- Combination THIO 180mg + cemiplimab achieved 38% overall
response rate (ORR) in difficult-to-treat, third-line non-small
cell lung cancer (NSCLC)
- ORR of 38% significantly exceeds standard of care ORR in NSCLC
third-line in patients without a targetable mutation who progressed
on checkpoint inhibitors and chemotherapy
MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the
“Company”), a clinical-stage biopharmaceutical company developing
targeted immunotherapies for cancer, today announced positive
efficacy data for third-line treatment in its Phase 2 THIO-101
clinical trial evaluating THIO sequenced with the immune checkpoint
inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell
lung cancer (NSCLC).
As of January 8, 2024, overall response rate (ORR),
characterized as partial or complete response to therapy, was 38%
(3 out of 8 patients) in the efficacy evaluable population for
combination THIO 180mg + cemiplimab in third-line treatment for
NSCLC patients who failed treatment with immune checkpoint
inhibitors in prior lines of therapy, with or without
chemotherapy.
“As an impressive measure of efficacy, the strong response rate
of 38% in third-line treatment supports our premise that THIO
administration prior to cemiplimab can improve tumor responses to
immunotherapy in advanced NSCLC patients resistant to CPIs and
other standard treatments,” said Vlad Vitoc, M.D., MAIA’s Chairman
and Chief Executive Officer. “Around 60-70% of NSCLC patients do
not have a targetable mutation and cannot benefit from a
biomarker-targeted therapy, making it the greatest unmet medical
need population in lung cancer. In currently available treatments
for these patients in third-line, response rates range around 6%.1
We are encouraged by the excellent efficacy findings in THIO-101 to
date, adding impressive ORR to unprecented disease control rates
(DCR), and further demonstrating the potential of our
first-in-class treatment to redefine the standard of care for NSCLC
patients.”
The efficacy evaluable population defined in the THIO-101
protocol considers all subjects who received at least one dose of
THIO treatment and have at least one postbaseline tumor assessment
(scans). Two third-line patients in the 180mg dose cohort did not
have recorded scans at the data cutoff. Safety remained consistent
with previous reports.
The Company recently announced early completion of enrollment in
the THIO-101 trial. THIO-101 is expected to be the first completed
clinical study of a telomere-targeting agent in the field of cancer
drug discovery and treatment.
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 cemiplimab (Libtayo®) followed by THIO 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 Journal of Thoracic Oncology, Volume 4, Number 12, December
2009. *Note: no updated 3rd line NSCLC data in recent years.
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Investor Relations Contact +1 (872) 270-3518
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