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)
Positive data from this study will not only strengthen the validity of such combination studies but also contribute to the validation of varlilumab as a clinically potent enhancer of anti-tumor immune response. A combination of these two drugs to treat tumors is backed by scientific rationale that varlilumab will activate immune response against the tumor while nivolumab will simultaneously preventing the shutting down of the immune response by the tumor cells.
Together, a combination of these two drugs is expected to exert a synergistic effect in cancer patients. Celldex retains the right to use varlilumab in other combinations with their internal assets as well as with external assets that are not pure-play PD-1, such as PDL-1.
Strategy Session July 10th, 2014- Celldex Therapeutics establishes preclinical proof of concept for new antibody drug conjugate CDX-014; Data
From where you got 91% institutional hold? seriously that's the reason you see -NO OPTIONS SELL for long term and most likely $20 range expected back soon.
CLDX FDA Releases Draft Guidance for Accelerated Approval of Breast Cancer Treatments
Tweet Again appeared - Biotechs on move $VRTX -FDA approval, $CLDX again that Big Pharma that they would buy smaller companies that are harnessing novel technologies to develop drug treatments for leukemias and lymphomas buyout potential based on recent AMGN buys Micromet for $11 a share in cash in its field
Celldex initiated a pilot study for CDX-1135 (soluble complement receptor 1) in a rare kidney disease (dense deposit disease). Dense deposit disease is associated with a mutation in the complement pathway that leads to uncontrolled pathway activation. There are high hopes around CDX-1135 given the fact that the drug’s mechanism of action is similar to that of Alexion’s (ALXN) Soliris.
Street Adam & Oppenheimer analyst Boris Peaker both remains optimistic on CDX-1135 further development plan as it still remains in the early stages of development also there are other indications where CDX-1135 can be pursued. CDX1135 can complement modulating drugs like Soliris from Alexion Pharmaceuticals (ALXN). As the potentials Sales of the drug in 2012 topped $1.1B for Soliris.