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Celldex Therapeutics, Inc. (CLDX)

NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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35.68-1.93 (-5.13%)
At close: 04:00PM EST
35.68 0.00 (0.00%)
After hours: 06:03PM EST
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  • P
    Peter
    CDX-0159 Chronic Inducible Urticaria - Phase Ib Cholinergic data expected to be presented Q1 2022
  • A
    Anonymous
    Any news from the conference this morning?
  • l
    longvrts
    Report out: inhibition of mast cells mitigates hypersensitivity reactions due to anti-drug antibodies induced by biologicals. Given the widespread use of biologicals- in fact the biggest blockbusters currently are biologicals- this is another substantial market for an effective anti-inflammatory like CDX-0159:

    Front Immunol . 2021 Nov 1;12:765747. doi: 10.3389/fimmu.2021.765747. eCollection 2021.

    How to Prevent and Mitigate Hypersensitivity Reactions to Biologicals Induced by Anti-Drug Antibodies?

    Alessandra Vultaggio 1, Margherita Perlato 2, Francesca Nencini 1, Emanuele Vivarelli 1, Enrico Maggi 3, Andrea Matucci 1
    Affiliations expand
    PMID: 34790200 PMCID: PMC8591239 DOI: 10.3389/fimmu.2021.765747
    Free PMC article

    Abstract
    Biologicals are widely used therapeutic agents for rheumatologic diseases, cancers, and other chronic inflammatory diseases. They are characterized by complex structures and content of variable amounts of foreign regions, which may lead to anti-drug antibodies (ADA) development. ADA onset may limit the clinical usage of biologicals because they may decrease their safety. In fact they are mainly associated with immediate hypersensitivity reactions (HSRs). Development of ADAs is reduced by concomitant immunosuppressive treatment, while it is increased by longer intervals between drug administrations; thus, regular infusion regimens should be preferred to reduce HSRs. Once ADAs have formed, some procedures can be implemented to reduce the risk of HSRs. ADAs may belong to different isotype; the detection of IgE ADA is advisable to be assessed when high and early ADAs are detected, in order to reduce the risk of severe HRs. In patients who need to reintroduce the biological culprit, as alternative therapies are not available, drug desensitization (DD) may be applied. Desensitization should be conceptually dedicated to patients with an IgE-mediated HSR; however, it can be performed also in patients who had developed non-IgE-mediated HSRs. Although the underlying mechanisms behind successful DD has not been fully clarified, the DD procedure is associated with the inhibition of mast cell degranulation and cytokine production. Additionally, some data are emerging about the inhibition of drug-specific immune responses during DD.

    Keywords: IgE; anaphylaxis; anti-drug antibodies; drug desensitization; hypersensitivity reactions; immunogenicity.
  • P
    Peter
    Lucky person who got 5 shares at $39.00
    After-Hours Trades:
    18:15:27 $39.00 5 shares
    16:52:28 $40.00 6 shares
    16:50:17 $41.54 3,485 shares
    16:39:50 $41.54 894 shares
    16:39:04 $41.54 201 shares
  • P
    Peter
    Celldex will be making a presentation at the Evercore ISI 4th Annual HealthCONx Conference on Tuesday, November 30, 2021 at 8:25 a.m. Eastern Time.
  • P
    Peter
    For every seller at this level, there's a buyer who is playing a longer game. I think that we all know how that game is going to end, so this is just a little bump in the bigger picture.
  • M
    Morgan
    CDX-0159 being formulated in SQ form!!!! This means all the indications longv has cited literature on can be treated as an outpatient $$$$ just like Dupixent $$$$.
  • P
    Peter
    Celldex today announced positive preclinical data from CDX-585, the Company’s bispecific antibody with dual targeting of ILT4 and PD-1 checkpoint pathways, developed from its bispecific antibody platform.
    The data show CDX-585 effectively combines the blockade of ILT4 and PD-1 into one molecule, with favorable biophysical and functional characteristics, supporting the initiation of development activities including manufacturing and IND-enabling studies. CDX-585 is the first compound from Celldex’s research and collaboration agreement with Biosion, Inc. and combines Celldex’s ILT4 mAb with Biosion’s PD-1 mAb.
  • l
    longvrts
    Report out: Mast cells cause liver damage and fibrosis. One more significant indication added to the long list of diseases where an effective mast cell inhibitor is urgently needed. CDX-0159 anti-inflammatory mast cell inhibitor is best-in-class and has demonstrated robust efficacy and safety in clinical trials:

    Hepatology. 2021 Nov;74(5):2684-2698. doi: 10.1002/hep.32028. Epub 2021 Sep 9.

