Tango Therapeutics Announces FDA Clearance of Investigational New Drug Application for TNG260, a First-in-Class CoREST Inhibitor for the Treatment of STK11-Mutant Cancers
03 Abril 2023 - 8:00AM
Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage
biotechnology company committed to discovering and delivering the
next generation of precision cancer medicines, today announced that
the U.S. Food and Drug Administration (FDA) has cleared the
Company’s Investigational New Drug (IND) application for TNG260, a
first-in-class inhibitor of the CoREST complex (Co-repressor of
Repressor Element-1 Silencing Transcription), for the treatment of
STK11-mutant cancers.
“FDA clearance of our IND application to initiate the TNG260
phase 1/2 trial is an important milestone in the development of
this novel treatment for STK11-mutant cancers. STK11 mutations
drive resistance to standard of care immunotherapy and are a major
challenge in treating many cancers, including non-small cell lung
cancer,” said Barbara Weber, M.D., President and Chief Executive
Officer of Tango Therapeutics. “We expect that TNG260 will be among
the first oncology molecules to leverage the benefits of
genetically-based patient selection (STK11-mutation) with
checkpoint inhibitor therapy. We look forward to initiating the
Phase 1/2 clinical trial of TNG260 in the second half of 2023.”
STK11 loss-of-function mutations are present in approximately
15% of non-small cell lung cancer (NSCLC), 15% of cervical, 10% of
carcinoma of unknown primary, 5% of breast and 3% of pancreatic
cancers. The Phase 1/2 clinical trial will evaluate the safety,
pharmacokinetics, pharmacodynamics and efficacy of TNG260 in
combination with pembrolizumab in patients with locally advanced or
metastatic cancer of any solid tumor with an STK11 loss-of-function
mutation.
The CoREST complex has been shown to play a major role in
regulating the expression of immunomodulatory proteins in
STK11-mutant cancers. In syngeneic models with an STK11 mutation
and an intact immune system, the combination of TNG260 with an
anti-PD-1 antibody resulted in sustained complete tumor regressions
and the induction of immune memory that prevented re-implantation
of the same tumor xenograft.
About Tango Therapeutics
Tango Therapeutics is a clinical-stage biotechnology company
dedicated to discovering novel drug targets and delivering the next
generation of precision medicine for the treatment of cancer. Using
an approach that starts and ends with patients, Tango leverages the
genetic principle of synthetic lethality to discover and develop
therapies that take aim at critical targets in cancer. This
includes expanding the universe of precision oncology targets into
novel areas such as tumor suppressor gene loss and their
contribution to the ability of cancer cells to evade immune cell
killing. For more information, please visit www.tangotx.com.
Forward-Looking Statements
Certain statements in this press release may be considered
forward-looking statements. Forward-looking statements generally
relate to future events, Tango’s future operating performance and
goals, the anticipated benefits of therapies and combination
therapies (that include a Tango pipeline product), expectations,
beliefs and development objectives for Tango’s product pipeline and
clinical trials. In some cases, you can identify forward-looking
statements by terminology such as “may”, “should”, “expect”,
“intend”, “will”, “goal”, “estimate”, “anticipate”, “believe”,
“predict”, “designed,” “potential” or “continue”, or the negatives
of these terms or variations of them or similar terminology. For
example, statements concerning the following include or constitute
forward-looking statements: the Company expects that TNG260 will be
among the first oncology molecules to leverage the benefits of
genetically-based patient selection (STK11-mutation) with
checkpoint inhibitor therapy; Tango looks forward to initiating the
Phase 1/2 clinical trial of TNG260 in second half of 2023; the
Phase ½ TNGO260 clinical trial to be conducted will evaluate
safety, pharmacokinetics, pharmacodynamics and efficacy of TNG260
in combination with pembrolizumab in patients with locally advanced
or metastatic cancer of any solid tumor with an STK11
loss-of-function mutation;; the expected benefits of the Company's
development candidates and other product candidates; and the
expected timing of: (i) development candidate declaration for
certain targets, (ii) initiating IND-enabling studies; (iii) filing
INDs; (iv) clinical trial initiation and (v) disclosing initial and
final clinical trial results. Such forward-looking statements are
subject to risks, uncertainties, and other factors which could
