HAMPTON, N.J., April 29, 2015 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business and financial highlights for the first quarter ended March 31, 2015. "2015 began with a significant accomplishment for RINTEGA®—the granting of Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma. We believe this designation underscores RINTEGA's therapeutic potential for these patients," said Anthony Marucci, Co-founder, President and Chief Executive Officer. "To this end, we look forward to presenting updated data from the ReACT study in the recurrent setting at ASCO and eagerly await data from the fully enrolled ACT IV study in the frontline setting. "This momentum is further supported by our growing pipeline. In the first quarter, we continued to advance several combination studies specifically designed to intervene at key points of immune regulation. The varlilumab/Opdivo® study and the varlilumab/Yervoy®/CDX-1401 study are now both open to enrollment. We also announced a clinical trial collaboration with Roche to combine their anti-PDL1 agent with varlilumab in a Phase 1/2 study that will initiate later this year. Additionally, glembatumumab vedotin is enrolling patients in two trials with plans for a third trial to start by year-end. Importantly, these initiatives, including our ongoing efforts to prepare for the potential commercial launch of RINTEGA, were further bolstered with the successful completion of an over-subscribed public offering in early March." Program Updates: RINTEGA® ("rindopepimut"; "rindo"; CDX-110), an EGFR vIII(v3)-specific therapeutic vaccine for glioblastoma (GBM)
- In February 2015, the U.S. Food and Drug Administration (FDA) granted RINTEGA Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma.
- Enrollment was completed in late 2014 in ACT IV (n=745), the Phase 3 registration study in newly diagnosed patients with GBM. Interim analyses will be conducted by an independent Data Safety and Monitoring Board at 50 and 75% of events. The first interim analysis is expected in mid-2015.
- Data from the Phase 2 ReACT study in patients with recurrent GBM will be presented in an oral session in the Clinical Science Symposium "Immunotherapy for Central Nervous System Tumors: Biomarkers and Novel Data" at the 2015 ASCO Annual Meeting on Sunday, May 31, 2015 at 8:00 a.m. by David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Center and Associate Professor of Medicine, Harvard Medical School, and the lead investigator of the ReACT study.
- Patient enrollment is accelerating in the Company's Phase 2b randomized study (METRIC) of glemba in patients with metastatic triple negative breast cancers that overexpress gpNMB, a molecule associated with poor outcomes for triple negative breast cancer patients and the target of glembatumumab vedotin. To date, 95 sites are open to enrollment across the United States, Canada and Australia. Trial expansion into the European Union is planned. Based on current projections, enrollment will extend into 2016.
- The METRIC study will be presented in a clinical trial in progress poster session at the 2015 ASCO Annual Meeting on Saturday, May 30, 2015.
- Data from the Phase 2 EMERGE study of glembatumumab vedotin in metastatic breast cancer were published in the Journal of Clinical Oncology. The data from this study supported the initiation of the METRIC study.
- Patient enrollment continues in the Phase 2 study of glembatumumab vedotin in metastatic melanoma. To date, eight of 10 planned sites are open to enrollment in the United States.
- Celldex continues to advance plans to expand the study of glembatumumab vedotin into other cancers in which gpNMB is expressed.
- Study design is being finalized for a Phase 2 study in squamous cell lung cancer and the study will commence 2H 2015.
- 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. Protocols for the study are currently being developed.
- In April 2015, the Company presented preclinical data that support varlilumab's expansion into combination studies with PD-1 inhibitors in a poster session at the AACR Annual Meeting 2015. Data demonstrated that the combination of varlilumab and anti-PD-L1 induces a potent immune-mediated effect that results in important changes in the tumor microenvironment. Most notably, it was observed that the combination strategy improved the ratio of effector T cells to regulatory T cells, which was accompanied by a reduction in the expression of PD-1 on both effector and regulatory T cells.
- In April 2015, Celldex announced the initiation of a Phase 1/2 study examining the combination of varlilumab and ipilimumab (Yervoy®; Bristol-Myers Squibb) in patients with Stage III or IV metastatic melanoma. This study is currently open to enrollment. In the Phase 2 portion of the study, patients with tumors that express NY-ESO-1 will also receive CDX-1401, Celldex's off-the-shelf antibody-based dendritic cell vaccine that targets tumors expressing the NY-ESO-1 oncoprotein.
- In April 2015, Celldex announced that it had entered into a clinical trial collaboration with Roche to evaluate the combination of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A (anti-PDL1), Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma. Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to open to enrollment in 2H 2015.
- In January 2015, Celldex announced that enrollment had opened in the Phase 1/2 study of varlilumab and Opdivo® in adult patients with advanced non-small cell lung cancer, metastatic melanoma, colorectal cancer, ovarian cancer, and head and neck squamous cell carcinoma. This study is being conducted by Celldex under a clinical trial collaboration with Bristol-Myers Squibb Company. The companies are sharing development costs.
- The Phase 1b study of varlilumab and ONT-10, Oncothyreon's therapeutic vaccine targeting the tumor-associated antigen MUC1, continues to actively enroll patients with advanced breast or ovarian cancer. Celldex is providing study drug and Oncothyreon is conducting the study.
- Efforts are underway for additional Phase 2 studies of varlilumab and the Company will provide updates on these studies as they are initiated.
- In April 2015, Celldex announced the initiation of a Phase 1/2 study examining the combination of varlilumab and ipilimumab (Yervoy®; Bristol-Myers Squibb) in patients with Stage III or IV metastatic melanoma. This study is currently open to enrollment. In the Phase 2 portion of the study, patients with tumors that express NY-ESO-1 will also receive CDX-1401, an off-the-shelf antibody-based dendritic cell targeted vaccine.
- Celldex continues to support several external collaborations, including a National Cancer Institute sponsored Phase 2 study of CDX-1401 and CDX-301 for patients with metastatic melanoma, which is open to enrollment.
- CDX-301 is being developed as a combination product with other immuno-oncology agents in a number of investigator-sponsored studies.
- A pilot study of CDX-301 alone and in combination with Mozobil® in hematopoietic stem cell transplantation was initiated in September of 2014 and is open to enrollment.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.—table follows—
|CELLDEX THERAPEUTICS, INC.|
|(In thousands, except per share amounts)|
|OF OPERATIONS DATA||Ended March 31,|
|Product Development and Licensing Agreements||$ 342||$ 35|
|Contracts and Grants||144||381|
|Research and Development||25,125||27,070|
|General and Administrative||6,089||4,582|
|Amortization of Acquired Intangible Assets||253||253|
|Total Operating Expense||31,467||31,905|
|Investment and Other Income, Net||807||1,586|
|Net Loss||$ (30,174)||$ (29,903)|
|Basic and Diluted Net Loss per Common Share||$ (0.33)||$ (0.33)|
|Weighted Average Common Shares Outstanding||92,437||89,270|
|BALANCE SHEETS DATA||March 31,||December 31,|
|Cash, Cash Equivalents and Marketable Securities||$ 359,773||$ 201,043|
|Other Current Assets||4,356||3,942|
|Property and Equipment, net||11,236||10,535|
|Intangible and Other Assets, net||32,335||32,494|
|Total Assets||$ 407,700||$ 248,014|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Current Liabilities||$ 21,148||$ 24,491|
|Total Liabilities and Stockholders' Equity||$ 407,700||$ 248,014|
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