If BMY has designs on Celldex as an acquisition, BMY has an interest in keeping as much positive Varli data private for as long as possible so that CLDX continues to languish until it runs out of money. I would like to know what, if any, anti-takeover provisions are included in the collaboration agreement. The separate collaboration with Roche could serve as an effective counterbalance to the agreement with BMY, and perhaps Celldex can play the two off each other.
BMY took advantage of its private knowledge of ipilimumab in development when it stole Medarex in a buyout for much, much, much less than it would have been worth if it had stayed independent until phase-3 ipilimumab data were publicly known. Marucci, the rest of management (some of whom are former Medarex employees) and CLDX shareholders who were also MEDX shareholders do not want a repeat of the MEDX takeunder in the case of CLDX, although right now a $2.4 billion buyout price (what BMY paid for Medarex) looks awfully good from the vantage point of today's share price. MEDX went through its volatile ups and downs too before being bought out.
The Varli/Nivo combination results is the only poster that really interests me at this point. I'm somewhat surprised but very pleased that BMY agreed to the release of results thus far; when asked about the combination trials, management kept emphasizing that it was up to BMY to agree to release any data, almost apologizing for BMY's apparent refusal to consent to release thus far.
The subtitle of the poster is intriguing: "activation across multiple immune pathways without untoward immune-related adverse events". Is that a harbinger of good news? Hope so. In the EOY conference call last month Tom Davis was coy about the responses seen in the Varli/Nivo combination trials so far; he merely said that the observed activity warranted expansion into the phase 2 cohorts.
Management knows what the data are. If the data are very good, then as disappointing as the Rintega setback is it will merely be a temporary setback.
Time for Ron Pepin to earn his salary. What has that guy done since joining management? He was highly touted as a dealmaker, but so far I don't see anything that he's contributed.
So, shareholder, are you bullish on Celldex at this point?
Tom Davis was previously at Medarex and was largely responsible for ipilimumab (Yervoy), which BMY successfully commercialized after buying Medarex. It doesn't say that on the website, but below is a citation from a July 2014 PR in which the two main science guys were promoted to Executive VPs; those bios contain a little more information about those men than what is currently on the website.
Tibor Keler, PhD has been promoted to Executive Vice President and Chief Scientific Officer of Celldex. Dr. Keler is a founder of Celldex and most recently served as the Company's Senior Vice President and Chief Scientific Officer. Prior to that, Dr. Keler was Senior Director of Preclinical Development and Principal Scientist at Medarex from September 1993 to March 2004. While at Medarex, he was responsible for the preclinical development of a number of Medarex clinical product candidates, including ipilimumab. In addition, Dr. Keler was responsible for the development of Celldex's core technology and related products. Dr. Keler received his BS in Unified Science and MS in Biology from Drexel University, and PhD in Microbiology from the University of Pennsylvania.
Tom Davis, MD has been promoted to Executive Vice President and Chief Medical Officer of Celldex. Most recently Dr. Davis served as Senior Vice President and Chief Medical Officer. Prior to that, he was Chief Medical Officer at GenVec and Senior Director of Clinical Science at Medarex, where he led the clinical development of ipilimumab. He has supervised clinical efforts in adult hematologic malignancies and marrow transplantation and therapeutic antibodies and vaccines at the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) and worked with Dr. Ron Levy on the development of rituximab and idiotype vaccines at Stanford University. Dr. Davis received his BA in Biophysics from Johns Hopkins, MS in Physiology and MD from Georgetown University, and Oncology training at Stanford University.
Perhaps the DSMB suspected that the control group had been severely tainted and recommended stopping the trial, among other reasons, so that management could begin immediately sorting through the data to get to the bottom of it. Nobody with experience and knowledge in the field would unquestioningly accept the control group data at face value: NOBODY. I wonder whether the DSMB would have shared their opinions about a possibly tainted control group with management and, if they did, whether management is keeping that mum during its investigation.
Frank, Celldex has more pressing problems than what Janet Yellen says or thinks. The S.S. Celldex just hit a submerged island in a sea route that other ships have cruised through without incident, the submerged island wasn't on any navigational chart in existence, engineers are busy determining the extent of the damage, oceanographers are trying to determine what caused the submerged island to appear when it wasn't there before, Captain Marucci, First Officer Davis and Chief of the Boat Keler aren't saying anything about the condition of the ship nor the cargo, crew are wondering whether the Rintega crates will have to be thrown overboard as jetsom so the ship can make it back to port without submerging, the hope of hailing a larger passing vessel to tow us seems unlikely, we're all on board the ship and you're worried about what someone back on land is saying that might affect the ship if it ever makes it back to port?
I'll start a campaign to ignore you. Everyone who agrees, red thumb johnnymac's moronic post and then put him on ignore.
You're wrong. Go to the company website, click on pipeline, see Rintega at the bottom of the list, click on Rintega, and find descriptions of both ACT IV and ReACT.
Rintega had been completely removed from the pipeline portion of the website. A few days later it was put back up.
Re: "I think it was just a mistake. Someone removed it from the entire website instead of just from the clinical trial portion of the site."
Maybe the same guy who filed the 10-K early and who checked the wrong box on the ASCO application a few years ago? Why do they keep that guy around?
Mr. Jimenez is getting an early trial by fire. I hope his considerable experience and expertise will be of great help to management in determining whether Celldex should press forward in filing for Rintega's approval.
