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  • Jefferson Adams

    Promising Celiac Disease "Vaccine" Nexvax2 Goes Down in Flames

    Jefferson Adams


    Reviewed and edited by a celiac disease expert.

      Drugmaker ImmusanT is discontinuing their work on Nexvax2, a "vaccine" intended to treat celiac disease. The drug was designed to reprogram celiac patients' immune systems so they stop reacting to gluten.


    Caption: Image: CC by 2.0--agressti vanessa

    Celiac.com 07/01/2019 - Drugmakers have pulled the plug on a phase II trial of Nexvax2, a promising drug for treating celiac disease. Pharmaceutical company ImmusanT, said that "results from an interim analysis revealed Nexvax2 did not provide statistically meaningful protection from gluten exposure for celiac disease patients when compared with placebo."

    That's a lot of fancy language to say that the drug simply didn't work. It did no better than a placebo. If there were any other way to spin it, the company would have spun it. They didn't. That basically means total failure.



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    We've written about Nexvax2 over the years, and followed it through its development. It was promising enough to earn fast-track development status by the FDA.

    The company's press release reads as follows: 

    ImmusanT Discontinues Phase 2 Clinical Trial for Nexvax2® in Patients With Celiac Disease
    CAMBRIDGE, Mass. – June 25, 2019 – ImmusanT, Inc., a clinical stage company leveraging its Epitope-Specific Immuno-Therapy™ (ESIT™) platform to deliver first-in-class peptide-based immunomodulatory vaccine therapies to patients with autoimmune diseases, has discontinued the Phase 2 global study for its lead candidate, Nexvax2®, intended as a treatment for celiac disease.

    Similar to earlier Phase 1 results, Nexvax2 was found to be safe and generally well tolerated. There were no concerning safety issues identified during the study. ImmusanT will be actively investigating data gathered from the trial to further understand this outcome. The company will provide further information once available."

    So, to boil it down: The drug is safe and well tolerated, but it doesn't work any better than a placebo. The company will not pursue further testing.

    That's sad news and an ignoble end for a drug that held such high hopes. Few topics have generated as much excitement among celiac sufferers as the tantalizing possibility of a vaccine. Many eagerly hoped for success, while some wouldn't take it on a bet.

     It's unclear what this means for the technology behind Nexvax 2, as the underlying mechanics for this vaccine, Epitope-Specific Immuno-Therapy (ESIT), were to serve as the platform for future autoimmune treatments.

    Stay tuned for more on this and related stories.


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    Thanks for the update Mr. Adams. I know this news may upset people, especially those who were willing to undertake the role of test subjects in the advancement of celiac research. In my opinion it is wise to pull the plug at this stage, and I am certain that is not easy for the researchers either. The wisdom is also knowing when to extinguish a non viable research path, to pursue another.

     

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    I’d have been one of the “not on a bet” team. Being 1000% gluten-free is sometimes inconvenient, but it’s just not that hard ... says a person for whom the diet works. 

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    Guest PreDestination

    Posted

    Maybe I misunderstood another persons comment above but, whether I did or didn't, if anyone thinks living on a gluten free diet is not that hard, feel free to shut up! I don't take frivolous comments on this matter lightly. Struggling with gluten alergies is a horrible relentless ongoing daily battle. To make my point further, there's been times I've asked to God to heal me or kill me, I've been that sick. On a much lighter note, I thank God gluten always comes out of the body generally in a few days. By drinking alot of water and 3 to 4 days of starving myself of food, I'm always much better. If the term starving doesn't work for you then, replace the word with fasting. I know in my heart researchers won't just give up and quietly go away. Thank you to all researchers and celiac.com for your endless commitments to relieving our gluten nightmares. God Bless! Peace!

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    6 hours ago, Guest PreDestination said:

    “Heal me or kill me”.

    I’ve been there many many many many times. For me it’s not a question of whether or not the “diet” is inconvenient. Of course its inconvenient and not easy and not fun but I’m pretty sure 99% of celiacs are over the “inconvenience” (yawn, old news). Convenience or ease is not my concern but IF that is your biggest concern and it’s the first thing that comes to mind when making a case for/against the drug, then you’re right, the drug is probably not right for you. You’re one of the lucky ones and should recognize that by cheering for yourself quietly and be grateful for your good fortune. With humility, try listening to others and encourage them. Tell them that their health and their lives are worth fighting for. So many of us are wondering how we’re going to live the rest of our lives, tired, sick, comorbid diseases, many who have developed cancers, some who have committed suicide. They also lived with a 1000% percent clean diet but this disease doesn’t treat everyone equally and one person does not deserve a better fate or less symptoms than the next. Seeing this today brought me to tears. I pray for the people who have it worse than me. There are far too many... 

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    Guest ANTHONY COLATRELLA

    Posted

    10 hours ago, Joel K said:

    Does anyone else smell a rat? Did Phase I not include clinical trials?

    Phase1 tests a drug's safety and tolerability not its efficacy--what rat is there to smell---why the distrust----the results were such that it was not economically feasible for the company to continue to invest millions

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    On 7/9/2019 at 8:37 AM, Joel K said:

    Does anyone else smell a rat? Did Phase I not include clinical trials?

    Phase I tests are generally for tolerance and safety. Phase II / III are more about effectiveness.

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    On 7/1/2019 at 9:44 PM, Awol cast iron stomach said:

    Thanks for the update Mr. Adams. I know this news may upset people, especially those who were willing to undertake the role of test subjects in the advancement of celiac research. In my opinion it is wise to pull the plug at this stage, and I am certain that is not easy for the researchers either. The wisdom is also knowing when to extinguish a non viable research path, to pursue another.

     

    I'm just glad to see they're being honest... AND that ImmunsanT was willing to include us all by reporting to Celiac.com during the entire process.  

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    I am very disappointed because I am tired of being sick and suffering. It’s like nobody is listening to our cry for help. Just know it’s not a good place to be physically or mentally. Praying for successful treatment and preventable measures.

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    12 hours ago, Guest Rebecca said:

    I am very disappointed because I am tired of being sick and suffering. It’s like nobody is listening to our cry for help. Just know it’s not a good place to be physically or mentally. Praying for successful treatment and preventable measures.

    Look up Lorazotide Acetate. That one sounds great!

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  • About Me

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,500 articles on celiac disease. His coursework includes studies in science, scientific methodology, biology, anatomy, medicine, logic, and advanced research. He previously served as SF Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

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