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Celldex Reports Second Quarter 2014 Results

HAMPTON, N.J., Aug. 6, 2014 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business and financial highlights for the second quarter ended June 30, 2014.

"Celldex has made tremendous progress advancing our pipeline this year—most notably, we will complete patient screening in the coming weeks for our Phase 3 ACT IV study of rindopepimut in newly-diagnosed glioblastoma, an aggressive form of brain cancer," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "The ACT IV study will include 700 patients with EGFR vIII positive glioblastoma from more than 200 clinical trial sites across 22 countries—the most comprehensive study conducted by a biotech company to date in this orphan disease. We are extremely proud of our team and very grateful to the patients, families and physicians who are participating in this study.

In the second quarter, we also accomplished a number of additional, significant milestones—advancing our accelerated approval study of glembatumumab vedotin in triple negative breast cancer, publishing positive data from the CDX-1401 program, presenting positive data from our Phase 1 varlilumab program at ASCO and announcing a clinical trial collaboration with BMS for the varlilumab program. This momentum is expected to continue in the second half of 2014 as we initiate multiple new studies across our pipeline and present data from our Phase 2 ReACT study in recurrent glioblastoma at year-end."

Program Updates:

Rindopepimut ("rindo"; CDX-110) in EGFR v III(v3)-Positive Glioblastoma (GBM):
  • Celldex will close screening in the next several weeks for ACT IV, the Phase 3 registration study of newly diagnosed patients with GBM. Patients whose tissues screen positive for EGFR vIII are randomized into the study after completion of surgery and standard chemoradiation, which can occur up to three months after screening. To date, 4,034 patients have been screened and, consistent with prior studies, 30.2% have been EGFR vIII positive. 614 patients have been enrolled in ACT IV to date, and, as expected, 263 of these patients were enrolled in the last 8 months. In total, 700 patients will be enrolled into ACT IV to reach the required 374 patients with minimal residual disease (assessed by central review) needed for analysis of the primary overall survival (OS) endpoint. All patients, including patients with disease that exceed this threshold, will be included in a secondary analysis of OS as well as analyses of progression-free survival, safety and tolerability, and quality of life.  
  • In the Phase 2 ReACT study in patients with recurrent GBM, Celldex has completed enrollment of both Group 1 (n=70 Avastin®-naïve patients) and the first 23 patients of Group 2C (n=up to 73 Avastin-refractory patients). Group 2C is designed as a two-stage cohort; evidence of anti-tumor activity in the first 23 patients will trigger full completion of enrollment to this arm of the study. Updated data from the study will be presented by year-end 2014.

Glembatumumab vedotin ("glemba"; CDX-011) targeting gpNMB in multiple cancers:
  • In December 2013, Celldex initiated a randomized, accelerated approval study (METRIC) of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress the tumor associated marker gpNMB. To date, 73 sites are open to enrollment across the United States, Canada and Australia. In total, the study is expected to include approximately 100 sites.    
  • Celldex continues to advance plans to expand the study of glembatumumab vedotin into other cancers in which gpNMB is expressed.  
    • The protocol for the Phase 2 study in metastatic melanoma has been finalized and the study will be initiated later this year.
    • Assay optimization and validation for the Phase 2 study in squamous cell lung cancer is expected to be completed by year-end and the study will commence soon thereafter.
    • Celldex and the National Cancer Institute have entered into a Cooperative Research and Development Agreement (CRADA) under which NCI will sponsor two studies of glembatumumab vedotin—one in uveal melanoma and one in pediatric osteosarcoma. Celldex will provide support for these studies.

Varlilumab ("varli"; CDX-1127), an immune modulating mAb targeting CD27 in solid tumors and hematologic malignancies: 
  • In May, Celldex announced that it had entered into a clinical trial collaboration with Bristol-Myers Squibb Company (BMS) to evaluate the safety, tolerability and preliminary efficacy of Opdivo® (nivolumab), BMS's investigational PD-1 immune checkpoint inhibitor, and varlilumab. Multiple tumor types will be explored in the study, which could potentially include non-small cell lung cancer (NSCLC), metastatic melanoma, ovarian, colorectal (CRC) and squamous cell head and neck cancers. The study will be conducted by Celldex and Celldex and BMS will share development costs. The study is expected to begin in the fourth quarter.
  • In June, Celldex presented data from the Phase 1 varlilumab program in two separate Poster Highlight Sessions at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting. Results presented included data from the lymphoid malignancies dose-escalation arm and solid tumor expansion cohorts in metastatic melanoma and renal cell carcinoma. Varlilumab was very well tolerated and demonstrated clear biologic activity and promising signs of clinical activity in advanced, treatment-refractory patient populations, which continue to support the rationale for combination studies with other immune activating therapies.
  • Celldex has finalized the protocol for a Phase 1/2 study of varlilumab and Yervoy plus CDX-1401 in NY-ESO+ patients with metastatic melanoma and this study will begin by year-end.
  • In May, Celldex announced that it had agreed to collaborate with Oncothyreon Inc. on a combined clinical trial of ONT-10, a therapeutic vaccine targeting the tumor-associated antigen MUC1, and varlilumab. This study will be conducted and funded by Oncothyreon.
  • Multiple efforts are underway to finalize designs and plans for additional Phase 2 studies of varlilumab and the Company will provide updates on these studies as they get closer to initiation. 

CDX-1401, an antibody-based dendritic cell targeted vaccine targeting tumors expressing the NY-ESO-1 oncoprotein:
  • In April, final data from the Phase 1 study of CDX-1401 in solid tumors, including long-term patient follow-up, was published in Science Translational Medicine (Vol 6 Issue 232). The data demonstrated robust antibody and T cell responses and evidence of clinical benefit in patients with very advanced cancers and suggested that CDX-1401 may predispose patients to better outcomes on subsequent therapy with checkpoint inhibitors. This data directly supports the initiation of the Phase 1/2 study of varlilumab and Yervoy plus CDX-1401 in NY-ESO+ patients with metastatic melanoma.
  • Celldex continues to provide support for the National Cancer Institute sponsored Phase 2 study of CDX-1401 and CDX-301 for patients with metastatic melanoma, which is currently open to enrollment.

CDX-301 (Flt3L), a potent hematopoietic cytokine that stimulates the expansion and differentiation of hematopoietic stem cells and dendritic cells:
  • Celldex continues to advance plans to initiate combination studies of CDX-301 in 2014 to explore its potential for improving hematopoietic stem cell transplantation and potentiating immune activation. A pilot study of CDX-301 alone and in combination with Mozobil® in hematopoietic stem cell transplantation will be initiated in the third quarter.
  • In addition, the investigator sponsored Phase 1/2 study of intratumoral injection of CDX-301 and Hiltonol® in combination with low-dose radiotherapy for patients with low-grade B-cell lymphomas has initiated and the first patients have been dosed.

Second Quarter and First Six Months 2014 Financial Highlights and 2014 Guidance

Cash position: Cash, cash equivalents and marketable securities as of June 30, 2014 were $252.4 million compared to $274.2 million as of March 31, 2014. The decrease was primarily driven by our second quarter net cash burn of $21.8 million, offset in part by a one-time payment of $5 million from BMS. As of June 30, 2014 Celldex had 89.4 million shares outstanding.

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