Kinaset Therapeutics is joining the search for a better severe asthma treatment, picking up where Vectura left off when it decided to clear house last year.
UK-based Vectura — which took a big hit when its most advanced candidate flopped in a Phase III asthma trial back in 2018 — recently shifted to a CDMO model, offloading all of its R&D programs. Robert Clarke, who’s worked on inhalable therapeutics for 21-plus years, had close contacts at the company and took a look at what they were offering. After doing some research, he was attracted by VR475, a pan-JAK inhibitor.
“I thought there was a really interesting opportunity here,” said Clarke, who hailed from Pulmatrix. So he jumped, building a company of his own around the candidate. On Monday, Kinaset launched with a $40 million Series A and its sights set on the clinic.
The small molecule candidate, renamed KN-002, is an anti-inflammatory — or as Clarke calls it, “a better mousetrap.” It targets “all of the JAKs,” he said, as opposed to just JAK1 or JAK2, for instance. “We’re hitting everything within that inflammatory cascade,” he continued.
The biotech is poised to launch a Phase I/Ib clinical trial for eosinophilic and non-eosinophilic severe asthma in the first half of 2021. Just north of 100 patients will be enrolled. First will be a single ascending dose study with healthy volunteers to establish safety and tolerability. Then the biotech will move into a mild to moderate asthma phenotype looking at safety, tolerability, as well as pharmacodynamic and pharmacokinetic markers. The third part of the study will test the drug in more severe patients.
Clarke says the Series A should see KN-002 through a Phase I/Ib readout, as well as a Phase II proof-of-concept. The round was co-led by 5AM Ventures and Atlas Venture, with a hand from European investor Gimv.
Kinaset and Vectura are keeping mum about the terms of their licensing deal. But they did say that Vectura will be responsible for manufacturing clinical trial supplies, and stands to earn regulatory and commercial milestones, as well as potential royalties on global net sales should the drug get approved.
JAK inhibitors have faced questions about their safety. AbbVie’s rheumatoid arthritis drug Rinvoq, for example, was slapped with a blackbox warning last year after studies showed 1% of patients came down with a serious infection, opportunistic infection, or herpes zoster.
“We expect that should not be an issue for us because we’ll be delivering a relatively low dose to the lung and keeping it out of the systemic circulation,” Clarke said of the safety concerns. “It’s going to be a… much preferred delivery profile.”
Kinaset isn’t too far behind Genentech and AstraZeneca, which both have inhaled JAK inhibitors for asthma in Phase I. Theravance Biopharma is ahead of the pack with two candidates in Phase II.
“If you have asthma and you take your typical asthma regimen of steroids and bronchodilators, over time the patients will find that those wane in effectiveness and they need something else in order to support that standard of care,” Clarke said, adding that Kinaset’s candidate could provide “particularly the non-eosinophilic patients with relief that they currently can’t get.”