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Celldex Therapeutics, Inc. (CLDX)

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  • 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
  • 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
    46.43 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
    Next earnings announcement on November 4. Then in January results of one of their study’s.
  • 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.
  • 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
  • V
    VONHEIMLER
    Where is the bottom folks? Near 42 offering? Bit disappointing drop for no apparent reason. But profit taking makes alot of sense.
  • 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
    Report out: Mast cells drive neuroinflammation in the brain, which is a causal factor in Alzheimer's, Parkinson's and MS. The list of indications for an effective anti-inflammatory drug like mast cell inhibitor CDX-0159 is nothing short of staggering, and places 0159 in the Humira anti-inflammatory market potential:

    Cells. 2021 Sep 2;10(9):2282. doi: 10.3390/cells10092282.

    P2X Receptor-Dependent Modulation of Mast Cell and Glial Cell Activities in Neuroinflammation
    Barbora Salcman 1, Karen Affleck 2, Silvia Bulfone-Paus 1

    PMID: 34571930 PMCID: PMC8471135 DOI: 10.3390/cells10092282
    Free PMC article

    Abstract
    Localisation of mast cells (MCs) at the abluminal side of blood vessels in the brain favours their interaction with glial cells, neurons, and endothelial cells, resulting in the activation of these cells and the release of pro-inflammatory mediators. In turn, stimulation of glial cells, such as microglia, astrocytes, and oligodendrocytes may result in the modulation of MC activities. MCs, microglia, astrocytes, and oligodendrocytes all express P2X receptors (P2XRs) family members that are selectively engaged by ATP. As increased concentrations of extracellular adenosine 5'-triphosphate (ATP) are present in the brain in neuropathological conditions, P2XR activation in MCs and glial cells contributes to the control of their communication and amplification of the inflammatory response. In this review we discuss P2XR-mediated MC activation, its bi-directional effect on microglia, astrocytes and oligodendrocytes and role in neuroinflammation.

    Keywords: P2X receptors; astrocytes; mast cells; microglia; oligodendrocytes.
  • T
    TP
    Apparently there are still people taking Rindopepimut:

    "Mark Griffin, a former trial attorney from Durham, NC, who was diagnosed with stage 4 glioblastoma multiforme, a highly aggressive brain tumor, in 2009. When the cancer returned after surgery, Griffin began undergoing intensive chemotherapy at the Preston Robert Tisch Brain Tumor Center at Duke Cancer Institute. After the chemo left him debilitated and seeking other options, his neuro-oncologist, Katherine Peters, MD, PhD, FAAN, associate professor of neurology at Duke, helped him enroll in an expanded access program for the investigational immunotherapy drug rindopepimut, manufactured by Celldex."

    "As of June 2021, Griffin had been receiving monthly injections of rindopepimut for more than eight years. Regular MRIs show no sign of his brain tumor progressing, and he has experienced no further symptoms like the seizures and vision problems that led to his diagnosis. 'Other people who started taking it at the same time didn't do as well,' he acknowledges. And results from clinical trials have been largely disappointing. 'But I've been fine for eight years and eight months now.'"
  • P
    Peter
    Celldex Presents Positive Data on Symptom Control and Quality of Life Measurements that Further Support CDX-0159 Clinical Benefit in Phase 1b Study in Chronic Inducible Urticaria at EADV 2021.
    - Rapid and sustained improvement in urticaria control after single dose of CDX-0159.
    - Greatly improved patient quality of life and reduced disease impact.
    - Data further support 95% complete response rate to provocation testing.
  • l
    longvrts
    Report out: Irritable bowel syndrome strongly associated with mast cell disorders, especially mast cell activation syndrome. The number of indications for an effective anti-inflammatory mast cell inhibitor like CDX-0159 keeps growing by leaps and bounds:

    Neurogastroenterol Motil. 2021 Sep 17;e14265. doi: 10.1111/nmo.14265. Online ahead of print.

    Irritable bowel syndrome is strongly associated with the primary and idiopathic mast cell disorders

    Michael Kurin 1, Abbinaya Elangovan 2, Muhammed Mustafa Alikhan 3, Basmah Al Dulaijan 3, Eli Silver 4, David C Kaelber 5, Gregory Cooper 6
    Affiliations expand
    PMID: 34535952 DOI: 10.1111/nmo.14265
    Full text linksCite

    Abstract
    Background: Mounting evidence supports a mechanistic association between irritable bowel syndrome (IBS) symptoms and mast cell hyperactivity. Yet, association between IBS and mast cell disorders (MCDs) has not been studied. We examined this association using two large databases and verified with manual chart review.

    Methods: The IBM Watson Health Explorys database (Somers, NY), an aggregate of electronic health record (EHR) data from over two dozen US healthcare systems, and Epic's SlicerDicer tool, a self-service tool containing de-identified data from the Epic EHR, were used to identify patients with IBS and MCDs. Patients with organic gastrointestinal disease or diseases associated with secondary mast cell hyperproliferation were excluded. Results were verified with manual chart review from two academic centers.

    Key results: Up to 4% of IBS patients had a comorbid MCD. IBS was strongly associated with all MCDs. The strongest association was between IBS and mast cell activation syndrome (OR 16.3; 95% CI 13.1-20.3). Odds ratios for IBS+urticaria, IBS+idiopathic urticaria, IBS+non-malignant mastocytosis, and IBS+mast cell malignancy ranged from 4.5 to 9.9. Patients from each of these overlap cohorts were predominantly female, and the overlap occurred with all IBS subtypes. Thorough endoscopic evaluation and comorbid mood disorders and migraines are more common in the overlap cohorts than in IBS alone.

