- Third orphan drug designation (ODD) granted to THIO by the FDA;
drug also holds ODDs for hepatocellular carcinoma and small cell
lung cancer
- Benefits include 7 years of U.S. market exclusivity after drug
approval and tax credits for qualified clinical testing
- Expected glioblastoma market growth from $2.2 billion to $3.2
billion globally in the next three years
MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA” or the
“Company”), a clinical-stage biopharmaceutical company developing
telomere-targeting immunotherapies for cancer, announced today that
the U.S. Food and Drug Administration (“FDA”) has granted orphan
drug designation to its lead asset THIO, a cancer
telomere-targeting agent, for the treatment of glioblastoma. This
is the third orphan drug designation granted to THIO, following the
receipt of orphan drug designations for hepatocellular carcinoma
(HCC) and small cell lung cancer (SCLC) in 2022.
“We are pleased to receive a third orphan drug designation for
THIO, further highlighting FDA’s recognition of THIO’s potential in
the treatment of multiple cancer indications, including rare ones
such as glioblastoma,” said Vlad Vitoc, M.D., MAIA’s Chairman and
Chief Executive Officer. “Each year, globally, more than 300,000
people are diagnosed with brain tumors, of which, 25,000 are in the
United States. Glioblastoma represents the majority of these cases
in the U.S., with 15,000 new patients diagnosed and more than
10,000 deaths yearly, making it an orphan indication. Given this
prevalence there is significant room for growth in the $2.2 billion
glioblastoma market, which is expected to reach $3.2 billion
globally in the next three years.1 We consider this ODD an
important milestone for our development strategy and for
glioblastoma patients who could benefit from a potentially
revolutionary therapy.”
“In the data presented to the FDA, THIO successfully penetrated
the blood brain barrier (BBB) in syngeneic and humanized mouse
models of telomerase-expressing brain cancers. Treatment with THIO
resulted in potent anticancer activity and significant expansion of
the animal lifespan for several difficult to treat cell lines and
xenograft mouse models,” added Sergei Gryaznov, Ph.D., MAIA’s Chief
Scientific Officer. “These results stem from THIO’s remarkable
mechanism of action and its BBB penetrating property that allows
for direct targeting of brain tumors in vivo and potentially in
glioblastoma patients.”
“Glioblastoma is the most aggressive and most common type of
cancer that originates in the brain. With very limited treatment
options available, glioblastoma patients have exceptionally short
survival durations, and only 7% remain alive five years after being
diagnosed with the condition,”2 said Mihail Obrocea, MD, MAIA’s
Chief Medical Officer. “We are optimistic about our
telomere-targeting agent’s ability to provide clinical benefit in
patients with glioblastoma, and we look forward to studying THIO
for the treatment of this highly unmet medical indication in a
future trial.”
Enrollment is ongoing in a Phase 2 trial of THIO, THIO-101,
evaluating the drug candidate in patients with advanced non-small
cell lung cancer (NSCLC). THIO is the only direct telomere
targeting agent currently in clinical development.
About Orphan Drug Designation
The FDA’s Orphan Drug Act of 1983 was designed to incentivize
the development of therapies that demonstrate promise for the
treatment of rare (orphan) diseases or conditions. A disease is
classified as “rare” if it affects fewer than 200,000 people total
in the U.S., or if the cost of developing a drug and making it
available in the U.S. for such diseases will exceed any potential
profits from its sale due to the small target population size. The
FDA’s ODD program provides multiple incentives to make orphan drug
development more financially possible for companies to pursue, such
as up to seven years of market exclusivity for the approved orphan
drug, up to 20 years of 25% federal tax credit for expenses
incurred in conducting clinical research within the U.S. and waiver
of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, a
value of approximately $2.9 million in 2021.
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 an anti-PD1 agent 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. 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.
____________________________
1 Market size and forecast from the
Business Research Company
2 National Brain Tumor Society, About
Glioblastoma
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Investor Inquiries MAIA Biotechnology Joe McGuire Chief
Financial Officer jmcguire@maiabiotech.com 904-228-2603
Investor Relations ir@maiabiotech.com
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