Slide 1: CDX-011 – EMERGE Topline Data
CDX-011 – EMERGE Topline Data May 23, 2012
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: The Target: GPNMB
The Target: GPNMB An internalizable glycoprotein expressed in ~40-75% of breast cancers, as well as other tumor types Promotes the migration, invasion, and metastasis of breast cancer Highly expressed in triple-negative breast cancers where it is associated with increased risk of recurrence Patients
Slide 4: 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 4 MMAE: dolastat
Slide 5: CDX-011: Consistent Clinical Experience
Phase 1/2 study in patients with heavily pre-treated metastatic melanoma (n=117), not selected for GPNMB expression CDX-011 well tolerated; Phase 2 dose defined at 1.88 mg/kg Exploratory analysis showed enrichment for tumor regression in patients with significant tumor GPNMB expression Phase 1/2 tri
Slide 6: EMERGE: Phase 2b Randomized Study in Advanced Breast Cancer
Advanced, GPNMB-expressing breast cancer patients refractory/resistant to approved therapies (targeted n=120) Study designed to examine whether anti-cancer activity of CDX-011 is dependent upon distribution/intensity of GPNMB expression Endpoints: overall response rate [primary], progression-free su
Slide 7: EMERGE: Tissue Screening for GPNMB Expression
EMERGE patients were selected for GPNMB expression using validated, centralized IHC method Generally historical samples from prior resections (primary or metastatic) Of 338 screened patients, 99% were considered eligible (> 5% of tumor or stroma cells expressing GPNMB) EMERGE: Tissue Screening for G
Slide 8: Baseline Characteristics
EMERGE: Baseline Characteristics All Treated Patients CDX-011 (N=81) Investigator’s Choice (N=41) Mean Age [Years (SD)] 56.4 (10.4) 55.8 (10.0) Breast Cancer Stage [n (%)] III 2 (2%) 0 IV 79 (98%) 41 (100%) Visceral disease (Liver or Lung) [n (%)] 67 (83%) 33 (80%) Mean Duration of Metastatic or Loc
Slide 9: Safety Summary
EMERGE: Safety Summary All Treated Patients 9 IC = Investigator’s Choice CDX-011 arm includes 15 patients who crossed over to receive CDX-011 treatment after progression on IC. Table presents treatment-related adverse events with incidence >15% overall, or >3% at Grade 3-4 severity, in either study
Slide 10: Activity of CDX-011 is Greatest in Patients with Triple Negative and GPNMB-Expressing Disease
EMERGE: Activity of CDX-011 is Greatest in Patients with Triple Negative and GPNMB-Expressing Disease Responses per RECIST 1.1; IC = Investigator’s Choice; PR = Partial Response; CDX-011 arm includes 15 patients who crossed over to receive CDX-011 treatment after progression on IC. Analysis of best
Slide 11: Correlation of Response and GPNMB Expression
EMERGE: Correlation of Response and GPNMB Expression 11 Tumor Cells Expressing GPNMB % Patients with Partial Response* CDX-011 Investigator’s Choice Low GPNMB expression is defined as expression in <25% of tumor cells, while high GPNMB expression is defined as expression in >25% of tumor cells. * In
Slide 12: Triple-Negative Patients Correlation of Response and GPNMB Expression
EMERGE: Triple-Negative Patients Correlation of Response and GPNMB Expression 12 Tumor Cells Expressing GPNMB % Patients with Partial Response* CDX-011 Investigator’s Choice Low GPNMB expression is defined as expression in <25% of tumor cells, while high GPNMB expression is defined as expression in
Slide 13: Early Progression-Free Survival in Triple Negative and GPNMB-Expressing Breast Cancer
EMERGE: Early Progression-Free Survival in Triple Negative and GPNMB-Expressing Breast Cancer Triple Negative High GPNMB Expression (>25% of Tumor Cells) Triple Negative and High GPNMB Expression Months Months Months CDX-011 IC P = 0.0996 CDX-011 IC P = 0.0032 CDX-011 IC P = 0.4071 13 Progression-Fr
Slide 14: Current Standard of Care Therapies Produce Low Response Rate in GPNMB+ Patients
EMERGE: Current Standard of Care Therapies Produce Low Response Rate in GPNMB+ Patients 14 Prior Studies in Treatment-Refractory Breast Cancer EMERGE Experience All Patients GPNMB expression in > 25% of Tumor Cells Halaven® (Eribulin) Partial Response 0% (0/13) 0% (0/6) Confirmed PR 12-13%1 0% (0/13
Slide 15: Preliminary EMERGE Results Consistent with Previous Data in Similar Population
Preliminary EMERGE Results Consistent with Previous Data in Similar Population Promising activity in triple-negative breast cancer (TNBC), where treatment options are limited CDX-011 response rate of 21% in TNBC compared to 0% for Investigator’s Choice (IC) therapy Significant tumor expression of GP
Slide 16: For additional information, please visit: www.celldextherapeutics.com
For additional information, please visit: www.celldextherapeutics.com 16