Dianthus Therapeutics is offering Nanjing Leads Biolabs up to $1 billion biobucks for licensing rights to a bispecific antibody designed to treat certain autoimmune disorders.
Under the terms of the deal, Dianthus will pay the Chinese biotech $30 million in upfront cash and near-term milestones, plus an $8 million milestone payment tied to the start of a Dianthus-led phase 1 study, according to an Oct. 16 release.
Leads Biolabs could also garner up to an additional $962 million in development, regulatory and sales-based milestones across multiple indications, plus tiered royalties.
In return, U.S. biotech Dianthus will gain the exclusive ability to develop and commercialize the asset—freshly dubbed DNTH212—except in the Greater China area.
DNTH212, also known as LBL-047, is a first-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor with best-in-class potential, according to the release.
The candidate is made to block two clinically validated pathways that are known drivers of several autoimmune diseases. The companies hope the program will improve clinical benefit and offer subcutaneous self-administration delivery with infrequent dosing.
During an Oct. 16 investor call, Dianthus management said DNTH212 has potential in conditions such as Sjögren’s syndrome, systemic lupus erythematosus (SLE), dermatomyositis, hidradenitis suppurativa, scleroderma and pemphigus vulgaris.
A two-part phase 1 study in China recruiting both healthy participants and patients with SLE is slated to start by the end of this year, Dianthus said. Topline results from the healthy volunteer portion of the trial are expected in the second half of next year.
After doling out the upfront $30 million, Dianthus expects to have a $525 million cash runway, money the company believes will stretch into 2028.
“We look forward to leveraging the pipeline-in-a-product potential of DNTH212,” Dianthus CEO Marino Garcia said in the release.
“We are excited to partner with Leads Biolabs and build upon our vision of becoming a leading autoimmune-focused biopharmaceutical company with the addition of DNTH212 to our pipeline,” Garcia said.
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Dianthus also boasts claseprubart, an antibody taking aim at generalized myasthenia gravis, in its pipeline. The candidate is also designed to boost patient convenience via less frequent self-administration. In September, the biotech said a phase 2 trial comparing claseprubart to placebo hit the primary endpoint measuring safety and tolerability, while also demonstrating efficacy.
“Overall, we view the deal, albeit early, as bolstering Dianthus’s emerging best-in-class positioning among the competitive autoimmune landscape for minimal impact to the balance sheet,” analysts at William Blair wrote in an Oct. 16 note.
The analysts highlighted DNTH212’s unique dual mechanism tackling both innate and acquired immune inhibition, noting that safety will be top of mind when evaluating the phase 1 data.
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As for Leads Biolabs, the Nanjing-based biotech recently debuted on the Hong Kong stock exchange, raising $189 million through an initial public offering.
Since emerging in 2012, Leads Biolabs has built out a pipeline consisting of 14 candidates, with six currently in the clinic. The biotech’s immune-oncology portfolio includes monoclonal and bispecific antibodies, T cell engagers and antibody drug conjugates.
