Cellectar Biosciences, Inc. · NASDAQ:CLRB
Cellectar Biosciences — Technical Presentation (February 2020)
43 slides from Cellectar Biosciences's technical presentation, Feb 20, 2020
Slide 1: Clinical Data Call February 19, 2020
Clinical Data Call February 19, 2020
Slide 2: Forward-looking statements
This presentation contains forward - looking statements . Such statements are valid only as of today and we disclaim any obligation to update this information . These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual futu
Slide 3: Presentation Topics
3 CLR 131 r/r Multiple Myeloma 1 Presentation Topics CLR 131 r/r B - cell Non - Hodgkin’s Lymphoma 2 CLR 131 Two Cycle Dosing Optimization 3 CLR 131 Clinical Development Next Steps 4 Conclusion 5
Slide 4: Multiple Myeloma Epidemiology
Multiple Myeloma Epidemiology U.S. and Top 5 EU Prevalence Multiple Myeloma Prevalence in U.S. (~131K 2 ) and Key Global Markets are Projected to Increase Significantly Through 2030 Across All Lines of Therapy 0 1 0 0 , 000 2 0 0 , 000 3 0 0 , 000 2 0 17 2 0 18 2 0 19 2 0 20 2 0 21 2 0 22 2 0 23 2 0
Slide 5: High Unmet Need Remains in Multiple Myeloma
High Unmet Need Remains in Multiple Myeloma General Population Median Survival vs. MM Patient Disease Segments 0 2 4 6 8 10 12 14 16 18 20 >5 prior lines 1-3 prior lines High Risk Post-ASCT High risk Non-transplant eligible/High risk Overall MM 75 yo (general population) 65 yo (general population) E
Slide 6: High Unmet Need: Response Rate Decreases with Each Relapse
2 nd Line 3 rd Line 4 th Line 45% 30% 15% NDMM No ASCT Early Relapse (1 - 2 prior lines) Late Relapse (>3 prior lines) ~15 - 43% ~30 - 42% <3% 1 st Line ORR 58% NDMM ASCT 2 sCR/CR 3 Induction ~35% Post - ASCT ~45 - 60% High Unmet Need Remains in Multiple Myeloma Overall Response Rate (ORR) & Depth o
Slide 7: High Unmet Need: Limited Progression Free Survival
High Unmet Need Remains in Multiple Myeloma Limited Progression Free Survival (PFS) for Patients in 3 rd Line or Later Disease Progression in Multiple Myeloma (Median PFS) ~5.7 years ~2 - 4+ years ~1 - 3.5 years ~4 months NDMM with ASCT NDMM without ASCT Second - Third Line Fourth Line + Progression
Slide 8: Competitive Landscape
r/r Multiple Myeloma Competitive Landscape Approved Products 3rd Line or Later Monotherapy Data Used for Approval Overall Response Rate (ORR) - % Progression Free Survival (PFS) - Months Selinexor 25.3 2.3 Daratumumab 29.2 3.7 Pomalidomide 29.2 4 Bortezomib 27.7 3 Carfilzomib 22.9 3 • All approved d
Slide 9: CLR 131 - A Phospholipid Ether Radio-Conjugate
CLR 131 - A Phospholipid Ether Radio - Conjugate Validated Mechanism of Targeted Delivery • Tumor cells utilize lipids at significantly greater quantities than normal tissue – Energy source ( b - oxidation) – Cell membrane production – Signaling molecules • Cellectar’s phospholipid ethers exploit in
Slide 10: CLR 131 Phase 1 Study
10 CLR 131 r/r Multiple Myeloma Phase 1 1 Study Total Body Dose (TBD) 2 ≤ 30 Minute Infusion 1. Phase 1 - NCT02278315 2. Dose received to the entire body, which is already adjusted for each individual body surface area (m2) 3. Denotes Phase 2 T otal Body Doses Primary Study Endpoints are Safety, Tol
Slide 11: MM and NHL Phase 2 Study Design
CLR 131 r/r MM and NHL Phase 2 1 Study Design U.S. Fast Track Designation Granted for Multiple Myeloma and DLBCL Screening Dose 1 (Day 1) Dose 2 (Day 8) Dose 3 (Day 1) Dose 4 (Day 8) Cycle 1 Cycle 2 Optional Study Days 78 - 180 11 1. Phase 2: NCT02952508 Patients Screened CLL/SLL, MZL, LPL DLBCL MM
Slide 12: Multiple Myeloma Patient Characteristics
Criteria Total Body Dose <50mCi ( n=10) Total Body Dose ~50mCi ( n=20) Total Body Dose ~75mCi (n=17) Total (n=47) Median Age (Min - Max) 68.5 (55 - 85) 70 (51 - 82) 70 (59 - 83) 70 (51 - 85) Male (%) 50 60 71 62 Median ECOG PS 2 1 1 0.5 1 Median Prior Therapies (Min - Max) 4 (3 - 12) 5 (2 - 13) 5 (3
