Tango Therapeutics Announces First Patient Dosed in TNG260 Phase 1/2 Trial in Patients With STK11-Mutant Cancers
24 Julio 2023 - 6:00AM
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 first patient has been dosed in the phase 1/2 trial evaluating
TNG260 in combination with pembrolizumab in patients with
STK11-mutant cancers. TNG260 is a first-in-class inhibitor of the
CoREST complex (Co-repressor of Repressor Element-1 Silencing
Transcription).
“The TNG260 phase 1/2 clinical trial is the first trial to use
genetic patient selection in combination with checkpoint inhibitor
therapy to reverse the cancer-specific immune evasion caused by
STK11 loss of function mutations. Resistance to immunotherapy is a
major challenge faced by patients with STK11-mutant cancers, which
TNG260 is specifically designed to overcome,” said Adam Crystal,
M.D., Ph.D., President of Research and Development of Tango
Therapeutics. “Our pipeline of precision oncology treatments based
on synthetic lethality has advanced significantly this year, as we
now have initiated three clinical trials.”
The phase 1/2 trial will evaluate the safety, pharmacokinetics
(PK), pharmacodynamics and efficacy of TNG260, with a one cycle
single agent run-in phase to evaluate the safety and PK of TNG260,
in combination with pembrolizumab, in patients with locally
advanced or metastatic solid tumors with an STK11 loss-of-function
mutation. STK11 loss-of-function mutations occur in approximately
15% of non-small cell lung cancer, 15% of cervical, 10% of
carcinoma of unknown primary, 5% of breast and 3% of pancreatic
cancers. Based on preclinical xenograft studies and retrospective
clinical analyses, the majority of STK11-mutant cancers are thought
to have primary resistance to checkpoint inhibition.
The CoREST complex plays a central role in regulating
immunomodulatory signaling in STK11-mutant cancers. In preclinical
studies, TNG260 reverses the immune evasion effect of STK11
loss-of-function mutations, restoring sensitivity to an anti-PD-1
antibody, inducing complete remissions in the majority of animals
and creating immune memory that prevents re-implantation and
regrowth of the tumor.
In April 2023, the U.S. Food and Drug Administration granted
Fast Track designation for TNG260 in combination with an anti-PD-1
antibody for the treatment of patients with previously treated
advanced non-small cell lung cancer with STK11-mutations.
About Tango TherapeuticsTango 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, implicit or explicit statements concerning the following
include or constitute forward-looking statements: TNG260 in
combination with checkpoint inhibitor therapy may reverse the
cancer-specific immune evasion caused by STK11 loss of function
mutations; TNG260 is designed to overcome resistance to
immunotherapy, a major challenge faced by patients with
STK11-mutant cancers; ; the expected benefits of the Company's
development candidates, including TNG260 in combination with a
checkpoint inhibitor; 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, interim 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, dosing the first patient, 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 and proof-of-concept) in the
anticipated timeframe (or at all); 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 (which may delay filing of
INDs, dosing patients, reporting clinical trial results and filing
new drug applications); 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
Partners tango@argotpartners.com
Media Contact:Amanda GalgaySVP, Corporate
Communications, Tango Therapeuticsmedia@tangotx.com
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