    Conclusions/inferences: In a large US database encompassing >53 million patients over >20 years, patients with IBS are at least 4 times more likely to have a MCD than the general population. Further study of mast cell involvement in the pathogenesis of IBS is warranted.

    Keywords: chronic urticaria; irritable bowel syndrome; mast cells; mastocytosis; urticaria.
  • K
    Ken
    Move down before the next move up. I bought today and will buy more if further move down.
  • s
    sal
    Why are we spiraling downwards? Anyone?
  • a
    anglesm
    Interesting MCAS research by CLDX with their CDX-0159 targeting tyrosine kinase KIT. As a long-term CLDX stock holder I had not made a connection to CDX-0159 as a possible Fibromyalgia med. To be honest, I found no research specific to FMS and CDX-0159. But I found numerous recent publications relating FMS and MCAS. Unfortunately, I could not find a clinic trail, but Mast Cell Activation research appears to be a rather new target for many aliments, or I should say as a trigger, leading to such problems.

    As Longvrts noted Irritable bowel syndrome (IBS) is just one of many inflammatory related diseases. Here's a link to an ncbi article discussing MCAS and Fibromyalgia. This could be just the start of a long useful life for CDX-0159 or spill-off meds to treat other inflammatory diseases.

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6687840/
    Fibromyalgia Syndrome (FMS) is a disorder of chronic, generalized muscular pain, accompanied by sleep disturbances, fatigue and cognitive dysfunction. There is no definitive pathogenesis except for altered central pain pathways. We previously reporte
    Fibromyalgia Syndrome (FMS) is a disorder of chronic, generalized muscular pain, accompanied by sleep disturbances, fatigue and cognitive dysfunction. There is no definitive pathogenesis except for altered central pain pathways. We previously reporte
    www.ncbi.nlm.nih.gov
  • l
    longvrts
    Editorial: Mast cells as potential target for treatment of unstable atherosclerotic plaques. Unstable atherosclerotic plaques are responsible for heart attacks and strokes. The indications for effective/safe anti-inflammatory mast cell inhibitor CDX-0159 point toward this mAb being one of the most important biologics ever developed, with revenue potential that will equal or exceed Humira:

    INVITED COMMENTARY|ARTICLES IN PRESS

    Are Mast Cells a Potential New Target for the Treatment of Unstable Atherosclerotic Plaques?

    Ryan G. e Melo
    Carlota F. Prendes

    Published:September 09, 2021DOI:https://doi.org/10.1016/j.ejvs.2021.08.002

    Atherosclerosis is a chronic inflammatory condition characterised by being systemic, progressive, and unpredictable. 1 ,2 When atherosclerotic plaques become unstable, cardiovascular events such as thrombosis or embolisation may occur. In patients with carotid stenosis, this may lead to the development of strokes, with potentially devastating consequences. Multiple studies have attempted to reveal the complex constitution of the unstable plaque, with remarkable knowledge acquisition and therapeutic advances over the last 20 years. 3 However, there remain a significant number of unanswered questions regarding how different inflammatory cells, including pro-inflammatory mediators (such as macrophages, T cells, and mast cells [MCs]), biological pathways, and histological components, interact. 4 Solving such residual questions could prove fundamental for the development of new treatment strategies and have the potential to revolutionise standard carotid stenosis management.
    Redirecting
    doi.org
  • A
    Anonymous
    CLDX very strong today on a bad day for biotechs.
    Stock holders don't want to sell- buyers need to bid up.
    From $2 to $54 in 1.5 years, CLDX is on fire.
    CLDX is the next REGN!
  • l
    longvrts
    Article: review of mast cell involvement in various liver diseases, including non-alcoholic fatty liver disease. The potential indications for a safe/effective mast cell anti-inflammatory like CDX-0159 is nothing short of staggering:

    Hepatology. 2021 Aug 26. doi: 10.1002/hep.32121. Online ahead of print.

    Mast Cells in Liver Disease Progression: An Update on Current Studies and Implications

    Linh Pham 1 2, Lindsey Kennedy 1 3, Leonardo Baiocchi 4, Vik Meadows 1, Burcin Ekser 5, Debjyoti Kundu 1, Tianhao Zhou 1, Keisaku Sato 1, Shannon Glaser 6, Ludovica Ceci 1, Gianfranco Alpini 1 3, Heather Francis 1 3

    PMID: 34435373 DOI: 10.1002/hep.32121

    Abstract
    Mast cells (MCs) induce the progression of liver diseases including, but not limited to, hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA), alcoholic and non-alcoholic fatty liver disease (ALD/NAFLD), primary biliary cholangitis (PBC), and primary sclerosing cholangitis (PSC). The effects of MCs during disease progression includes alterations in ductular reaction, steatosis, hepatic fibrosis and inflammation. In addition, there is significant crosstalk between MCs, MC mediators (histamine, tryptase, chymase) and MC-derived cytokines (transforming growth factor beta, tumor necrosis factor alpha, interleukins). Studies have been performed in rodent models, cultured cells, and human tissues to demonstrate the intracellular signaling implications of MC infiltration during liver disease. Targeting MCs may offer novel therapeutic strategies to treat liver disease. Our concise review will encompass the most recent studies involving MCs, their mediators and liver disease with the overall goal to inform the reader about the diverse role of these inflammatory immune cells in liver damage.

    Keywords: cholangiopathies; ductular reaction; hepatic fibrosis; histamine; inflammatory immune cells.
  • P
    Peter
    Here are the different levels Celldex could trade at when the stock breaks out above 56.86
    75.80
    67.38
    62.09
    60.03
    59.82
    59.44
  • P
    Peter
    9/17/2021 Jefferies Financial Group

    Initiated Coverage Buy $66.00