Whipper, Go back and review how many combination studies they announced in combination with 1127/Varli and other Celldex compounds and other company's approved treatments. The shear number of combo treatments make it clear that Celldex brass expects great results from Varli in combination with untold other treatments. They seam especially excited to combine 301, with 1401, and 1127Varli.
and they are expanding 011 to other indications as well, including lung cancer.
This is no time to get cold feet.
"This past year was transformational for Celldex as we continued to make strides in cultivating one of the most robust, well-staged pipelines in immuno-oncology," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "We enter 2014 with five candidates in the clinic, including rindopepimut and glembatumumab vedotin in registration studies. By year-end, we anticipate the initiation of four new Celldex-sponsored clinical trials and several investigator-sponsored studies, including multiple combination regimens. These combination studies are designed to address what we believe is the next great opportunity for the immuno-oncology field--further unlocking the power of the immune system to deliver the greatest benefit to the largest population of patients possible. With last year's successful financing of the Company and current cash projected to fund our planned activities through 2016, we look forward to what we believe will be an exceptionally productive year."
This is really Strong language for Anthony Marucci.
"we look forward to what we believe will be an exceptionally productive year."
"""These combination studies are designed to address what we believe is the next great opportunity for the immuno-oncology field--further unlocking the power of the immune system to deliver the greatest benefit to the largest population of patients possible."""
I read this as they have very big plans for CDX-1127, and expect great results.
"Current standard of care mobilization treatments produce grafts, or transplanted tissues, that may not contain sufficient numbers of hematopoietic stem cells or may cause graft-versus-host disease (GVHD), a common complication following allogeneic transplantation in which the immune cells in the graft recognize the host, or recipient, as foreign and react by attacking the host's cells. This study found that the combination of CDX-301 and Mozobil® mobilized the highest rate and amount of hematopoietic stem cells into peripheral blood compared to the mice treated with granulocyte colony-stimulating factor (G-CSF, an FDA-approved mobilization treatment) alone, or the combination of G-CSF with Mozobil®. In a model of autologous stem cell transplantation, there was greater than 70% survival among mice exposed to an otherwise lethal dose of radiation that had received grafts mobilized with the combination of CDX-301 and Mozobil® or CDX-301 alone, whereas survival was only 35% when grafts were mobilized by G-CSF combined with Mozobil®, and there was no survival with either G-CSF or Mozobil® alone. Further, in a mouse model of allogeneic stem cell transplantation, the combination of CDX-301 with Mozobil® or CDX-301 alone again resulted in significantly greater survival at four months (80% and 66%, respectively) than did the combination of G-CSF with Mozobil® (13%) or did either agent alone (0%). The better outcomes from the CDX-301 alone or in combination with Mozobil® appeared to be due to suppression of GVHD and also better hematopoietic reconstitution of stem cells. "
From a press release late 2013
"We need novel interventions to advance hematopoietic stem cell mobilization techniques and transplantation, and based on our studies to date, this could be a promising alternative approach for these patients," said Steven Devine, MD, Professor of Internal Medicine and Director, Blood and Marrow Transplant Program, The Ohio State University Comprehensive Cancer Center.
"The data presented today further demonstrate the potential for CDX-301 to improve both autologous and allogeneic hematopoietic stem cell transplantation and, importantly, show the ability for CDX-301 to combine effectively with other cell mobilization agents," said Tibor Keler, PhD, Senior Vice President and Chief Scientific Officer of Celldex. "If what has been demonstrated in preclinical models can be applied to a clinical setting, this regimen could improve stem cell transplantation outcomes for patients across a broad range of indications. We plan to initiate a pilot clinical study evaluating CDX-301 alone and in combination with Mozobil® in the transplant setting in early 2014 and look forward to seeing how this program progresses."
to be continued
Temporal, I think those you are speaking of got scared when 1135 did not go as planned.
By the way, when something goes wrong, 110 being left a the alter, messing up the ASCO application, we get pounced on by shorts. But this time, we have many other things going very well, so they are only able to test the support levels 3 months ahead of ASCO. The same group will be screaming "buy" in a week or less, and they will actually mean it.
