Moleculin Receives FDA Allowance to Begin a Phase 1 Study of WP1122 for the Treatment of Glioblastoma Multiforme

New US IND enables parallel development of WP1122 as a cancer therapy

HOUSTON – Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical-stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) is allowing the Company’s Investigational New Drug (IND) application to study WP1122 for the treatment of Glioblastoma Multiforme (GBM) to go forward. With this IND now cleared, Moleculin plans to initiate a Phase 1 open-label, single-arm, dose-escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.
The Company believes WP1122 has significant potential as both an antiviral therapy and as a cancer therapy. Moleculin recently announced its plans to initiate a Phase 1a clinical trial of WP1122 in healthy volunteers in the United Kingdom to facilitate future testing in COVID-19 patients. This new US IND sets the stage for parallel development of WP1122 as a cancer therapy. Consistent with its strategy of leveraging external funding for many of its clinical trials, Moleculin intends to seek opportunities for an investigator-initiated clinical trial of WP1122 in cancer patients in 2022.
“This IND underscores our dual-pronged approach to the development of WP1122 for the treatment of both certain types of cancers and viruses. In addition to the trial in the UK designed to position WP1122 as antiviral therapy, we can now be advancing the cancer therapy path in parallel. Along with GBM, we believe WP1122 has the potential to be well suited as a treatment for other highly glycolytic cancers such as pancreatic cancer,” commented Walter Klemp, Chairman and CEO of Moleculin.
GBM is the most aggressive malignant primary brain tumor and remains an incurable tumor with a median survival of only 15 months. It is the most common malignant primary brain tumor making up 54% of all gliomas and 16% of all primary brain tumors, and despite advancements, survival rates for patients with GBM have shown no notable improvement in population statistics in the last three decades. The average annual age-adjusted incidence rate of GBM is 3.19 per 100,000 persons in the United States.

About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical-stage pharmaceutical company focused on the development of a broad portfolio of drug candidates for the treatment of highly resistant 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.
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 COVID-19 and other viruses, as well as cancer indications including brain tumors, pancreatic and other cancers.
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