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Celldex Therapeutics, Inc. (CLDX)

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  • l
    longvrts
    6/23/22 8K filed: CLDX reaches favorable settlement re Kolltan contingent payments
  • r
    raysfrom98
    HAMPTON, N.J., June 21, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in a Phase 2 clinical study of barzolvolimab for the treatment of chronic spontaneous urticaria (CSU). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. The activation of the mast cells in the skin results in episodes of itchy hives, swelling and inflammation of the skin that can go on for years or even decades.

    “We are excited to advance barzolvolimab into Phase 2 as we believe it can produce potentially transformative therapeutic activity against CSU and other mast cell driven diseases,” said Diane C. Young, M.D, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. “The initiation of this study marks an important milestone for Celldex and for the patients we aim to benefit. CSU is an often serious and debilitating disease with significant impacts on patient quality of life, and there is a high unmet need for new treatment options.”

    Dr. Young continued, “This CSU study is part of our chronic urticaria program, where we are also moving forward with a second Phase 2 trial in chronic inducible urticaria, which is expected to initiate dosing shortly.”
  • T
    TrufflesDrive
    I think the current market cap of 1.4 billion makes CLDX a potential takeover for some BP.
  • M
    MERVATA
    why the July options are so high? Something is cooking. Can anyone explain. Thanks
  • M
    MERVATA
    Continue:

    or life-threatening disease and address an unmet medical need. A fast track eligible drug must show some advantage over available treatment, such as:

    • Showing superior effectiveness
    • Avoiding serious side effects of an available treatment
    • Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
    • Decreasing a clinically significant toxicity of an available treatment
    • Addressing an expected public health need
    Priority Review:
    Is a program of the United States FDA to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for priority review to a drug developer as an incentive to develop treatments for drugs that might otherwise not be profitable to develop because of a smaller pool of patients needing treatment.

    Accelerated Approval:

    FDA Drug Approval Pathway:

    • Preclinical studies—animal models; safety profile
    • Investigational New Drug Application to conduct human trials submitted to FDA
    • Phase 1 Clinical Trial—safety profile, dosage
    • Phase 2a and 2b Clinical Trials—safety and efficacy
    • Phase 3 Clinical Trials—Pivotal large-scale studies to acquire data for FDA approval
    • New Drug Application for marketing product submitted to FDA
    • AdCom meetings—expert independent panelists review
    • PDUFA date—FDA decision on approving a drug for market
  • l
    longvrts
    6/16/22 CLDX BOD news: CLDX enlarges BOD with 2 appointments. They have impressive credentials with regard to obtaining FDA approvals and building out commercial organizations. I was a Medivation investor until PFE bought them out, and Cohen did an outstanding job as Chief Commercial Officer building out the commercial organization and successfully launching Xtandi.

    "GlobeNewswire

    Celldex Announces Two New Appointments to its Board of Directors

    CLDX
    +0.85%
    Celldex Therapeutics, Inc.
    Thu, June 16, 2022, 1:01 PM
    In this article:

    CLDX
    +0.85%

    Celldex Therapeutics, Inc.

    HAMPTON, N.J., June 16, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that it has appointed Cheryl L. Cohen and Dr. Garry Neil to the company’s Board of Directors.

    “We are thrilled to welcome Cheryl and Garry to our Board of Directors during an important time for Celldex,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “Their combined expertise brings well rounded experience to provide guidance as we progress our clinical and corporate goals. I am confident that they will offer valuable perspectives as we continue to execute our development strategy.”

    Ms. Cohen has served as President of CLC Consulting, a pharmaceutical and biotechnology consulting firm that specializes in new product start-ups and commercialization. From August 2011 to July 2014, Ms. Cohen served as Chief Commercial Officer of Medivation, Inc., where she built the company’s commercial organization and lead her team to successfully launch the oncology drug, Xtandi®. Prior to joining Medivation, Ms. Cohen spent over ten years at Johnson & Johnson, most notably as Vice President of the Rheumatology Franchise. Ms. Cohen began her career at Solvay Pharmaceuticals in management and sales. Ms. Cohen currently serves on the Board of Directors of MEI Pharma, Immunity Bio (previously NantKwest) and Ignyte Acquisition Corp., all of which are publicly traded companies. She earned a B. A. degree from Saint Joseph College.

