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Celiac.com 02/20/2019 - Pharmaceutical company ImmusanT is developing a celiac disease vaccine called Nexvax 2. Many vaccines provide long-term or permanent protection against disease after just one, or several doses. Because celiac disease is not caused by a virus, like polio, but is a response to the presence of an antigen (similar to an allergen that triggers an allergy), the approach to creating a vaccine like Nexvax 2 is different and, in some ways, easier, than creating a traditional vaccine, like the HPV vaccine. Nexvax 2 is a vaccine in much the same way that allergy shots are, but not in the way the polio vaccine is. Celiac Vaccine is Similar to Allergy Shots Unlike traditional vaccines, such as the polio vaccine, or the measles vaccine, Nexvax 2 does not inject a small dose of dead or weakened virus, or any virus fragment, into the patient to achieve disease immunity. Allergy shots work by desensitizing the body’s reaction by strengthening the immune system, thereby reducing or eliminating reactions to certain allergens. Nexvax 2 would work in a similar manner to allergy shots. It would build tolerance levels until there was little or no immune reaction to gluten exposure. Anyone who’s ever had allergy shots knows that their effectiveness can range from person to person. Some people get minimal relief, though most see good to excellent results. Many experience tremendous relief, and see their symptoms disappear. Nexvax 2 Faces Easier Path to Approval Because Nexvax 2 works less like a traditional vaccine, and more like allergy therapy, the process for testing and approval is potentially easier and shorter; several years, rather than a decade or more. The hope is that, once treated with Nexvax 2, “the immune system, now seeing these fragments of gluten in a different way, might learn to tolerate gluten," said Benjamin Lebwohl, director of clinical research at the Celiac Disease Center at Columbia University. Certainly, the ability to reduce or neutralize the body’s reaction to gluten in people with celiac disease would be a major breakthrough in the treatment of celiac disease. Benefits for celiac patients could include a reduction in severity of gluten contamination symptoms, and potentially an elimination of symptoms entirely. Nexvax 2 treatment, if successful, could allow some people with celiac disease to safely consume wheat. That is potentially huge news. Phase two clinical trials of the Nexvax 2 are slated for completion by the end of 2019. Read more: Promising Celiac Vaccine Nexvax 2 Begins Phase Two Trials

Celiac.com 11/05/2018 - ImmusanT, Inc. is a clinical stage company looking to deliver innovative peptide-based immunomodulatory vaccine therapies to patients with autoimmune diseases, initiated enrollment in Australia and New Zealand for its celiac disease vaccine. Along with Nexvax2, ImmusanT is working to develop vaccines for other HLA-associated autoimmune diseases, including type 1 diabetes. The Phase 2 trials will assess the safety, tolerability and efficacy of its celiac vaccine, Nexvax2, on celiac patients who carry the immune recognition genes for HLA-DQ2.5. Carriers of HLA-DQ2.5 account for approximately 90% of people with disease, and Nexvax2 is designed to protect these patients from the effects of gluten exposure. Nexvax2 is currently the only disease-modifying therapeutic candidate in clinical development for patients with celiac disease. Injections of Nexvax2 are designed to reprogram T cells that trigger an inflammatory response to gluten, thereby suppressing inflammation in patients with celiac disease. Phase 1 studies showed Nexvax2 to be safe and well-tolerated at even its highest dose levels. In Phase 2 clinical trials, ImmusanT hopes to confirm clinical efficacy of Nexvax2 administered by injection into the skin for treatment of celiac disease. The study plan consists of an initial screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up. The trials will be conducted at sites in Melbourne, Perth, Adelaide and Brisbane, in addition to sites in New Zealand. For the U.S. study researchers will enroll approximately 150 patients across the U.S., Australia and New Zealand. Phase 2 is a randomized, double-blind, placebo-controlled clinical study of Nexvax2 in adults with confirmed celiac disease who have followed a gluten-free diet for at least a year prior to screening. “This trial is important in establishing clinical proof-of-concept for a treatment that would provide benefit beyond that of the gluten-free diet,” and will “test if Nexvax2 can specifically target the immune response to gluten in people with celiac disease and modify associated symptoms,” said Jason Tye-Din, MBBS, Ph.D., principal investigator at the Royal Melbourne Hospital and head of celiac research at the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia. For more information about RESET CeD, including inclusion and exclusion criteria, please visit www.clinicaltrials.gov (Identifier: NCT03644069).

