Good job, J20! We can spot these miscreants a mile away, and they're not worth the time it takes to read their posts. On any given day at least 85% of the posts are invisible to me because I have ignored their authors. It makes the MB much more tolerable by filtering out the ignorant bashers and the ignorant leftists who goad conservatives rather than enter into sincere truth-seeking argument.
ACT IV is a blinded trial. The IDMC will not release any data at the second interim analysis unless the trial is stopped, so Celldex management won't know what the p-value is at that point if the IDMC simply issues a "go" for the trial to continue to the end.
So, no, if the p-value is any greater than 0.018 it will not give anybody "ammunition" to submit a BLA for Rintega in rGBM. The only thing that might help in that regard would be long-term survival data of ReACT patients, which I believe will be presented at a conference in November.
CLDX is not going to run until unexpected and surprising, significantly positive news is announced. No significant news is scheduled for release anytime soon; any positive news will surprise the market. Only unexpected and surprising, significantly positive news will cause CLDX to sail against the extremely strong headwinds in the overall market and in biotech in particular. An early stop of ACT-IV for efficacy in December would be the sort of thing that would do the trick, and it is probably the earliest realistically conceivable possible announcement that could occur aside from an announcement of a buyout at an absurdly low valuation. Between now and then there will be the 3Q earnings (losses) press release, which will probably be an occasion for more selling, based on the market's historical reaction to newsless announcements of a high cash burn. The most realistically optimistic scenario is that CLDX treads water or begins a slow climb back to the mid teens.
Celldex traded at its highest valuation in its history, over three times the current valuation.
Two years ago the company was in poorer financial and fundamental shape than it is today.
Two years in the future Rintega and Glemba will have been commercialized and the world will have a good idea of what Varli's potential is.
Longs will look back on today's share price the way you remember a bad hangover from years past: no harm done and a full recovery since then, but it was a very unpleasant experience when it occurred.
I started ignoring zorbs a long time ago when it became clear that he's a whiney weasel who gets his investing ideas from stock tweets and attempts to influence stock prices with his own tweets, and he would desperately beg people to post reassuring information or opinions about stocks he owned. Check market pulse on yahoo to see what I mean; he's all over it. Zorbs lost money buying high and selling low because he doesn't have the patience nor the savvy required for biotech investing. If he's claiming he wants to buy back in lower, he's just putting a lame spin on losing money in order to avoid the conclusion that he's a terrible investor.
It has been silly ever since it dropped below $24. Now it is Alice in Wonderland, nonsensically absurd.
No. I expect Celldex will announce the trial when it begins to recruit patients. The listing on the clinicaltrials website indicates that the trial status is "not yet recruiting".
Yes, I agree that the increasing number of Varli combo trials is a good sign. The unreleased data in the trials in progress must be auspicious, and management wants to have as much evidence as possible that Varli will bolster the efficacy of just about every other cancer treatment out there. When investors get wind of that, the share price will be in triple digits as a base.
Yes, good to see. I posted about this trial on September 9 and received 4 red thumbs. Let's see how many red thumbs you get for this positive, factual post. Shorts are so stupid. How can you red thumb straight facts and consider yourself to be intelligent or reasonable?
What keeps the Message Board Bonehead here is his pathological need for attention that his parents never gave him. I wish MBB would ignore me instead of red-thumbing my posts. I've ignored him for about two years now and have never replied to nor unignored his greyed-out messages, yet I notice that he still replies to my posts and gives me red thumbs. His ticker symbol is LOSR.
Not yet recruiting. Study just appeared on the clinicaltrials website. Scheduled to begin this month. Genentech (subsidiary of Roche) is listed as a trial collaborator.
It's being tested in a host of indications:
Carcinoma, Renal Cell
Neoplasms by Histologic Type
Clear-cell Metastatic Renal Cell Carcinoma
Triple Negative Breast Cancer
Head and Neck Cancer
Non-small Cell Lung Cancer
Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and may act to promote anti-tumor effects.
Atezolizumab is an engineered anti-PD-L1 antibody.
