Last stock offering underwriters paid $24, Bristol's up-front payment was small relative to upfront payments made by big pharma and big biotechs in the past year, but the real benefit to Celldex is in the renegotiation of its license with Medarex and the potential to cozy up more closely with Bristol's promising oncology business.
CDX-1135 was the fourth maybe fifth most talked about product in Celldex's pipeline last year. It was being tested to treat a disease that affects just 300-500 patients in the U.S., and for this indication has very limited fundamental upside. Yet, it's similar to Alexion Pharmaceuticals's (ALXN) Soliris, which is what made it so attractive.
Soliris is a complement modulator, and works by binding to a component called C5, which has been linked to several genetic and blood diseases. Alexion Pharmaceuticals has grown to a $35 billion company with just this one single FDA approved drug, which earned $1.55 billion in sales last year. Currently, Soliris is approved to treat a life-threatening genetic disorder atypical hemolytic uremic syndrome and the blood disease paroxysmal nocturnal hemoglobinuria, but is being studied to treat five additional conditions. If successful at treating all diseases, some analysts predict peak sales reaching $5 billion worldwide due to Alexion's ability to price the drug sky-high in treating these ultra-rare conditions.
Now, back to Celldex: CDX-1135 works in the same way, binding to the exact same component. The only difference is that it also binds to the C3 component, which is why many long-term investors, including myself, believe that CDX-1135 is a secret value buried deep within the company's pipeline. Because after all, given the success of Soliris, conventional wisdom implies that CDX-1135 could be tested to treat various rare diseases, could be priced high, and would support an Alexion-like premium multiple once CDX-1135 is proven successful in clinical trials.
Three Phase 2 trials of rindopepimut have been completed in newly diagnosed EGFRvIII-positive glioblastoma patients with consistent results—ACTIVATE, ACT II, ACT III —and multiple patients continue to be followed for survival. Across all three studies, rindopepimut has been generally well tolerated with generation of robust, specific and durable immune responses.
DCVax-L DMC Phase III due 2-7-14 per the biopharmcatalyst site.
Soon will have $20 range...
Uneducated Car Salesman like ADAM FURESTEIN shall know 2 things. Where Clinical Trials done (Not at ADAMS BEDROOM) and WHO ACCEPTED THE ABSTRACT ( NOT ADAMS HEDGE FUNDS)
1. ASCO is attended by 30000 Oncologist
2. Clinical Trials are done at MD ANDERSON The Company is currently conducting a 60-patient Phase I/II trial with DCVax-Direct for five main types of inoperable tumors, including lung, colon, breast with brain metastases, melanoma and pancreatic cancers, as well as some others. The University of Texas MD Anderson Cancer Center is the lead site of the trial. In pre-clinical animal studies, injection of DCVax-Direct into inoperable tumors was able to cause tumor cell death, and the shrinkage or elimination of existing solid tumors.
ASCO is the largest and most important annual conference on cancer treatments, with some 30,000 oncologists and other medical personnel, analysts and others attending from all over the world. Last year, immune therapy emerged as the top new focus area. This year, the focus on immune therapies like DCVax is expected to be even greater.
ASCO's acceptance of the abstract about the Company's DCVax-Direct technology and its large Phase I/II trial provides an opportunity for leading oncologists, analysts, investors and media to learn more about the unique DCVax-Direct program, now in trials on a range of multiple inoperable cancers. The abstract will be presented in a general poster session.
The Company will also have a large exhibit booth in the ASCO exhibit hall, where further information will be provided about the Company's DCVax technology. Its DCVax-L and DCVax-Direct clinical trial programs provide a series of customized vaccine injections which educate a patient's immune system to attack that individual's specific cancer without any toxic side effects. In clinical trials to date on a variety of solid tumor cancers, the results have been encouraging.
DCVax-Direct product offers a potential new treatment option for the wide range of clinical situations in which patients' tumors are considered “inoperable” ...
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.
