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Moleculin Biotech, Inc. reports developments as a clinical-stage pharmaceutical company advancing drug candidates for hard-to-treat tumors and viruses. Its lead program is Annamycin, also known as naxtarubicin, a next-generation anthracycline designed to avoid cardiotoxicity and multidrug resistance, with development focused on relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases.
Recurring news covers Annamycin clinical and preclinical data, the MIRACLE study of Annamycin in combination with cytarabine, oncology conference presentations, intellectual-property protection for liposomal Annamycin, and corporate financial updates. Additional pipeline coverage includes WP1066, an immune/transcription modulator targeting p-STAT3 and other oncogenic transcription factors, and WP1122, an antimetabolite program for pathogenic viruses and cancer indications.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has partnered with the University of Campinas, Brazil, to advance research on WP1122, a drug candidate targeting COVID-19. Recent studies indicate that WP1122, a pro-drug of 2-deoxy-D-glucose (2-DG), may inhibit SARS-CoV-2 replication by targeting glycolysis. The collaboration aims to enhance resources for WP1122's development, with potential in vivo testing slated for early 2021. The company continues to evaluate its strategy and plans for an Investigational New Drug request to the FDA.
Moleculin Biotech, a clinical stage pharmaceutical company, announced its participation in ROTH Capital's healthcare event titled "COVID-19 Therapeutics in Development" on October 28, 2020. The session, titled "Indirect Antivirals Against SARS-CoV2 Virus," will take place from 12:00 to 1:20 PM ET. The company focuses on developing drug candidates for treatment-resistant tumors and viruses, including Annamycin for AML and WP1066 for brain tumors and pancreatic cancer. For details, visit their website.
Moleculin Biotech (Nasdaq: MBRX) announced validation of Annamycin's ability to target lung-localized tumors through independent laboratory studies. Annamycin may address significant unmet needs in treating sarcomas that have metastasized to the lungs, outperforming the standard treatment, doxorubicin. The drug accumulates in lungs 9-fold higher than doxorubicin and more than 30-fold in its liposomal form. The company plans to submit an IND application for Annamycin before year-end, with potential applications for various cancers beyond sarcoma.
Moleculin Biotech (Nasdaq: MBRX) announced additional preliminary data from its Phase 1 clinical trial of WP1066, an immuno-stimulating STAT3 inhibitor for glioblastoma (GBM). Three patients completed treatment in the third cohort with no adverse events, allowing progression to the fourth and final dose escalation of 16 mg/kg. WP1066 is designed to cross the blood-brain barrier, and trials indicate it may enhance immune response against tumors. A future study is proposed to examine WP1066 in combination with radiation therapy.
Moleculin Biotech, Inc. (MBRX) announced positive preliminary findings from its collaboration with the Rega Institute, indicating that drug candidates WP1096 and WP1097 exhibit significant in vitro activity against various infectious diseases, including COVID-19, HIV, Zika, and Dengue Fever. The company is expanding its infectious disease program while continuing clinical development of Annamycin for acute myeloid leukemia and WP1066 for brain tumors and pancreatic cancer. CEO Walter Klemp emphasized the potential for these drug candidates to address critical unmet medical needs and attract governmental support.
Moleculin Biotech, Inc. (Nasdaq: MBRX) appointed Elizabeth (Liz) Cermak to its Board of Directors on October 5, 2020. With nearly four decades in the healthcare sector, Cermak is expected to leverage her extensive experience in drug commercialization and licensing to advance Moleculin's oncology and infectious disease drug pipelines. Previously, she held significant roles at POZEN and Johnson & Johnson, overseeing large product portfolios. Chairman and CEO Walter Klemp emphasized her potential to provide valuable guidance for the company's future endeavors.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced positive preliminary results from its phase 1 clinical trial at Emory University for WP1066, targeting pediatric brain tumors. The first cohort of three patients received a 4 mg/kg dose without adverse effects, leading to progression to the 6 mg/kg dose level. Notably, one patient with diffuse intrinsic pontine glioma (DIPG) exhibited clinical improvement and tumor size reduction. CEO Walter Klemp highlighted the promising results amid a challenging landscape for DIPG treatments and emphasized the company's commitment to its diverse drug candidate pipeline.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a significant discovery regarding its new drug candidate, WP1096, which exhibited substantial in vitro antiviral activity against SARS-CoV-2. Laboratory tests revealed a therapeutic index exceeding 10, suggesting strong commercial potential for antiviral drugs. Chairman and CEO Walter Klemp indicated that this unexpected result could lead to expanded therapeutic applications, including other viruses. The company will continue preclinical development for WP1122 while pursuing further studies for WP1096 and WP1097, anticipating a twelve-month timeline for clinical assessment.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a contract with an independent laboratory to test its antiviral drug candidate WP1122 in a COVID-19 animal model using hamsters. Initial data may be available in December 2020, and this study aims to support an Investigational New Drug (IND) application to the FDA in 2021. Moleculin is also conducting additional in vitro studies of its WP1122 portfolio against SARS-CoV-2. The company remains focused on developing treatments for highly resistant tumors and viruses.
Moleculin Biotech, Inc. (Nasdaq: MBRX) will present virtually at two upcoming conferences: H.C. Wainwright's 22nd Annual Global Investment Conference on September 14, 2020, at 5:00 PM ET, and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2020, at 10:00 AM ET. Management will engage in 1-on-1 meetings with investors, with replays of the presentations available on the Company's website for 90 days post-event. Moleculin focuses on developing cancer therapies targeting resistant tumors and viruses.