Slide 13: CLR 131 Well Tolerated Safety Profile
CLR 131 r/r Multiple Myeloma Well Tolerated Safety Profile 1. Data as of 31Jan2020 2. Treatment Emergent Adverse Events 13 • Most frequent TEAEs 2 are cytopenias • The cytopenias are very predictable and manageable – Nadir occurs ~34 days post initial dose; recovery occurs within ~21 days post nadir
Slide 14: Heavily Pretreated Patient Population - Prior Treatments
CLR 131 r/r Multiple Myeloma Heavily Pretreated Patient Population - Prior Treatments Total Evaluable Patients n=43 1 MM Prior Therapies - Median (Range) 5 (2,17) Prior Autologous SCT 2 [n (%)] 29 (64%) Exposed n (%) Refractory n (%) Bortezomib 42 (97.7) 24 (57.1) Carfilzomib 17 (39.5) 13 (76.5) Len
Slide 15: Response Rate by Total Body Dose
0% 25% 50% 75% 100% Response Rate by Total Body Dose (n=43) PD SD MR PR VGPR CBR 78.6% DCR 100% DCR 100% CBR 45% CBR 40% 10 4 4 1 6 4 DCR 100% CLR 131 r/r Multiple Myeloma Achieves Efficacy Endpoint • 100% of patients achieved stable disease or better (Disease Control Rate) • 85.7% of patients treat
Slide 16: CLR 131 Meets & Exceeds ORRs of Prior Approvals
CLR 131 r/r Multiple Myeloma Meets & Exceeds ORR’s Provided For All Prior Approvals • Product profile at 50mCi and 75mCi TBD demonstrates efficacy – Median of 5 prior lines of therapy – Greater than 30% of patients are high risk – 95% of patients exposed to 3 classes of drugs were triple class refra
Slide 17: CLR 131 Demonstrates a Clear Dose Response in r/r MM
-100.0% -75.0% -50.0% -25.0% 0.0% 25.0% 50.0% 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 Overall Response Summary by Total Body Dose <50mCi Total Body Dose ~50mCi Total Body Dose ~75mCi Total Body Dose VGPR PR MR PD SD CLR 131
Slide 18: CLR 131 Patient Subsets with High Unmet Need
0% 10% 20% 30% 40% 50% 60% <50 mCiTBD ~50 mCi TBD ~75 mCi TBD High Risk Patients ORR (n=14) 0% 5% 10% 15% 20% 25% 30% 35% <50 mCiTBD ~50 mCi TBD ~75 mCi TBD Triple Class Refractory Patients ORR (n=19) CLR 131 r/r Multiple Myeloma Patient Subsets with High Unmet Need • 30% of patients are high risk;
Slide 19: CLR 131 Data Update Conclusion
CLR 131 r/r Multiple Myeloma Data Update Conclusion • Prevalence of MM is increasing in all key global markets • High unmet medical need remains ‒ Overall Response rates, durability of responses and safety/tolerability ‒ 40% of eligible 3 rd line plus patients decline further treatment • CLR 131 tes
Slide 20: Presentation Topics
20 CLR 131 r/r Multiple Myeloma 1 Presentation Topics CLR 131 r/r B - cell Non - Hodgkin’s Lymphoma 2 CLR 131 Two Cycle Dosing Optimization 3 CLR 131 Clinical Development Next Steps 4 Conclusion 5
Slide 21: B-cell Lymphoma Epidemiology and Response Rates
• Estimated 2019 incidence: 74,200 • Median age at diagnosis: 67 years 2 • Response rates and survival decrease significantly in second or third - line treatment − DLBCL survival in third line is ≤20% − MCL survival in second line is 50% B - cell Lymphoma Epidemiology and Response Rates 0% 10% 20% 3
Slide 22: Non-Hodgkin's Lymphoma Patient Characteristics
CLR 131 r/r Non - Hodgkin’s Lymphoma 1 Patient Characteristics 2 Total Body Dose ~50mCi ( n=12) Total Body Dose ~75mCi ( n=7) Total (n=19) Median Age (Min - Max) 70 (52 - 79) 72 (65 - 86) 70 (52 - 86) Male (%) 47.5 71 55 Median ECOG PS 3 1 1 1 Median Prior Therapies (Min - Max) 3 (1 - 9) 3 (2 - 5) 3
Slide 23: CLR 131 in r/r NHL Well Tolerated Safety Profile
CLR 131 in r/r NHL Well Tolerated Safety Profile 1. Lymphoma patients include: Chronic Lymphocytic Leukemia (CLL); Lymphoplasmacytic Lymphoma (LPL); Marginal Zone Lymphoma (M ZL) ; Mantle Cell Lymphoma (MCL); Diffuse Large B - cell Lymphoma (DLBCL) 2. Data as of 31Jan2020 • Predominate TEAEs are cyt
