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Press Release

ImmusanT Provides Year-End Update and Outlines Goals for 2018

ImmusanT,Inc.
Posted on: 04 Jan 18

ImmusanT, Inc., a clinical-stage company developing Nexvax2®, a therapeutic vaccine designed to protect patients with celiac disease against exposure to gluten and ultimately restore immune tolerance in celiac disease, today provided an update on accomplishments from 2017 and outlined goals for 2018.

“In 2017, we showed Nexvax2 to be well-tolerated in three phase 1 trials, identified a dosing strategy, raised $40 million in new funding, expanded our board, and demonstrated an ability to identify those living with celiac disease through a simple blood test,” said Leslie Williams, Chief Executive Officer of ImmusanT. “2018 will be yet another year of progress for ImmusanT, as we advance Nexvax2 into a phase 2 trial, continue developing the first non-invasive diagnostic for celiac disease, and begin applying our epitope-specific immunotherapies to other autoimmune diseases.”

2017 Accomplishments

  • Validated advancement of Nexvax2 to phase 2 clinical trials –the company completed three phase 1 studies supporting the safety and relevant bioactivity of Nexvax2 in celiac disease. The results of two of these studies were published in the The Lancet Gastroenterology and Hepatology. In total, ImmusanT has conducted four phase 1 clinical studies demonstrating Nexvax2 to be well-tolerated with early signals of efficacy.
  • Identified improved dosing strategy – In November, data demonstrating that Nexvax2 can be administered at dose levels six times higher than those previously identified were published in EBioMedicine, and presented at United European Gastroenterology (UEG) Week. This is significant because dose strength is believed to determine efficacy of peptide-based immunotherapy, and at these higher levels Nexvax2 may be used as a maintenance treatment for those living with celiac disease.
  • Raised funds to support phase 2 trial of Nexvax2 and platform expansion – In November, the company announced a $40 million Series C equity financing from ARCH Venture Partners and existing investor Vatera Healthcare Partners. The proceeds will fund the phase 2 clinical trial of Nexvax2, continued advancement of the company’s diagnostic biomarker program and expansion of the company’s Epitope-specific Immunotherapy (ESIT) platform to other autoimmune diseases.
  • Added Drs. Steven Gillis and Tom Daniel to Board – Concurrent with the financing, immunologist and pioneer in the field of cytokine and cytokine receptors Steven Gillis, Ph.D., and clinical development expert Thomas O. Daniel, M.D., joined the ImmusanT Board of Directors.
  • Expanded precision medicine and clinical operations expertise through strategic hires – In December, Gautam Goel, Ph.D. was hired as Director of Precision Medicine and Susan Gould was brought in as a consultant for clinical operations. Both will be involved in expanding applications of our ESIT platform.
  • Validated continued development of diagnostic tools through data presented at UEG Week In November, the company announced data demonstrating an ability to differentiate celiac disease and non-celiac gluten-sensitive patients through cytokine levels found in blood. The findings suggest the potential for the first non-invasive diagnostic for celiac disease.

Expected Key 2018 Accomplishments

  • Initiate a phase 2 Study of Nexvax2 therapeutic vaccine for celiac disease
  • Continue expanding the team, including executive-level hires
  • Advance the company’s diagnostic tools for use in celiac disease
  • Reinforce the scientific credibility and activity of Nexvax2 through peer-reviewed publications and presentations
  • Advance new applications for the ESIT platform in potential new indications including type 1 diabetes

About Celiac Disease
Celiac disease is an acquired, T cell-mediated autoimmune gastrointestinal disease triggered by the ingestion of gluten from wheat, rye and barley. About 90% of individuals affected by celiac disease carry the human leukocyte antigen-DQ2.5 (HLA-DQ2.5) immune recognition gene which facilitates the immune response to peptide fragments of gluten. A gluten-free diet is the only current management for this disease. The global prevalence of celiac disease is approximately 1%. General awareness of celiac disease is increasing as serological testing becomes more widespread in medical practice, but presently over 80% of cases go unrecognized in the United States. When a person with celiac disease consumes gluten, the individual’s immune system responds by triggering T cells to fight the offending proteins, damaging the small intestine and inhibiting the absorption of important nutrients into the body. Undiagnosed, celiac disease can contribute to poor educational performance and failure to thrive in children. Untreated disease in adults is associated with osteoporosis and increased risk of fractures, anemia, reduced fertility, problems during pregnancy and birth, short stature, dental enamel hypoplasia, dermatitis, recurrent stomatitis and cancer. With no available drug therapy, the only option is a strict and lifelong elimination of gluten from the diet. Compliance is often challenging and the majority of people continue to have residual damage to their small intestine in spite of adherence to a gluten-free diet.

About Nexvax2 ®
Nexvax2® is the only therapeutic approach for celiac disease in clinical development today that targets the fundamental cause of the disease; the loss of immune tolerance to gluten. Nexvax2 is a therapeutic vaccine that reprograms the T-cells responsible for the symptoms of celiac disease to stop triggering a pro-inflammatory response. Nexvax2 intends to protect patients with celiac disease against inadvertent exposure to gluten.

About ImmusanT, Inc.
ImmusanT is a privately held biotechnology company focused on protecting patients with celiac disease against the effects of gluten. By harnessing new discoveries in immunology, ImmusanT aims to improve diagnosis and medical management of celiac disease by protecting against the effects of gluten exposure while patients maintain a gluten-free diet. The company is developing Nexvax2®, a therapeutic vaccine for celiac disease, and diagnostic and monitoring tools to improve celiac disease management. ImmusanT’s targeted immunotherapy discovery platform can be applied to a variety of autoimmune diseases. To learn more about ImmusanT, visit www.ImmusanT.com, or follow ImmusanT on Twitter.

View source version on businesswire.com: http://www.businesswire.com/news/home/20180104005243/en/

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Last updated on: 04/01/2018

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