Liked your post, It had a certain level of reason to it.
Yes, but only by the design of the trial, as it was very restrictive to the patients and their families. However, Celldex thought they could get the 5 patients needed. They were wrong.
Honestly, I wonder if Alexion ran any interference.
Neshua, I think the temporary shelving of 1135 is simply a move to prioritize spending and effort in the short term. As I think the Current staff is so very busy with three other fast moving trials, and the start of 2 new trials, that restarting 1135 properly, was not the best use of resources for the moment.
I assume discussions with other companies over 1127 combos is taking a lot of current human resources, and may pay the way for further evaluation of 1135 and many other drugs eventually.
She was bending, but she did not break. She held just like she was suppose to. I think someone sold a share or two below 24.33, just to test it. Which gave me my purchase at 24.33. Neshua, was that you selling down there?
attempt to purchase CDX-1127,
should read (attempt to purchase CDX-1135)
Neshua, let me remind you, Alexion's drug Soliris (eculizumab), you know the one with a 35billion market cap, also failed in it's attempt to treat DDD, yet it is worth a 35 billion market cap.
Alexion would be foolish if they did not at least attempt to purchase CDX-1127, in an attempt to keep it's current market share in tact, and maybe develop an even better mouse trap. If they wait until Celldex starts another trial, Celldex may tell them to take a hike when Alexion eventually calls.
Lucky, I think you should sell all your pretend shares immediately, for it must be terribly painful to think so poorly of a company you supposedly have invested in, and continue to hold.
I tell you what, you sell tomorrow, and I will buy your shares. Then you will have pretended to sell something you do not own, and I can add pretend shares to my actual shares. A win win, because then we never need to hear from you again.
Which is exactly why it may be feasible to think 1135 might be for sale. Personally, I don't want them to sell it. I wan't them to use it in a trial that can signup patients. Longterm value of 1135 may be billions per year. And Celldex is not the only one that knows this.
All is good J20, 1135 is still an asset, and all those who are currently pushing her down, will be pushing her up soon. They always do.
If 1135 can be that damaging to another company's existence, then they will pay much more to control it. Maybe the phone is already ringing.
"Mr M., you have Alexion on line one." A billion dollar phone call?
This article is the first sign we are headed higher soon. Too crazy to stay out of Celldex.
Then you did not read the same article. Nichols basically says 1135 is still worth Billions to Celldex and investors, and Celldex may/could already be entertaining sale of the asset.
Since Celldex announced the closing of its DDD study, shares are lower by more than 15%. The reason for this loss ties into the two points I made: Many investors thought Celldex had a flawless pipeline and CDX-1135's potential beyond DDD appears high.
With that said, CDX-1135's potential beyond DDD is still high, but the key is whether Celldex pushes forward and initiates new trials. Based on the company's statement, it would appear that CDX-1135 is going to take a backseat for now at least, which means Celldex is no longer a rare breed of immuno-oncology and orphan, but is competing strictly in the crowded oncology space in hopes that its products can all show a distinct clinical benefit, and that it has the market presence to fundamentally succeed.
Personally, this news alone is not reason enough for me to sell my position, as the 15% of valuation lost likely warrants the news. Furthermore, I wouldn't be surprised if there is more to the story, or something in play for CDX-1135. Perhaps Alexion is looking to acquire the asset, or maybe Celldex is receiving acquisition/partnership offers from big pharma as a pure immuno-oncology play. Either scenario would be fine with me as an investor, but given the similarities to Soliris, I'd find it unacceptable if Celldex abandoned the CDX-1135 program altogether if it remains solo.
Essentially, the absence of CDX-1135 does change the long-term investment outlook for Celldex. With CDX-1135, Celldex could have Alexion-like upside to combine with its already bullish immuno-oncology prospects. To me, this is too great of upside to ignore, and hopefully, Celldex places value in the necessary research to explore CDX-1135 or at least explain to investors why they feel the need to abandon all further clinical testing. For investors, this will be an interesting story to follow, as in looking at Alexion Pharmaceuticals, Celldex's next move might very well be the difference in tens of billions in long-term market cap