NORTH CHICAGO, Ill. and
NEWARK, Calif., June 24, 2021 /PRNewswire/ -- 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 (R/R
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.
About AbbVie
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.
Forward-Looking Statements
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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SOURCE AbbVie