Celiac.com 10/19/2018 - Work to develop a vaccine for celiac disease could soon lead to a vaccine for diabetes. After successful phase 1 studies of Nexvax2, their peptide-based therapeutic vaccine for celiac disease, ImmusanT has seen a significant investment from venture philanthropy organization JDRF T1D. ImmusanT's peptide therapy program for celiac disease may provide lessons for a similar therapeutic treatment for Type 1 diabetes. The investment will support ImmusanT as it attempts to develop a vaccine to prevent Type 1 diabetes, based on the early success of its peptide immunotherapy program for celiac disease, the two entities announced in a press release. ImmusanT’s celiac peptide therapy program works by identifying antigens that trigger an inflammatory responses in people with autoimmune diseases. Once identified, the peptide therapy is used to neutralize the autoimmune response. This celiac disease program goes back to 1998, when Anderson first began his efforts to find and identify the peptides. The findings were published in 2010, and the company was founded shortly afterward by Leslie Williams, BS, RN, MBA, director, president and CEO of ImmusanT. From there, ImmusanT conducted five phase 1 trials for its celiac therapy. Those trials have proven very promising, and the latest investment into a similar drug for diabetes is proof of that promise. In the case of celiac disease, the drug works by “targeting T cells in patients. Those T cells that are engaged as peptides are distributed throughout the body after the injection, and we see evidence that the T cells are being activated about 2 hours later,” Robert Anderson, BMedSc, MB, ChB, PhD, FRACP, chief scientific officer for ImmusanT, told Endocrine Today. “We found that if we gradually increase the dose in patients building up to a maintenance dose level, they become non-reactive to those peptides.” With much of the early research targeted towards demonstrating the drug’s safety, and getting the right dose and dose regimen, the development of a version targeted at diabetes, says Anderson, “should be more streamlined due to the lessons learned during the celiac disease program. That’s partly because the team knows “a lot more going into Type 1 diabetes about how peptide therapy works and how to optimize it than we did when we started celiac disease, where it was a blank slate.” This is really exciting news. A vaccine for celiac disease is exciting, to be sure, but a viable vaccine for diabetes would be a major development in disease prevention. Stay tuned for more news as the story develops. Read more at Healio.com

Celiac.com 12/22/2017 - Venture capital firms Arch Venture, and Vatera are betting big on biotech startup ImmusanT, the makers of potential celiac disease vaccine Nexvax2. Arch and Vatera have funded a $40 million B round that will support ImmusanT's development of their celiac treatment through Phase II testing. Full data are expected in mid-2019. As part of it's efforts, Arch Venture partner and former head of research at Celgene, Tom Daniel, will join the board at ImmusanT. Additionally, renowned immunologist and Arch managing director Steven Gillis will also join the board at ImmusanT. Nexvax2 is the first prong in ImmusanT's efforts to develop a treatment that creates immune system tolerance to thwart autoimmune diseases. If they are successful in tackling celiac disease, the company is looking to expand the technology to include treatments for type 1 diabetes and other ailments. Celiac disease is a great place to start, says ImmusanT CEO Leslie Williams, because scientists already know the antigen that triggers the disease. Williams says that her company has scoured 17,000 peptides to "create a hierarchy of the key components that trigger the T cell response" in celiac disease. Nexvax2 is designed to work by slowly coaxing the immune system to ignore the trigger. Patients exposed to Nexvax2 react as if they have eaten gluten, says Williams. The goal is to harness that immune reactions and to modulate it. Williams is looking to double the size of the company's tiny 7-person staff as the ImmusanT journeys through a mid-stage trial. She will then look to an expanded set of programs as well as the data to determine the best direction for the company. Williams says that all options are currently open, including another funding round, an IPO or even a strategic deal. Read more at: endpts.com

Celiac.com 04/03/2017 - Massachusetts biotech firm ImmusanT has announced the successful completion of its first phase 1b trial of Nexvax2, an immunotherapy drug designed to protect celiac sufferers from the adverse effects of gluten exposure, including gastrointestinal symptoms, such as diarrhea, abdominal pain and bloating. Nexvax2 is a drug that relies on three peptides designed to promote T cells involved in the inflammatory reaction in celiac disease to become tolerant to gluten. The company hopes that an initial course will promote gluten-tolerance, which can then be maintained by periodic boosters of the vaccine. The phase 1b trial in 38 patients showed no issues with safety or tolerability, and indicated that the immunotherapy seemed to work as designed. The study also helped ImmusanT to determine dosages for phase 2 trials to determine if Nexvax2 can protect patients on a gluten-free diet from inadvertent gluten exposure, which ImmusanT sees as the quickest route to approval. If Nexvax2 proves to be effective in preventing accidental gluten exposure in celiac patients, the company plans a follow-up program to see if immunotherapy with Nexvax2 can eliminate the need for a gluten-free diet in celiac patients; a step that represents a daunting challenge, and is somewhat of a Holy Grail for celiac researchers. ImmusanT is also developing diagnostic protocols for the vaccine, which are designed to guide its use and help improve diagnosis rates. Nexvax2 is just the latest in a large crop of auxiliary treatments aimed at celiac disease. Switzerland's Anokion teamed up with Japanese pharma Astellas in 2015 to form Kanyos, a company working on an immunotherapy for celiac disease along with type 1 diabetes. A company called Sanofi is also working with Selecta on a similar approach. Meanwhile, in 2013 AbbVie licensed rights to Alvine Pharmaceuticals AVL003, an oral therapy designed to break down gluten in the GI tract before it can cause damage. So, stay tuned celiac sufferers, the next few years could produce some very interesting new treatments for celiac disease, something considered impossible just ten years ago. Source: Fierce Biotech