This study will evaluate the safety, tolerability and efficacy of the anti-CD27 antibody varlilumab in combination with atezolizumab.
Eligible patients that enroll in the dose escalation portion of the study will be assigned to one of three dose levels of varlilumab in combination with 1200 mg of atezolizumab. The first phase of the study will enroll up to 18 patients and test the safety profile of the combination of varlilumab and atezolizumab in patients with various tumor types and determine which dose of varlilumab will be studied in Phase ll of the study which will enroll only patients with RCC.
During Phase ll, up to 37 patients will be enrolled and receive the recommended Phase ll dose of varlilumab in combination with atezolizumab 1200 mg.
All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
Naysayers and anyone who hasn't already seen the graphs needs to look at the graphs on the poster that is linked to in the press release from April 20, 2015. I called attention to them soon after the PR was issued. The results of varli/anti-PDL1 combo therapy are jaw-droppingly amazing in eliminating tumors and providing immunity against tumor recurrence. If those results can be duplicated in humans, Celldex will skyrocket to over $200 per share overnight. If the results can be approximated, Celldex will still have a very valuable asset in varlilumab. The combo trials currently underway will go a long way toward providing evidence of how much promise varli holds, but we will have to wait a considerable amount of time for results.
Celldex used the word "cured" in its press release dated April 20, 2015. I'll take Tibor Keler's opinion over yours any day.
The combination of varlilumab and anti-PD-L1 resulted in a significant improvement in survival over monotherapy in multiple preclinical tumor models, including a CT-26 colon model, an E.G7 thymoma model and a BCL1 disseminated lymphoma model. The properties of the BCL1 lymphoma model allowed for further analysis into the mechanism of synergy between varlilumab and anti-PD-L1. Importantly, mice cured by the combination therapy were shown to have developed protective immunity against the BCL1 tumor, demonstrating that a long lasting and potent memory response was generated during treatment. Additional key observations were made by analyzing the spleens (the primary site of tumor growth) following treatment. The major changes associated with the combination therapy included:
• A greater reduction in tumor cells (as measured by % decrease in CD19+ cells)
• Increased numbers of functional CD4+ and CD8+ T cells (as measured by IFNγ production)
• An increase in the ratio of CD8+ T cells (effector T cells) to regulatory T cells or Tregs
• A notable increase in myeloid cells, particularly neutrophils
These changes at the site of tumor growth, particularly the balance between effector T cells and regulatory T cells, are consistent with an immune-mediated effect resulting in the destruction of tumor cells. The increase in myeloid cells merits further investigation into their role in the combination therapy effect. Other changes including increases in natural killer cells and decreased PD-1 expression on T cells were noted, but these were similar in magnitude to the monotherapy treatments.
The preclinical data presented in the spring about combination varli and anti-PDL1 treatment showed that the synergy is virtually a cure that not only eliminates tumors but also halts tumor recurrence.
That's hilarious, dbegley, You know, the Message Board Bonehead (mbb) has had no credibility since rays and I caught it deleting its old posts in a failed attempt to cover its lies about its posting history. Many of us have ignored it for a long time. Your evidence about its inconsistency is more proof that it is simply not worth paying any attention to.
A small study in children was conducted at Stanford University. The study was terminated in fall 2013; didn't lead to anything.
A Phase I Study of Rindopepimut After Conventional Radiation in Children With Diffuse Intrinsic Pontine Gliomas
This is a research study of patients with diffuse intrinsic pontine gliomas. We hope to learn about the safety and efficacy of treating pediatric diffuse intrinsic pontine glioma patients with the EGFRvIII peptide vaccine after conventional radiation.
Stanford is not currently accepting new patients for this trial.
You may want to check clinicaltrials.gov to see if other locations are recruiting.
◾Albert J. Wong, M.D.
◾Paul Graham Fisher, MD
◾Michael S. B. Edwards, MD
◾Michael S. B. Edwards, MD
◾Gordon Li, MD
◾biological : Rindopepimut
Phase: Phase 1
Ages Eligible For Study:
3 Years - 18 Years