Slide 1: 2012 Results and 2013 Strategic Outlook Conference Call
2012 Results and 2013 Strategic Outlook Conference Call March 7, 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: Rindopepimut: Targeting a High Unmet Need in Glioblastoma
Rindopepimut: Targeting a High Unmet Need in Glioblastoma 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 Control Datasets (all data from study entry) MD Anderson EGFRvIII-positive
Slide 4: 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 Control (KLH) + Bevacizumab Rindo pepimut /GM - CSF + Bevacizumab Randomization (1:1) Patients w
Slide 5: Rindopepimut (front-line) KOL/MD Feedback
Rindopepimut (front-line) KOL/MD Feedback Respondents’ Likelihood to Prescribe Rindopepimut to Newly Diagnosed Patients Newly Diagnosed GB OS data: A six-month improvement was considered unprecedented and highly favorable in a newly diagnosed GB population. Most respondents discussed readily using t
Slide 6: CDX-011: First-in-class Therapeutic Antibody for Metastatic Breast Cancer
CDX-011: First-in-class Therapeutic Antibody for Metastatic Breast Cancer; SABCS 2012 Final EMERGE Data > 25% GPNMB Expression TNBC and > 25% GPNMB Expression CDX-011 IC CDX-011 IC Median OS (months) 10.0 5.7 10.0 5.5 p=0.18 p=0.003 Median PFS (months) 2.7 1.5 3.0 1.5 p=0.14 p=0.008 Analyses include
Slide 7: CDX-011 Accelerated Approval Registration Study Design in GPNMB Over-expressing TNBC
CDX-011 Accelerated Approval Registration Study Design in GPNMB Over-expressing TNBC Study Parameters Randomization 2:1 N Approximately 300 Control Capecitabine (Xeloda) Patient Population Anthracycline- and taxane-resistant; GPNMB over-expressing TNBC Primary Endpoints: with a trial size of apx. 30
Slide 8: CDX-1135: A Potent Complement Inhibitor
CDX-1135: A Potent Complement Inhibitor CDX-1135 is a clinically proven effective complement inhibitor with unique properties—blocks both alternative and classical complement activation pathways Clear path to clinical opportunity in Dense Deposit Disease (DDD) Potent activity in mouse model of DDD C
Slide 9: CDX-1127: A Novel Immune Modulator Targeting CD27
Phase 1 study: two arms Solid Tumors (CD27-) 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 planned in 2013 Lymphoma/L
Slide 10: CDX-301 and CDX-1401
CDX-301 and CDX-1401 CDX-301 FMS-like tyrosine kinase 3 Ligand (Flt3L) Completed 30 patient healthy volunteer Phase 1 study Potent inducer of stem cells and dendritic cells at various dose regimens Well tolerated and non-immunogenic Next study – Hematopoietic stem cell transplant CDX-1401 Antibody-b
Slide 11: Anticipated Milestones for 2013
Anticipated Milestones for 2013 Rindopepimut Targeted accrual of ACT IV registration study by YE 2013 ReACT data: both Avastin naïve and refractory groups in 2H 2013 CDX-011 - Initiate accelerated approval study in metastatic breast cancer in 2H 2013 CDX-1135 - Initiate pilot study in DDD; data by Y
Slide 12: For additional information, please visit: www.celldextherapeutics.com
For additional information, please visit: www.celldextherapeutics.com