One company, Celldex (NASDAQ:CLDX), has seen great appreciation in its stock price due to its lead drug candidate, rindopepimut (CDX-110), a targeted immunotherapeutic which is now in Phase III. The market cap of Celldex in this presently challenging biotech market (due to Fed comments twice this year) is now at $1.2 billion and was 3 times higher earlier this year. So, if Ziopharm can demonstrate very early success in this open label trial to that level or greater, then I am sure that it would at least add $100 million or more to its market cap in Phase I to Phase II. And there is such a great need for a treatment of Glioblastoma and treatment will likely end up being the best of what is to be seen in a combo treatment either after success of singular trials with great success, or a required combo treatment trial as determined by the FDA or data to come.
Sources: National Cancer Institute; National Cancer Institute Physician Data Query (PDQ); American Cancer Society Cancer Facts & Figures 2014; Cedars Sinai Brain Tumors and Brain Cancer web page; GLOBOCAN 2012; CRI grantee progress reports and other CRI grantee documents Last Updated June 2014 -
It is estimated that 1 in 161 individuals born today will develop brain or nervous system cancer at some point in their lives. In the U.S., 23,380 men and women are diagnosed with cancer of the brain and nervous system every year, and 14,320 deaths are caused by the disease. Although significant advances have been made in understanding the biology of brain cancers—as well as in tumor diagnosis, treatments, and quality of life of patients with the disease—the mortality rate for brain cancer has remained steady for more than 30 years. The cause of brain tumors is not yet understood. Glioblastoma (GBM) is the most dangerous and aggressive form of brain cancer. GBM patients typically have short-term life expectancies; few will live to see three years after diagnosis. For newly diagnosed GBM patients treated with current standard of care, median progression free survival is just 6.9 months, and median overall survival is 14.6 months. Only a quarter of newly diagnosed GBM patients survive for 24 months, and under 10% of patients survive more than 5 years. -
Rindopepimut (CDX-110), a therapeutic vaccine targeting a mutant peptide called EGFRvIII, that is expressed in approximately one-third of GBM tumors. Rindopepimut is currently being tested in the following trials that are enrolling patients with EGFRvIII positive tumors: a phase III trial in patients with newly diagnosed glioblastoma (NCT01480479) and a phase II trial in patients with relapsed glioblastoma (NCT01498328). For information on the 3 phase II trials of rindopepimut that formed the basis for the current randomized phase III trial, see Celldex’s recent news release summarizing the results.
"The ACT IV study will include 700 patients with EGFRvIII positive glioblastoma from more than 200 clinical trial sites across 22 countries—the most comprehensive study conducted by a biotech company to date in this orphan disease. We are extremely proud of our team and very grateful to the patients, families and physicians who are participating in this study.
In the second quarter, we also accomplished a number of additional, significant milestones—advancing our accelerated approval study of glembatumumab vedotin in triple negative breast cancer, publishing positive data from the CDX-1401 program, presenting positive data from our Phase 1 varlilumab program at ASCO and announcing a clinical trial collaboration with BMS for the varlilumab program. This momentum is expected to continue in the second half of 2014 as we initiate multiple new studies across our pipeline and present data from our Phase 2 ReACT study in recurrent glioblastoma at year-end
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Pfizer’s (PFE) anti-4-1BB antibody PF-05082566 reached a safe dose in Phase 1 without undue toxicity signals (ASCO 2014, Abstract #3007). Pfizer disclosed combination trials with rituximab in Non-Hodgkin Lymphoma (NHL) and pembrolizumab (anti-PD-1). The BMY antibody urelumab was tolerated through its’ dose escalation cohorts, and ex vivo analysis showed activation of CD8+ T cells and NK cells (ASCO 2014, Abstract #3017). The Celldex anti-CD27 mAb also has demonstrated safe dose escalation, although to date without signs of clinical activity (ASCO 2014, Abstracts #3024 and #3027). Celldex (CLDX) claims planned studies in combination with nivolumab, ipilimumab, and the targeted therapeutics darafenib and trametinib.
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ReACT's Avastin refractory cohort was expanded following positive interim data in late 2013. More than 50 sites are open (goal ~100 sites) for patient screening for the accelerated approval METRIC study of glembatumumab vedotin in metastatic TNBC, and the company plans to expand the drug into Phase II studies in metastatic melanoma and squamous cell lung cancer in 2H14.”
Pantginis sees Celldex solidifying itself as a “premier cancer immunotherapy company” with a broad pipeline and robust partnering potential.
Bristol, Celldex Collaborating on Cancer Immunotherapy Study by Adam Feuerstein
Posted on May 21, 2014
The phase I/II study will combine Bristol’s PD-1 checkpoint inhibitor nivolumab with Celldex’s CD27-targeted antibody varlilumab, also known as CDX-1127. Multiple tumor types will be treated, including non-small cell lung cancer, melanoma, ovarian, colon and head-and-neck cancer.‘
‘Nivolumab works by removing a cloaking mechanism used by cancer cells to hide from the body’s immune system. Bristol intends to file nivolumab for FDA approval as a new treatment for advanced lung cancer before the end of the year.‘
Steve Brozak - WBB Securities - Analyst : Okay. Last question
I noticed that the UK acceptance is off the charts here, and they are usually the most conservative, and obviously they are always looking at cost constraints and such. Can you tell me why they are close to 100% in terms of on the KOL acceptance side.
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Bret Holley - Guggenheim Securities - Analyst : Thanks for taking the questions. I'm just wondering on the commercial front with rindo, with the service that you've done, I'm just wondering if you explored kind of a sensitivity analysis to the OS benefit? I think, as said, versus the six-month benefit, they'd be highly enthusiastic. And I'm just wondering if you explored, like I said, kind of a range of benefits from where there might be a cut off in sensitivity to or enthusiasm about patients using rindo in vIII positive glioblastoma?
Question: Jonathan Aschoff - Brean Capital - Analyst : Congrats on the progress. I was wondering, the unconfirmed PR with the renal cell patient at ASCO on 1127, is that a confirmed PR now?
Question: Jonathan Aschoff - Brean Capital - Analyst : Great. Thank you. And rindo recap data in late 2014, do you mean SNO or after the SNO conference?
Question: Jonathan Aschoff - Brean Capital - Analyst : Okay. And two more. Bristol, does Bristol still determine if data from the 1127 PD-1 trial will or will not be released, or is it already clear to them that that is immaterial to Celldex?
That said, Norman added that he fully expects Ebola to come into the United States and Europe at some point in the future. However, being able to treat Brantly and Writebol in the United States actually gives doctors and other medical staff valuable experience, so that they can learn more about the virus and make better preparations.
"We know what we're dealing with now and can deal with it," he said. "I think we're going to learn a lot more about the biology of the virus over time."