Celldex Therapeutics, Inc. · NASDAQ:CLDX
Celldex Therapeutics — Investor Presentation (January 2013)
27 slides from Celldex Therapeutics's investor presentation, Jan 7, 2013
Slide 1: Corporate Presentation January 2013
Corporate Presentation January 2013
Slide 2: Forward Looking Statement
Forward Looking Statement This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forwa
Slide 3: Multiple late-stage products with near-term inflection points
Multiple late-stage products with near-term inflection points Rindopepimut (ACT IV) Phase 3 trial in front-line GB to complete enrollment by YE 2013 Rindopepimut (ReACT) Phase 2 trial in recurrent GB (both Avastin naïve and refractory) data in 2H 2013 Initiate CDX-011 late-stage study in metastatic
Slide 4: Celldex – Clinical Development Product Pipeline
Celldex – Clinical Development Product Pipeline CANDIDATE PHASE 3 Rindopepimut CDX-011 Rindopepimut CDX-1135 CDX-1127 CDX-301 CDX-1401 INDICATION Front-line Glioblastoma Breast Cancer Recurrent Glioblastoma Dense Deposit Disease Lymphoma, Cancer HSC Transplantation Multiple Solid Tumors PHASE 2 PHAS
Slide 5: Celldex: Realizing the Potential of Immunotherapy
Celldex: Realizing the Potential of Immunotherapy Therapies that activate the patient’s immune system are changing the approach to cancer treatment Validation: antibodies that block negative signals to immune cells (anti-CTLA-4, anti-PD1) have shown profound clinical effects in various cancers These
Slide 6: Rindopepimut: Targeting a High Unmet Need in Glioblastoma
Rindopepimut: Targeting a High Unmet Need in Glioblastoma Rindopepimut is the only vaccine in development specifically targeting EGFRvIII EGFRvIII Highly tumor specific, expressed only in tumors not normal tissues Target has been validated, gaining importance as a tumor marker Historical poor progno
Slide 7: Rindopepimut Overall Survival Across Three Phase 2 Studies in EGFRvIII-Positive Glioblastoma
Rindopepimut Overall Survival (OS) Across Three Phase 2 Studies in EGFRvIII-Positive Glioblastoma vs Independent Control Datasets Rindopepimut Phase 2 Studies (all data from study entry) Median (months) OS 3 years ACT III (n=65) 21.8 26% ACT II (n=22) 20.5 23% ACTIVATE (n=18) 20.4 33% Independent Co
Slide 8: Rindopepimut: OS from Diagnosis
Rindopepimut: OS from Diagnosis Survival Probability Median (months) OS at 24 Months OS at 36 Months Comparison to Historical Control ACT III (n=65) 24.6 52% 31% p = <0.0001 ACT II (n=22) 24.4 50% 23% p = 0.0034 ACTIVATE (n=18) 24.6 50% 33% p = 0.0003 Matched historical control (n=17) 15.2 6% 6% Vac
Slide 9: Rindopepimut: Correlative Biological Activity
Rindopepimut: Correlative Biological Activity Induction of potent immune response to EGFRvIII 85% of patients developed significant anti-EGFRvIII antibody titers which increased with time on study Majority (67%) developed titers above 1:12,800 Anti-EGFRvIII titers maintained for >6 months following
Slide 10: Rindopepimut Currently Enrolling International Phase 3 Study—ACT IV
Rindopepimut Currently Enrolling International Phase 3 Study—ACT IV Randomized (1:1), double-blind, placebo controlled study in 300 to 450 patients with newly diagnosed, surgically resected, EGFRvIII-positive glioblastoma (adaptive design); 150 to 200 international sites in 20+ countries Rindopepimu
Slide 11: Rindopepimut: ReACT Phase 2 Program
Rindopepimut: ReACT Phase 2 Program Phase 2 trial in recurrent glioblastoma (“ReACT”) Rindopepimut in combination with bevacizumab Up to 95 bevacizumab naive and refractory patients in 1st or 2nd relapse Targeted accrual of 12 months and follow up of 6-12 months Control (KLH) + Bevacizumab Rindopepi
Slide 12: CDX-011: First-in-class, Next Generation Therapeutic Antibody
CDX-011: First-in-class, Next Generation Therapeutic Antibody Antibody drug conjugate designed to release MMAE upon internalization into GPNMB-expressing tumor cells Celldex proprietary target and antibody Toxin and linker licensed from Seattle Genetics Same technology as AdcetrisTM MMAE: dolastatin
Slide 13: CDX-011: EMERGE Phase 2b Randomized Study in Advanced Breast Cancer
Advanced breast cancer patients who are refractory/resistant to all approved therapies Patients selected for GPNMB expression 120 patients randomized (2:1) to receive CDX-011 or “Investigator’s Choice” single agent chemotherapy Endpoints included overall response rate, duration of response, PFS, O/S
Slide 14: EMERGE: Balanced Baseline Characteristics
