Tango Therapeutics Announces Clearance of TNG908 IND by FDA and Recent Pipeline Progress Updates
24 Janeiro 2022 - 9:00AM
Tango Therapeutics, Inc. (NASDAQ: TNGX), a biotechnology company
committed to discovering and delivering the next generation of
precision cancer medicines, today announced progress updates across
its pipeline and recent corporate highlights.
“Last year we achieved a critical milestone, becoming a
publicly-traded company with a sufficient cash balance that we
believe will fund operations into the second half of 2024. We are
excited to start 2022 with important corporate updates, including
recent achievements and anticipated milestones in our research and
development programs,” said Barbara Weber, M.D., President and
Chief Executive Officer of Tango Therapeutics. “With the IND
cleared for our lead program, TNG908, an MTA-cooperative PRMT5
inhibitor selective for cancers with MTAP deletions, we expect to
initiate a Phase 1/2 clinical trial in the coming months.
Additionally, we have accelerated the timeline for our Target 3
program and continue to progress our USP1 program. We look forward
to providing additional updates throughout the year.”
Pipeline Progress Updates
- TNG908 IND cleared and first-in-human clinical trial
expected to start in 1H 2022. The U.S. Food and Drug
Administration (FDA) has cleared the Investigational New Drug (IND)
application for the Company’s lead program, TNG908, a synthetic
lethal small molecule inhibitor of protein arginine
methyltransferase 5 (PRMT5) designed to selectively kill cancer
cells with an methylthioadenosine phosphorylase (MTAP) deletion.
MTAP deletions occur in 10% - 15% of all human cancers, including
non-small cell lung cancer, mesothelioma, pancreatic cancer and
cholangiocarcinoma. Tango expects to initiate a Phase 1/2 clinical
trial in the first half of 2022, with preliminary safety and
efficacy data expected in the first half of 2023. Enrollment will
be limited to patients with confirmed MTAP-deleted tumors. In
preclinical studies TNG908 demonstrated strong selectivity for
MTAP-deleted tumors with robust anti-tumor effects in vitro and in
vivo.
- Target 3 inhibition reverses immune evasion in STK11
mutant cancers; development candidate planned for 1H 2022.
Target 3, an undisclosed synthetic lethal target, reverses the
immune evasion effect of serine-threonine kinase 11 (STK11)
loss-of-function mutations. Target 3 was discovered using our novel
in vivo target discovery platform. In syngeneic mice, Target 3
inhibition, in combination with an anti-PD1 antibody, resulted in
complete regressions in all treated mice, and the induction of
immune memory against re-implantation of tumors in the majority.
Tango expects to advance a development candidate in the first half
of 2022 and file an IND in 2023.
- USP1 development candidate anticipated in 2H
2022. Tango anticipates advancing a development candidate
for their ubiquitin-specific protease 1 (USP1) program, a synthetic
lethal target for BRCA1-mutant breast, ovarian and prostate cancer,
in the second half of 2022. USP1 inhibition is synergistic with
poly (ADP-ribose) polymerase (PARP) inhibition in BRCA1 mutant
cancer cell lines and murine xenograft models. Clinical trials of
the USP1 inhibitor will be conducted both as a single agent and in
combination with PARP inhibitors in BRCA1-mutant cancers. Tango
expects to advance a development candidate in the second half of
2022 and file an IND in 2023.
Recent Corporate Highlights
- Michael Palmieri, PhD, Head of Chemistry,
Manufacturing, & Controls (CMC). Today, Tango is
announcing the addition of Dr. Palmieri to the leadership team as
Head of CMC, where he will be responsible for leading all
CMC-related activities for the Company, including process
chemistry, drug substance, drug product, analytical, and
formulation activities. Dr. Palmieri has more than 20 years of
experience, most recently at Alkermes, where he led small molecule
CMC activities from the lead optimization phase through to
commercialization.
About Tango Therapeutics
Tango Therapeutics is a 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,
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. 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:
anticipated advancements in pipeline programs in 2022; the Company
believes that it has with sufficient cash balance to fund
operations into the second half of 2024; anticipated milestones in
the Company’s research and development programs; the Company
expects to initiate a Phase 1/2 study for TNG908 in the first half
of 2022; a number of patients may benefit from treatment with a
MTAP-selective PRMT5 inhibitor; preliminary safety and efficacy
data expected in the TNG908 Phase 1/2 clinical trial in the first
half of 2023; the expected benefits of TNG908; with respect to
Target 3, the Company expects to advance a development candidate in
the first half of 2022 and file an IND in 2023; the Company
anticipates advancing a development candidate for the USP1 program
in the second half of 2022 and file an IND in 2023; and the
expected timing of: (i) development candidate declaration for
certain targets, (ii) initiating IND-enabling studies; (iii) filing
INDs and (iv) clinical trial initiation. 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 with conducting clinical trials
(and will rely on a third party to operate the clinical trial for
TNG908) and may not be able to commence the clinical trial when
expected and may not generate results in the anticipated timeframe
(or at all); benefits of product candidates seen in pre-clinical
analyses may not be evident when tested in clinical trials; the
benefits of Tango pipeline products 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 (and Tango or a third-party may not
be able to obtain approval or commercial sales of any combination
therapies); Tango has a limited operating history and has not
generated any revenue to date from drug sales, and may never become
profitable; 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 IND
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; 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 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 Quarterly Report
on Form 10-Q filed with the SEC on November 9, 2021. 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/Michael BarronArgot
Partnerstango@argotpartners.com
Media Contact:Joshua R. Mansbach Argot Partners
tango@argotpartners.com
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