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.
Unique insider clinical opinion - KOLs report
This new KOL Insight report Breast Cancer –new targeted therapies transform treatment provides everyone interested in this dynamic cancer sector with a complete understanding of the targeted products which are shaping the current landscape and the research which will change future treatment paradigms.
Every aspect of the report is informed by insights gained from thorough 60-minute interviews with 12 experienced key opinion leaders (KOLs) from across major markets to provide expert views on the current treatment landscape and how it will change in the future. KOLs are selected based on their clinical experience, authored scientific publications, involvement in clinical trials and with the Pharma industry, their participation in treatment guideline development, and their record of presenting at high-profile in
Did you noticed ? Some buying activity for 266,000 shares at Avg price of $15.25 today at 1:53pm !!
This report Published on Aug 06, 2014 and was Priced $106.00
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."
10 years PFS for Brain Cancer survival of Rindopepimut is remarkable findings.
For the past 10 years, DeGrand has been going to Duke once a month for a shot of Rindopepimut, a vaccine that stimulates his immune system to produce antibodies that fight the protein. He has been cancer-free since beginning the treatment.
The research into such personalized medicine includes targeted immunotherapy, too -- that is, teaching a patient's own immune system to fight the cancer. "I wanted to find a hospital that deals with glioblastomas, that is doing research and has other options to offer," says Ryan DeGrand of St. Louis, Missouri, who chose to have surgery locally 10 years ago when he was diagnosed with one of the deadliest forms of brain cancer but then looked at his broader options. That search led to a vaccine treatment at Duke Cancer Institute in Durham, North Carolina. "My local hospital was honest," he says. "They said, 'You may live 18 months. You may live two years. We just don't know.'" DeGrand was 32 at the time with two young children, and that prognosis wasn't acceptable.
This is a very important statement which US-FDA might consider as the one of the many clinical results towards accelerated approvals.
" - DeGrand has been going to Duke once a month for a shot of Rindopepimut, a vaccine that stimulates his immune system to produce antibodies that fight the protein. He has been cancer-free since beginning the treatment-"
Do You Need to Ask for Genetic Testing After a Cancer Diagnosis?
Experts say that depends. Some of the more common genetic tests performed today are so-called reflex tests for known diagnostic markers, says Lichtenfeld. These include the HER2 protein for breast cancer; EGFR, a protein, and ALK for lung cancer; the fusion gene BCR-ABL for chronic myeloid leukemia; the KRAS gene for colon cancer and BRAF for melanoma. "If you have one of these cancers, you're going to get that test," he says.
Advanced genetic screening, in which hundreds of genes are tested, may not be currently necessary for common or early-stage tumors, says Richard Haspel, assistant professor of pathology at Beth Israel Deaconess Medical Center in Boston. These tests may be useful if the "tumor is advanced or rare and the oncologist has limited treatment options," Haspel says. The important question for a patient to ask, he says, is "Does my doctor understand what genetic testing is available and when it's appropriate?"
SRPT looks more fraud when CEO makes baseless claims.....He has Ebola vaccine in his pocket and if asked by FDA he can show it. Well will it Works....? Hummm.... CEO says he tried long back and will show it only if FDA ask him....LOL
As per SEC fillings CDX-011 ReACT study in recurrent GBM to produce interim data anticipated by year-end 2014, and a potential Hampton, N.J.-based Celldex could file for faster approval of CDX-011, which the company has developed without a partner, if positive results come to pass in either of the co-primary endpoints of the trial, objective response rate or PFS. In short CLDX catching up with PBYI before their NDA filling in Mid 2015.
CLDX immunotherapy combinations under investigations are - Avastin-Genentech, Yervoy(R) and Opdivo(R) - Bristol-Myers Squibb, Mozobil(R)-Genzyme Corporation; Hiltonol(R) - Oncovir.
But researchers have seen the most eye-catching results when the drugs are used in combination with another very similar immune therapy, which targets part of a completely different T-cell ‘handshake’ – a molecule called CTLA4.
CTLA4 ‘handshakes’ take place in our lymph glands, where T-cells meet up with other immune cells called ‘antigen-presenting cells’, or APCs. Here, APCs alert the T cells to invaders (or tumour cells) and signal to the T cells to gear up for action and start dividing rapidly – into an army of clones, primed to recognise and zap that invader wherever it resides in the body (this is what causes swollen glands when you’re ill).
But CTLA4 ‘handshakes’ switch off this process, preventing the eager army from growing, and hampering their ability to march out and fight the enemy. In a parallel story, researchers have already developed drugs that target CTLA4, and in doing so, have proved that unleashing the immune system, rather than targeting the cancer itself with drugs, is hugely promising.
One of these drugs, ipilimumab (Yervoy) BMS , is already on the market and has shown benefits for patients with advanced melanoma . Another, tremelimumab, PFE is in advanced trials.
Now we’re discovering that when PD-1 blockers and CTLA4 blockers are used together, they have a much greater impact than either alone: knocking out CTLA4 allows the body to create an army of anti-cancer T-cells, and knocking out PD-1 or PD-L1 allows this army to attack.
Preliminary trial results, again, have been extremely promising.
Before PBYI apply for NDA in Early 2015, CLDX will catch up with solid results from more than 100 clinical sites from world over.
this according to Analyst ....
Good thing about CLDX is that they are modest in PR or Earnings call and despite so diverse platform they are not giving out any PR to hype the market. PBYI was the another example of modest and lucky companies for investors without being in limelight.