Without the CuraGen merger, Celldex provided guidance at the time for adequate liquidity to fund operations for at least the next 12 months, which included an analysis of expected cash inflows from grants / collaborations, income interest, and pre-merger cash / equivalents. However, the balance sheet has been significantly strengthened with the closing of the CuraGen merger, which included a price tag of about $93.5 million after making adjustments for CuraGen's $53.5 million in net cash.

Celldex Therapeutics has emerged as a bio-pharmaceutical company that is developing a robust pipeline of innovative, applied immunology product candidates focused on the treatment of cancer and infectious disease. The Company's Precision Targeted Immunotherapy Platform generates product candidates for clinical development that include therapeutic cancer vaccines, monoclonal antibodies, and vaccines which are targeted to specific markers associated with the underlying disease.

The CuraGen acquisition includes its lead compound in development, CR011-vcMMAE, which is being evaluated as an antibody-drug conjugate that is currently enrolled in two Phase 2 trials for the treatment of melanoma and metastatic breast cancer, in addition to a Phase I trial to evaluate the safety and activity of alternate dosing schedules. CuraGen has previously provided guidance for presenting updated data for the breast cancer study during 2H09 and Celldex plans to provide an update on the development status for this compound during 1H10.

CR011 is an antibody-drug combination comprised of CR011 (a fully-human monoclonal antibody) linked to the compound, monomethylauristatin E (vcMMAE). CR011 targets a specific molecule located on the surface of cancer cells called glycoprotein NMB (GPNMB) and after the antibody-drug conjugate (CR011-vcMMAE) binds to this target protein, it is transported inside the cancer cell where vcMMAE is separated from the antibody and causes cancer cell death.

CLDX is developing CDX-110 as a peptide-based cancer immunotherapy product candidate targeting the tumor specific molecule called EGFRvIII, which is a functional variant (tumor-specific) of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy (i.e. Erbitux). While originally discovered in GBM (glioblastoma multiforme / the most common and aggressive form of primary brain cancer), the expression of EGFRvIII has also been observed in a variety of other cancers.

CLDX presented mature data at ASCO 2009 from the Phase 2 ACTIVATE trial and updated data from the continuation study (ACT II) of CDX-110 in patients with newly diagnosed EGFRvIII-positive GBM. In both studies, CDX-110 was generally well-tolerated with local injection site reactions being the most commonly reported toxicity. In the single-arm Phase 2 ACTIVATE study, median overall survival (OS) was 26 months and median time to progression (TTP) was 14.2 months and three patients remain without relapse more than four years from surgery and continue to receive the vaccine. In the single-arm Phase 2 ACT II study, median TTP is 15.2 months and three patients continue without relapse after more than two years.

Results to date from this ongoing study estimate median OS to be 23.6 months. In collaboration with partner Pfizer (NYSE: PFE), CLDX is currently performing a Phase 2 study (ACT III) of CDX-110 in patients with newly diagnosed GBM. According to the ClinicalTrials.gov entry for this study (NCT00458601) (last updated 10/11/09, reflecting a quicker study completion date of April 2012), February 2010 is the estimated date for the primary outcome / progression-free survival status with full results likely to be presented at ASCO 2010.