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Celldex Reports First Quarter 2014 Results

HAMPTON, N.J., May 1, 2014 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business and financial highlights for the first quarter ended March 31, 2014.

"Celldex continues to advance one of the most robust, well-staged pipelines in immuno-oncology," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "We anticipate completing enrollment in our Phase 3 study of rindopepimut in brain cancer later this year and are making excellent progress with our accelerated approval study of glembatumumab vedotin in triple negative breast cancer with more than 50 sites now open to screen patients. We are also completing the necessary preparations to significantly expand clinical development of glembatumumab vedotin into metastatic melanoma and squamous cell lung cancer and varlilumab into several Phase 1/2 trials and look forward to updating on our progress as new studies begin over the coming months."

Program Updates:

Rindopepimut ("rindo"; CDX-110) in EGFR v III(v3)-Positive Glioblastoma (GBM):
  • Celldex continues to enroll newly diagnosed patients with GBM in ACT IV, the Phase 3 registration study and, consistent with previous guidance, anticipates completion of enrollment in mid-2014.  
  • Celldex continues to enroll patients with recurrent GBM in ReACT, a Phase 2 study that includes patients both naïve and refractory to Avastin ®. Enrollment to Group 1 (n=70 Avastin-naïve patients) and enrollment of at least the first 23 patients in Group 2C (n=up to 73 Avastin-refractory patients) is expected to be completed by year-end 2014. (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, 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 more than 50 sites are open to enrollment. In total, the study is expected to include approximately 100 sites in the United States, Canada and Australia.  
  • Celldex continues to advance plans to initiate Phase 2 studies of glembatumumab vedotin in metastatic melanoma and squamous cell lung cancer in the second half of 2014.

Varlilumab ("varli"; CDX-1127), an immune modulating mAb targeting CD27 in solid tumors and hematologic malignancies:
  • Celldex continues to advance plans to initiate multiple Phase 1/2 studies of varlilumab in combination with various agents in the second half of 2014, including a Phase 1/2 study of varlilumab and Yervoy ® (and potentially other checkpoint inhibitors) plus CDX-1401 in NY-ESO+ patients with metastatic melanoma and a Phase 1/2 study of varlilumab plus B-raf targeted pathway agents (followed sequentially by a checkpoint inhibitor) for patients with B-raf mutated metastatic melanoma.
  • Celldex will present data from the Phase 1 varlilumab program in two separate Poster Highlight Sessions at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting. The first presentation will include dose-escalation data from the solid tumor arm of the study and data from the expansion cohorts in metastatic melanoma and renal cell carcinoma; the second will include dose-escalation data from the hematologic malignancies arm of the study.

CDX-1401, an antibody-based dendritic cell targeted vaccine targeting tumors expressing the NY-ESO-1 oncoprotein:
  • On April 16, 2014, 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.
  • A Phase 1/2 study of varlilumab and Yervoy (and potentially other checkpoint inhibitors) plus CDX-1401 in NY-ESO+ patients with metastatic melanoma is planned to initiate in the second half of 2014. In addition, Celldex will provide support for a National Cancer Institute sponsored Phase 2 study of CDX-1401 and CDX-301 for patients with metastatic melanoma to start later this year.

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, Celldex will support an 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 in 2014.

First Quarter 2014 Financial Highlights and 2014 Guidance

Cash position: Cash, cash equivalents and marketable securities as of March 31, 2014 were $274.2 million compared to $303.0 million as of December 31, 2013. The decrease was primarily driven by our first quarter net cash burn of $28.8 million which includes a one-time $2.5 million milestone payment to Seattle Genetics for the METRIC study initiation. As of March 31, 2014 Celldex had 89.4 million shares outstanding.

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