The decision to exercise the option was based on an interim analysis of the ongoing Phase I trial of TNB-383B.
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AbbVie announced it was exercising its exclusive right to acquire TeneoOne, an affiliate of TeneoBio, and its lead asset, TNB-383B.
The compound is a BCMA-targeting immunotherapeutic for relapsed or refractory multiple myeloma (R/R MM). It simultaneously targets BCMA and CD3, using Teneobio’s anti-CD3 platform. Because of this dual targeting mechanism, the drug is engineered to direct the body’s own immune system to attack and kill BCMA expressing tumor cells.
In February 2019, AbbVie and Teneobio and TeneoOne entered a global strategic deal to develop and commercialize TNB-383B. Under the terms of the agreement, AbbVie paid TeneoOne $90 million upfront, and TeneoOne would continue developing the drug through Phase I. AbbVie had the rights to acquire the company and the drug.
The decision to exercise the option was based on an interim analysis of the ongoing Phase I trial of TNB-383B. The data demonstrated an objective response rate (ORR) of 79%, a very good partial response (VGPR) or better of 63%, and a complete response (CR) of 29% at doses greater than or equal to 40 mg in the dose escalation cohorts, with a median follow-up of 6.1 months. At this time, the median duration of response (DOR) has not been reached.
“Since the beginning of this partnership, we have been encouraged by the potential of TNB-383B as a promising new therapy for multiple myeloma, and our analysis of the Phase I data to date has allowed us to make this decision with confidence,” said Michael Severino, vice chairman and president, AbbVie.
“While other BCMA and CD3 bispecific therapies require weekly administration, the recommended Phase II dose of TNB-383B will investigate infrequent dosing of every three weeks for intravenous administration, which is an important treatment factor for people living with multiple myeloma.”
The most frequently seen adverse events were cytokine release syndrome in 52% of cases, fatigue in 25%, and neutropenia in 24%. At the recommended Phase II dose of 60 mg dose every three weeks, the CRS rate was 67% in all grades.
The Phase I monotherapy dose escalation and expansion trial look at the drug’s safety, clinical pharmacology, and clinical activity in R/R MM patients who have had at least three previous lines of therapy. The trial has two portions, a monotherapy dose escalation arm and a monotherapy dose expansion arm. At the time of the interim analysis, 103 patients had been treated with TNB-383B.
No further financial details have been released. However, the original deal announcement indicated that if AbbVie exercised its right to acquire TeneoOne, the former stockholders of TeneoOne would be eligible for regulatory and commercial sales milestones.
“Our aim in developing TNB-383B and our T-cell redirecting anti-CD3 platform is to maximize the therapeutic window of a class of therapeutic molecules that have been clinically challenged by dose-limiting toxicities,” said Roland Buelow, chief executive officer of Teneobio.
“AbbVie recognized the potential of Teneobio’s platform and shared our vision to assess its clinical validation. The clinical data support the unique features of TNB-383B and our T-cell redirecting CD3 platform. We are confident that AbbVie is the right partner to rapidly develop TNB-383B with the ultimate goal to bring this potential new therapy to myeloma patients in need.”
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