Slide 24: NHL Efficacy in Heavily Pretreated Patients
0% 5% 10% 15% 20% 25% 30% 35% 40% 45% Phase 2 Response Rates 1 ORR 4 CR 5 ORR ORR CR CR CLR 131 r/r NHL Efficacy in Heavily Pretreated Patients • Diverse, advanced and heavily pretreated patient population – Multiple r/r B - cell lymphoma histologies: DLBCL, transformed DLBCL, CLL/SLL, MZL, MCL, LPL
Slide 25: NHL Efficacy by Sub-indications
CLR 131 r/r NHL Efficacy by Sub - indications 30% 33% 100% 0% 0% 25% 50% 75% 100% Percent of Patients Responding Overall Response Rates by Indication n=10 n=3 n=4 MCL • Activity demonstrated in both aggressive and indolent NHL disease • 75% of LPL/WM patients were refractory to rituximab or ibrutini
Slide 26: DLBCL Patient Case Study - Complete Response
• Female, 52 years old with subpectoral lymph node mass – Germinal cell DLBCL – Single hit: MYC positive; BCL - 2 negative • 3 prior lines of treatment - R - CHOP, RICE and chemotherapeutic combination • Relapse within 10 months of 1 st line treatment, refractory to 2 nd and 3 rd line TRX • Patient
Slide 27: LPL/WM Epidemiology
LPL/WM Epidemiology U.S., Top 5 EU and Asia Prevalence 1. Datamonitor Healthcare; Centers for Disease Control and Prevention, 2017; Ferlay et al., 2018; National Cancer Institute, 201 7; Steingrímsson et al., 2017; United Nations, 2017 2. Leukemia & Lymphoma Society (2018). Waldenstrom Macroglobulin
Slide 28: LPL/WM Market: Significant Unmet Treatment Need Remains
LPL/WM Market Significant Unmet Treatment Need Remains 0 0.5 1 1.5 2 2.5 3 3.5 4 1st Line 2nd Line Years Median Progression Free Survival Rituximab - based Regimen 2 Ibrutinib - Oral Daily • Similar to Multiple Myeloma, LPL/WM is an incurable disease • There are limited early - line and no late - li
Slide 29: LPL/WM Competitive Landscape
LPL/WM Competitive Landscape 2nd Line or Later Monotherapy - 1 Approved Product 29 Overall Response Rate (ORR) Complete Response Rate Ibrutinib 1 (n=63) 90.5% 0% Zanubrutinib 2 80.8% 0% Acalabrutinib 3 93% 0% Venetoclax (n=30) 86% 0% • Rituximab combinations are first line treatments • Ibrutinib is
Slide 30: LPL/WM Response Rates
CLR 131 r/r LPL/WM Response Rates 4 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% • CLR 131 demonstrates highly encouraging efficacy ‒ 100% Overall Response Rate; 25% Complete Response Rate • All patients were relapsed or intolerant to ibrutinib and rituximab combinations CLR 131 Only Reported Monothe
Slide 31: LPL/WM Patient Case Study - Complete Response
CLR 131 r/r LPL/WM Patient Case Study - Complete Response • Baseline pleural effusion & multiple large tumor nodules; third line treatment ‒ Patient was refractory to all previous treatments • Day 187 CT: 100% overall tumor burden reduction & complete resolution of 5/5 tumors • Day 406 CT: Confirmed
Slide 32: NHL Data Update Conclusion
CLR 131 r/r NHL Data Update Conclusion • CLR 131 tested in heavily pretreated and extremely challenging patients ‒ Median 3 prior lines of systemic therapy ‒ ~47 % of patients were refractory to prior therapy ‒ ~53% of patients were refractory to rituximab • Both the ~50mCi and ~75mCi doses demonstr
Slide 33: Presentation Topics
33 CLR 131 r/r Multiple Myeloma 1 Presentation Topics CLR 131 r/r B - cell Non - Hodgkin’s Lymphoma 2 CLR 131 Two Cycle Dosing Optimization 3 CLR 131 Clinical Development Next Steps 4 Conclusion 5
Slide 34: CLR 131 Two Cycle Dosing Optimization: Bexxar and DeNardo Data
CLR 131 Two Cycle Dosing Optimization Analysis of Bexxar and DeNardo Data • To achieve optimal efficacy with iodine - 131 (Bexxar), 75cGy identified as target absorbed dose • To attain the absorbed dose of 75cGy, patients with rapid clearance require higher doses to achieve necessary AUC 1 • To achi
Slide 35: Two Cycle Dosing Optimization: Bexxar and DeNardo Data Cont.
