ABBVie (NYSE: ABBV) and Teneobio, Inc. announced today that ABBVie exercised its exclusive right to acquire TeneoOne, an affiliate of Teneobio, Inc., and TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of relapsed or refractory multiple myeloma (RR MM). 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 (ORR) of 79 percent, very good partial response (VGPR) or better of 63 percent, and complete response (CR) of 29 percent at doses ≥40 mg in the dose escalation cohorts with a median follow-up time of 6.1 months (n=24). 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 1 data to date has allowed us to make this decision with confidence," said Michael Severino , M.D., 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."
In this interim analysis, the most frequent treatment emergent adverse events observed across all grades were cytokine release syndrome (CRS) (52 percent), fatigue (25 percent), and neutropenia (24 percent). At the recommended Phase 2 dose of 60 mg administered intravenously every three weeks (Q3W), the CRS rate was 67 percent (all grades) with a grade ≥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, Inc. "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."
This first-in-human, ongoing Phase 1 monotherapy dose escalation and expansion study evaluates 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.
The acquisition is subject to customary closing conditions, including clearance by the U.S. antitrust authorities under the Hart-Scott-Rodino Act.
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
About Teneobio, Inc.
Teneobio, Inc. is a clinical stage biotechnology company developing a new class of biologics, Human Heavy-Chain Antibodies (UniAb®), for the treatments of cancer, autoimmunity, and infectious diseases. ' 'Teneobio's discovery platform, TeneoSeek, comprises genetically engineered animals (UniRat® and OmniFlic®), next-generation sequencing, bioinformatics and high-throughput vector assembly technologies. TeneoSeek rapidly identifies large numbers of unique binding molecules specific for therapeutic targets of interest. Versatile antibody variable domains (UniDab®) derived from UniAb® can be assembled into multi-specific and multivalent therapeutic proteins, surpassing limitations of conventional antibody therapeutics. 'Teneobio's "plug-and-play" T-cell engaging platform includes a diverse set of anti-CD3 antibodies for therapeutics with optimal efficacy and reduced toxicity.
For more information, please visit www.teneobio.com .
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