    Mast Cells Regulate Ductular Reaction and Intestinal Inflammation in Cholestasis Through Farnesoid X Receptor Signaling

    Vik Meadows 1 2, Lindsey Kennedy 2, Burcin Ekser 3, Konstantina Kyritsi 2, Debjyoti Kundu 2, Tianhao Zhou 2, Lixian Chen 2, Linh Pham 2, Nan Wu 2, Jennifer Demieville 4, Laura Hargrove 4, Shannon Glaser 4, Gianfranco Alpini 1 2, Heather Francis 1 2

    PMID: 34164827 DOI: 10.1002/hep.32028
    Full text linksCite

    Abstract
    Background and aims: Cholestasis is characterized by increased total bile acid (TBA) levels, which are regulated by farnesoid X receptor (FXR)/FGF15. Patients with primary sclerosing cholangitis (PSC) typically present with inflammatory bowel disease (IBD). Mast cells (MCs) (i) express FXR and (ii) infiltrate the liver during cholestasis promoting liver fibrosis. In bile-duct-ligated (BDL) MC-deficient mice (B6.Cg-KitW-sh /HNihrJaeBsmJ [KitW-sh ]), ductular reaction (DR) and liver fibrosis decrease compared with BDL wild type, and MC injection exacerbates liver damage in normal mice.

    Approach and results: In this study, we demonstrated that MC-FXR regulates biliary FXR/FGF15, DR, and hepatic fibrosis and alters intestinal FXR/FGF15. We found increased MC number and biliary FXR expression in patients with liver injury compared with control. Histamine and FGF19 serum levels and small heterodimer partner expression increase in patients PSC and PSC-IBD compared with healthy controls. MC injection increased liver damage, DR, inflammation, biliary senescence/senescence-associated secretory phenotype (SASP), fibrosis, and histamine in KitW-sh mice. Inhibition of MC-FXR before injection reduced these parameters. BDL and KitW-sh mice injected with MCs displayed increased TBA content, biliary FXR/FGF15, and intestinal inflammation, which decreased in BDL KitW-sh and KitW-sh mice injected with MC-FXR. MCs increased ileal FXR/FGF15 expression in KitW-sh mice that was reduced following FXR inhibition. BDL and multidrug resistance 2/ATP-binding cassette family 2 member 4 knockout (Mdr2-/- ) mice, models of PSC, displayed increased intestinal MC infiltration and FXR/FGF15 expression. These were reduced following MC stabilization with cromolyn sodium in Mdr2-/- mice. In vitro, MC-FXR inhibition decreased biliary proliferation/SASP/FGF and hepatic stellate cell activation.

    Conclusions: Our studies demonstrate that MC-FXR plays a key role in liver damage and DR, including TBA regulation through alteration of intestinal and biliary FXR/FGF15 signaling.
  • L
    Libor
    Less than 300 shares this morning trying hard to appear like its the end of the world. It’s not. $CLDX =$80 buy out target
  • l
    longvrts
    CDX-1140 clinical trial update: Trial NCT03329950 in collaboration with MRK (Keynote-A23) expanded to include blood cancers in addition to advanced solid malignancies. CDX-1140 is being tested as monotherapy and in combination with CDX-301, Keytruda and chemotherapy. Primary completion date has been moved out to July '22 instead of Nov'21. If CDX-1140 trial successful in either solid and/or blood cancers then CLDX will have a second multi $ billion asset in addition to anti-inflammatory mAb CDX-0159:

    "Detailed Description:
    This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability and efficacy of CDX-1140 alone (Part 1) or in combination with CDX-301 (Part 2), pembrolizumab (Part 3), or chemotherapy (Part 4) in patients with cancer.

    Eligible patients that enroll to the dose-escalation portion of the study will be assigned to one of several dose levels of CDX-1140. The dose-escalation part of the study will test the safety profile of CDX-1140, alone or in combination with CDX-301, pembrolizumab or chemotherapy and determine which dose(s) of CDX-1140 will be studied in the expansion portions of the study.

    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.

