Celldex Therapeutics (CLDX) Discontinues Study of Brain Cancer Vaccine, Shares Crater

Shares of Celldex Therapeutics Inc. (CLDX) were trading down -4.28 or -52.26 percent to $3.91 per share in Monday’s premarket after the company announced the discontinuation of a late stage study of its brain cancer vaccine. Celldex Therapeutics stock closed at $8.19, down -0.06 or -0.73 percent in Friday’s regular trading session.

Hampton, New Jersey based Celldex Therapeutics is a biopharmaceutical company that focuses on the development of targeted therapies for devastating diseases based on enhancing or suppressing the body’s immune response.
Celldex’s pipeline is made up of immune system modulators, therapeutic antibodies, vaccines and drug conjugates, creating a leading pipeline in immune-oncology. The company’s therapies are currently in clinical trials for treatment of: bladder cancer, colorectal cancer, breast cancer, glioblastoma, melanoma, head and neck cancer, non-small cell lung cancer, prostate cancer, ovarian cancer and renal cell carcinoma.

Celldex announced early this morning that based on a recommendation by the Data Safety and Monitoring Board or DSMB, an independent agency, it would discontinue its Phase 3 ACT IV study of Rintenga or ridopepimut in patients with newly diagnosed EGFRvIII-positive glioblastoma.

The Rintenga vaccine targets specific genetic mutations found in approximately 30 percent of GBM or glioblastoma multiform tumors. The independent data safety study and monitoring board found that overall survival of newly diagnosed patients with GBM were the same as those in a control group. After the discontinuation of the study, Celldex does not anticipate incurring any additional costs related to Rintenga.

Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics stated in the company’s press release that, “We are extremely disappointed for patients that the ACT IV study was not successful. On behalf of Celldex, I want to express our gratitude to the ACT IV investigators, patients and families who participated in this trial. While this is certainly not the desired outcome, we remain steadfast believers in the power of immunotherapy to transform the future of cancer treatment.”

The company said that all patients that participated in the Rintega arm of the ACT IV study, prior Phase 2 studies and other compassionate use patients will be offered access to rintega on a compassionate use basis. Celldex first received the results of the independent study on March 4th and is currently reviewing the data.

Celldex currently has seven ongoing clinical trials for five product candidates and expects to report the results of a number of the studies over the next three to 18 months. The trials include a registration study for triple negative breast cancer, as well as a number of Phase I and Phase II cancer immunotherapy combination trials.

Celldex stock has sold off significantly since trading just under $32 per share in March of last year. The stock will open at a new all-time low this morning in the regular trading session after having lost more than half of its value in this morning’s premarket.

Other News About CKEC

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Celldex's Q4 Loss Narrower than Expected; Focus on Pipeline

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Published on Mar 7, 2016
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

Copyrighted 2016. Content published with author's permission.

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