Strong preclinical evidence of Annamycin's
potential for treating pancreatic cancer presented at AACR expands
collaboration
HOUSTON, Nov. 4, 2024
/PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX)
(Moleculin or the Company), a late stage pharmaceutical
company with a broad portfolio of drug candidates targeting
hard-to-treat tumors and viruses, today announced the appointment
of Daniel D. Von Hoff, M.D.,
F.A.C.P., FASCO, FAACR to its Annamycin Scientific Advisory
Board.
Walter Klemp, Chairman and Chief
Executive Officer of Moleculin commented, "We are very pleased to
welcome Dr. Von Hoff to our
Annamycin Scientific Advisory Board (SAB). Although there has been
tremendous focus on Annamycin's opportunity in the treatment of
AML, there is an even greater unmet need in pancreatic cancer. The
organotropic nature of Annamycin and its ability to accumulate at
unexpected levels in the pancreas was presented at the Annual
Meeting of the AACR and Dr. Von Hoff
was among those who recognized the importance of these findings. As
a result, he has demonstrated his enthusiasm for Annamycin's
potential by agreeing to join our SAB. This is another important
reminder that Annamycin has the potential for use in a wide range
of cancers."
Daniel D. Von Hoff, M.D.,
F.A.C.P., FASCO, FAACR
Dr. Von Hoff currently serves as
the Distinguished Professor at the Translational Genomics Research
Institute (TGen) in Phoenix,
Arizona and City of Hope. He holds the Virginia G. Piper
Distinguished Chair for Innovative Cancer Research at HonorHealth
Clinical Research Institute. He is also Professor of Medicine at
the Mayo Clinic, Scottsdale, AZ.
Over the course of his career, Dr. Von
Hoff has focused primarily on the development of new
anticancer agents, both in the clinic and in the laboratory. He and
his colleagues were involved in the beginning of the development of
many FDA approved agents now used routinely, including:
mitoxantrone, fludarabine, paclitaxel, docetaxel, gemcitabine,
irinotecan, nelarabine, capecitabine, lapatinib, vismodegib,
nab-paclitaxel, nal-IRI, pexidartinib and others. These agents have
improved survival for multiple indications from leukemia to colon
cancer to breast cancer and prostate cancer. Dr. Von Hoff's clinical trial work has led to the
approval of 3 of the 4 drugs approved by the FDA for treatment of
patients with advanced pancreatic cancer.
Over the course of his career, Dr. Von
Hoff has published more than 790 papers, 143 book chapters
and over 1190 abstracts. He is the recipient of the 2010 David A.
Karnofsky Memorial Award from the American Society of Clinical
Oncology for his outstanding contributions to cancer research
leading to significant improvement in patient care and he received
the American Association for Cancer Research (AACR) Distinguished
Public Service Award in recognition of his extraordinary clinical
research career and leadership in establishing the AACR/ASCO
Methods in Clinical Cancer Research Workshop to educate and train
young clinical investigators. He is also the recipient of the Gold
Medal from Columbia University for his
outstanding contributions to cancer research leading to significant
improvements to patient care.
Dr. Von Hoff was appointed to President Bush's National
Cancer Advisory Board in 2004-2010. Dr. Von
Hoff is the past President of the AACR, a Fellow of the
American College of Physicians, and a member and past board member
of the American Society of Clinical Oncology. He is a founder of
ILEX™ Oncology, Inc. (acquired by Genzyme after Ilex had 2 agents,
alemtuzumab and clofarabine approved by the FDA for patients with
leukemia). Dr. Von Hoff is founder
and the Editor Emeritus of Investigational New Drugs – The Journal
of New Anticancer Agents; and past Editor-in-Chief of Molecular
Cancer Therapeutics. He is a co-founder of the AACR/ASCO Methods in
Clinical Trial Cancer Research Workshop, which has graduated more
than 3,000 clinical trial physicians.
Dr. Von Hoff stated, "I think
Annamycin's organotropism and pancreatic data are particularly
compelling. I look forward to exploring the breadth of the
potential for Annamycin and assisting in the advancement of its
development to address areas of significant unmet medical
need."
Annamycin is currently being evaluated in ongoing clinical
trials for the treatment of relapsed or refractory acute myeloid
leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
Annamycin currently has Fast Track Status and Orphan Drug
Designation from the FDA for the treatment of relapsed or
refractory acute myeloid leukemia, in addition to Orphan Drug
Designation for the treatment of soft tissue sarcoma. Furthermore,
Annamycin has Orphan Drug Designation for the treatment of relapsed
or refractory acute myeloid leukemia from the European Medicines
Agency (EMA).
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a Phase 3 clinical stage
pharmaceutical company advancing a pipeline of therapeutic
candidates addressing hard-to-treat tumors and viruses. The
Company's lead program, Annamycin, is a next-generation
anthracycline designed to avoid multidrug resistance mechanisms and
to eliminate the cardiotoxicity common with currently prescribed
anthracyclines. Annamycin is currently in development for the
treatment of relapsed or refractory acute myeloid leukemia (AML)
and soft tissue sarcoma (STS) lung metastases.
The Company is initiating the MIRACLE (Moleculin
R/R AML AnnAraC Clinical Evaluation)
Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating
Annamycin in combination with cytarabine, together referred to as
AnnAraC, for the treatment of relapsed or refractory acute myeloid
leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the
Company believes it has substantially de-risked the development
pathway towards a potential approval for Annamycin for the
treatment of AML. This study is subject to appropriate future
filings with potential additional feedback from the FDA and their
foreign equivalents.
Additionally, the Company is developing WP1066, an
Immune/Transcription Modulator capable of inhibiting p-STAT3 and
other oncogenic transcription factors while also stimulating a
natural immune response, targeting brain tumors, pancreatic and
other cancers. Moleculin is also engaged in the development of a
portfolio of antimetabolites, including WP1122 for the potential
treatment of pathogenic viruses, as well as certain cancer
indications.
For more information about the Company, please
visit www.moleculin.com and connect on Twitter,
LinkedIn and Facebook.
Forward-Looking Statements
Some of the statements in this release are forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. Forward-looking statements in this press
release include, without limitation, whether the results shown in
the animal models can be replicated in clinical trials.
Although Moleculin believes that the expectations reflected in
such forward-looking statements are reasonable as of the date made,
expectations may prove to have been materially different from the
results expressed or implied by such forward-looking statements.
Moleculin has attempted to identify forward-looking statements by
terminology including 'believes,' 'estimates,' 'anticipates,'
'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,'
'could,' 'might,' 'will,' 'should,' 'approximately' or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. These statements are only
predictions and involve known and unknown risks, uncertainties, and
other factors, including those discussed under Item 1A. "Risk
Factors" in our most recently filed Form 10-K filed with the
Securities and Exchange Commission ("SEC") and updated from time to
time in our Form 10-Q filings and in our other public filings with
the SEC. Any forward-looking statements contained in this release
speak only as of its date. We undertake no obligation to update any
forward-looking statements contained in this release to reflect
events or circumstances occurring after its date or to reflect the
occurrence of unanticipated events.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com
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SOURCE Moleculin Biotech, Inc.