EMERGE: Balanced Baseline Characteristics † Status at cross-over is displayed for the 15 IC patients who received CDX-011 after progression. CDX-011 (N=81) Investigator’s Choice (N=41) Cross Over† (n=15) Age, years [Median (range)] 57 (34-77) 58 (34-73) 51 (36-65) Female [n (%)] 81 (100%) 41 (100%)
Slide 15: EMERGE: Safety Profile Consistent with Chemotherapies
EMERGE: Safety Profile Consistent with Chemotherapies CDX-011(n=96) IC (n=41) All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4 Hematologic Neutropenia 29% 16% 6% 44% 22% 7% Leukopenia 10% 3% 1% 27% 15% 0% Thrombocytopenia 4% 0% 1% 15% 2% 0% Non-hematologic Rash 47% 4% 0% 2% 0% 0% Fatigue 38% 7%
Slide 16: EMERGE: ORR and Disease Control Data
EMERGE: ORR and Disease Control Data Responses per RECIST 1.1; IC = Investigator’s Choice; CDX-011 arm includes 15 patients who crossed over to receive CDX-011 treatment after progression on IC. Analysis of best response excludes patients who discontinued from study without evaluable post-baseline r
Slide 17: EMERGE: OS and PFS Data
EMERGE: OS and PFS Data All Patients Triple Negative High GPNMB Expression Triple Negative and High GPNMB Expression CDX-011 IC CDX-011 IC CDX-011 IC CDX-011 IC Median OS (months) 7.5 7.4 6.9 6.5 10.0 5.7 10.0 5.5 p=0.24 p=0.30 p=0.18 p=0.003 Median PFS (months) 2.1 2.0 2.3 1.6 2.7 1.5 3.0 1.5 p=0.3
Slide 18: EMERGE: Final OS and PFS Curves in Targeted Populations
EMERGE: Final OS and PFS Curves in Targeted Populations Months Months TN and High GPNMB High GPNMB Analyses include all treated patients. Patients who initially received Investigator’s Choice (IC) and subsequently crossed over to receive CDX-011 (n=15) are included in the PFS analysis for each treat
Slide 19: CDX-011: Next Steps and Additional Therapeutic Indications
CDX-011: Next Steps and Additional Therapeutic Indications Initiate late-stage study in metastatic breast cancer in 2H 2013 Positive end of Phase 2 meeting with the FDA in late December Finalize study design; provide update on YE 2012 call in early March Activity in melanoma Phase 2 open-label trial
Slide 20: CDX-1135: A Potent Complement Inhibitor
CDX-1135: A Potent Complement Inhibitor Complement inhibition in rare disease indications is a successful business model CDX-1135 is a clinically proven effective complement inhibitor with unique properties—blocks both alternative and classical complement activation pathways Clear path to clinical o
Slide 21: CDX-1135: Next Steps
CDX-1135: Next Steps Initiate open-label, multicenter pilot study in pediatric and adult patients with DDD in up to 5 patients in Q1 2013 Areas of investigation: Normalization of complement Improvement in kidney function Pathologic improvement in the kidneys With positive results, pursue study expan
Slide 22: CDX-1127: Targeting the Immune System with Antibodies
Immune system is regulated by a complex network of molecules that increase or dampen immune responses Antibodies can be used to turn these molecules on or off Adapted from Nature, December 2011 CDX:1127: Targeting the Immune System with Antibodies Yervoy is a registered trademark of Bristol-Myers Sq
Slide 23: CDX-1127: A Novel Immune Modulator Targeting CD27
CDX-1127: A Novel Immune Modulator Targeting CD27 CD27 is a co-stimulatory molecule on T cells and is over-expressed in certain lymphomas/leukemias CDX-1127 has 2 mechanisms of action: Immune activation Effector function Strong pre-clinical data Immune Activation- Activation of T cells through co-st
Slide 24: CDX-1127: Phase 1 Study – Arms
CDX-1127: Phase 1 Study – 2 Arms Solid Tumors: Immune sensitive tumors Include melanoma, NSCLC, prostate, ovarian, RCC, colorectal Dose range 0.1mg/kg – 10 mg/kg 5 cohorts: single and multiple doses have completed accrual; well tolerated to date, including at the highest dose level Expansion cohort
Slide 25: CDX-1127: Product Opportunity
CDX-1127: Product Opportunity Monotherapy Melanoma, RCC (“naturally immunogenic” tumors) CD27+ cancers (various lymphoma and leukemia) Combination with chemotherapy Chemo or ADC that reduce tumor burden and provide source of tumor antigens Combination with vaccines/immunotherapy APC Targeting combin
Slide 26: Anticipated Milestones for 2013
Anticipated Milestones for 2013 Rindopepimut Compete accrual of ACT IV registration study by YE 2013 Complete accrual of ReACT Phase 2 study— recurrent Q3 2013/refractory 1H 2013; data in 2H 2013 from both studies CDX-011 - Initiate late stage study in metastatic breast cancer in 2H 2013 CDX-1135 -
Slide 27: For additional information, please visit: www.celldextherapeutics.com
For additional information, please visit: www.celldextherapeutics.com
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