• Animal studies demonstrated fractionation allowed for a higher rate of complete tumor response – Corroborated by CLR 131 data • In NHL patients, fractionation also demonstrated an ability to increase the TBD and efficacy without increasing the toxicity – Tumor absorbed dose was increased – Bone ma
Slide 36: Two Cycle Dosing Pharmacokinetics - Increase of Area Under the Curve
1000 10000 100000 1000000 10000000 100000000 CLR 131 (Median dpm/mL) Time (Days) <50 mCi TBD ~50 mCi TBD ~75 mCi TBD ~100 mCi TBD CLR 131 Two Cycle Dosing Optimization Pharmacokinetics - ~200% Increase of Area Under the Curve • Increased plasma exposure demonstrates increased tumor uptake and respon
Slide 37: Patients Receiving a Second Cycle: Additional Reduction in Efficacy Marker
-100.0% -75.0% -50.0% -25.0% 0.0% 25.0% 50.0% 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 Overall Response Summary by Total Body Dose <50mCi Total Body Dose ~50mCi Total Body Dose ~75mCi Total Body Dose VGPR PR MR PD SD CLR 131
Slide 38: CLR 131 Dosing Optimization with Two Cycles
CLR 131 r/r Multiple Myeloma Dosing Optimization with Two Cycles 1 38 • Two cycle fractionated treatment further increases total body dose which may: ‒ Improve response rates, the depth and durability of response and PFS ‒ Maintain safety and tolerability profile • Patients that progress remain resp
Slide 39: Presentation Topics
39 CLR 131 r/r Multiple Myeloma 1 Presentation Topics CLR 131 r/r B - cell Non - Hodgkin’s Lymphoma 2 CLR 131 Two Cycle Dosing Optimization 3 CLR 131 Clinical Development Next Steps 4 Conclusion 5
Slide 40: Two Cycle Dosing Optimization Phase 2 Study Extension
Two Cycle Dosing Optimization Screening 40 CLR 131 r/r Hematologic Malignancies Phase 2 Study Extension Day 1 Infusion 1 15 Infusion 2 57 71 Infusion 3 Infusion 4 Cycle 1 Cycle 2 720 360 Follow - up Period 1 Follow - up Period 2 • Protocol extension approved by FDA and investigator sites • Target en
Slide 41: CLR 131 Pivotal Study Designs
Proposed Pivotal Study Design Program Timing 2 Clinical Costs 2 • Granted U.S. ODD 1 , Fast Track and EU ODD • Relapsed/refractory 5 th line Multiple Myeloma • Pivotal, single - arm (n=75 - 100) – Primary endpoint: Overall Response Rate (ORR) • Pursuing traditional & innovative regulatory strategies
Slide 42: Clinical Development Strategy
Late - line Hematologic Pivotal Study Expand into Additional Hematologic Indication(s) Evaluate Pre - transplant MRD+ Evaluate Early - line Combination Therapies CLR 131 Adult Hematology Additional Market Opportunities 42 C linical Development Strategy
Slide 43: CLR 131 and NHL Data Update Conclusion
CLR 131 r/r Multiple Myeloma and NHL Data Update Conclusion • Prevalence of MM and NHL increasing in all key global markets • High unmet medical need remains in r/r MM and NHL • CLR 131 r/r MM and NHL efficacy impressive and consistent in heavily pretreated patients at either a ~50mCi or ~75mCi Tota
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