Meaning of PR from MD Anderson is that - IN OPEN LABLE UNBLINDED STUDY - MD ANDRSON will disclose results only at the end of the study. But if company wants to disclose they can at their discretion and results are documented in patients file.
Reason No. 1
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.
Although rindopepimut did show encouraging signs of improving survival rates and progression-free survival compared to historical benchmarks in a mid-stage study, we have seen similar results from other drugs that went on to fail in late-stage studies. Put simply, shorts are betting that rindopepimut will ultimately fail in its quest to become a breakthrough treatment for this devastating form of cancer.
Reason No. 2
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.
Although Roche, Seattle Genetics, and others have invested heavily in this technology for nearly two decades, we have only seen a handful of approvals so far. Moreover, the first ADC to be approved, Mylotarg, was withdrawn from the market due to serious adverse events.
The problem is that off-site toxicity issues haven't been completely resolved and researchers are still working on ways to improve tissue targeting for ADCs. So while Celldex is pursuing a hot-ticket item in oncology research with Glembatumumab, the technology is far from perfect. The short thesis would thus appear to be that Glembatumumab won't succeed where the majority of experimental ADCs have failed. Time will tell.
Sky would be the new Limit for NWBO Prices. Germans are NOT STUPID to give go ahead for NWBO. Also AF misguided people by demanding P3 interim results from NWBO management whereas AF knows very well that IDMC controls such information and cannot be released until IDMC conclude anything.
AF - Said all BS to people.
We are heading for better results on DCVax Direct and its better than ICPT which open $440 after close at $70 in March 2014
Solaris $1.5Billion Sales in 2013 - Mkt Cap for ALXN $32Billion = CLDX atleast expected to be $20Billion Mkt Cap Management guidance is that final results on ReACT will be available in 2H, 2014. ... comparable to Alexion's (ALXN) $1.5 billion blockbuster drug Solaris. .... Read more on Alternative Investing
Celldex Therapeutics, Inc. (NASDAQ: CLDX) announced that data from its Phase 1 study of varlilumab, a fully human monoclonal antibody targeting CD27, will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2014 in Chicago. The abstracts accepted for poster presentation are listed below. In addition, the data will be discussed during a Poster Highlight Session entitled "Modulating the Anti-tumor Immune Response" by Dr. Cassian Yee of The University of Texas MD Anderson Cancer Center on Monday, June 2, 2014 from 5:15 to 5:30 p.m. CDT.
-- (# 3024) Data from the hematologic malignancy dose-escalation arm will be presented by Stephen M. Ansell, MD, PhD, Professor of Medicine, Mayo Clinic, in a poster entitled "Phase 1 Evaluation of an Agonist Anti-CD27 Human Antibody (CDX-1127) in Patients with Advanced Hematologic Malignancies" on Monday, June 2 from 1:15 to 4:15 p.m. CDT.
-- (# 3027) Data from the solid tumor expansion cohorts in metastatic melanoma and renal cell carcinoma will be presented by Jeffrey R. Infante, MD, Director, Drug Development Program, Sarah Cannon Research Institute, in a poster entitled "Immunologic Activity of an Activating Anti-CD27 Antibody (CDX-1127) in Patients with Solid Tumors" on Monday, June 2 from 1:15 to 4:15 p.m. CDT.
Data contained in the published abstracts was current as of the submission deadline of February 4, 2014. Data to be presented in the poster sessions will include comprehensive data from the trials as of May.
Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review
Expediting Availability of New Drugs for Patients with Serious Conditions
Speeding the development and availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or have advantages over existing treatments. The Food and Drug Administration (FDA) has developed four distinct and successful approaches to making such drugs available as rapidly as possible: Priority Review, Accelerated Approval, Fast Track Designation, and breakthrough therapy designation. Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them.
The following summary describes each element, how they differ, and how they complement each other.
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.
Harry Boxer predicted CLDX is ready to move to $22 ... FDA grants accelerated approval to cancer drug Beleodaq (belinostat); CLDX