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whippersnapper65 745 posts  |  Last Activity: 3 hours ago Member since: Jun 20, 2009
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  • oh, for the days when the ignore button still worked...

    the cycopath is obviously worried as heck about a Trump victory

  • Reply to

    Marucci's Absence At Leerink

    by sooninjailinlasvegas Sep 29, 2016 11:28 PM
    whippersnapper65 whippersnapper65 Sep 30, 2016 12:00 AM Flag

    A partnership nearing completion crossed my mind too. Strange, because only one week ago Marucci was announced as participating in the presentation. Something important developed over the past six days.

    Marucci would be wise to partner glemba. He knows he needs to give the company a financial runway for the next ten years and he needs to provide shareholders some confidence in his leadership and a substantial boost in the share price. Davis' explanation at Leerink today of all Celldex's treatments, how the company foresees combinations with other companies' drugs and within Celldex's own pipeline, easily leads one to realize that Celldex has a broad vision for combination immunotherapy that it is not able to bankroll by itself. All those permutations would have to be tested separately for approval, which will be time-consuming and expensive. It makes sense for Celldex to partner glemba at this time.

    I have also noticed that the openings for medical science liaisons and a SVP for global regulatory affairs have gone unfilled for about six months. A partnership for glemba would obviate the need to hire for those positions internally because the partner would take care of those responsibilities.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Sep 29, 2016 11:03 PM Flag

    Do you think this trial's results are sufficient for FDA approval? I thought I heard Tom Davis mention during the Leerink presentation today that the company could decide to conduct another phase II, single-arm study of glemba in the same population of melanoma patients to serve as a basis for approval if the data in the current trial warranted it.

    Sentiment: Strong Buy

  • whippersnapper65 by whippersnapper65 Sep 29, 2016 2:39 PM Flag

    Tom Davis and Sarah Cavanaugh were there, but Sarah didn't even make a peep.

    What kept Marucci away? He was previously announced as one of the presenters.

    Sentiment: Strong Buy

  • Reply to

    The ESMO glemba in melanoma abstract

    by whippersnapper65 Sep 28, 2016 9:32 AM
    whippersnapper65 whippersnapper65 Sep 28, 2016 11:43 PM Flag

    The mature results will be better. One complete response (a complete response in metastatic melanoma -- amazing!) and many patients with stable disease (some ongoing) in the preliminary results is already impressive in metastatic melanoma patients, for whom there are few good options and who are pretty much expecting the cancer to kill them.

    The abstract doesn't provide information about whether the CR and PR were in the (n=50/51) subgroup whose tumors expressed gpNMB. The statement that "rash may correlate with efficacy" leads me to believe that they are, in which case the ORR will be higher for glemba's target group of patients.

    The breakdown and analysis of the mature data will be interesting to see after it has been presented at the conference.

    Sentiment: Strong Buy

  • Reply to

    The ESMO glemba in melanoma abstract

    by whippersnapper65 Sep 28, 2016 9:32 AM
    whippersnapper65 whippersnapper65 Sep 28, 2016 2:51 PM Flag

    I don't think the market is reacting to a relatively obscure CLDX abstract today. CLDX is the victim of other, more widespread market influences.

    Maybe during tomorrow's discussion Marucci or Davis will elaborate on what we can expect in the updated data. The abstract was written in May; by now a more complete and mature set of data is available.

    Sentiment: Strong Buy

  • Reply to

    Welcome those new to the board

    by oldmcvet23 Sep 28, 2016 1:00 PM
    whippersnapper65 whippersnapper65 Sep 28, 2016 1:09 PM Flag

    I doubt many new people come to this incarnation of the message board anymore because you can't access it via a link on Yahoo's Finance page. Unless you know the URL to access it, which all the old-timers do, you can't get here.

  • whippersnapper65 by whippersnapper65 Sep 28, 2016 9:32 AM Flag

    1147P - A phase 2 study of glembatumumab vedotin (GV), an antibody-drug conjugate (ADC) targeting gpNMB, in advanced melanoma

    Background

    gpNMB is an internalizable transmembrane glycoprotein expressed in multiple tumor types including melanoma. The ADC GV (CDX-011) delivers the potent cytotoxin MMAE to gpNMB+ cells. GV has shown promising activity in advanced melanoma and breast cancer (Ott JCO 2014; Yardley JCO 2015).