    Dr. Neil has served as Chief Executive Officer at Avalo Therapeutics (formerly Cerecor, Inc.), a publicly held biotechnology company. Prior to that, Dr. Neil was Senior Scientific Adviser and Chief Scientific Officer at Avalo since its February 2020 merger with Aevi Genomic Medicine, Inc., a biotechnology company where Dr. Neil had served as Chief Scientific Officer from September 2013 to February 2020. Prior to joining Aevi, Dr. Neil was a Partner at Apple Tree Partners, a life science private equity firm, from September 2012 to September 2013, and held a number of senior positions in the pharmaceutical industry, including most recently Corporate Vice President of Science & Technology at Johnson & Johnson from November 2007 to August 2012. Prior to these roles, Dr. Neil served as Group President at Johnson & Johnson Pharmaceutical Research and Development, Vice President of Research & Development at Merck KGaA/EMD Pharmaceuticals, and Vice President of Clinical Research at AstraZeneca and Astra Merck. Dr. Neil has served on the Board of Directors of Arena Pharmaceuticals, Inc. since February 2017 and as its Chair since February 2021. From August 2016 to May 2019, he previously served on the board of GTx, Inc., a publicly traded biopharmaceutical company. He is a member of the board of the Center for Discovery and Innovation of the Hackensack Meridian Medical School in Hackensack, New Jersey and is the Founding Chairman of TransCelerate Biopharma, Inc., a non-profit pharmaceuticals industry Research & Development consortium, and is a past member of the TransCelerate Board from 2012 to 2019. He served on the board of Reagan Udall Foundation for the FDA from 2007 – 2021, the board of Foundation for the National Institutes of Health (NIH) from 2010 – 2012 and on the Science Management Review board of the NIH from 2010 - 2012. Dr. Neil is also the past Chairman of the Pharmaceutical Research and Manufacturers Association (PhRMA) Science and Regulatory Executive Committee and the PhRMA Foundation board. Dr. Neil holds a B.S. from the University of Saskatchewan and an M.D. from the University of Saskatchewan College of Medicine. He completed postdoctoral clinical training in internal medicine and gastroenterology at the University of Toronto. Dr. Neil also completed a postdoctoral research fellowship at the Research Institute of Scripps Clinic.
  • l
    longvrts
    6/10/22 Form S-13G filed: Viking Global Investments declares 20.4% ownership of CLDX (filing is pretty complex, and it's possible that there's overlap between the different Viking Funds, which would reduce from 20% to something like 15%...nevertheless a very significant % acquisition of CLDX shares)
  • l
    longvrts
    ASCO'22: CLDX will have minimal presence at ASCO with basically a trial description for a PI study testing the triple combo of doxorubicin, CDX-1140 (CD40 agonist), and CDX-301 (Flt3 ligand) in patients with metastatic or unresectable locally advanced triple-negative breast cancer. No presentations on any of the other oncology assets; CLDX is essentially about CDX-0159 at this stage:

    https://meetings.asco.org/abstracts-presentations/213259
  • M
    MERVATA
    I am not sure if this has been posted before and so I am sharing this information:
    This article was posted on 2/1/2022

    "CDX-0159
    In its most recent news Celldex announced dosing the first patient in its Phase 1 CDX-1059 Prurigo Nodularis trial on December 8, 2021. Prurigo Nodularis causes serious, long-term itching of the skin. Patients typically present with nodules that have been scratched and which can become infected. While itching may seem like a minor problem, or a low priority, this form of it is quite a detriment to those who suffer it. Current therapy tends to steroids, with varying effect.

    CDX-0159 is an antibody that binds to and inhibits KIT, a tyrosine kinase that mediates inflammatory responses. More specifically, KIT interferes with the activity of mast cells, which are a key player in Prurigo Nodularis and chronic urticaria.

    Clinical trials of CDX-0159 for chronic urticaria, or hives, are more advanced. Interim results from the Phase 1b, open label chronic inducible urticaria trial were presented on September 29, 2021. A single 3 mg/kg dose of CDX-0159 resulted in a rapid and sustained improvement in urticaria control. 80% of patients achieved well-controlled status by week 4, and that increased to 100% by week 8. No safety concerns were reported.

    Relief for prurigo and urticaria patients would doubtless be welcome. It is too early for me to speculate on just how much insurers would be willing to pay for such a therapy. While preliminary results look brilliant, often Phase 2 and later trials do not reproduce results from earlier trials. In particular, trials with larger numbers of patients may begin to show adverse events that were not in smaller trials.

