Rare Daily Staff
AbbVie has exercised its exclusive right to acquire TeneoOne, an affiliate of TeneoBio, and TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of relapsed or refractory multiple myeloma.
Multiple myeloma is a rare cancer that forms in plasma cells, a type of white blood cell, in the bone marrow. The cancerous plasma cells accumulate in the bone marrow, crowd out healthy blood cells that help fight infection by producing antibodies, and produce abnormal proteins that can cause complications.
In February 2019, AbbVie and TeneoOne entered a strategic transaction to develop and commercialize TNB-383B, a bispecific antibody that simultaneously targets BCMA and CD3 and is designed to direct the body’s own immune system to target and kill BCMA-expressing tumor cells. AbbVie exercised its exclusive right to acquire TeneoOne and TNB-383B based on an interim analysis of an ongoing phase 1 study.
Interim results from the ongoing phase 1 study demonstrated an objective response rate of 79 percent, very good partial response or better of 63 percent, and complete response of 29 percent at doses greater than or equal to 40 mg in the dose escalation cohorts with a median follow-up time of 6.1 months (n=24). The median duration of response 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 1 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 2 dose of TNB-383B will investigate infrequent dosing of every 3 weeks for intravenous administration, which is an important treatment factor for people living with multiple myeloma.”
This first-in-human, ongoing phase 1 monotherapy dose escalation and expansion study is evaluating the safety, clinical pharmacology, and clinical activity of TNB-383B in patients with R/R MM who have received at least three prior lines of therapy. The study consists of two portions, a monotherapy dose escalation arm and a monotherapy dose expansion arm. At the interim analysis, 103 subjects have been treated with TNB-383B.
In this interim analysis, the most frequent treatment emergent adverse events observed across all grades were cytokine release syndrome (52 percent), fatigue (25 percent), and neutropenia (24 percent). At the recommended phase 2 dose of 60 mg administered intravenously every three weeks, the complete response rate (CRS) rate was 67 percent (all grades) with a grade greater than or equal to 3 CRS rate of 3 percent (1/39 subjects). No CRS of grade 4 or higher was observed. Onset of CRS generally occurred on the same or next day following the first dose.
“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, CEO of TeneoBio.
Photo: Roland Buelow, CEO of TeneoBio