THIO’s favorable disease control and overall response rates
exceed reported standard-of-care data in third line
treatment
MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the
“Company”), a clinical-stage biopharmaceutical company developing
targeted immunotherapies for cancer, today announced new efficacy
data from its Phase 2 THIO-101 clinical trial evaluating THIO
sequenced with the immune checkpoint inhibitor (CPI) cemiplimab
(Libtayo®) in patients with advanced non-small cell lung cancer
(NSCLC) who failed 2 or more standard-of-care therapy regimens.
Updated results show a favorable overall response rate (ORR) of 38%
and a disease control rate (DCR) of 85% from THIO + CPI in
third-line treatment. The new data was presented in a poster
session at the American Society of Clinical Oncology (ASCO) 2024
Annual Meeting on June 3, 2024.
The primary objectives of THIO-101 Phase 2 trial are to examine
the safety and tolerability of THIO as an anticancer drug and as an
immune system primer, and to examine the clinical efficacy of THIO
in the form of ORR. At the time of the most recent data cut-off
(April 30, 2024), all evaluable patients had completed ≥1
post-baseline assessment.
Results from third-line treatment:
- Disease control rate (DCR) was 85% for THIO vs. standard of
care DCR of 25–35% for chemotherapy1
- 65% of patients crossed the 5.8-month overall survival (OS)
threshold2
- 85% of patients crossed the 2.5-month progression-free survival
(PFS) threshold3-4
- Median survival follow-up time is currently 9.1 months
(n=20)
Results from third-line treatment with THIO 180mg (optimal dose
selection)
- Median PFS of 5.5 months (24.1 weeks)
- 78% OS rate at 6 months
- 38% ORR vs. standard of care 6–10% for chemotherapy2
- 75% of patients crossed the 5.8-month OS threshold2
- 88% of patients crossed the 2.5-month PFS threshold3-4
- Median survival follow-up time is currently 9.1 months
(n=8)
1 Matsumoto H, et al. Transl Lung Cancer Res 2021;10:2278–89. 2
Girard N, et al. J Thorac Onc 2009;12:1544-1549. 3 Shepherd F, et
al. N Engl J Med 2005;353:123-132. 4 Fossella F, et al. J Clin
Oncol 2000;18(12):2354-62.
“All exceptional measures of efficacy in our trial to date have
exceeded our own expectations and outperformed standard of care
treatments,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief
Executive Officer. “The data presented at ASCO advances THIO’s
excellent clinical profile as a strong, safe, and highly effective
alternative for patients who progressed following chemotherapy and
other available treatments. We eagerly anticipate full efficacy
data from THIO-101 in the second half of this year.”
To date, treatment with THIO + cemiplimab has been generally
well tolerated in a heavily pre-treated patient population. Full
enrollment in THIO-101 was completed on February 19, 2024, earlier
than expected as per trial design. The Company expects that
THIO-101 will be the first completed clinical study of a telomere
targeting agent in the field of cancer drug discovery and
treatment.
The poster and updated Company presentations can be accessed on
the company’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 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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