Moleculin Announces Formation of Scientific Advisory Board to Support Development of Annamycin

Rhea-AI Summary

Moleculin Biotech, Inc. announced the formation of its Annamycin Scientific Advisory Board, appointing Dr. Martin Tallman as the inaugural clinician member. Dr. Tallman, an internationally renowned clinician, brings extensive experience in leukemia-targeting therapies. The company aims to advance the development of Annamycin, a promising treatment for AML and STS lung mets.

Positive

• Appointment of Dr. Martin Tallman, an esteemed clinician, enhances the scientific expertise of Moleculin's Annamycin development programs.

• The preliminary AML data for Annamycin indicates a potential new treatment option for AML patients, addressing a significant unmet medical need.

• Annamycin holds Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML, offering expedited regulatory pathways.

• Orphan Drug Designation from the FDA for STS lung mets and the European Medicines Agency for AML highlights the therapeutic potential of Annamycin in addressing rare diseases.

Negative

• None.

–     Company appoints internationally renowned clinician, Martin S. Tallman, MD as inaugural clinician member

HOUSTON, May 1, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the formation of its Annamycin Scientific Advisory Board and inaugural appointment of Dr. Martin Tallman.

Dr. Tallman is an internationally renowned clinical investigator whose discoveries have fueled the progress of leukemia-targeting therapies, most recently with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. Prior to his role at Lurie Cancer Center where he focused on the management and development of new treatments for patients with both acute and chronic leukemias, he was at Memorial Sloan Kettering Cancer Center where he served as chief of the Leukemia Service and Professor of Medicine at the Weill Cornell Medical College in New York. He was the president of the American Society of Hematology (ASH) in 2021, chaired the Leukemia Committee of the Eastern Cooperative Oncology Group (ECOG) for 16 years, and served as immediate past chair of the National Comprehensive Cancer Network (NCCN) Acute Myeloid Leukemia Panel. Dr. Tallman previously served at Northwestern University Feinberg School of Medicine as Professor of Medicine prior to his appointment at Sloan Kettering.

Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, "We continue to be encouraged by the growing body of data Annamycin has demonstrated across our ongoing development programs. As we continue on our pathway forward, we are pleased to bolster our Annamycin development programs with the formation of this Scientific Advisory Board and add the internationally-renowned knowledge and expertise of Dr. Tallman. We are committed to advancing our clinical and regulatory strategies toward our next phase of development for Annamycin."

Dr. Tallman added, "The latest preliminary AML data suggest that Annamycin could result in a promising new the treatment for AML. I am excited to work alongside the Moleculin team to continue advancing its development and further explore its potential to address these areas of significant unmet need."

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of relapsed or refractory AML and Orphan Drug Designation for the treatment of STS lung mets, in addition to Orphan Drug Designation from the European Medicines Agency for the treatment of AML.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses. The Company's lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. All interim and preliminary data discussed above is subject to change.

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, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of viruses, as well as cancer indications including brain tumors, pancreatic and other cancers.

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, the timing of the commencement of a pivotal registration study of Annamycin as a 2^nd line therapy in AML before year end. 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
(833) 475-8247
MBRX@jtcir.com 

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SOURCE Moleculin Biotech, Inc.

FAQ

Who was appointed as the inaugural clinician member of Moleculin's Annamycin Scientific Advisory Board?

Dr. Martin Tallman was appointed as the inaugural clinician member.

What is the current status of Annamycin in terms of regulatory designations?

Annamycin currently holds Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML, as well as Orphan Drug Designation for STS lung mets and AML from the European Medicines Agency.

What areas of treatment does Annamycin target?

Annamycin targets hard-to-treat tumors and viruses, focusing on acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

What is Dr. Tallman's background and expertise in the medical field?

Dr. Martin Tallman is an internationally renowned clinical investigator with a focus on leukemia-targeting therapies, having held key positions at prestigious institutions and organizations.

What is the goal of Moleculin in forming the Annamycin Scientific Advisory Board?

The formation of the board aims to enhance the development of Annamycin and advance its clinical and regulatory strategies under the guidance of experts like Dr. Tallman.