    Study Design
    Go to sections
    Study Type : Interventional (Clinical Trial)
    Estimated Enrollment : 260 participants
    Allocation: Non-Randomized
    Intervention Model: Single Group Assignment
    Masking: None (Open Label)
    Primary Purpose: Treatment
    Official Title: A Phase 1 Study of CDX-1140 as Monotherapy or in Combination in Patients With Advanced Malignancies
    Actual Study Start Date : December 1, 2017
    Estimated Primary Completion Date : July 2022
    Estimated Study Completion Date : July 2023
  • P
    Peter
    Stocks on the move. Celldex makes that list today. Up 2.26 to 48.21 a 4.92% gain. Let’s see if it can be up 5% by end of day. I think it can.
  • P
    Peter
    45.45 up 60% is equal to 72.72 unbelievable but the calculator does not lie.
    Like Libor said yesterday 80 is what the stock will go to.
  • Z
    Zorbs
    Very odd that the. shares dropped this much. Volume increasing throughout the day on multiple days. Shares dont sell off like this for zero reason. Not adding shares till more is known, which I expect we will find out soon enough. Funds got a glimpse of study results ? Dont say its illegal becuase working in pharma industry I can tell you many get previews before the public.... results always slip through the cracks. Not saying thats what happened but cant think of any reason why this stock has sold off almost 30%.
  • P
    Peter
    46.50 in after hours. Another 5% and its back above 48.
  • l
    longvrts
    Report out: mast cell activation directly implicated in irritable bowel syndrome (IBS). There are 140 million patients in US +EU suffering from IBS. Even a 0.5% market penetration for mast cell inhibitor CDX-0159 represents 0.7 million patients. At a treatment cost of let's say $38,000/patient after discounts, we're still looking at $26.6 billion/yr. And that's only one disease indication for CDX-0159:

    JCI Insight. 2021 Oct 7;e146529. doi: 10.1172/jci.insight.146529. Online ahead of print.

    High FODMAP diet causes barrier loss via lipopolysaccharide mediated mast cell activation

    Prashant Singh 1, Gintautas Grabauskas 1, Shi-Yi Zhou 1, Jun Gao 1, Yawen Zhang 1, Chung Owyang 1

    Affiliation
    1Department of Internal Medicine, University of Michigan, Ann Arbor, United States of America.
    PMID: 34618688 DOI: 10.1172/jci.insight.146529
    Free article

    Abstract
    A diet high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) (HFM) induces gastrointestinal symptoms in patients with irritable bowel syndrome (IBS) and a diet low in FODMAPs (LFM) improves symptoms in up to 60% of IBS patients. However, the mechanism by which FODMAPs affect IBS symptoms is unclear. We showed that mice fed on an HFM diet have mast cell activation and colonic barrier loss. Using mast cell-deficient mice with/without mast cell reconstitution, we showed that HFM-mediated colonic barrier loss is dependent on TLR4-dependent mast cell activation. In in vitro studies, we demonstrated IBS fecal supernatant stimulates mast cell significantly more compared to fecal supernatant from healthy controls. This effect of IBS fecal supernatant on mast cell stimulation is ameliorated in absence of TLR4 receptor and after an LFM diet. Translating these findings into IBS patients, we found an LFM diet improves colonic barrier function and reduces mast cell activation while decreasing fecal LPS levels. Our findings indicate that a HFM diet causes mast cell activation via LPS which in turn leads to colonic barrier loss and an LFM diet reverses these pathophysiologic mucosal changes.

    Keywords: Gastroenterology; Mast cells.
  • P
    Peter
    Offering was gobbled up at 42 just a few months ago. Fidelity takes a 12% stake. Latest update about 0159 continued to be very successful, no reason to be concerned, they are continuing with ph2 and another indication. The potential for this to be a blockbuster is very real. Not worried. Plenty of inexplicable drops and rises over last 19 months, often on low volume, heavily manipulated by funds, same ole same ole here I think. Sucks to bleed 24% from recent high of 57 but let's not forget it was only a few weeks back we got SEVERAL recent price target upgrades. Averting 66...which is right where I think we will be hitting next leg up in coming months. No leaks in my opinion.
    Bullish
  • P
    Peter
    46.43 is the high this morning. In the afternoon it could take that high. If it can go down 3 dollars in one day it can go up over 3 dollars in one day. It could be back above 50 by Friday.
  • P
    Peter
    9/17/2021 Jefferies Financial Group
    Initiated Coverage Buy $66.00
    9/13/2021 HC Wainwright
    Boost Price Target Buy $54.00 ➝ $60.00
    9/10/2021 SVB Leerink T. Smith
    Initiated Coverage Outperform $68.00
    7/22/2021 Guggenheim
    Initiated Coverage Buy $66.00
  • l
    longvrts
    10/12/21 SC 13G filed: FMR LLC declares CLDX 12% ownership:

    Cusip #15117B202
    Item 1: Reporting Person - FMR LLC
    Item 2: (a) [ ]
    (b) [ ]
    Item 4: Delaware
    Item 5: 421,707
    Item 6: 0
    Item 7: 5,615,333
    Item 8: 0
    Item 9: 5,615,333
    Item 11: 12.080%
    Item 12: HC

    Cusip #15117B202
    Item 1: Reporting Person - Abigail P. Johnson
    Item 2: (a) [ ]
    (b) [ ]
    Item 4: United States of America
    Item 5: 0
    Item 6: 0
    Item 7: 5,615,333
    Item 8: 0
    Item 9: 5,615,333
    Item 11: 12.080%
    Item 12: IN
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