- Unprecedented disease control rate (DCR) of 100% in second-line
of treatment far surpasses standard of care (SoC) DCR of
53-64%
- DCR is far stronger than overall response rate (ORR) in
predicting overall survival benefit, as shown in recent
meta-analysis of 74 clinical trials worldwide1
MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage
company developing telomere-targeting immunotherapies for cancer,
today reported positive preliminary efficacy data from its ongoing
Phase 2 clinical trial, THIO-101, evaluating THIO in patients with
advanced Non-Small Cell Lung Cancer (NSCLC) in sequential
combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo®).
Key findings:
- 100% Preliminary DCR observed in second-line and 88% in
third-line, in highly difficult-to-treat patients who already
progressed through previous lines of treatment.
- DCRs across all dose levels met the pre-determined statistical
requirements earlier than expected to proceed to next stage of the
trial.
“In NSCLC patients who received at least one line of therapy,
DCRs have shown to be excellent predictors of overall survival.1
Observing 100% DCR to date in second-line treatment is
unprecedented compared to DCRs for the SoC ranging from 53-64%,2”
said Vlad Vitoc, M.D., MAIA’s Chief Executive Officer. “We have
also observed unprecedented high DCRs in third-line, with an 88%
control rate, with treatment of THIO followed by cemiplimab. The
results are even more remarkable given patients in this population
have previously failed treatment with a checkpoint inhibitor.
Currently, there is no SoC for third-line, but previous studies
have reported an approximate 30% DCR.3 These exceptional
preliminary results underscore our confidence in advancing the
trial to bring our novel treatment to advanced stage NSCLC
patients.”
1 Matsumoto H et al. Transl Lung Cancer
Res. 2021 May; 10(5): 2278–2289
2 REVEL
https://www.cyramza.com/hcp/nsclc-treatment/revel-response-rate-efficacy
3 Journal of Thoracic Oncology (VOLUME 16,
ISSUE 10, OCTOBER 2021), T. Beninato et al.
Study Disease Control Rates by Line of Treatment
Treatment Line Standard of Care Treatment DCR
Treatment Line THIO + Libtayo® (cemiplimab) DCR
NSCLC-1 pembrolizumab (KEYNOTE-024)
71%
NSCLC-1 TBD NSCLC-2 ramucirumab + docetaxel (REVEL)
64%
NSCLC-2
100%
docetaxel monotherapy (REVEL)
53%
NSCLC-3 chemotherapy (RWD)
25-35%
NSCLC-3
88%
The Company presented the data at the European Society for
Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October
23, 2023. Full preliminary data is detailed in the poster available
here.
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, 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 Regeneron’s anti-PD-1 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 a 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 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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Investor Inquiries MAIA Biotechnology Joseph McGuire
Chief Financial Officer jmcguire@maiabiotech.com 904-228-2603
Investor Relations ir@maiabiotech.com
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