MAIA Biotechnology Reports Updates on Disease Control Rates for THIO-101 Phase 2 Trial for Advanced Non-Small Cell Lung Cancer
11 Julho 2023 - 9:00AM
Business Wire
- Of the first 11 patients with post-baseline scans, 9 met the
disease control primary endpoint at first response assessment.
MAIA Biotechnology, Inc. (NYSE American: MAIA) today announced
updates on disease control data in the Part A safety lead-in of its
ongoing THIO-101 phase 2 trial, evaluating THIO in sequential
combination with cemiplimab in patients with advanced Non-Small
Cell Lung Cancer (NSCLC).
Of the first 11 patients enrolled in THIO-101 to complete at
least 1 post baseline response assessment, 9 (82%) met the primary
endpoint of disease control (defined as a Complete Response,
Partial Response, or Stable Disease per RECIST 1.1). All patients
enrolled have previously failed 2 or more prior lines of treatment
including an immune checkpoint inhibitor (CPI) and platinum-based
chemotherapy for advanced NSCLC. No new safety analysis was
conducted at this time.
“The 82% disease control rate observed so far with this
combination is highly encouraging, especially in the heavily
pre-treated population with previous immune CPI resistance, where
typically the Disease Control Rates are in the 25-35% range. This
preliminary data aligns with our pre-clinical data which showed
that THIO, followed by an immune checkpoint inhibitor, greatly
slowed and reduced tumor progression when compared to treatment
with CPI alone. We look forward to continue the monitoring of these
patients and evaluate disease control rates on a longer time frame
with the next response assessment phases,” said Vlad Vitoc, MAIA’s
Chief Executive Officer.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an
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. THIO is being 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
potential immune system activation effects in NSCLC patients by
administering THIO in sequential combination with Regeneron’s
anti-PD1 therapy, Libtayo® (cemiplimab), allowing for immune
activation and PD-1 sensitivity to take effect. The trial will test
the hypothesis that low doses of THIO administered prior to a
checkpoint inhibitor 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 agent and a
priming immune system agent (2) to assess the clinical efficacy of
THIO using Overall Response Rate (ORR) as the primary clinical
endpoint. 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 Inquiries MAIA Biotechnology Joseph McGuire
Chief Financial Officer jmcguire@maiabiotech.com 904-228-2603
Investor Relations ir@maiabiotech.com
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