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Celldex Therapeutics Inc (CLDX.OQ)

CLDX.OQ on NASDAQ Stock Exchange Global Select Market

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23 Sep 2016
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Latest Key Developments (Source: Significant Developments)

Celldex reports second quarter 2016 results
Monday, 8 Aug 2016 04:01pm EDT 

Celldex Therapeutics Inc : Q2 revenue $1.4 million versus $2.7 million . Q2 earnings per share view $-0.34 -- Thomson Reuters I/B/E/S . Celldex reports second quarter 2016 results . Q2 loss per share $0.32 .Q2 revenue view $850,000 -- Thomson Reuters I/B/E/S.  Full Article

Celldex Therapeutics initiates phase 1/2 study of Varlilumab in combination with Sunitinib in Metastatic Clear Cell Renal Cell Carcinoma
Thursday, 28 May 2015 09:23am EDT 

Celldex Therapeutics:Says initiation of an open-label, Phase 1/2 safety and tolerability study examining the investigational combination of varlilumab and sunitinib (SUTENT) in patients with metastatic clear cell renal cell carcinoma (CC-RCC).Varlilumab is Celldex's fully human monoclonal agonist antibody that binds and activates CD27, a critical co-stimulatory molecule in the immune activation cascade.Sunitinib is approved by the FDA as monotherapy for the treatment of advanced renal cell carcinoma (RCC), as well as certain advanced gastrointestinal stromal tumors and pancreatic neuroendocrine tumors.Varlilumab is currently being studied in four Phase 1/2 combination studies, and additional combination studies will be initiated in 2015.  Full Article

Celldex Therapeutics announces initiation of phase 1/2 study of varlilumab in combination with ipilimumab and CDX-1401 in metastatic melanoma
Monday, 6 Apr 2015 08:01am EDT 

Celldex Therapeutics Inc:Announced the initiation of a Phase 1/2 safety pilot and expansion study examining the investigational combination of varlilumab and ipilimumab (Yervoy(); Bristol-Myers Squibb) in patients with Stage III or IV metastatic melanoma.Varlilumab is Celldex's fully human monoclonal antibody that targets CD27, a critical co-stimulatory molecule in the immune activation cascade.Ipilimumab, a recombinant, human monoclonal antibody that blocks CTLA-4, is FDA approved for the treatment of unresectable or metastatic melanoma.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.  Full Article

Celldex Therapeutics, Inc announces clinical trial collaboration with Roche to Evaluate Combination of Varlilumab and MPDL3280A
Tuesday, 17 Mar 2015 08:01am EDT 

Celldex Therapeutics, Inc:Enters into clinical trial collaboration with Roche to evaluate safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A (anti-PDL1).Says Varlilumab and MPDL3280A are part of new class of investigational medicines known as cancer immunotherapies.Says these are designed to harness body's own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells.Celldex's Phase 1 study of varlilumab in multiple solid tumors, promising signs of clinical activity in patients with refractory renal cell carcinoma were observed, including a durable partial response that has continued to decrease in tumor volume over time and prolonged stable disease.Under terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015.  Full Article

Celldex Therapeutics, Inc prices public offering of common stock
Wednesday, 25 Feb 2015 06:49pm EST 

Celldex Therapeutics, Inc:Announced the pricing of an underwritten public offering of 7,250,000 shares of its common stock, offered at a price to the public of $24.00 per share for an aggregate offering of $174.0 million of common stock.The net proceeds to Celldex from this offering are expected to be about $164.2 million after deducting underwriting discounts and commissions and other estimated offering expenses payable by Celldex.The underwriters have been granted a 30-day option to purchase up to an aggregate of 1,087,500 additional shares of common stock.The offering is expected to close on or about March 3, 2015.Jefferies LLC and Leerink Partners LLC are acting as the joint book-running managers and underwriters for the proposed offering.Guggenheim Securities, LLC is acting as a lead manager in the offering.Oppenheimer & Co. Inc., Brean Capital, LLC, Cantor Fitzgerald & Co. and Roth Capital Partners, LLC are acting as co-managers of the offering.  Full Article

Celldex Therapeutics Inc announces proposed public offering of common stock
Tuesday, 24 Feb 2015 04:00pm EST 

Celldex Therapeutics Inc:Announced that it is offering 7.25 million shares of its common stock in a proposed underwritten public offering.Offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.Jefferies LLC and Leerink Partners LLC are acting as the joint book-running managers and underwriters for the proposed offering and Guggenheim Securities, LLC is acting as a lead manager in the offering.  Full Article

Celldex Therapeutics Inc's Rindopepimut receives FDA breakthrough therapy designation for the treatment of adult patients with EGFRvIII-positive Glioblastoma
Monday, 23 Feb 2015 08:01am EST 

Celldex Therapeutics Inc:Announced that the U.S. Food and Drug Administration (FDA) has granted rindopepimut (Rintega) Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma (GBM).Says this application was based on data from the Phase 2 ReACT study in recurrent GBM, the Phase 2 ACT III study in newly diagnosed GBM and additional supportive Phase 2 studies.An international Phase 3 study of rindopepimut, called ACT IV, in newly diagnosed GBM completed enrollment (n=745) in Dec. of 2014.  Full Article

Oncothyreon and Celldex Therapeutics announce initiation of Combination Immunotherapy clinical trial of ONT-10 and Varlilumab
Monday, 10 Nov 2014 04:05pm EST 

Oncothyreon Inc and Celldex Therapeutics, Inc:Initiated a combined clinical trial of ONT-10 and varlilumab.ONT-10 is a therapeutic vaccine targeting the tumor-associated antigen MUC1.Varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes.The trial is an open-label Phase 1b study of ONT-10 administered at the recommended single agent dose in combination with varlilumab at two dose levels in up to 42 patients with advanced breast or ovarian cancer.Primary objective of the trial is to determine the safety and tolerability of the combined therapy.Additional objectives include evaluations of the impact of combination treatment on MUC1-specific humoral and cellular immune responses, T-cell activation markers and levels of regulatory T-cells, and anti-tumor effects.Phase 1b trial will be conducted by Oncothyreon under the terms of a previously announced collaboration agreement between Oncothyreon and Celldex.Two companies will jointly own the data from the trial and will make any plans for potential future development of the combination therapy together.Under the agreement, neither company has granted the other a license, or any other rights, to its product candidate.  Full Article

BRIEF-Celldex appoints Elizabeth Crowley as chief product development officer

* Celldex appoints Elizabeth Crowley as chief product development officer Source text for Eikon: Further company coverage: