Published online Oct 21, 2014. doi: 10.1186/s12967-014-0291-1 "Anti-EGFR targeted therapy seems to be a promising approach in malignant gliomas. EGFR variant III (EGFR vIII) is one of the most frequent mutations in GBM (about 40% of total) . Variant III is a deletion in the 267 position of the EGFR extracellular domain, not expressed in normal glioma tissue but only in glioblastoma cells. The most promising peptide vaccine targeting EGFR vIII is rindopepimut (CDX-110), which contains a peptide derived from the novel fusion junction amino acid sequence of EGFR vIII. Rindopepimut is able to activate humoral and cellular immunoreactivity, and has been shown to induce EGFR vIII-specific immune responses in preclinical and clinical studies . A phase II, multicenter trial was conducted to assess the immunogenicity of rindopepimut and to estimate the PFS and OS of vaccinated patients with newly diagnosed EGFR vIII-positive GBM with minimal residual disease . PFS was 14.7 months in the vaccine group (n = 18) and 6.3 months in the historical control group who received temozolomide (n = 17). Median OS was 26.0 months in the vaccine group and 15.0 months in the control group. Based on these promising results, a phase II study of the safety and efficacy of rindopepimut in combination with bevacizumab is ongoing (ReACT study). Patients with GBM and EGFR vIII mutation who relapse after RT plus temozolomide are randomized to receive bevacizumab plus rindopepimut or keyhole limpet hemocyanin as a control. As bevacizumab blocks VEGF and has immunosuppressive properties, the hypothesis is that the combination could enhance the immunogenic response of rindopepimut against EGFR vIII-expressing GBM cells."
"a real advance"
“I’m pleased to see this; I would say it’s a real advance,” says Donald O’Rourke, an associate professor of neurosurgery at Penn Medicine, who isn’t involved with Celldex. “Once you get a recurrence [of glioblastoma], it’s a really difficult population of patients to treat. Patients who recur from this tumor are typically on steroids and their immune systems are not functioning well. They’ve been treated a lot, and would not be the group of patients you would expect to see any kind of immune response, and yet [here] they are [responding].”
Ben Fidler writes a detailed article about Rindo.
Investors got what they wanted from Celldex Therapeutics Inc.’s interim update of the phase II ReACT study with rindopepimut (rindo), an immunotherapy targeting epidermal growth factor variant III (EGFRvIII) in glioblastoma: statistically significant overall survival (OS) benefit in patients with recurring disease who have not been treated with Avastin (bevacizumab, Roche AG).
The data were unveiled this afternoon at the 4th Quadrennial Meeting of the World Federation of Neuro-Oncology held in conjunction with the 19th Annual Meeting of the Society for Neuro-Oncology in Miami. Abstracts disclosed at the start of this month provided no update on OS or progression-free survival (PFS), and Celldex-watchers were hoping for a better look.
They got it. Thomas Davis, chief medical officer of Celldex, told BioWorld Today the results available now are better than any seen before in glioblastoma. “There’s a clear benefit in the PFS at six months, but most importantly there is that survival benefit,” he said. “It’s a very real survival benefit, with a low hazard ratio, a clearly significant ‘p’ value, and it does look like there’s a tail on the curve. Some of these patients are going a very long time without relapsing and it’s not just one or two. It’s a good number of patients.”
Such an outcome was “certainly not expected from an immunotherapy like rindo,” he added.
Rulebreaker, you still here? How did you make your play leading into the ReACT data release? And what are you next steps?
Care to share your wisdom?
Deadpainting, your level of stupid has got to hurt.
The 290lb, 6ft 5inch "kid" attacked a police officer, pushing him back into his police cruiser, the" kid" hit the officer in the head, and the "kid" attempted to disarm the officer, while also attempting to turn the gun on the officer while the officer was fighting for control of his gun, as the "kid" had his hand over the officers gun. All the while the "Kid" was saying, "you are too much of a PU**Y to shoot me. Shortly there after, the officer attempted to discharge his weapon in defense, but the "kids" hand on the gun, prevented the gun from firing. Finally, after much struggle with the "kid", the gun actually fired, and the "kid" grew even more enraged.
And you say the "kid" did not attack the cop?
Maybe we need to get you the witness transcripts. Can you read?
"Based upon initial studies in breast cancer and melanoma, we believe gpNMB could be a very important target in oncology, especially in melanoma. Despite significant advances in the field, metastatic melanoma has one of the fastest growing incidence rates and large numbers of patients still require additional treatment options," said Thomas Davis, MD, Executive Vice President and Chief Medical Officer of Celldex Therapeutics. "In a previous study of patients with metastatic melanoma that did not select for gpNMB expression, we observed an impressive 15% overall response rate and a progression-free survival of 3.9 months in all-comers. Upon further analysis, the data suggested a trend toward prolonged PFS in patients with high gpNMB expression. Fundamental to this new study and planned future studies of glembatumumab vedotin in additional indications, we will evaluate whether potential clinical benefit is linked to the degree of gpNMB expression." - See more at: http://www.globenewswire.com/news-release/2014/12/04/688845/10111115/en/Celldex-Therapeutics-Initiates-a-Phase-2-Study-of-Glembatumumab-Vedotin-in-Patients-with-Advanced-Melanoma.html#sthash.meFS0F3S.dpuf
Fat, I was right, I looked in the mirror this morning and I was really grateful I was not you.
MBB, time, he has been correct over much time on the science. SP is not usually what he speaks of. You give much advice and then chastise others for not following your advice, but I and others don't know you! Care to explain why we should listen to your advice, according to you, and yet not consider what longvrts has to say, according to you?
I can't wait for your response.
WRONG AGAIN Jay!
If you are going as a Republican, you give away your own hard earned candy, to those of your choosing, and at far higher percentages than your Democrat neighbor across the street.
If you go as a Democrat, you will confiscate all your neighbors hard earned candy, and let the federal government decide who's bags will get a small portion of the candy, but most of the candy will be eaten by those doing confiscation and distribution. The young ones, the kids, all get screwed in the end, as we actually borrowed their money to finance additional candy giving every day of the year.
SEATTLE and HAMPTON, N.J., Nov. 10, 2014 (GLOBE NEWSWIRE) -- Oncothyreon Inc. (ONTY) and Celldex Therapeutics, Inc., (CLDX) today announced that they have initiated a combined clinical trial of ONT-10 and varlilumab. ONT-10 is a therapeutic vaccine targeting the tumor-associated antigen MUC1. Varlilumab is a fully human monoclonal antibody that targets CD27, a critical molecule in the activation pathway of lymphocytes.
The trial (ClinicalTrials.gov Identifier: NCT02270372) is an open-label Phase 1b study of ONT-10 administered at the recommended single agent dose in combination with varlilumab at two dose levels in up to 42 patients with advanced breast or ovarian cancer. The primary objective of the trial is to determine the safety and tolerability of the combined therapy. Additional objectives include evaluations of the impact of combination treatment on MUC1-specific humoral and cellular immune responses, T-cell activation markers and levels of regulatory T-cells, and anti-tumor effects.
A little free advice; maybe you should consider a significantly different approach, this one is not working.
"sell crazy someplace else, we're all stocked up here."
We are looking for a person to fill the Bio/Pharm Sales Training & Development position in our Hampton, NJ facility. The Senior Manager be responsible for leading the development and execution of training content for field based teams, ensuring that all training is consistent with commercial strategy. They will create training/development strategies and content that proactively and directly impact the successful global launches of late stage Celldex compounds.
The Senior Manager will be also be charged with establishing the Training/Development system for Celldex, as well as developing the launch and ongoing training for the company’s inaugural product. This position will demand a large degree of cross-functional cooperation with matrix-team members including but not limited to marketing (commercial and payer), medical affairs, clinical science, market research, market access/reimbursement, and legal/regulatory/medical content review teams.
Among other responsibilities:
The Development of New Hire and Launch curriculum for field team.
The Development of new hire training resources.
Longvrts2, the plethora of positive news for Celldex is beginning to get a bit overwhelming. Don't you think so? I missed this report last week. This is very exciting, and gives me even greater confidence the Glemba will be successful in breast cancer as well. And we haven't even paired these treatments with Varli, yet.
As always, your analysis is highly appreciated.
Nothing has changed Whipper, only your view of the potential timeline. All systems are go, but it takes time.
Shorts always take advantage when there is a dearth of news.
You should buy bonds, maybe in GM, sounds more your speed. And hey, that can't go bad. Right?
Stimpy, You Eediot!!!!
They are not supposed to have earnings at this stage.
"Don't let anybody tell you, you know, it's corporations and businesses that create jobs..., you know that OLD THEORY, TRICLE DOWN ECONOMICS, that has been tried, that has failed."
"Don't let anyone tell you the corporations and businesses create jobs"
She and her handlers defended the statement for several days, now they/she are wanting to walk it back a bit.
Do you really want to do the progressive thing for 10 more years? (2more Obama +8 Clinton)
Doesn't that sound very close to Obama's " You didn't build that"?