Tango Therapeutics Announces FDA Clearance of Investigational New Drug Application for TNG462; Provides Additional Business Updates
25 Janeiro 2023 - 9:00AM
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 an
Investigational New Drug (IND) application for TNG462, a
next-generation MTA-cooperative PRMT5 inhibitor for the treatment
of patients with MTAP-deleted cancers. The Company also announced
that TNG908 was granted Orphan Drug Designation (ODD) for the
treatment of malignant glioma and provided additional business
highlights.
“The IND clearance for TNG462 is a critical step toward
addressing the significant unmet need of patients with MTAP-deleted
solid tumors,” said Barbara Weber, M.D., President and Chief
Executive Officer of Tango Therapeutics. “By advancing both TNG908
and TNG462 into the clinic, we not only increase our strategic
optionality to develop and potentially commercialize a PRMT5
inhibitor, but also maximize the opportunity to help patients with
MTAP-deleted cancers given the breadth of potential indications. We
look forward to results from these trials to optimize our
development plans for these programs.”
Recent Business Highlights
Pipeline Update
TNG462 IND cleared; first-in-human clinical trial
initiation expected in mid-2023.
- The U.S. FDA has cleared the IND
application for TNG462, a next-generation
methylthioadenosine-cooperative (MTA) inhibitor of protein arginine
methyl transferase 5 (PRMT5) for the treatment of cancers with
methylthioadenosine phosphorylase (MTAP) deletion.
- The Company expects to initiate a Phase
1/2 clinical trial in mid-2023. The trial, which will require all
patients to have an MTAP deletion, will evaluate cancers including
non-small cell lung cancer, mesothelioma and cholangiocarcinoma.
Unlike TNG908, glioblastoma will be excluded from the clinical
trial as TNG462 does not cross the blood-brain barrier in
preclinical non-human primate models.
- TNG462 has the same mechanism of action
as TNG908 with enhanced potency and selectivity in MTAP-deleted
xenograft models. In preclinical studies, TNG462 is 45X selective
for MTAP-deletions (3-fold greater than TNG908) and 20 times more
potent than TNG908, which may provide a wider therapeutic index and
stronger target inhibition than TNG908.
TNG908 granted ODD for the treatment of malignant
glioma.
- The FDA has granted Orphan Drug
Designation (ODD) to TNG908 for the treatment of malignant glioma.
ODD is granted to investigational therapies addressing rare medical
diseases or conditions that affect fewer than 200,000 people in the
United States. This designation provides for a seven-year marketing
exclusivity period upon regulatory approval, as well as certain
incentives, including federal grants and tax credits.
- TNG908, an MTA-cooperative PRMT5
inhibitor designed to selectively kill cancer cells with MTAP
deletions, is currently being evaluated in a Phase 1/2 clinical
trial.
Upcoming Milestones
- A dose escalation update is expected
from the Phase 1/2 clinical trial of TNG908 in patients with
MTAP-deleted solid tumors during the first half of 2023.
- The initiation of the Phase 1/2
clinical trial for TNG462, a next-generation MTA-cooperative PRMT5
inhibitor, is expected in mid-2023.
- The IND filing for TNG260, a
first-in-class CoREST inhibitor, is on track for the first half of
2023.
- The IND filing for TNG348, a novel USP1
inhibitor that is being developed for treatment of BRCA1 and
BRCA2-mutant cancers, is on track for mid-2023.
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”, “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: first-in-human TNG462 Phase 1/2
clinical trial initiation expected in mid-2023; the IND clearance
for TNG462 is a critical step toward addressing the significant
unmet need of patients with MTAP-deleted solid tumors;
by advancing both TNG908 and TNG462 into the clinic, the Company
not only increases its strategic optionality to develop and
potentially commercialize a PRMT5 inhibitor, but also maximize the
opportunity to help patients with MTAP-deleted cancers given the
breadth of potential indications; the Company is looking forward to
results from the TNG908 and TNG462 trials to optimize our
development plans for these programs; TNG462 may provide a wider
therapeutic index and stronger target inhibition than
TNG908; a dose escalation update is expected from the
Phase 1/2 clinical trial of TNG908 in patients with MTAP-deleted
solid tumors during the first half of 2023 (and the information to
be provided in such update); TNG462 may provide even stronger
target inhibition than TNG908 and thus enhanced clinical efficacy;
the potential of the Company’s PRMT5 therapies to address the high
unmet need in MTAP-deleted cancers; the indications expected to be
included in Company clinical trials; 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 in filing INDs and conducting clinical trials (and will
rely on a third party to operate its clinical trials) and may not
be able to initiate clinical trials (including opening clinical
trial sites and enrolling and dosing an adequate number of clinical
trial participants (including the first patient dosed in the
trial)) when expected and may not generate results (including final
or initial safety and efficacy data) 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, products in clinical trials, and potential combination
therapies that are seen in pre-clinical experiments (as a single
agent or in combination) 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
or orphan drug designation (and such designations 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, 2021, 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:Joshua R. Mansbach Argot Partners
tango@argotpartners.com
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