- Late breaking abstract to provide new updates from THIO-101
Phase 2 clinical trial in non-small cell lung cancer (NSCLC)
- Poster to highlight long-term therapeutic benefits of THIO
sequenced with cemiplimab beyond treatment cessation
MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”,
the “Company”), a clinical-stage biopharmaceutical company
developing targeted immunotherapies for cancer, today announced
that a late-breaking abstract (LBA) detailing new updates from its
Phase 2 THIO-101 clinical trial was selected for oral and poster
presentation at the 2024 Annual Meeting of the Society for
Immunotherapy of Cancer (SITC), being held November 6-10, 2024, in
Houston, Texas. The updates will include new data on efficacy and
safety from its clinical trial evaluating THIO sequenced with
Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®)
in patients with advanced non-small cell lung cancer (NSCLC) who
have failed two or more standard-of-care therapy regimens.
“We are honored to have our THIO-101 data recognized by SITC in
a late-breaking abstract, a category reserved for research that has
the potential to change medical practices. We believe that our
latest data is compelling and further supports the ability of THIO
to produce cancer cell specific immune memory and to remain active
against cancer cells after extended periods of time,” said Vlad
Vitoc, M.D., Chairman and CEO of MAIA. “Our findings to date are
particularly significant for advanced-stage patients resistant to
CPI and chemotherapy treatments who are in desperate need of new
treatment options. In our opinion, the combination of THIO with a
CPI is showing promise as a durable and effective NSCLC
treatment.”
Presentation details:
Title:
Telomere-Targeting Agent THIO in
Sequential Combination with Cemiplimab Demonstrates Long Term
Therapeutic Benefits Beyond Treatment Cessation — A Phase 2 Trial
in Advanced Immune Checkpoint Inhibitor Resistant Non-Small Cell
Lung Cancer Patients
Abstract number:
1492
Session:
Late Breaking Abstract Session 1
Date:
Friday, November 8, 2024
Time:
11:45 a.m.-12:15 p.m. CST
MAIA Presenter:
Victor Zaporojan, M.D., Sr. Medical
Director
Poster access:
MAIA’s poster will be available at
maiabiotech.com/publications on November 8, 2024
According to SITC, a late-breaking abstract (LBA) submission is
solely for abstracts with late-breaking data from interventional
clinical trials in humans. The reference does not refer to
abstracts that are submitted “late,” as in after submission
deadlines.
As of August 1, 2024, 16 patients in the THIO-101 trial had
survival follow-up surpassing 12 months, including 9 in third line
treatment (3L). Interim median survival follow-up in 3L was 10.6
months. THIO's substantial survival benefit in third line NSCLC
surpasses current standard-of-care overall survival of 5.8
months.1
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 nucleotide
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 and activates 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 THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2
clinical trial. It is the first trial designed to evaluate THIO’s
anti-tumor activity when followed by PD-(L)1 inhibition. The trial
is testing the hypothesis that low doses of THIO administered prior
to Regeneron’s PD-1 inhibitor cemiplimab (Libtayo®) will enhance
and prolong immune response in patients with advanced NSCLC who
previously did not respond or developed resistance and progressed
after first-line treatment regimen containing another checkpoint
inhibitor. The trial design has two primary objectives: (1) to
evaluate the safety and tolerability of THIO administered as an
anticancer compound and a priming immune activator (2) to assess
the clinical efficacy of THIO using Overall Response Rate (ORR) as
the primary clinical endpoint. Treatment with THIO followed by
cemiplimab (Libtayo®) has been generally well-tolerated to date in
a heavily pre-treated population. For more information on this
Phase II trial, please visit ClinicalTrials.gov using the
identifier NCT05208944.
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 Girard N, et al. J Thorac Onc
2009;12:1544-1549.
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Investor Relations Contact +1 (872) 270-3518
ir@maiabiotech.com
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