cause actual results to differ materially from those expressed or
implied by such forward looking statements. These forward-looking
statements are based upon estimates and assumptions that, while
considered reasonable by Tango and its management, are inherently
uncertain. New risks and uncertainties may emerge from time to
time, and it is not possible to predict all risks and
uncertainties. Factors that may cause actual results to differ
materially from current expectations include, but are not limited
to: Tango has limited experience conducting clinical trials (and
will rely on a third party to operate its clinical trials) and may
not be able to commence the clinical trial (including opening
clinical trial sites and enrolling and dosing an adequate number of
clinical trial participants) when expected and may not generate
results (including final or initial safety, efficacy data and
proof-of-mechanism) in the anticipated timeframe (or at all);
benefits of product candidates seen in preclinical analyses may not
be evident when tested in clinical trials or when used in broader
patient populations (if approved for commercial sale); the benefits
of Tango pipeline products, development candidates and potential
combination therapies that are seen in pre-clinical experiments may
not be present in clinical trials or in use commercially or may not
be safe and/or effective in humans; Tango has a limited operating
history and has not generated any revenue to date from product
sales, and may never become profitable; other companies may be able
to identify and develop product candidates more quickly than the
Company and commercially introduce the product prior to the
Company; the Company’s proprietary discovery platform is novel and
may not identify any synthetic lethal targets for future
development; the Company may not be able to identify development
candidates on the schedule it anticipates due to technical,
financial or other reasons; the Company may not be able to file
INDs for development candidates on time, or at all, due to
technical or financial reasons or otherwise; the Company may
utilize cash resources more quickly than anticipated; Tango will
need to raise capital in the future and if we are unable to raise
capital when needed or on attractive terms, we would be forced to
delay, scale back or discontinue some of our development programs
or future commercialization efforts; we may be unable to advance
our preclinical development programs into and through the clinic
for safety or efficacy reasons or commercialize our product
candidates or we may experience significant delays in doing so as a
result of factors beyond Tango’s control; the Company may not be
able to realize the benefits of fast track designation (and such
designation may not advance any anticipated approval timelines);
Tango’s approach to the discovery and development of product
candidates is novel and unproven, which makes it difficult to
predict the time, cost of development, and likelihood of
successfully developing any products; Tango may not identify or
discover additional product candidates or may expend limited
resources to pursue a particular product candidate or indication
and fail to capitalize on product candidates or indications that
may be more profitable or for which there is a greater likelihood
of success; our products candidates may cause adverse or other
undesirable side effects (or may not show requisite efficacy) that
could, among other things, delay or prevent regulatory approval;
our dependence on third parties for conducting clinical trials and
producing drug product; our ability to obtain and maintain patent
and other intellectual property protection for our technology and
product candidates or the scope of intellectual property protection
obtained is not sufficiently broad; and delays and other impacts on
product development and clinical trials from the COVID-19 pandemic.
Additional information concerning risks, uncertainties and
assumptions can be found in Tango’s filings with the SEC, including
the risk factors referenced in Tango’s Annual Report on Form 10-K
for the fiscal year ended December 31, 2022, as supplemented and/or
modified by its most recent Quarterly Report on Form 10-Q. You
should not place undue reliance on forward-looking statements in
this presentation, which speak only as of the date they are made
and are qualified in their entirety by reference to the cautionary
statements herein. Tango specifically disclaims any duty to update
these forward-looking statements.
Investor Contact:Sam Martin/Andrew VulisArgot
Partnerstango@argotpartners.com
Media Contact:Amanda GalgaySVP, Corporate
Communications, Tango Therapeuticsmedia@tangotx.com
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