvant CRC Study Shows Promising Results Treatment with BOT/BAL led to significant tumor reduction within four weeks; well tolerated Pathologic Tumor Reductions (%) by Individual Patient 0% 0% -10% -10% -20% -30% -25% -40% -50% -50% -50% -60% -70% -80% -80% -90% -90% -
Slide 12: BOT: Potential to Become a Backbone Therapy in CRC
BOT: Potential to Become a Backbone Therapy in CRC US/EU5 - CRC Patients Treated Annually 2/3L+ MSS CRC 2/3+ • >300 patients treated with BOT/BAL MSS, NLM only – ORR: 24%; 74% 12-month OS; mOS: not reached (n=70) ~13,000 • Fast Track Designation granted by FDA in April 2023 Initial Opportunity • BLA
Slide 13: Rapid Development Pathway for BOT/BAL in 2/3L+ MSS CRC
Rapid Development Pathway for BOT/BAL in 2/3L+ MSS CRC Registration Strategy Regulatory Engagement Case Study: Recent Precedence for Accelerated Approval in • No active liver mets (clinical marker) US Advanced mCRC • Filing planned for midyear 2024 • Fast Track designation granted • Tucatinib & tras
Slide 14: Go-To-Market Strategy
Go-To-Market Strategy Experienced leadership team in place to deliver successful launch of BOT upon approval Clinical Team with I/O Pioneers Extensive Medical Affairs Engagement Commercial Preparedness ✓ KOL relationships across 40+ countries ✓ 25+ FTEs with big pharma and biotech experience ✓ Robus
Slide 15: 2L Pancreatic
Immunotherapy Revolution 2.0 2L Pancreatic
Slide 16: Clinical Data in 2L Pancreatic Cancer
Clinical Data in 2L Pancreatic Cancer Patients (n=6) dosed with 150mg BOT+gem/abraxane after FOLFIRINOX failure for metastatic disease All patients had liver metastases Tumor Marker % Change From Baseline Clinical Data on Six Patients CA19-9 or CEA % tumor reduction after one (8W) or two (16W) scans
Slide 17: BOT Potential in Advanced Pancreatic
BOT Potential in Advanced Pancreatic US/EU5 - Pancreatic Patients Treated Annually 2L Pancreatic Cancer 2L • Randomized Phase 2 (N=60) ongoing with BOT + gem/Abraxane; expected to be fully Relapsed/Refractory to enrolled by EOY 2023 FOLFIRINOX • High unmet need: SOC has <15% ORR, 7-8 month mOS ~22,0
Slide 18: 2L+ Melanoma
Immunotherapy Revolution 2.0 2L+ Melanoma
Slide 19: BOT and BOT/BAL Responses in CTLA-4/PD-1 R/R (2L+) Melanoma
BOT and BOT/BAL Responses in CTLA-4/PD-1 R/R (2L+) Melanoma Cutaneous melanoma patients receiving BOT monotherapy or BOT/BAL combination 100 90 Prior Treatment Cutaneous 2L+ Melanoma 80 70 PD-1 Relapsed/Refractory (R/R) Efficacy Evaluable (First study n=10) Percent Change from Baseline 60 PD-1/CTLA-
Slide 20: BOT Monotherapy Responses in CTLA-4/PD-1 R/R (2L+) Melanoma
BOT Monotherapy Responses in CTLA-4/PD-1 R/R (2L+) Melanoma Demonstration of BOT differentiated profile Dose BRAF Prior Tx BORR BORR% Sites Phase 1 1. BRAF + MEK inhibtor C800-01 271-212 2mg/kg Mutant 2. anti-PD-1 PR -50% Adrenal, Inguinal, Oral/ Cervical 3. anti-CTLA-4 + anti-PD-1 1. anti-PD-1 447-
Slide 21: BOT Potential in Advanced Melanoma
