MAIA Biotechnology Announces Dose Selection in THIO-101 Phase 2 Clinical Trial for Non-Small Cell Lung Cancer
19 Diciembre 2023 - 6:00AM
Business Wire
- Selected dose shows unprecedented disease control and overall
response rates in a NSCLC clinical trial
MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the
“Company”), a clinical-stage biopharmaceutical company developing
telomere-targeting immunotherapies for cancer, today announced dose
selection for THIO-101, a Phase 2 clinical trial evaluating its
lead asset, THIO, in sequential combination with Regeneron’s
anti-PD-1 cemiplimab (Libtayo®) in patients with advanced non-small
cell lung cancer (NSCLC).
During the dose-finding stage of THIO-101, patients were
administered either 60mg, 180mg, or 360mg of THIO per cycle,
followed by 350mg of cemiplimab (Libtayo®). The selected dose,
180mg/cycle, presented better safety profile and outperformed the
other doses in the key measures of efficacy for NSCLC trials.
Subsequently, all future trial participants will be treated with
THIO 180mg/cycle.
“All THIO dose levels tested exceeded the disease control rate
(DCR) thresholds in Stage 1 of the THIO-101 Phase 2 trial. We
observed disease control in the first 8 to 9 patients with a post
baseline scan in each arm, beating our goal of disease control in 8
out of 19 patients per arm. Among the three studied doses, the
180mg dose showed stronger DCR and preliminary response rates
compared to other doses,” said Vlad Vitoc, M.D., MAIA’s Chairman
and Chief Executive Officer.
“These results are particularly impressive in this pool of
patients who were heavily pre-treated and resistant to prior
treatments with immune checkpoint inhibitors, a group that does not
yet have standard of care treatment. We are highly encouraged by
the unprecedented clinical data generated thus far in our Phase 2
trial, and as we move forward, we plan to pursue accelerated
approval for THIO in the U.S. for the treatment of patients with
advanced NSCLC. We believe THIO’s DCRs and ORRs in second line
treatment suggest the drug’s potential to define the standard of
care for this NSCLC patient population.”
THIO is the only direct telomere targeting agent currently
undergoing clinical development 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.
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