• 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.

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