FDA fast tracks ImmusanT’s lead candidate Nexvax2

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ImmusanT has gained Fast Track designation from the US FDA for its lead therapeutic candidate, Nexvax2, which is being developed to protect celiac disease (CeD) patients who carry the HLA-DQ2.5 immune recognition genes.

Patients with the HLA-DQ2.5 genes account for more than 90% of the CeD population. A global Phase 2 study assessing Nexvax2 is currently recruiting patients.

“We view the fast track designation for our lead candidate, Nexvax2, as a testament to the significant need for bringing therapeutic solutions to patients with celiac disease as quickly as possible,” said ImmusanT CEO Leslie Williams.

“Currently, there are no disease-modifying therapies for this condition, and the only solution for patients is strict adherence to a lifelong, gluten-free diet.

“Our hope is that by helping restore immune tolerance towards gluten, Nexvax2 will improve quality of life and prevent the serious complications of chronic gluten exposure in celiac disease patients.

“The development of Nexvax2 aligns with our strategic vision of transforming how patients with autoimmune diseases are treated.”

Nexvax2 consists of a proprietary combination of three, short peptides that represent the gluten-derived immune-activating epitopes in HLA-DQ2.5+ patients.

Administered as a subcutaneous injection, Nexvax2 has completed multiple Phase 1b clinical trials, which yielded data supporting safety and tolerability as well as proof-of-mechanism and effectiveness.