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Moleculin Biotech, Inc. (NASDAQ: MBRX) is a clinical stage pharmaceutical company focused on developing therapies for hard-to-treat tumors and viruses. Known for its innovative drug candidates, Moleculin's pipeline aims to address significant unmet medical needs. The company's flagship product, Annamycin, is a next-generation anthracycline designed to overcome multidrug resistance mechanisms and minimize cardiotoxicity. Annamycin is currently in Phase II clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
Moleculin's research is rooted in discoveries from the acclaimed M.D. Anderson Cancer Center. In addition to Annamycin, the company is developing WP1066, an Immune/Transcription Modulator targeting brain tumors, pancreatic cancer, and other malignancies. WP1066 aims to inhibit oncogenic transcription factors such as p-STAT3 while stimulating the patient's immune response.
Another promising candidate, WP1220, an analog of WP1066, is being developed for the topical treatment of cutaneous T-cell lymphoma. The company also has a robust antimetabolite portfolio, including WP1122, which is being investigated for its potential in treating both viral infections and various cancers.
Recent achievements highlight Moleculin's significant progress. Positive preclinical data for Annamycin were presented at the American Association for Cancer Research (AACR) Annual Meeting, demonstrating its non-cardiotoxic properties and potent inhibition of topoisomerase II-beta. Annamycin has also received Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA) for AML, providing Moleculin with extended market exclusivity and reduced regulatory fees.
Financially, Moleculin maintains a solid footing with sufficient capital to support its ongoing clinical trials and future projects. The company's recent financial report indicates a strategic focus on advancing its clinical and regulatory strategies. With multiple patents issued and pending, Moleculin continues to strengthen its intellectual property portfolio, positioning itself favorably for potential partnerships and market expansion.
Collaborations with leading institutions such as Northwestern University and funding from entities like the National Institutes of Health (NIH) underscore the robust support for Moleculin's initiatives. The company's innovative approach and commitment to addressing challenging medical conditions make it a noteworthy entity in the biopharmaceutical landscape.
For more details, please visit Moleculin's website and connect on Twitter, LinkedIn, and Facebook.
Moleculin Biotech has completed its End of Phase 2 (EOP2) meeting with the FDA for its Phase 1B/2 clinical trial of Annamycin combined with Cytarabine for treating AML (MB-106). The meeting focused on reviewing clinical data and planning the next steps, with official outcomes expected by Q3 2024. Interim results show that out of 22 enrolled subjects, 45% achieved a composite complete remission (CRc) and 40% had a complete remission (CR). For second-line treatments, 50% achieved CR and 60% achieved CRc. Annamycin holds Fast Track Status and Orphan Drug Designations for relapsed or refractory AML in the U.S. and EMA.
Moleculin Biotech reported additional positive interim data from its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (AnnAraC) for acute myeloid leukemia (AML). The trial enrolled 22 subjects, with 20 completing efficacy evaluations. The results showed a composite complete remission (CRc) in 45% of subjects, a median durability of response (mDOR) of 6 months and increasing, and no cardiotoxicity. In a 2nd line setting, AnnAraC achieved a median overall survival (mOS) of 6 months and 50% complete remissions (CR). The data was presented at the European Hematology Association (EHA) 2024 Hybrid Congress and showcased promising efficacy outcomes, especially for poor prognosis patients.
Moleculin Biotech (Nasdaq: MBRX) announced its participation in the Virtual Investor Pitch Conference on June 18, 2024, at 3:00 PM ET. Walter Klemp, Chairman and CEO, will present an elevator pitch and discuss the company's upcoming milestones. Investors can submit questions during the live video webcast, available on Moleculin's website. A replay will be accessible for 90 days post-event.
Moleculin Biotech (Nasdaq: MBRX) announced its participation in the Virtual Investor Lunch Break: The Moleculin Opportunity event scheduled for June 12, 2024, at 12:00 PM ET. Walter Klemp, Chairman and CEO, will provide a corporate overview and business outlook. The event includes a live Q&A session where attendees can submit questions. A live webcast will be available on Moleculin's website, with a replay accessible for 90 days.
Moleculin Biotech (Nasdaq: MBRX) announced that its abstract has been accepted for a poster presentation at the European Hematology Association (EHA) 2024 Hybrid Congress. The event will take place from June 13-16, 2024, in Madrid, Spain, and virtually.
The presentation will focus on the study titled 'Liposomal Annamycin (L-ANN) in Combination with Cytarabine for Treatment of Patients with Acute Myeloid Leukemia (AML) Refractory to or Relapsed After Induction Therapy (MB-106 Study).'
The presenting author will be Dr. Wolfram C. M. Dempke, European Chief Medical Officer of Moleculin.
Moleculin Biotech has announced the start of a Phase 2 clinical trial evaluating WP1066 in combination with radiation therapy for glioblastoma, in collaboration with Northwestern University.
The trial, funded by the NIH and BrainUp, is aimed at improving treatment options for glioblastoma, which has a median survival rate of 15 months.
WP1066 has shown promise in animal models, demonstrating both therapeutic responses and immune 'memory' effects. This trial will focus on progression-free survival and tumor microenvironment analysis.
Moleculin's WP1066 is designed to activate immune responses and inhibit important oncogenic transcription factors involved in tumor survival and proliferation. The company has also received Orphan Drug Designation for WP1066 for brain tumors and Rare Pediatric Disease designation for other pediatric indications.
Moleculin Biotech, Inc., reported strong financial results for the first quarter of 2024. The company achieved a 62% CRc rate in 1st and 2nd line AML subjects with Annamycin in combination with Cytarabine. The MB-106 trial reached 20 subjects with a CRc rate of 45% in 1st – 7th line. The company also highlighted the positive interim data for Annamycin and announced the formation of the Annamycin Scientific Advisory Board. Financially, R&D expenses decreased due to clinical trials activity levels, while cash and cash equivalents stood at $16.8 million as of March 31, 2024.
Moleculin Biotech, Inc. announced the receipt of a U.S. Patent for Lipid-Based Delivery Technology for Annamycin, extending through 2040 with potential for further extensions. The drug Annamycin is moving towards a pivotal AML study in 2024, possibly qualifying for accelerated approval. The Company aims to establish a strong patent estate for Annamycin and drive its development forward, with promising results in clinical trials.
Moleculin Biotech, Inc. (Nasdaq: MBRX) will report its Q1 2024 financial results on May 10, 2024. The company focuses on drug candidates for hard-to-treat tumors and viruses. A conference call and webcast to discuss the results will be held on May 13, 2024, at 8:30 AM ET.
Moleculin Biotech, Inc. reports positive interim data for Annamycin in treating acute myeloid leukemia (AML). The CRc rate reached 62% in 1st and 2nd line AML subjects, with a 45% CRc in the full MB-106 trial. The presentation of data supports advancing to a Phase 2 trial (MB-108) for potential New Drug Approval. A virtual AML Clinical Day was held on May 7, 2024. Key data shows promising results and progression towards registration for Annamycin in AML.
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