    I am not yet willing to put a numerical value on CDX-0159, but I am impressed by the science behind controlling mast cells. That could be beneficial in quite a few disease conditions beyond the two already mentioned. By way of disclosure, I should note that I had owned stock in Celldex when its leading candidate failed in 2018. In theory that trial should be statistically independent of these trials, so I may be being more cautious than is warranted. Celldex has said it will use a subcutaneous formulation of CDX-0159 when it begins Phase 2 trials for chronic urticaria in this first half of 2022. Usually for non-life-threatening diseases a Phase 3 trial will be required for regulatory approval."
  • I
    Ignatz
    Phase 1b Results of CDX-0159 in patients with antihistamine refractory chronic spontaneous urticaria (CSU) are to be presented at the European Academy of Allergy and Clinical Immunology (EAACI), being held July 1-3, 2022. Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin will be presenting. Dr. Maurer is a powerhouse, and was on the call announcing the dramatic results in the earlier trial. No doubt, he will link his presentation to the previously announced PH II trial now underway.

    I expect a bump up, either in anticipation or as a result.
  • r
    raysfrom98
    Does anyone know who the seller is? If this drops below 20, I may start buying again.
  • T
    TrufflesDrive
    Why did the stock drop 14% today ?
  • l
    longvrts
    4/28 Dupixent news shines a positive light on the significant potential of CDX-0159: Dupixent performance boosts prospects for 0159 which has better mechanism of action and clinical efficacy in overlapping indications. 0159 on track to become a high impact drug in the auto-immune segment:"PHARMASanofi's Dupixent puts on another stellar show, and it's still 'at the beginning' of its journey: execBy Angus LiuApr 28, 2022 08:37amSanofi recently raised Dupixent?s peak sales target to more than 13 billion euros and looks to add at least 1.5 million additional eligible patients worldwide by 2025. (sanofi)Five years after its first FDA approval in eczema, Sanofi?s Dupixent is still blazing a trail in inflammatory diseases.That?s the evaluation of Bill Sibold, Sanofi?s global head of specialty care, after the Regeneron-partnered drug posted a 46% revenue increase in the first quarter to 1.61 billion euros ($1.79 billion), ahead of industry watchers? expectations.?We?re still only at the beginning of our journey, with approximately 8% [Dupixent] market penetration in adults? in atopic dermatitis, Sibold said during an investor call Thursday.The relocation provides added laboratory technology, automation. and sample storage capacity to address increasing demand for molecular and immuno- assay development and testing services; supporting growth in vaccine, and immuno-oncology development.Dupixent?s 46% revenue growth at constant currencies marks the largest of a first quarter for the med so far. Sales outside of the U.S. jumped 69%. And the drug?s 38% U.S. increase is ?even more impressive,? Sibold said, because less than 90% of physicians? offices have reopened since the beginning of the pandemic.Amid competition, there may be some ?downward pressure? on Dupixent?s net price in the U.S., but Sibold said, ?there is nothing out of the ordinary here.?Sanofi recently raised Dupixent?s peak sales target to at least 13 billion euros. More than 430,000 patients are now on the IL-4/13 inhibitor across inflammatory disease indications, Sibold said, and the French pharma is planning to add at least 1.5 million eligible patients worldwide by 2025 with new label expansions.On a roll, Sanofi raises Dupixent's peak sales target to #$%$13B-plusOn that front, the FDA recently put Dupixent?s application for eosinophilic esophagitis under priority review, potentially making it the first approved drug for the disorder. Sanofi and Regeneron have also filed the drug for the itch condition prurigo nodularis with U.S. and European regulators.Meanwhile, competitors are piling into the market. Leo Pharma in December won an FDA go-ahead for IL-13-specific injection Adbry in moderate to severe atopic dermatitis. Eli Lilly just posted what Jefferies analysts called ?compelling? phase 3 data for its own IL-13 antibody lebrikizumab, with skin clearance at least on par with Dupixent or better by absolute numbers. In less direct threats to Dupixent, oral JAK inhibitors such as AbbVie?s Rinvoq and Pfizer?s Cibinqo are also entering the ring. But Sanofi is undeterred.?We believe that the additional treatment options for patients contribute to unlocking significant incremental growth potential for Dupixent through market expansion as well as improved physician and patient awareness,? Sibold said.?We?ve seen it around the world where competitors have come into the market, it helps to accelerate growth,? he added. ?As the product with the best profile, guess who wins??Sanofi, Regeneron score fast FDA review for Dupixent in eosinophilic esophagitisIn addition to Dupixent as ?the foundation and the cornerstone? in type 2 inflammatory diseases, CEO Paul Hudson noted Sanofi currently has 10 molecules in development in the area, including injectables, oral drugs and a topical candidate. Those programs could start to enter the market as early as 2025.Outside of immunology, Sanofi is trying to catch up in oncology under Hudson?s leadership. The company?s CD38 drug Sarclisa reeled in 65 million euros. In its head-to-head competition against Johnson & Johnson?s Darzalex, Sarclisa expects a delayed key readout in the second half of the year in newly diagnosed multiple myeloma.Under generic pressure to its top-selling cancer drug Jevtana in Europe, Sanofi?s entire oncology portfolio brought in 244 million euros sales in the first quarter, up 6.8% at unchanged exchange rates.Overall, Sanofi?s first-quarter haul came in at 9.67 million euros, representing an 8.6% increase at constant currencies."
  • l
    longvrts
    4/4 CDX-0159 related news: FDA prioritizes review of Dupixent in eosinophilic esophagitis due to unmet urgent need. Clinical efficacy of Dupixent in EoE patients has been modest. CDX-0159 is mechanistically a better positioned drug for treating EoE. CLDX will initiate PII trial for EoE patients in 4Q'22. Dupixent is projected at peak sales of $15 Billion/yr and CDX-0159 has an opportunity to take a big chunk of that:

    "FDA Accepts Dupixent® (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis
    NEWS PROVIDED BY

    Regeneron Pharmaceuticals, Inc.
    Apr 04, 2022, 00:59 ET

    If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis

    There are approximately 160,000 patients in the U.S. living with eosinophilic esophagitis who are currently treated, of whom approximately 48,000 have failed multiple treatments

    TARRYTOWN, N.Y. and PARIS, April 4, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow. The target action date for the FDA decision on this investigational use is August 3, 2022.

    The sBLA is supported by data from two Phase 3 trials evaluating the efficacy and safety of Dupixent 300 mg weekly in patients aged 12 years and older with EoE (Part A and Part B), and data from an active long-term extension trial. Dupixent 300 mg weekly significantly improved the signs and symptoms of EoE at 24 weeks compared to placebo, including the ability to swallow and reduction in eosinophil count in the esophagus. The safety results of these trials were generally consistent with the known safety profile of Dupixent in its approved indications. The most common adverse event observed with Dupixent, in Part A and Part B, was injection site reactions.

    In September 2020, the U.S. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Regulatory filings around the world are also planned in 2022. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority."
  • A
    Anonymous
    Celldex Therapeutics Presents Positive Data from CDX-0159 Phase 1b Study in Chronic Inducible Urticaria at EAACI 2021
    BY GlobeNewswire
    — 6:01 PM ET 07/09/2021
    - 95% complete response rate after single dose of CDX-0159 -
    - Rapid, profound and durable responses offer patients opportunity for quick, lasting, meaningful relief -
    - Median duration of response 77+ days in Cold Urticaria and 57+ days in Symptomatic Dermographism -
    - Serum tryptase and skin mast cell depletion mirror clinical activity -
    - Favorable safety profile -
    - Company to host webcast conference call on Monday, July 12 at 8:15 a.m. ET -

    HAMPTON, N.J., July 09, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. ( CLDX
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    ) today announced updated data from the Company’s ongoing, open label Phase 1b clinical trial of CDX-0159 in patients with antihistamine refractory cold urticaria and symptomatic dermographism, the two most common forms of chronic inducible urticaria. These diseases, which are often severe and debilitating, can significantly impact patients’ lives. CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity.

    All 19/19 (100%) patients who received a single full dose of CDX-0159 experienced a clinical response to provocation testing. 18/19 (95%) experienced a complete response and 1/19 (5%) experienced a marked partial response. Responses were rapid, profound, and durable and correlated with a depletion of skin mast cells. CDX-0159 was generally well tolerated. These data were presented by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin, in Berlin during a late-breaking poster discussion session (#1046) as part of the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2021.

