ImmusanT abandons coeliac disease vaccine after phase 2 flop

US biotech ImmusanT  has been left without any R&D programmes in the clinic after pulling a coeliac disease vaccine that had reached phase 2 testing.

The peptide-based immunomodulatory vaccine – called Nexvax2 – proved to be safe and well-tolerated in the trial but didn’t come close to the efficacy needed to warrant further clinical development.

Coeliac disease – an autoimmune disease caused by a reaction to gluten in foods – affects millions of people around the world and is characterised by inflammation of the small intestine. It causes symptoms including diarrhoea, abdominal pain and bloating, as well as impairing the ability to absorb nutrients from the diet.

Nexvax2 was intended to train the immune systems of coeliac patients to tolerate gluten – a protein found in grains like wheat, barley, and rye – rather than seeing it as a foreign invader and mounting an attack.

It was granted fast-track status by the FDA earlier this year, on the grounds there are currently no ways to treat coeliac disease other than restricting gluten in the diet.

“The results from an interim analysis revealed Nexvax2 did not provide statistically meaningful protection from gluten exposure for coeliac disease patients when compared with placebo,” said Arch Venture-backed ImmusanT in a statement.

The Massachusetts-based biotech has been running the phase 2 trial of Nexvax2 since September 2018, having raised $40 million in backing from Arch and Vatera a year earlier to take the vaccine into a proof-of-concept study.

With its lead candidate now canned, ImmusanT is left with a type 1 diabetes candidate in preclinical development, based on the same technology as Nexvax2, plus a couple of other undisclosed preclinical programmes.

The demise of the immunotherapy will be a blow to coeliac sufferers, but there are some other candidate therapies coming through the biopharma industry’s development pipeline.

Last year, Provention Bio picked up rights to an interleukin-15-targeting antibody originally developed by Amgen for rheumatoid arthritis, rebadging it from AMG 714 to PRV-015.

The drug had previously advanced to phase 2 testing in coeliac disease under licensee Celimmune, but was returned to Amgen’s portfolio after it acquired the company in 2017.

Meanwhile, ImmunogenX recently started phase 2 trials of its coeliac candidate latiglutenase, an oral therapy that combines two protease enzymes to break down gluten in the gut.

The drug was originally developed by Alvine Pharma which partnered with AbbVie on the programme in a $70 million upfront deal signed in 2013, before being acquired by ImmunogenX in 2016. ImmunogenX is also developing a companion diagnostic for coeliac disease.

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