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Moleculin Biotech commenced dosing in its first-in-human Phase 1a study to evaluate the safety and pharmacokinetics of WP1122 in healthy volunteers for the treatment of COVID-19. The Phase 1a, first-in-human, overlapping Single and Multiple ascending dose will investigate the effects of WP1122 administered as an oral solution in healthy human volunteers in the U.K. This study in healthy volunteers will explore safety and PK, and subsequent antiviral clinical development will be in patients infected with SARS-CoV-2 to further evaluate safety and establish a favorable risk/benefit profile. Moleculin is also in the process of identifying additional countries where potential future Phase 2 COVID-19 clinical studies could occur.

Moleculin Biotech announced that it has received approval from the UK MHRA to proceed with a first-in-human Phase 1a study to evaluate the safety and pharmacokinetics of WP1122 in healthy volunteers for the treatment of COVID-19, or MB-301. The approval follows Moleculin's having submitted a protocol amendment allowing for a higher ratio of diluting excipients to drug substance to facilitate a faster and simpler mixing procedure before drug administration. WP1122, the Company's lead metabolism/glycosylation inhibitor, is a prodrug of a well-known glucose decoy called 2-deoxy-D-glucose, or 2-DG, currently being developed for inhibition of viral replication and disease manifestations in humans infected with SARS-CoV-2, the virus responsible for COVID-19. The mechanism of action of 2-DG includes both the inhibition of glycolysis and the disruption of glycosylation, two processes that are important to both viral activity and tumor development. WP1122 was developed as a 2-DG prodrug to provide a more favorable pharmacological profile, and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher glycolytic activity than normal cells. WP1122 has also been shown to have a more potent antiviral effect than 2-DG against SARS-CoV-2 in MRC-5 cells in culture.

Moleculin Biotech has received allowance from the Polish Department of Registration of Medicinal Products - URPL -, as well as the requisite Ethics Committee approval, to proceed with its Phase 1/2 clinical trial in Poland of Annamycin in combination with Cytarabine ) in the treatment of subjects with acute myeloid leukemia - AML - who are refractory to or relapsed after induction therapy. The Phase 1/2 L-ANN /ARA-C combination trial, an open label trial, builds on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials in the U.S. and Europe and the preclinical data discussed below. The study is expected to commence patient enrollment in the first half of 2022. Annamycin is the company's next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines.

Moleculin Biotech announced that the FDA is allowing the company's Investigational New Drug application to study WP1066 for the treatment of recurrent malignant glioma. With this IND now cleared, Moleculin plans to evaluate strategic partnerships and collaborations to conduct a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1066 in adult patients with recurrent malignant glioma. WP1066 is the company's flagship Immune/Transcription Modulator designed to stimulate the immune response to tumors by inhibiting the errant activity of Regulatory T-Cells while also inhibiting key oncogenic transcription factors. These transcription factors are widely sought targets that are believed to contribute to an increase in cell survival and proliferation. WP1066 is currently being evaluated for the treatment of pediatric brain tumors. The company has received Orphan Drug Designation for WP1066 for the treatment of brain tumors, as well as Rare Pediatric Disease designation for three other pediatric indications. Additionally, WP1066 + radiation is being evaluated, pre-clinically, in the treatment of Glioblastoma Multiforme. Glioma is a common type of tumor originating in the brain. About 33% of all brain tumors are gliomas.

Moleculin Biotech announced the launch its new corporate branding and website www.moleculin.com. "As we drive clinical development across our broad portfolio of drug candidates, expand our growing body of clinical data and build value among all stakeholders, we believed it was an important step to refresh our corporate branding identity and website to align with the true potential and vision we have for Moleculin. We are wholeheartedly committed to potentially solving some of the toughest challenges and importantly, bringing better treatments to patients where there remains unmet medical need. The work completed and data demonstrated to-date bolsters our confidence as we believe we can successfully execute on a number of key clinical and regulatory milestones that will be instrumental in establishing a clear path to approval and commercialization of Annamycin. I am excited for this evolution of Moleculin and to take another step forward towards the future of this exciting company," commented Walter Klemp, Chairman and CEO of Moleculin.

Moleculin Biotech announced that preclinical data of Annamycin tested in syngeneic models of metastatic colorectal cancer established in lungs or liver was accepted for poster presentation at the American Association for Cancer Research, or AACR, Annual Meeting 2022, being held April 8-13. Annamycin exhibited robust antitumor activity in both models. In the lung metastasis model, a dose-dependent delay in the tumor progression was visualized by both BLI and CT scan in the Annamycin treated group. The delay correlated with 272% extension of survival in the group receiving 6 mg/kg Annamycin and 234% for the animals dosed with Annamycin at 4 mg/kg. In the liver metastasis model, all vehicle-treated mice showed massive tumors in the liver and peritoneal cavity as monitored by BLI and MRI. In the vehicle group, 13/14 died or were euthanized by 35d. Yet, no tumors were detected by BLI or MRI in Annamycin treated mice as of 44d and 0/14 mice died. This indicates a highly significant extension of survival, the company said. "We continue to be encouraged by the growing body of robust preclinical and human clinical data demonstrated by Annamycin. The positive results seen in these preclinical models provide added confidence in the potential follow-on development opportunities we believe Annamycin holds. While metastatic colorectal cancer is not an immediate area of focus for us, this data set continues to provide valuable insight as we advance its clinical development for the treatment of highly resistant tumors," commented Walter Klemp, Chairman and CEO of Moleculin.