BOT Potential in Advanced Melanoma US/EU5 - Melanoma Patients Treated Annually 2L+ Melanoma 2L+ • Phase 2 cohorts with BOT monotherapy enrollment complete; expansion with BOT/BAL Relapsed/Refractory cohorts ongoing to Ipi/Nivo • High unmet need: no established Standard of Care in IO relapsed/refract
Slide 22: 2L+ NSCLC
Immunotherapy Revolution 2.0 2L+ NSCLC
Slide 23: Responses from Phase 1 in 2L+ NSCLC
Responses from Phase 1 in 2L+ NSCLC 100 90 Efficacy Evaluable (n=9) 80 70 ORR, % 56% Best % Change from Baseline 60 50 40 30 BOR, n (%) 20 10 0 CR 0 (0) -10 -20 -30 PR 5 (56) -40 -50 -60 SD 3 (33) -70 -80 PD 1 (11) -90 -100 0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 DCR (CR + PR + SD),
Slide 24: 2L+ Sarcomas
Immunotherapy Revolution 2.0 2L+ Sarcomas
Slide 25: BOT/BAL Combination Response in Refractory Sarcomas
BOT/BAL Combination Response in Refractory Sarcomas Responses in heterogenous sarcoma population RECIST Efficacy Evaluable (N=41)* iRECIST v1.1 Other subtypes (excluding ddLipo, UPS) AS (c) AS (v) LMS ddLipo UPS 20% 17% ORR†, % (95% CI) (9—35) (7—32) 1mg/kg (n=27) 15% 11% 2mg/kg (n=14) 29% 29% BOR
Slide 26: BOT/BAL Combination Response in Refractory Sarcomas
BOT/BAL Combination Response in Refractory Sarcomas Broad activity in heterogenous sarcoma population RECIST Efficacy Evaluable (N=41)* iRECIST v1.1 20% 17% AS LMS Other ORR†, % (95% CI) (9—35) (7—32) 1mg/kg (n=27) 15% 11% 2mg/kg (n=14) 29% 29% BOR, n (%) CR 0 0 PR 8 (20) 7 (17) SD 18 (44)
Slide 27: 2L+ Ovarian
Immunotherapy Revolution 2.0 2L+ Ovarian
Slide 28: Platinum R/R Ovarian BOT/BAL Efficacy
Platinum R/R Ovarian BOT/BAL Efficacy Histology Efficacy Evaluable (n=24) Best Percent Change From Baseline (%) High grade serous Clear cell Carcinosarcoma ORR, %* 33% (95% CI, 15.6-55.3%) Endometrioid/clear cell 20% Tumor Growth BOR, n (%) ∞ CR 1* (4) PR 7* (29) 30% Tumor Reduction SD 8 (33) 0 6 12
Slide 29: BOT Mechanism of Action
Immunotherapy Revolution 2.0 BOT Mechanism of Action
Slide 30: BOT: Multi-Functional Anti-CTLA-4 Immune Activator
BOT: Multi-Functional Anti-CTLA-4 Immune Activator BOT Mechanism of Action “Turning Cold Tumors Hot” • Primes and expands T cells to eradicate tumor • Activates Natural Killer (NK) cells, and antigen presenting cells (APCs) to identify and attack the cancer • Reduces regulatory T cells that suppress
Slide 31: BOT/BAL Safety
Immunotherapy Revolution 2.0 BOT/BAL Safety
Slide 32: BOT Has a Manageable Toxicity Profile
BOT Has a Manageable Toxicity Profile TRAEs of ≥10% related to BOT; data from expanded Phase 1b study All Patients Treated with BOT/BAL Combo at 1mg/kg or 2mg/kg BOT (n = 255) n (%) All Grade Grade 3 Grade 4 Any TRAE 204 (80) 70 (27) 5 (2) GASTROINTESTINAL Immune-mediated diarrhea/colitis* 84 (33) 3
Slide 33: Achievements & Upcoming Catalysts
Immunotherapy Revolution 2.0 Achievements & Upcoming Catalysts
Slide 34: Achievements & Upcoming Catalysts
Achievements & Upcoming Catalysts 2023 (Completed) 1H 2024 Mid 2024 2H 2024 1H 2025 ✓ Data from Phase 1b: 2/3L+ • Phase 2 Data: 2L • Planned BLA filing: • Phase 2 Data: • Potential BLA MSS CRC (ASCO GI 2023) Pancreatic 2/3L+ MSS CRC 2L+ Melanoma filing: Pancreatic ✓ Data from Phase 1b: ovarian • Pha