MAIA Biotechnology Announces Updates in Enrollment in Phase II Clinical Trial: THIO-101 Has Enrolled 29 Patients
20 Junho 2023 - 9:00AM
Business Wire
MAIA Biotechnology, Inc. (NYSE American: MAIA) announced today
that 29 patients have been dosed in MAIA’s Phase 2 clinical trial,
THIO-101, evaluating THIO in patients with advanced Non-Small Cell
Lung Cancer (NSCLC). With the addition of sites in Hungary, Poland,
and Bulgaria in March 2023, THIO-101 has rapidly increased the
number of patients enrolled and dosed with THIO. Thirteen sites
were activated with another two new additional sites ready to open
in the coming weeks.
THIO is a first-in-class cancer telomere targeting agent
administered in sequence with a checkpoint inhibitor (CPI). The
main objectives of the THIO-101 trial are to evaluate the safety,
tolerability, and preliminary clinical efficacy of THIO in patients
with advanced NSCLC who have experienced disease progression or
relapse after initial treatments with an immune CPI alone or in
combination with chemotherapy. The trial dosed its first patient in
Australia in July 2022 and expanded to include European patients in
March 2023.
“We are very pleased with the progress of enrollment in Europe.
Since our last update, we have more than doubled the number of
patients dosed to 29, bringing us closer to our target of 184
patients planned to be treated in the trial. With a large number of
lung cancer cases in Europe, we anticipate a robust rate of
enrollment in the upcoming weeks,” stated Vlad Vitoc, M.D., MAIA’s
Chairman and Chief Executive Officer.
“With rapid enrollment in the trial, we project a substantial
number of patients completing 3-6 months of treatment by the fall
which will allow us a preliminary evaluation of the treatment
efficacy,” added Mihail Obrocea, MD, MAIA’s Chief Medical
Officer.
About THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose selection 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 advance of administration of an immune
checkpoint inhibitor allowing for immune activation and PD-1
sensitivity to take effect. The trial is testing 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 and (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 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230620763303/en/
Investor Inquiries MAIA Biotechnology Joseph McGuire
Chief Financial Officer jmcguire@maiabiotech.com 904-228-2603
Investor Relations ir@maiabiotech.com
Maia Biotechnology (AMEX:MAIA)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Maia Biotechnology (AMEX:MAIA)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024