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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) will participate in the Virtual Investor 2022 Top Picks Conference on January 27, 2022, at 9:00 AM ET, led by CEO Walter V. Klemp. The event will feature a corporate presentation and a moderated Q&A session where attendees can submit questions live or in advance. A live video webcast of the presentation will be available on the Company's website, followed by a replay for one year. Moleculin focuses on drug candidates for highly resistant tumors, including its lead program, Annamycin, for acute myeloid leukemia and soft tissue sarcoma.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has reported updated safety data from its Phase 1 trials of Annamycin, targeting acute myeloid leukemia (AML) and soft tissue sarcoma with lung metastases. An independent review confirmed no evidence of cardiotoxicity in 30 patients, supporting Annamycin's safety profile. Furthermore, less than 10% of patients treated with Annamycin experienced alopecia, significantly lower than the 65%-92% rate associated with doxorubicin, enhancing patient quality of life. The company's ongoing trials aim to establish the recommended Phase 2 doses while navigating recruitment challenges in certain regions.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that President and CEO Walter Klemp will present at the virtual H.C. Wainwright BioConnect Conference from January 10-13, 2022. The presentation will be available on-demand starting January 10, 2022, at 7:00 AM ET for registered participants and accessible on the Company's website for 90 days thereafter. Moleculin is focused on developing a portfolio of drug candidates targeting resistant tumors and viruses, including Annamycin for acute myeloid leukemia and WP1066 for various cancers.
Moleculin Biotech, Inc. (Nasdaq: MBRX) reported preliminary results from its ongoing Phase 1b/2 clinical trial of Annamycin for soft tissue sarcoma (STS) lung metastases. The trial, focusing on dose escalation, recently concluded its third cohort safety review and proceeded to the fourth cohort. Initial data indicate encouraging activity, with three of six patients in earlier cohorts showing stable disease for over four months. Notably, Annamycin has demonstrated no cardiotoxicity, positioning it as a safer alternative to current anthracyclines. The trial continues to enroll subjects at an accelerated pace.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that the FDA has approved its IND application to study WP1122 for the treatment of Glioblastoma Multiforme (GBM). This allows the company to initiate a Phase 1 study assessing the safety and efficacy of oral WP1122 in adult GBM patients. Moleculin plans to conduct an additional trial in the UK to evaluate WP1122 as a potential COVID-19 therapy. Their strategy aims to address highly glycolytic cancers and leverage external funding for future clinical trials, particularly in 2022.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced participation in a Virtual Investor Roundtable Event on November 18, 2021, at 11:00 AM ET. CEO Walter V. Kemp and Senior CMO Dr. John Paul Waymack will present, joined by Dr. Sant P. Chawla. The event will include a presentation, moderated discussion, and live Q&A. Participants can submit questions via the conference website. A live video webcast will be available, with a replay accessible afterward. Moleculin focuses on developing drugs for resistant tumors and viruses, including Annamycin for acute myeloid leukemia and soft tissue sarcoma.
Moleculin Biotech, Inc. (Nasdaq: MBRX) reported its financial results for Q3 2021, revealing a decrease in R&D expenses to $4.1 million, down from $4.4 million in 2020. General and administrative expenses rose to $2.0 million. The Company recorded a net loss of $13.1 million for the nine-month period. Moleculin is advancing its oncology drug pipeline, with six clinical trials underway or expected for clearance by year-end 2021. A significant milestone includes the authorization for a Phase 1a trial of WP1122 for COVID-19 in the UK.
Moleculin Biotech (Nasdaq: MBRX) announced on Oct. 19, 2021, the authorization from the MHRA to start a Phase 1a clinical trial for WP1122 in the UK. WP1122, a prodrug of 2-deoxy-D-glucose, aims to inhibit viral replication in COVID-19 patients. The trial will involve about 80 healthy volunteers to assess the drug's safety and pharmacokinetics. Preclinical data show WP1122's potential as a more potent antiviral compared to 2-DG. Moleculin is also exploring additional countries for Phase 2 studies and developing other antimetabolites.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced interim results from its Phase 1b/2 clinical trial for Annamycin, targeting soft tissue sarcoma (STS) lung metastases. Preliminary data shows encouraging responses, with four out of five patients demonstrating clinical activity, including one with over 30% tumor size reduction. The trial is progressing well, having quickly completed two cohorts within four months. Annamycin, designed to be non-cardiotoxic, has received Fast Track Status and Orphan Drug Designation from the FDA. Patient enrollment for additional cohorts is currently underway.
Moleculin Biotech, Inc. (Nasdaq: MBRX), a clinical stage pharmaceutical company, announced that its CEO, Walter Klemp, will present at the 2021 Cantor Virtual Global Healthcare Conference on September 27, 2021, at 8:40 AM ET. Moleculin will also offer virtual one-on-one meetings for qualified investors. The live webcast will be accessible on the Investors section of their website, with a replay available for 90 days.