- THIO treatment leads to profound activation of innate and
adaptive anti-tumor responses
- THIO depletes cancer initiating cells (CICs) and thus
diminishes tumor initiation and metastasis-forming potential in
various in vivo models
- THIO previously awarded orphan drug designation (ODD) by FDA
for small cell lung cancer (SCLC) treatment
MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the
“Company”), a clinical-stage biopharmaceutical company developing
targeted immunotherapies for cancer, today announced the
publication of extensive work describing preclinical studies for
lead candidate THIO in small cell lung cancer (SCLC) in the
peer-reviewed scientific journal Nature Communications. The
reported findings from the research, conducted in collaboration
with the University of Texas Southwestern (UTSW) scientists, led by
corresponding author Dr. Esra Akbay, demonstrate the
immune-enhancing, metastasis-reducing effects of MAIA’s
telomere-targeting agent THIO (6TdG) in several well-characterized
in vitro and in vivo models of SCLC.
“This publication highlights a rather unique dual mechanism of
action for THIO as a first-in-clinic telomere-targeted anticancer
agent for potential treatment of SCLC,” said Sergei M. Gryaznov,
PhD., MAIA’s Chief Scientific Officer. “In addition to the direct
and potent cancer cell depletion activity, the observed specific
interferons stimulation, immune responses-enhancement, and
metastasis-reducing effects of THIO provide solid scientific
foundation for further advancement of this compound in clinical
development.”
A prominent characteristic of lung cancer small cells is their
reliance on telomerase activity, a key enzyme essential for the
continuous proliferation of SCLC. While 85-90% of all human cancers
are telomerase positive, SCLCs are nearly all telomerase positive1,
suggesting that telomerase targeting may be an effective strategy
in the treatment of SCLC.
Key findings in the published paper include:
- Human and mouse SCLC lines are sensitive to THIO (6TdG)
treatment in vitro and in vivo
- THIO decreases cancer initiating cells and diminishes tumor
initiation potential in vitro and in vivo
- Low doses of THIO are effective in treating metastatic mouse
SCLC tumors
- THIO activates type-I interferon pathway through cGAS-STING
signaling
- THIO is highly effective in combination with ionizing radiation
treatment regiments
“With few, if any, effective treatments for small cell lung
cancer, there is a widespread need for innovative therapeutic
strategies. The positive outcomes reported in our publication show
THIO’s potential as a new therapeutic approach,” said Vlad Vitoc,
M.D., MAIA’s Chairman and Chief Executive Officer. “THIO already
holds Orphan Drug Designation for SCLC, underscoring the FDA’s
recognition of THIO’s potential to improve outcomes for this highly
lethal disease. With the positive preclinical and clinical data we
have obtained to date for THIO, we have entered the Phase 2
planning stage for a clinical trial of THIO in SCLC along with two
other cancers.”
Orphan Products Development grants orphan designation status to
drugs and biologics that are intended for the treatment, diagnosis
or prevention of rare diseases, or conditions that affect fewer
than 200,000 people in the U.S. Orphan Drug Designation provides
certain benefits, including financial incentives, to support
clinical development and the potential for up to seven years of
market exclusivity for the drug for the designated orphan
indication in the U.S. if the drug is ultimately approved for its
designated indication.
About the Publication
Nature Communications, volume 15, article number: 672 (2024), “A
telomere-targeting drug depletes cancer initiating cells and
promotes anti-tumor immunity in small cell lung cancer,” published
22 January 2024. Co-author disclosures included in manuscript.
About Small Cell Lung Cancer
Small cell lung cancer (SCLC) accounts for 13% of lung cancers.
As the deadliest of all lung cancers, SCLC is one of the leading
causes of cancer-related mortality in United States with 30,000
deaths annually. It is less common than non-small cell lung cancer
(NSCLC), but is more aggressive and rapidly spreads (metastasizes)
throughout the body.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class
investigational telomere-targeting agent currently in clinical
development to evaluate its activity in Non-Small Cell Lung Cancer
(NSCLC). Telomeres, along with the enzyme telomerase, play a
fundamental role in the survival of cancer cells and their
resistance to current therapies. The modified nucleoside
6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent
telomeric DNA modification, DNA damage responses, and selective
cancer cell death. THIO-damaged telomeric fragments accumulate in
cytosolic micronuclei activating both innate (cGAS/STING) and
adaptive (T-cell) immune responses. The sequential treatment with
THIO followed by PD-(L)1 inhibitors resulted in profound and
persistent tumor regression in advanced, in vivo cancer models by
induction of cancer type–specific immune memory. THIO is presently
developed as a second or later line of treatment for NSCLC for
patients that have progressed beyond the standard-of-care regimen
of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on
the development and commercialization of potential first-in-class
drugs with novel mechanisms of action that are intended to
meaningfully improve and extend the lives of people with cancer.
Our lead program is THIO, a potential first-in-class cancer
telomere targeting agent in clinical development for the treatment
of NSCLC patients with telomerase-positive cancer cells. For more
information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of
historical facts contained in this press release, are
forward-looking statements. Forward-looking statements are subject
to known and unknown risks, uncertainties, and other factors that
may cause our or our industry’s actual results, levels or activity,
performance or achievements to be materially different from those
anticipated by such statements. The use of words such as “may,”
“might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,”
“believe,” “estimate,” “project,” “intend,” “future,” “potential,”
or “continue,” and other similar expressions are intended to
identify forward looking statements. However, the absence of these
words does not mean that statements are not forward-looking. For
example, all statements we make regarding (i) the initiation,
timing, cost, progress and results of our preclinical and clinical
studies and our research and development programs, (ii) our ability
to advance product candidates into, and successfully complete,
clinical studies, (iii) the timing or likelihood of regulatory
filings and approvals, (iv) our ability to develop, manufacture and
commercialize our product candidates and to improve the
manufacturing process, (v) the rate and degree of market acceptance
of our product candidates, (vi) the size and growth potential of
the markets for our product candidates and our ability to serve
those markets, and (vii) our expectations regarding our ability to
obtain and maintain intellectual property protection for our
product candidates, are forward looking. All forward-looking
statements are based on current estimates, assumptions and
expectations by our management that, although we believe to be
reasonable, are inherently uncertain. Any forward-looking statement
expressing an expectation or belief as to future events is
expressed in good faith and believed to be reasonable at the time
such forward-looking statement is made. However, these statements
are not guarantees of future events and are subject to risks and
uncertainties and other factors beyond our control that may cause
actual results to differ materially from those expressed in any
forward-looking statement. Any forward-looking statement speaks
only as of the date on which it was made. We undertake no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise, except as required by law. In this release, unless the
context requires otherwise, “MAIA,” “Company,” “we,” “our,” and
“us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
_________________________________ 1 Hiyama, K. et al. Telomerase
activity in small-cell and non-small-cell lung cancers. J Natl
Cancer Inst 87, 895-902, doi:10.1093/jnci/87.12.895 (1995).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240207835567/en/
Investor Relations Contact +1 (872) 270-3518
ir@maiabiotech.com
Maia Biotechnology (AMEX:MAIA)
Historical Stock Chart
From May 2024 to Jun 2024
Maia Biotechnology (AMEX:MAIA)
Historical Stock Chart
From Jun 2023 to Jun 2024