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MAIA Biotechnology Welcomes Leading Hepatocellular Carcinoma Clinician-Scientists to Scientific Advisory Board Planning for Phase 2 clinical trial in hepatocellular carcinoma (HCC) underway CHICAGO

Key Takeaway: MAIA Biotechnology, Inc. has appointed prominent oncologists Claudia Fulgenzi and David J. Pinato to its Scientific Advisory Board to support a Phase 2 clinical trial focusing on hepatocellular carcinoma (HCC). These experts will provide insights on trial designs and protocols for the company's lead candidate, ateganosine. The company anticipates receiving necessary approvals to begin patient enrollment by year's end. In 2022, ateganosine was granted Orphan Drug Designation for HCC treatment, which may lead to market exclusivity for up to seven years.

Market Sentiment Analysis

POSITIVE FACTORS

  • Appointment of renowned clinician-scientists to the advisory board indicates strong expertise.
  • Prospective Phase 2 clinical trial for hepatocellular carcinoma is underway, highlighting active development.
  • Ateganosine has gained Orphan Drug Designation, enhancing market potential.

Full Press Release Details

Biotechnology Welcomes Leading Hepatocellular Carcinoma Clinician-Scientists to Scientific Advisory Board
for Phase 2 clinical trial in hepatocellular carcinoma (HCC) underway
- June 24, 2025 - MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage
biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced the appointment of two prominent
oncologists to its Scientific Advisory Board (SAB), Claudia Fulgenzi, MD, and David J. Pinato, MD, MRCP (UK), PhD. Both are specialists
in hepatocellular carcinoma (HCC), a tumor type to be studied in future clinical trials of MAIA's lead candidate ateganosine
(THIO) sequenced with a checkpoint inhibitor.
SAB members they will advise MAIA on designs and protocols for its company sponsored trial (CST) in HCC and may participate in future
investigator sponsored trials (IST).
Pinato and Fulgenzi are scientific experts on inflammation as a pathogenic and prognostic mechanism in primary liver cancers. Together,
their research has focused on improving the treatment of HCC, particularly with the use of anti-cancer immunotherapy," said MAIA
Chairman and CEO Vlad Vitoc, M.D. "They will bring a wealth of knowledge to our SAB, with specialized expertise that will inform
our plans and preparations for our upcoming clinical program in HCC.
the end of this year, we expect to have all required approvals to begin enrolling patients in a HCC trial," Dr. Vitoc added.
was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for ateganosine as a treatment for HCC in 2022.
ODDs can provide up to seven years of market exclusivity.
David Pinato is a clinician scientist in the Department of Surgery and Cancer at Imperial College London and a consultant oncologist
at Imperial College Healthcare NHS Trust. As Director of Developmental Cancer Therapeutics at Imperial College, he leads a translational
research program focused on the early clinical implementation of novel experimental anticancer therapies with particular emphasis on
anti-cancer immunotherapy.
Pinato's research efforts in liver cancer have been recognized by the American Society of Clinical Oncology (ASCO) and the Society for
Immunotherapy of Cancer (SITC). He has received awards by the British Society of Pharmacology and the Royal Society of Medicine, and
fellowships by the European School of Oncology and Fulbright Program.
Pinato completed his core medical training across some of the busiest acute hospitals in London and was elected to the Royal College
of Physicians (MRCP). His research has been published in leading journals in the field including the Journal of Clinical Oncology, Annals
of Oncology, Hepatology and many others. Dr. Pinato lectures internationally in the field of molecular oncology with a specific interest
in HCC and acts as a reviewer for several peer-reviewed journals including The Lancet, Cancer Discovery, Hepatology and Journal of Hepatology.
Claudia Fulgenzi is a specialist in medical oncology at Imperial College London, with dedicated professional interest in the field
of immune-oncology and gastro-intestinal cancers, particularly hepatic-biliary malignancies. Dr. Fulgenzi graduated in medicine from
the University of Rome Tor Vergata and subsequently specialized in medical oncology at the University Campus Bio Medico of Rome, Italy.
Her contributions to the field have been recognized with prestigious awards including the ASCO Merit Award, the Young Investigator award
by the International Liver Cancer Association (ILCA) and the American Society of Clinical Oncology.
Fulgenzi is actively engaged in clinical practice in London, serving as an honorary consultant in oncology at Chelsea and Westminster
Hospital and as a specialty doctor in the early phase clinical trial unit at Hammersmith Hospital. In these capacities, she conducts
clinical and translational research, contributes to clinical trial design, and provides expert medical guidance to cancer patients.
carcinoma is the most frequently occurring primary liver tumor representing approximately 90% of all liver cancers. HCC currently
ranks 5th by incidence and 3rd by mortality on a global scale.
(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
induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric
fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential
treatment of ateganosine 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. Ateganosine 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.
MAIA Biotechnology, Inc.
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
ateganosine (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.
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.

Frequently Asked Questions

Who were appointed to MAIA's Scientific Advisory Board?

Claudia Fulgenzi, MD, and David J. Pinato, MD, were appointed.

What is the focus of MAIA's Phase 2 clinical trial?

The trial focuses on hepatocellular carcinoma (HCC) treatment.

What is ateganosine used for?

Ateganosine is an investigational drug for liver cancer treatment.

What designation did ateganosine receive from the FDA?

Ateganosine was granted Orphan Drug Designation for HCC in 2022.

What is hepatocellular carcinoma?

HCC is the most common primary liver tumor, comprising 90% of liver cancers.

Last updated: Jun 24, 2025