    Results

    Enrollment (n = 62) completed in April 2016: median age = 67 years; 55% male; 21% BRAF mutation; 53% 2 lines prior therapy. Preliminary tumor response data (n = 57 evaluable; 5 pts pending 1st response assessment): 1 complete response (CR) and 7 partial response (PR [current confirmed ORR = 14%]); 1 single time-point PR; 26 stable disease (SD) (duration 6-51+ weeks, 11 ongoing). Thus far, 50/51 evaluable pts had gpNMB+ tumors, and 38/51 had 100% of epithelial cells gpNMB+. Toxicities include rash, alopecia, fatigue, neuropathy, nausea, neutropenia, decreased appetite and diarrhea; rash may correlate with efficacy.

    Conclusions

    GV has shown promising activity including induction of partial and complete responses in patients with heavily pre-treated melanoma. The safety profile is manageable and consistent with cytotoxic treatment. DOR, PFS, OS, and correlation of biomarkers with outcome will be analyzed on the mature dataset. An additional cohort will be treated with GV in combination with varlilumab, an activating anti-CD27 monoclonal antibody, in order to evaluate safety and efficacy of the combination.

    Sentiment: Strong Buy

  • Reply to

    Road to vindication..?!

    by goatroper1984 Sep 25, 2016 10:43 AM
    whippersnapper65 whippersnapper65 Sep 25, 2016 3:59 PM Flag

    Agree. Remember that Keler and Catlin bought shares a couple weeks ago. That wasn't a pessimistic move.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Sep 25, 2016 3:58 PM Flag

    Data that would virtually guarantee Celldex could get AA for glemba in melanoma should send CLDX into the $20s at a minimum.

    You're right about the share price. It shouldn't be below $10, even with the Rintega setback, but the market is both punishing CLDX and unsure about a future revenue stream, and short sellers have pounded the stock down.

    Data (and a partnership) that restores the market's confidence that Celldex will have a revenue stream to fund operations will rapidly put life back into the share price, and short covering will accelerate and magnify the parabolic price increase.

    Once Celldex answers the question about how it will be financially viable, the share price will recover and should begin a steady bullish trend as the deeper pipeline assets are developed and move closer to approval.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Sep 23, 2016 2:06 PM Flag

    You got that right.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Sep 23, 2016 2:02 PM Flag

    The science guys at Celldex have chosen their targeted therapeutics well. I wish that would be coupled soon with a commercial success. It's frustrating to wait years and years for the first success, even more frustrating to see other, lesser companies reach that success on weaker data than what Celldex has already demonstrated.

    Celldex has the pipeline to be a biotech behemoth, but it's still trying to break out of the R&D egg.

    Sentiment: Strong Buy

  • Reply to

    October 2013 - today Do we invest the wrong stock???

    by aqnguyen Sep 22, 2016 10:17 PM
    whippersnapper65 whippersnapper65 Sep 22, 2016 11:25 PM Flag

    If you had asked that question in February 2016, the answer would not have been so clear: the share prices were fairly close to each other. Much can change in a short time in biotech stocks. The only reason SRPT is trading so much higher now than it was in February is because of good news from the FDA based on a study with n=12. Amazing.

    If Celldex announces good news on October 10 about glemba in metastatic melanoma (and we know that it won't be bad news because management has already stated that the trial has exceeded the target ORR, but we don't know by how much the target was exceeded), then CLDX will experience another bullish run, most especially if the ORR is considered good enough to apply for accelerated approval with the FDA. The glemba market in all indications is enormous, and demonstration that glemba is working in gpNMB+ melanoma will increase confidence that it will also work against other gpNMB+ cancer types; after all, gpNMB is gpNMB, wherever it is located, and glemba seeks it out to destroy cells that express it.

    Couple that with the possibility that Celldex could decide to apply for approval of Rintega after the company announces the results of its ACT IV analysis at SNO on November 17, and there is potential in the fourth quarter for CLDX to have an impressive bullish run in a short period of time, similar to what SRPT has done over the past six months.

    That is why I continue to maintain that CLDX is a strong buy.

    Sentiment: Strong Buy

  • Reply to

    The Animals Once Again Burning and Looting

    by j20tower20 Sep 22, 2016 9:21 AM
    whippersnapper65 whippersnapper65 Sep 22, 2016 1:55 PM Flag

    Every riot by miscreants, every Islamic terrorist attack on America, helps convince more people to vote for the Law and Order presidential candidate: Trump.