    “The achievement of a 95% complete response rate, rapid onset and sustained durability after a single dose is unprecedented in this patient population and clearly demonstrates that CDX-0159 has the potential to become an important new treatment option for patients suffering with chronic inducible urticaria,” commented Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics ( CLDX
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    ). “We believe these impressive early data show that CDX-0159 safely depletes mast cells which indicates its potential to impact other diseases with mast cell involvement. We continue to make excellent progress across the CDX-0159 development program in urticaria and expect to expand into prurigo nodularis later this year, and additional indications with mast cell involvement in the future.”

    “These early-stage results are stunning and represent a major breakthrough for patients with inducible urticarias where current treatment options have been unable to provide relief from often severe symptoms,” said Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin, who is conducting the study. “While individuals with inducible urticaria go to great lengths to avoid disease triggers in their daily lives, many find it impossible to do so and are impacted by severe itching and burning hives that impair all parts of their lives—their work, their concentration, their sleep and their social behavior. CDX-0159 clearly provided a real benefit to these patients and has meaningfully improved their lives. This novel mast cell depleting mechanism is especially exciting because it can provide insights into the involvement of mast cells across many diseases where their role is not yet well understood by the scientific community.”

    Summary of data from ongoing Phase 1b Trial of CDX-0159:

    As of the data cut-off on June 11, 2021, 20 patients had received a single intravenous infusion of CDX-0159 at 3 mg/kg, including 11 patients with cold urticaria and 9 patients with symptomatic dermographism. Patients had high disease activity as assessed by provocation threshold testing. In patients with cold urticaria and symptomatic dermographism baseline critical temperature thresholds were 18.9°C/66°F (range: 5-27°C/41-80.6°F) and FricTest® thresholds were 3.8 (range: 3-4) of 4. Safety results are reported for all 20 patients; activity results are reported for the 19 patients who received a full dose of CDX-0159. 14 of 19 patients completed the 12-week study observation period and five were ongoing (range of 2-8 weeks) as of June 11, 2021.

    All 19/19 (100%) patients experienced a clinical response as assessed by provocation threshold testing; 18/19 (95%) experienced a complete response and 1/19 (5%) experienced a partial response.
    10/10 (100%) patients with cold urticaria experienced a complete response.
    8/9 (89%) patients with symptomatic dermographism experienced a complete response and 1/9 (11%) experienced a partial response.
    Compete responses were observed in all 3 patients (1 cold urticaria; 2 symptomatic dermographism) with prior X
  • l
    longvrts
    Report out: Mast cells implicated in transition from undifferentiated arthritis to psoriatic arthritis. CLDX has the first-in-class and best-in-class mast cell inhibitor in CDX-0159:

    Front Med (Lausanne). 2021 Apr 9;8:656667. doi: 10.3389/fmed.2021.656667. eCollection 2021.

    Synovial Immunohistological Biomarkers of the Classification of Undifferentiated Arthritis Evolving to Rheumatoid or Psoriatic Arthritis

    Andrea Cuervo 1, Raquel Celis 1, Antonio Julià 2, Alicia Usategui 3, Regina Faré 3, Julio Ramírez 1, Ana Belen Azuaga 1, Andrés Lorenzo 1 4, Raimon Sanmartí 1, José L Pablos 3, Juan D Cañete 1
    Affiliations expand
    PMID: 33898490 PMCID: PMC8062857 DOI: 10.3389/fmed.2021.656667

    Abstract
    Background: Undifferentiated arthritis (UA) is defined as an inflammatory arthritis that does not fulfill criteria for a definite diagnosis. Delay in reaching a specific diagnostic and therapy may lead to impaired functional outcomes. Our aim was to identify synovial biomarkers associated with definitive diagnostic classification in patients with UA. Methods: DMARD-naïve UA patients with available initial synovial tissue (ST) and a final diagnosis of rheumatoid arthritis (RA) or psoriatic arthritis (PsA) during follow-up were included and compared with patients with well-defined disease (RA or PsA). Clinical, arthroscopic, and pathological data were compared between groups. Pathology included quantitative immunohistochemical (IHC) analysis of cell types and human interferon-regulated MxA. Principal component analysis (PCA) was performed to extract disease patterns. Results: One hundred and five patients were included: 31 patients with DMARD-naïve UA (19 evolving to RA and 12 to PsA during a median follow up of 7 years), 39 with established RA, and 35 with established PsA. ST from the UA group showed higher macrophage density compared with the established RA and PsA groups. Patients with UA evolving to RA (UA-RA) showed higher MxA expression and CD3+ T-cell density compared with established RA. UA patients evolving to PsA (UA-PsA) showed increased vascularity and lining synovial fibroblast density compared with established PsA. Synovitis of UA-PsA patients showed more mast cells and lining fibroblasts compared with UA-RA. No between-group differences in local or systemic inflammation markers were found. Conclusions: Our results show differences in the cellular composition of UA synovium compared with RA and PsA, with higher density of the cellular infiltrate in the UA groups. Initial expression of the interferon inducible gene MxA could be a biomarker of progression to RA, while higher mast cell and fibroblastic density may be associated with PsA progression.
  • l
    longvrts
    Report out: Combination of CD40 activation plus PD-1/TIGIT blockade eliminates pancreatic cancer in preclinical model. CLDX's CD40 agonist CDX-1140 has demonstrated the highest systemic dosing with an acceptable AE profile. 1140 is currently being tested in a clinical trial against pancreatic cancer in combination with chemo. This report from one of the leading academic cancer research labs suggests that CLDX should test 1140 in combination with PD-1/TIGIT blockers in PC:

    Cancer Cell. 2021 Jul 27;S1535-6108(21)00384-6. doi: 10.1016/j.ccell.2021.07.007. Online ahead of print.

    The CD155/TIGIT axis promotes and maintains immune evasion in neoantigen-expressing pancreatic cancer

    William A Freed-Pastor 1, Laurens J Lambert 2, Zackery A Ely 2, Nimisha B Pattada 3, Arjun Bhutkar 3, George Eng 4, Kim L Mercer 3, Ana P Garcia 3, Lin Lin 3, William M Rideout 3rd 3, William L Hwang 5, Jason M Schenkel 6, Alex M Jaeger 3, Roderick T Bronson 3, Peter M K Westcott 3, Tyler D Hether 7, Prajan Divakar 7, Jason W Reeves 7, Vikram Deshpande 8, Toni Delorey 9, Devan Phillips 9, Omer H Yilmaz 10, Aviv Regev 11, Tyler Jacks 12
    PMID: 34358448 DOI: 10.1016/j.ccell.2021.07.007

    Abstract
    The CD155/TIGIT axis can be co-opted during immune evasion in chronic viral infections and cancer. Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy, and immune-based strategies to combat this disease have been largely unsuccessful to date. We corroborate prior reports that a substantial portion of PDAC harbors predicted high-affinity MHC class I-restricted neoepitopes and extend these findings to advanced/metastatic disease. Using multiple preclinical models of neoantigen-expressing PDAC, we demonstrate that intratumoral neoantigen-specific CD8+ T cells adopt multiple states of dysfunction, resembling those in tumor-infiltrating lymphocytes of PDAC patients. Mechanistically, genetic and/or pharmacologic modulation of the CD155/TIGIT axis was sufficient to promote immune evasion in autochthonous neoantigen-expressing PDAC. Finally, we demonstrate that the CD155/TIGIT axis is critical in maintaining immune evasion in PDAC and uncover a combination immunotherapy (TIGIT/PD-1 co-blockade plus CD40 agonism) that elicits profound anti-tumor responses in preclinical models, now poised for clinical evaluation.
  • l
    longvrts
    7/9/21 CDX-0159 late-breaking abstract at EAACI 2021: robust efficacy/safety, prolonged duration of treatment and molecular mechanism of action defined.

    In a nutshell: CDX-0150 is an innovative, revolutionary drug that will transform the treatment landscape for mast cell caused disease.

    My take: CDX-0159 is a mega blockbuster in the making. CLDX valuation will at least triple from current levels in the short to mid-term. Long term:....?
  • a
    anglesm
    Guess what? Here we go again.

    HAMPTON, N.J., July 12, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced that it is proposing to offer and sell, subject to market conditions, $175 million of shares of its common stock in an underwritten public offering. Celldex expects to grant the underwriters a 30-day option to purchase up to an additional $26.25 million of shares of common stock offered in the public offering.

    Ref: https://ir.celldex.com/news-releases/news-release-details/celldex-therapeutics-announces-proposed-public-offering-common-2
    The Investor Relations website contains information about Celldex Therapeutics's business for stockholders, potential investors, and financial analysts.
    The Investor Relations website contains information about Celldex Therapeutics's business for stockholders, potential investors, and financial analysts.
    ir.celldex.com
  • 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.'"