Meitheal, Xentria make pact to market XTMAB-16
Agreement should speed development of the pulmonary sarcoidosis candidate
Under the terms of the agreement, Meitheal gains the sole rights to sell and distribute XTMAB-16 in North America. Xentria retains the rights to sell it in all other countries while it remains responsible for the therapy’s clinical development.
A proof-of-concept Phase 1b/2 clinical trial (NCT05890729) designed to test the therapy in adults with pulmonary sarcoidosis is expected to be launched soon.
“The collaboration will leverage the strengths of both companies to accelerate the development of XTMAB-16, which could emerge as one of a few therapeutics in development specifically for treating pulmonary sarcoidosis, in contrast to symptomatic steroid treatment as the current standard of care,” Kirsten Anderson, Xentria’s chief operating officer, said in a joint company press release.
“The partnership also validates compelling pre-clinical data and the potential of XTMAB-16 to fill the existing treatment gap in pulmonary sarcoidosis as we enter the first trial in patients living with the condition,” Anderson added.
Details of the deal
As per the deal, Xentria will receive $45 million upfront and up to $35 million if certain milestones are met, such as the submission of a regulatory application seeking XTMAB-16’s approval and effective approval.
If the deal generates more than $600 million in royalties based on other milestones, the ownership of the medicine’s intellectual property will transfer to Meitheal’s parent company, Hong-Kong King Friend Industry.
“Meitheal is thrilled to be collaborating with Xentria, as we seek to bring XTMAB-16 to patients in North America and we look forward to creating a new branded division to further its advancement and potential commercialization,” said Tom Shea, CEO of Meitheal.
The most common form of sarcoidosis, pulmonary sarcoidosis is characterized by the formation and accumulation of small clusters of inflammatory immune cells, called granulomas, in the lungs. These granulomas can affect how the lungs work and cause symptoms such as coughing and shortness of breath.
How XTMAB-16 works
Administered directly into the bloodstream, XTMAB-16 is an antibody-based therapy designed to work as a TNF-alpha inhibitor. This means it blocks TNF-alpha, a pro-inflammatory molecule that contributes to sarcoidosis’ chronic inflammation and granuloma formation.
By suppressing TNF-alpha, XTMAB-16 is expected to ease inflammation and slow granuloma formation. The therapy has been granted orphan drug designation in the U.S. for sarcoidosis, which is meant to speed its clinical development and regulatory review.
A previous Phase 1 trial (NCT04971395) evaluated the safety, tolerability, and pharmacokinetics of a single XTMAB-16 infusion (at two different doses) against a placebo in 25 healthy adults ages 19 to 45. Pharmacokinetics refers to the therapy’s movement into, through, and out of the body.
A total of 10 participants received 2 mg/kg of XTMAB-16, nine received a higher dose of the therapy, 4 mg/kg, and six received a placebo.
According to a clinical study report from Xentria, Phase 1 trial data showed that six participants (24%) experienced side effects: three (33%) in the higher-dose group, two (20%) in the lower-dose group, and one (17%) in the placebo group.
The most common side effects were headache and a blocked nose. There were no treatment-related serious adverse events and none of the participants dropped out of the study due to side effects.
The highest level of XTMAB-16 in the blood was reached within 2-3 hours after dosing. The medicine was removed slowly from the body, and could be detected in the blood for up to 71 days (about 10 weeks) after dosing.
Researchers also looked at the therapy’s immunogenicity, or its ability to trigger an immune response, by analyzing changes in blood levels of antibodies against XTMAB-16. Before the study, there were none. After dosing, it was more frequent to find these antibodies in the lower-dose versus the higher-dose group (60% vs. 22%).
Phase 1b/2 trial planned
Based on these findings, Xentria will launch a two-part Phase 1b/2 trial to test the therapy against a placebo in up to 94 pulmonary sarcoidosis patients with or without disease manifestations outside the lungs.
In its first part, XTMAB-16 will be given at two different doses (2 and 4 mg/kg) and two different treatment intervals (every other week and every four weeks) for 12 weeks (about three months).
Data on the therapy’s safety and its ability to reduce steroid treatment dose will be used to determine the optimal dose and regimen to be tested further against a placebo in the trial’s second part. In part two, treatment will be given for 24 weeks (nearly six months).