- New science for cancer therapy drives powerful value
proposition
- Exceptional measures of efficacy by lead drug THIO in Phase
2 clinical trial
- Funding of more than $12M year-to-date, including $7.4
million in Q2’24 so far
- Secured continued insider investment through independent
board members’ participation in private placement equity
financings
- Newest data shows THIO’s strong outperformance against
standard-of-care treatments in non-small cell lung cancer
(NSCLC)
- 38% overall response rate (ORR) in third-line (3L) setting
(THIO 180mg) vs. ~6% for currently available treatments in a
similar population
- 5.5 months median progression-free survival (PFS) (3L, THIO
180mg) more than double PFS of current chemotherapy
treatments
MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the
“Company”), a clinical-stage biopharmaceutical company developing
targeted immunotherapies for cancer, today announced Company
highlights and key achievements year-to-date, including recent
clinical progress for lead candidate THIO, a potential
first-in-class cancer telomere targeting agent in clinical
development to evaluate its activity in non-small cell lung cancer
(NSCLC).
“MAIA’s new science for cancer therapy is driving a powerful
value proposition for our portfolio of novel anticancer compounds,”
said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer.
“Our most recent clinical data points to THIO’s promising disease
control, response rates, and post-therapy patient benefits.
Third-line treatment with THIO has significantly outperformed
reported standard-of-care data in NSCLC.
“Our confidence in the science and clinical pathways for our
immuno-oncology therapies continues to grow,” Dr. Vitoc added.
“This week at ASCO 2024, our poster presentation and prospects for
conducting studies in various geographies has generated a wealth of
positive response and excitement from U.S. and foreign oncologists
and investigators about our growing cancer treatment business.”
THIO’s dual mechanism of action is designed to induce telomeric
DNA damage and boost cancer-specific immune responses. The Phase 2
THIO-101 clinical trial evaluates THIO sequenced with an immune
checkpoint inhibitor (CPI), cemiplimab, in patients with advanced
non-small cell lung cancer (NSCLC) who failed two or more
standard-of-care therapy regimens prior to THIO dosing. MAIA
successfully secured a high value clinical supply agreement for the
cemiplimab used throughout the THIO-101 trial.
As of April 30, 2024, THIO-101 data from THIO 180mg + CPI in
third-line treatment showed, in part:
- overall response rate (ORR) of 38% -
disease control rate (DCR) of 85% - median progression-free
survival (PFS) of 5.5 months - median survival follow-up time of
9.1 months
“THIO works well in all doses and has an excellent safety
profile, but 180mg has shown the greatest efficacy and is well
tolerated compared to existing therapies. Hence, we selected 180mg
per cycle as the dose going forward,” noted Dr. Vitoc. “For this
heavily pre-treated population, comparative third-line data is
limited. Checkpoint inhibitor resistant and platinum resistant
patients are by far the largest populations with unmet medical
needs in NSCLC and are also a substantial part of NSCLC cancer
therapy market. We believe that our trial is providing the first
real dataset in CPI-resistant patients like this. We are confident
about THIO’s prospects for substantially extending patient survival
and establishing a new standard of care for cancer.
“We remain steadfast in our goals for responsible access to
capital. We have increased our access to cash while keeping
dilution to a minimum. We plan to continue this strategy, which has
shown desired outcomes so far this year while our share price has
more than tripled,” added Dr. Vitoc.
MAIA reported cash and current assets of $8.7 million as of
March 31, 2024. The Company’s cash position has significantly
improved due to approximately $12.4 million in funds raised since
February 2024 pursuant to a combination of private placements of
our equity securities and sales under our at-the-market offering
facility, of which approximately $7.4 million has been raised since
April 1, 2024 with $6.4 million of this amount due to sales under
the ATM facility to fund continuing clinical development. Our
independent directors have shown continued support by investing
almost $900,000 in our March and April 2024 private placements with
other accredited investors.
MAIA’s Phase 2 THIO-101 clinical trial is expected to near
completion in 2024. The Company is also engaged in research and
development for a portfolio of second-generation THIO-like
compounds.
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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Investor Relations Contact +1 (872) 270-3518
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Grafico Azioni Maia Biotechnology (AMEX:MAIA)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni Maia Biotechnology (AMEX:MAIA)
Storico
Da Gen 2024 a Gen 2025