In the annals of pivotal trials, has there ever been an instance of a trial failing for dubious reasons and subsequently, upon further examination of the data and correction of errors in the original analysis, having the trial be declared a success?
Or is there an example of the FDA being willing to overlook an obviously aberrant control arm and approving a treatment that in a phase-3 trial demonstrated consistent efficacy with earlier trials and would have demonstrated superiority over control in the phase-3 trial had it not been for the anomalous control group in the trial?
Re: "Maybe it wouldn't be ethical though given what they know right now that we don't."
Indeed, insider trading is illegal. If management has material information that is not public, it cannot buy or sell securities based on that knowledge.
Catlin exercised some options last week but reportedly didn't sell the shares he received. There was a form stating he had disposed of the shares but no sale price was listed; I wonder whether he gave them to grandchildren as gifts, taking advantage of the low share price to be able to give thousands of shares to family members without incurring gift tax liability.
Larry Elberger, chairman of the board, bought 20,000 shares on the open market in August of last year between $13 and $15 per share. Marucci only bought 5,000 shares at roughly the same time.
Re: "I don't think it's [Rintega's approval] as big a long shot as one might think."
Well, if management announces that after encouraging discussions with the FDA it is submitting a BLA for Rintega I will be floored. Such a thing would be wholly unprecedented and unexpected (as the abysmal share price reflects); it would be as unprecedented and unexpected as ACT IV's control arm outperforming all prior similar sets of patients in medical history. It would be as if someone were to rise from the dead.
It is peculiar that although CDX-1135 was completely removed from the company website even though it is still being tested in an investigator-sponsored trial, Rintega has reappeared on the company website after having been removed even though the company has stated that ACT IV failed and it will not continue to pursue study of Rintega in the near future.
Yes, the METRIC trial is considered a registrational trial and is identified as such on the company website. There was some concern when the company revised the trial protocol near its beginning in order to increase enrollment, and the trial stopped being an "accelerated approval" trial; but management assured investors that regulatory authorities in the U.S. and the E.U. both agreed that the revised protocol would still be satisfactory for regulatory approval, provided the trial met its endpoint. Yes, the hope is that approval of Glemba for the high gpNMB TNBC population (and possibly for all TNBC patients) would be granted in 2H 2017.
BTD was not granted solely on the basis of ReACT data. The company PR announcing BTD status for Rintega stated that safety and efficacy data from phase-2 studies in newly-diagnosed patients (ACTIVATE, ACT II and ACT III) were also factors in the FDA's decision.
In my opinion it would be a poor use of remaining funds to initiate ReACT2 (how about "ReACTIVATE" as a name with a sense of humor -- ha ha!) because the company needs to conserve cash until Glemba begins to produce revenue. Supposing Glemba is approved in high gpNMB TNBC (possibly in all TNBC) in 2017, then Celldex would have a revenue stream that might make it worth considering another shot at Rintega's approval. The small number of patients in relapsed GBM who also express EGFRviii is too small to justify incurring more expenses pursuing approval for just that patient population.
If management is not absolutely certain that Glemba will begin to produce revenues in 2017, it needs to partner Varli. As much as none of us want to see that, it would be prudent to strengthen the company's financial situation. A bird in the hand is worth more than two in the bush. Management pursued the two in the Rintega bush, but they flew away. Now there are two in the Glemba bush that we have our eyes on, but we are holding one Varli bird in the hand. What to do?
The Glemba trial in TNBC is open label. Management must know EXACTLY how that trial is proceeding and whether the end of the trial is likely to produce statistical significance in high gpNMB TNBC. After all, they can run new trial outcome scenarios as the data roll in to their headquarters from trial sites, and there aren't many more patients left to enroll.
I would be utterly floored if the FDA even agreed to entertain a BLA for Rintega. I would be just as astonished as I was when ACT IV was stopped for futility.
Although Rintega has been removed from the pipeline chart it is once again listed (now at the bottom of the list) as one of Celldex's pipeline treatments. The description of ACT IV has been updated to state that the trial has been discontinued.
Why continue to feature a dead candidate on your website?
For want of a nail, the war was lost. For want of a normal control arm, the trial failed.
One of the reasons Celldex's management and longs on this board were so confident that ACT IV would succeed was because Optune's control arm, which was contemporaneous with ACT IV, performed consistently with all prior medical data on GBM patients. There was little reason to believe the control arm in ACT IV would deviate from established norms; but it did.
Had ACT IV had the Optune trial's control arm data, ACT IV would have succeeded and Rintega would be on the way to approval. Had the Optune trial had ACT IV's control arm data, it would have failed and Optune would not have been approved.
Such is Celldex's unfortunate bad luck to have had ACT IV's control arm consist of the only anomalously outperforming set of GBM patients in the history of studying GBM. There is a reason ACT IV's control arm performed anomalously; we just don't know what that reason is yet.
Your post is getting at the common-sense question: why should Rintega be refused approval simply because ACT IV's control arm anomalously exceeded all prior data sets for similar patients? Indeed, common sense would realize that something went awry with ACT IV's control arm and that Rintega, since it displayed efficacy consistent with all prior trials, should have its efficacy compared with historical data sets rather than ACT IV's anomalous data set; that would show Rintega's superiority and lead to its approval. Unfortunately, that is not how the FDA works.
But even if the FDA doesn't work, doctors know that Rintega works, which is why they are continuing to seek it for patients in compassionate use programs.
Rintega is dead on arrival at the FDA, even though everyone knows it works.
For want of a nail....