  • Don't know whether that decision was made before ACT IV was stopped for futility or after. If Rintega were a bust, I doubt Celldex management would continue to pay $40,000 per year to be a SNO sponsor. One could ask what would be the point and what would Celldex gain from a sponsorship if its neuro-oncology treatment was not going to advance any further.

    The 15-minute slot reserved for ACT IV during the plenary session on the opening day of the SNO annual meeting should be interesting.

    Sentiment: Strong Buy

  • ACT III -- note, not ACT IV -- was the subject of a very peculiar protocol change on August 9 of this year. This would have gone unnoticed by me because I usually only look at open trials for changes, but today I decided to check completed trials; glad I did.

    Here are the protocol changes:

    1) In the descriptions of the investigative therapy, EVERY occurrence of CDX-110 by itself was replaced with the descriptor "CDX-110 with GM-CSF". (That change corresponds to the descriptions used in the trial protocols for both ACT IV and ReACT.)
    2) An arm description, "Maintenance temozolomide plus intradermal injections of CDX-110 with GM-CSF." was removed from the protocol.

    Isn't it odd that protocol changes would be made to ACT III so many years after the trial completed enrollment and after the study has been completed? Why bother?

    This strikes me as window dressing for a BLA submission based on what the company has learned in its analysis of ACT IV data: the company appears to be setting the stage for making the case that "CDX-110 with GM-CSF" is the active therapeutic agent and that data from numerous trials supports whatever they have confirmed in the analysis of ACT IV about Rintega's efficacy (administered with GM-CSF). Why else would the company bother to make such a protocol change to an old trial such as ACT III so that the description of the drug matches the descriptions used in both ACT IV and ReACT?

    It might be worth mentioning, too, that the date of the protocol change is only one day after the Q2 earnings CC.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Sep 19, 2016 12:39 PM Flag

    If the ACT IV data presented at SNO in November show a long-term survival benefit in 15%-25% of Rintega patients similar to what has occurred in every prior trial of CDX-110, I would hope that management would seek approval on that basis, making the case with the FDA and EU that immunotherapy takes longer for its benefits to become apparent than is the case with conventional treatments. There's no disputing Rintega's safety, and the data consistently show its long-term efficacy in a significant subset of patients that is literally life-saving.

    Sentiment: Strong Buy

  • Reply to

    Anybody know about this?

    by grey3840 Sep 16, 2016 10:09 PM
    whippersnapper65 whippersnapper65 Sep 16, 2016 10:58 PM Flag

    It comes up on the clinical trials site when you search for trials by Celldex, but it's not a Celldex Therapeutics trial. Last I recall, it is for a diet drug and the name of the trial is Celldex (contraction of Cellodextrin).

  • Reply to

    Cy on ignore

    by mcschafer Sep 16, 2016 12:48 PM
    whippersnapper65 whippersnapper65 Sep 16, 2016 1:21 PM Flag

    How do you do that? I don't see an option to ignore users anymore. Ever since Yahoo switched to the new message board format but kept this site operating, all of the users I had put on ignore over the years became visible once again, with no option to ignore them.

  • This overlooked: on July 27, among the protocol changes to the glemba in metastatic melanoma trial that were made (adding a second cohort to test glemba in combination with varli) was this statement: "Patients in cohort 2 must submit a recently obtained biopsy of the skin fold for gpNMB analysis."

    We have read patient accounts of skin rashes, varying in severity. Celldex has been aware of that side effect and has reasoned that the intensity of the skin rash correlates with the levels of gpNMB in a patient's skin cells. With the added requirement that patients in the newly added cohort 2 must have their skin analyzed for gpNMB, the company seems to want to be able to study that correlation.

    All of which supports the belief that glemba is working: attacking gpNMB+ cells wherever they are, which means it is showing efficacy in killing gpNMB+ cancer cells. Glemba could very well surprise positively in October and eventually have wide application. I believe the promotion of Elizabeth Crowley to a chief officer is a harbinger of glemba's success because Crowley was instrumental in guiding glemba through early development at CuraGen prior to its acquisition by Celldex. Glemba might be Celldex's inaugural product.

    Sentiment: Strong Buy

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