Even after a year - This p2 results are still valid just waiting for the interim results.
Celldex has already proven that its drug works. CDX-011 has already extended life, slowed progression, and had a high response rate in 120 patients. To me, it is clear which product has the highest upside in the breast cancer market. When you consider CDX-011’s sales potential of $700 million and the fact that Celldex has a large pipeline with one other late-stage brain cancer drug, I think it’s clear that Celldex makes a great investment.
CDX-011 is a vaccine used to treat patients with advanced/metastatic breast cancer who express the protein GPNMB. The FDA has granted Fast Track designation to CDX-011 for the treatment of advanced, refractory/resistant GPNMB-expressing breast cancer.
What’s impressive about CDX-011 is that it was proven effective on patients who had no longer responded to a median of five-six prior therapies; meaning most difficult to treat. Yet, of the 120 patients treated with CDX-011, 33% had a response rate compared to no response in patients using chemotherapy. Moreover, CDX-011 slowed the growth of tumors by 100% compared to its control arm.
Due to the stage of the disease, such progress is considered incredible. The technology used is equally impressive, as the success from the trial proves that targeting GPNMB is highly effective in treating such violent diseases. Thus, investors are excited that this protein is also expressed in multiple tumors such as melanoma and glioma.
Moving forward, the question is not whether the drug will be approved, but rather when it will be approved. The FDA is already showing favoritism towards the drug, and has a history of rapidly approving drugs for life-threatening cancers. As a result, there’s a lot to like when it comes to Celldex.
CLDX will give out interim results by 6th August as they said during QTRLY report wrap up 2014.
Leaked: This coming blockbuster will make every biotech jealous
The best biotech investors consistently reap gigantic profits by recognizing true potential earlier and more accurately than anyone else. Let me cut right to the chase. There is a product in development that will revolutionize not just how we treat a common chronic illness, but potentially the entire health industry. Analysts are already licking their chops at the sales potential.
Rindopepimut - Brain Cancer
Celldex's most advanced clinical candidate, rindopepimut, is indicated as a potential treatment for glioblastoma multiforme, a particularly aggressive and difficult-to-treat form of brain cancer. What's key to understand is that numerous experimental treatments for glioblastoma have failed in clinical trials over the years. Roche's Avastin was the first pharmaceutical approved by the Food and Drug Administration to treat any form of glioblastoma in over a decade, and even it can only claim marginal clinical benefits for this terrible disease.
Glembatumumab- Breast Cancer
The company's second most advanced clinical candidate, Glembatumumab vedotin, is based on Seattle Genetics' (NASDAQ: SGEN ) promising antibody-drug conjugate, or ADC, technology that consists of a human monoclonal antibody linked to a potent cellular toxin. Glembatumumab is being tested as a potential treatment for breast cancer and melanoma.
Puma Biotechnology Inc. (PBYI) almost tripled in extended trading after the company said a clinical trial of its experimental drug blocked the return of breast cancer in women with a type of early-stage disease.
The drug, neratinib, improved disease-free survival by 33 percent compared with a placebo in a trial of 2,821 women with early-stage HER2-positive breast cancer, Los Angeles-based Puma said today in a statement. Disease-free survival refers to the interval a patient remains alive and free of signs of the illness. The company said it would apply for U.S. regulatory approval in the first half of 2015 based on the results.
Puma almost tripled to $169.48 in extended trading at 5:35 p.m. New York time after closing at $59.03. The company had declined 43 percent this year.
If PANDORA of CDX1135 OPENED again I m sure this will attract many more indications then Alexion Solaris. I really don't understand that why they are not pursuing other indications where possibilities are many?
With Soliris being the priciest drug in the U.S., having multiple uses, and being expected to generate sales over $2 billion this year, investors were excited about CDX-1135's developmental possibilities. Theoretically, if CDX-1135 was successful, many believed it could one day challenge Alexion in treating many of the same diseases. This would consequently potentially effect Soliris' pricing and Alexion's $30 billion market capitalization. It was a big blow for Celldex to close the program, but it was possibly a big win for Alexion.
In three previous clinical trials in patients with newly diagnosed EGFRvIII-positive glioblastoma, patients given rindopepimut and the standard treatment, temozolomide, had encouraging clinical results compared to historical control patients who were treated with temozolomide alone.
The ACT IV study is a Phase III study to investigate the effect rindopepimut has on the survival rate, time to disease progression, and quality of life of patients with newly diagnosed EGFRvIII-positive glioblastoma.
Approximately 440 people are expected to participate in the study, which is being conducted at nearly 200 locations around the world.
Some positive outcome may be the O/S of 25% or above will take CLDX $100 or even higher in ACT IV— a Phase 3 Study of Rindopepimut in Patients with Newly Diagnosed EGFRvIII-Positive Glioblastoma.
Adam Feuerstein -Yellen quote about biotech stocks from transcript of her speech.
Small Biotech already declined ! CLDX from $38 from beginning of this year to now $14?
Moreover, implied volatility for the overall S&P 500 index, as calculated from option prices, has declined in recent months to low levels last recorded in the mid-1990s and mid-2000s, reflecting improved market sentiment and, perhaps, the influence of "reach for yield" behavior by some investors.
Harry Boxer predicted CLDX is ready to move to $22 ... FDA grants accelerated approval to cancer drug Beleodaq (belinostat); CLDX
Bristol-Myers Squibb and Celldex Therapeutics, Inc. to evaluate the safety, tolerability and preliminary efficacy of nivolumab, Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, and varlilumab, Celldex’s CD27 targeting investigational antibody in a Phase 1/2 study. As leaders in immuno-oncology, Bristol-Myers Squibb is advancing the science of how immunotherapy can harness the body’s immune system to fight multiple types of cancers
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.
• Complete accrual of ACT IV, the Phase 3 registration study for patients with frontline GBM
• Complete accrual of ReACT, the Phase 2 study for patients with recurrent GBM (both Group 1 and 2C); report data in late 2014
• Continue accrual of METRIC, the accelerated approval study for patients with triple negative breast cancer
• Initiate a Phase 2 study for patients with metastatic melanoma
• Initiate a Phase 2 study for patients with squamous cell lung cancer
• Complete the Phase 1 solid tumor expansion cohorts and hematologic dose-escalation cohorts; data anticipated in mid-2014. Initiate expansion cohorts in lymphocytic malignancies as appropriate
• Initiate a Phase 1/2 study of varlilumab and Yervoy (and potentially other checkpoint inhibitors) plus CDX-1401 in NY-ESO+ patients with metastatic melanoma
• Initiate a Phase 1/2 study of varlilumab plus Tafinlar® and Mekinist™ (followed sequentially by a checkpoint inhibitor) for patients with B-raf mutated metastatic melanoma
• Support a Phase 2 study of CDX-1401 and CDX-301 for patients with metastatic melanoma (NCI sponsored)
• Initiate a pilot study of CDX-301 alone and in combination with Mozobil in hematopoietic stem cell transplantation
• Support a 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 (investigator sponsored)