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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) announced on March 13, 2023, that it has no exposure to Silicon Valley Bank (SVB), which has been taken over by the Federal Deposit Insurance Corp. due to liquidity issues. The company confirmed it does not hold any deposits or investments at SVB. Moleculin is a clinical stage pharmaceutical company focused on developing therapies for hard-to-treat tumors and viruses, including its lead drug Annamycin, aimed at relapsed acute myeloid leukemia and soft tissue sarcoma lung metastases. The company's pipeline includes several promising drug candidates targeting various cancers and viral infections.
Moleculin Biotech, Inc. (NASDAQ: MBRX) announced the publication of data supporting Annamycin, a non-cardiotoxic anthracycline. The research shows Annamycin's potential in treating hard-to-treat tumors. An independent review of 42 subjects indicated no cardiotoxicity, distinguishing Annamycin from traditional anthracyclines like doxorubicin. Key modifications to Annamycin have enhanced its efficacy against multidrug-resistant tumors. Annamycin is currently being evaluated for soft tissue sarcoma and acute myelogenous leukemia. The manuscript, titled ‘Anthracycline-induced cardiotoxicity – are we about to clear this hurdle?’ was published in the European Journal of Cancer.
Moleculin Biotech, Inc. (NASDAQ: MBRX) announced the treatment of the first subject in Italy as part of its Phase 1/2 trial, MB-106, evaluating Annamycin combined with Cytarabine for refractory acute myeloid leukemia (AML). The Phase 1/2 trial builds on earlier successful trials, with the MB-105 study showing an 80% overall response rate. Annamycin is designed to avoid cardiotoxicity and demonstrate higher efficacy against chemotherapy-resistant cancers. The company aims to expand recruitment and has received Fast Track and Orphan Drug Designation from the FDA for Annamycin. The final clinical study report is expected to be published soon.
Moleculin Biotech, Inc. (MBRX) announced positive topline results from its MB-105 Phase 1 trial assessing Annamycin for treating relapsed or refractory acute myeloid leukemia (AML). The trial showcased an 80% overall response rate (ORR) in patients aged 60 and above, with no reported cardiotoxicity. The median number of prior therapies was four, indicating a challenging patient population. The company is optimistic about Annamycin, especially given its encouraging preliminary efficacy data and safety profile. Annamycin is also in ongoing combination trials with Cytarabine, aiming for further indications in AML treatment.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announces a presentation by CEO Walter Klemp at the Virtual Investor 2023 Companies to Watch Event on January 17, 2023, at 9:00 AM ET. The event will focus on Moleculin's innovative drug candidates designed to combat resistant tumors and viruses, including Annamycin for acute myeloid leukemia and WP1066 for brain tumors. A live video webcast will be accessible, with a replay available for 90 days.
Moleculin Biotech, Inc. (MBRX) announced the approval from Italy's AIFA and ISS for its Phase 1/2 trial of Annamycin in combination with Cytarabine (Ara-C) for treating refractory or relapsed Acute Myeloid Leukemia (AML). This adds to the ongoing approval in Poland, where three sites are already recruiting. The company expects to treat its first subject in Italy in Q1 2023. Annamycin has shown significant potential in preclinical studies, enhancing overall survival rates. The company is expanding its clinical trial efforts across Europe to improve recruitment rates.
Moleculin Biotech announced an impressive 80% overall response rate (ORR) in the final cohort of its Phase 1 clinical trial for Annamycin in treating relapsed/refractory acute myeloid leukemia (AML). The drug has shown significant safety results, with an independent report confirming no cardiotoxicity in 42 subjects across three trials. Additionally, Annamycin has received FDA Fast Track and Orphan Drug Designation for AML and STS lung metastases. The company is expanding its clinical trials into Europe to improve recruitment.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced on December 7, 2022, that the FDA granted Fast Track designation for its drug WP1122 to treat Glioblastoma Multiforme (GBM). This designation aims to expedite the development of therapies for serious conditions with unmet needs, allowing more frequent regulatory communication. Walter Klemp, CEO, emphasized the significance of this designation and the promising preclinical data for WP1122. With GBM having a median survival of only 15 months, WP1122 shows potential as a treatment option, especially after receiving Orphan Drug Designation and IND clearance for a Phase 1 study.
Moleculin Biotech reported its Q3 2022 financial results, highlighting significant progress in clinical trials. The company is conducting three Phase 1/2 studies for Annamycin, with no evidence of cardiotoxicity in treated patients. Moleculin has sufficient capital of $50.4 million to fund operations through mid-2024. Their R&D expenses rose to $14.8 million, reflecting increased clinical activities. Additionally, the FDA granted Orphan Drug Designation for WP1122 aimed at treating Glioblastoma Multiforme. A conference call to discuss these results was held on November 10, 2022.
Moleculin Biotech, Inc. (Nasdaq: MBRX) will release its financial results for Q3 2022 on November 10, 2022. An inaugural quarterly conference call will follow at 5:00 PM ET to discuss both operational and financial outcomes. Moleculin specializes in developing drug candidates for resistant tumors and viral infections, with lead program Annamycin aimed at treating relapsed acute myeloid leukemia and soft tissue sarcoma. The company also has ongoing projects targeting brain tumors and COVID-19.