- Expansion study to enroll patients in the U.S. and select
countries in Europe and Asia
- Multiple milestones attainable for 2025
MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA,”
the “Company”), a clinical-stage biopharmaceutical company
developing targeted immunotherapies for cancer, today announced the
trial design for the expansion of its THIO-101 pivotal Phase 2
trial in non-small cell lung cancer (NSCLC). Following successful
outcomes to date in THIO-101, the expansion of the study will
assess overall response rates (ORR) in advanced NSCLC patients
receiving third line (3L) therapy who were resistant to previous
checkpoint inhibitor treatments (CPI) and chemotherapy.
The THIO-101 study in 3L will enroll up to 48 patients with two
arms: Arm 1, continuing the evaluation of THIO sequenced with
Libtayo® (cemiplimab); and Arm 2, evaluating THIO as a monotherapy,
to further gain experience of THIO in the contribution of
components. Treatment cycles for patients in both arms will
administer THIO on 3 consecutive days, followed by immune
activation on day 4. Arm 1 will administer Libtayo on day 5. The
Company plans to enroll an additional 100 patients for the
registration phase of the trial. MAIA expects to conduct the trials
in the U.S. and select countries in Europe and Asia.
MAIA recently announced an amended clinical supply agreement
with Regeneron to include the expansion portion of THIO-101. Under
terms of the amended agreement, MAIA continues to sponsor THIO-101
and Regeneron will provide Libtayo for the treatment of all
patients including the additional patients in the expansion and
potentially, the registration studies.
“We are excited to start the expansion arm of our THIO-101 trial
which is designed to determine overall response rates in third line
NSCLC. We expect to have new patients enrolled in the coming
weeks,” said Vlad Vitoc, M.D., CEO of MAIA. “Through THIO-101 to
date, THIO has delivered unprecedented disease control, response,
and survival results. Continued efficacy and safety data generated
by our study could support an FDA NDA submission directly,
particularly as we plan to seek an accelerated approval of THIO in
the U.S.
“We have multiple milestones that we believe are attainable for
2025 and we look forward to keeping our shareholders and investors
well informed of our progress on value creation,” Dr. Vitoc
added.
As of January 15, 2025, data indicated that Median Overall
Survival (OS) in third-line treatment was reached at 16.9 months,
with a 95% confidence interval (CI) lower bound of 12.5 months and
a 99% CI lower bound of 10.8 months). The treatment has been
generally well-tolerated to date in this heavily pre-treated
population1.
________________________________
1
Details on safety can be found on the
previously announced SITC 2024 presentation available on MAIA’s
website.
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 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.
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Investor Relations Contact +1 (872) 270-3518
ir@maiabiotech.com
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