BioInvent International AB has earned a $1 million milestone payment following Takeda's advancement of mezagitamab (TAK-079) into Phase 3 clinical trials. The anti-CD83 monoclonal antibody, identified from BioInvent's proprietary n-CoDeR® antibody library, is being evaluated for persistent or chronic primary immune thrombocytopenia (ITP).
The Phase 3 trial (NCT06722235) will assess mezagitamab's efficacy and safety in adult patients with chronic primary immune thrombocytopenia, a rare autoimmune disorder characterized by low platelet counts and increased risk of bleeding.
"We are excited to see mezagitamab progress into Phase 3 trials, marking a significant step for Takeda and our n-CoDeR platform," said Martin Welschof, Chief Executive Officer of BioInvent. "This milestone not only validates the consistent high quality of drug candidates identified from our n-CoDeR antibody library, but it also highlights the success of our out-licensing strategy and its ability to drive real-world impact through strategic partnerships."
Regulatory Status and Development Path
Mezagitamab has received Orphan Drug Designation for the treatment of ITP and Fast Track Designation for treatment of chronic/persistent ITP from the U.S. Food and Drug Administration (FDA). These designations underscore the drug's potential to address significant unmet needs in the treatment landscape for this rare autoimmune condition.
The antibody is being developed under a complex licensing arrangement. Takeda is developing mezagitamab under a royalty and milestone agreement with XOMA Corporation, which includes a sublicense to the BioInvent antibody. BioInvent and XOMA maintain a long-standing cross-licensing agreement covering BioInvent's proprietary n-CoDeR antibody library and XOMA's bacterial protein expression technology.
Immune Thrombocytopenia: An Unmet Medical Need
Primary immune thrombocytopenia is an acquired autoimmune disorder characterized by isolated thrombocytopenia (low platelet count) in the absence of other causes. The condition can lead to increased risk of bleeding, ranging from minor bruising to severe internal hemorrhage in more serious cases.
Current treatment options for ITP include corticosteroids, immunoglobulins, thrombopoietin receptor agonists, and in some cases, splenectomy. However, many patients experience inadequate responses or relapse after initial treatment, highlighting the need for novel therapeutic approaches like mezagitamab.
BioInvent's Technology Platform and Business Model
This milestone payment exemplifies BioInvent's dual business strategy. The company focuses on developing its own pipeline of novel immuno-modulatory antibodies for cancer therapy while generating revenue through strategic partnerships and licensing agreements.
BioInvent's proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, creating a robust engine for discovering new immune-modulatory candidates. The company currently has five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors.
The advancement of mezagitamab to Phase 3 represents a significant validation of BioInvent's technology and business approach. As the antibody progresses through late-stage clinical development, it may potentially provide a new treatment option for patients with persistent or chronic primary immune thrombocytopenia while generating additional revenue for BioInvent through its licensing agreement.
