BridgeBio announces FDA clearance of IND application for BBO-8520, a first-in-class direct inhibitor of KRASG12C (ON)
03 Januar 2024 - 1:30PM
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the
“Company”), a commercial-stage biopharmaceutical company focused on
genetic diseases and cancers, has announced that the United States
Food and Drug Administration (FDA) has cleared the investigational
new drug (IND) application for BBO-8520, a first-in-class orally
bioavailable and highly potent small molecule direct inhibitor of
KRASG12C (ON) state. BBO-8520 binds covalently to the Switch II
pocket in both the GTP-bound (ON) and GDP-bound (OFF) state
conformations of KRASG12C, leading to rapid and robust inhibition
of KRASG12C activity.
BBO-8520’s ability to inhibit the (ON) state should provide
optimal target coverage and address KRASG12C amplification and
receptor tyrosine kinase activation - the two key mechanisms of
adaptive resistance to current (OFF) state inhibitors. BBO-8520
drives substantial tumor growth inhibition in multiple preclinical
models, even after emergence of resistance to sotorasib, an FDA
approved (OFF) state inhibitor of KRASG12C.
“Clinical results from the first generation of KRASG12C
inhibitors suggest that compounds with better potency and the
ability to target the ON state are likely to lead to better
outcomes,” said Frank McCormick, Ph.D., Chairman of Oncology at
BridgeBio, David A. Wood Distinguished Professor of Tumor Biology
and Cancer Research at UCSF and advisor to the National Cancer
Institute’s RAS Initiative at Frederick National Laboratory for
Cancer Research (FNL). “BBO-8520 is the most potent G12C inhibitor
with an IND, and the only compound that directly binds and targets
the ON state. We hope that this drug will bring significantly
improved benefit for patients suffering from KRASG12C cancers.”
BBO-8520’s discovery was the result of a collaboration between
the RAS Initiative FNL, Lawrence Livermore National Laboratory and
BridgeBio. It is specifically designed to provide patients
afflicted with KRASG12C mutant cancers with a best-in-class, oral
small molecule therapy that directly targets the tumor at its
source - oncogenic KRASG12C GTP-bound (ON) signaling. Enrollment of
patients with KRASG12C mutant non-small cell lung cancer into the
ONKORAS-101 trial is expected to begin in H1 of this year.
About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. is a commercial-stage biopharmaceutical
company founded to discover, create, test, and deliver
transformative medicines to treat patients who suffer from genetic
diseases and cancers with clear genetic drivers. BridgeBio’s
pipeline of development programs ranges from early science to
advanced clinical trials. BridgeBio was founded in 2015 and its
team of experienced drug discoverers, developers and innovators are
committed to applying advances in genetic medicine to help patients
as quickly as possible. For more information visit bridgebio.com
and follow us on LinkedIn and Twitter.
BridgeBio Pharma, Inc. Forward-Looking
Statements
This press release contains forward-looking statements.
Statements in this press release may include statements that are
not historical facts and are considered forward-looking within the
meaning of Section 27A of the Securities Act of 1933, as amended
(the Securities Act), and Section 21E of the Securities Exchange
Act of 1934, as amended (the Exchange Act), which are usually
identified by the use of words such as “anticipates,” “believes,”
“hopes,” “estimates,” “expects,” “intends,” “may,” “plans,”
“projects,” “seeks,” “should,” “continue,” “will,” and variations
of such words or similar expressions. We intend these
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 27A
of the Securities Act and Section 21E of the Exchange Act. These
forward-looking statements, including statements relating to the
clinical and therapeutic potential of BBO-8520, including the
expectation that BBO-8520 will significantly improve outcomes for
patients with KRASG12C driven malignancies by providing optimal
target coverage and addressing mechanisms of adaptive resistance to
first generation KRASG12C (OFF) state inhibitors, our clinical
development program for BBO-8520, including the expected timeline
to initiate enrollment of patients with KRASG12C mutant non-small
cell lung cancer in the ONKORAS-101 trial in the first half of
2024, the statements regarding the potency and potential benefit of
BBO-8520 and of our clinical trial in the quotes of Dr.
McCormick, and the timing of these events, reflect our current
views about our plans, intentions, expectations and strategies,
which are based on the information currently available to us and on
assumptions we have made. Although we believe that our plans,
intentions, expectations, and strategies as reflected in or
suggested by those forward-looking statements are reasonable, we
can give no assurance that the plans, intentions, expectations, or
strategies will be attained or achieved. Furthermore, actual
results may differ materially from those described in the
forward-looking statements and will be affected by a number of
risks, uncertainties and assumptions, including, but not limited
to, initial and ongoing data from our clinical trials not being
indicative of final data, the design and success of ongoing and
planned clinical trials, difficulties with enrollment in our
clinical trials, adverse events that may be encountered in our
clinical trials, the FDA or other regulatory agencies not agreeing
with our regulatory approval strategies, components of our filings,
such as clinical trial designs, conduct and methodologies, or the
sufficiency of data submitted, potential adverse impacts due to the
global COVID-19 pandemic such as delays in regulatory review,
manufacturing and supply chain interruptions, adverse effects on
healthcare systems and disruption of the global economy, the
impacts of current macroeconomic and geopolitical events, including
changing conditions from the COVID-19 pandemic, hostilities in the
Middle East and Ukraine, increasing rates of inflation and rising
interest rates, on our overall business operations and
expectations, as well as those risks set forth in the Risk Factors
section of our Annual Report on Form 10-K for the year ended
December 31, 2022 and our other filings with the U.S. Securities
and Exchange Commission. Moreover, we operate in a very competitive
and rapidly changing environment in which new risks emerge from
time to time. These forward-looking statements are based upon the
current expectations and beliefs of our management as of the date
of this press release and are subject to certain risks and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. Except as
required by applicable law, we assume no obligation to update
publicly any forward-looking statements, whether as a result of new
information, future events or otherwise.
BridgeBio Contact:
Vikram Balicontact@bridgebio.com(650)-789-8220
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