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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 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.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has provided an update on its Phase 1a clinical trial for WP1122, designed to treat resistant tumors and viruses. The second multiple ascending dose (MAD) cohort was halted due to adverse events in 2 subjects, leading to the initiation of MAD cohort 2a at 48 mg/kg. The trial includes around 70 subjects and aims to establish a maximum tolerated dose. While initial doses were well tolerated, the company aims to explore WP1122's potential against COVID-19 and other severe infections. Future studies may occur in additional countries.
Moleculin Biotech announced that its compound WP1096, part of the WP1122 portfolio, will undergo animal studies funded by NIAID. This investigation aims to assess WP1096's potential as a therapy for hemorrhagic fever viruses, which currently lack FDA-approved treatments. Preliminary studies show WP1096 exhibits a broader antiviral spectrum compared to 2-DG. Moleculin is also advancing other projects, including a Phase 1 trial for another compound, WP1122, in COVID-19 patients. The company aims to further develop WP1096 if animal studies demonstrate significant efficacy.
Moleculin Biotech announced a live moderated video webcast for its Phase 1/2 study of Annamycin, targeting Acute Myeloid Leukemia (AML). The event is scheduled for September 28, 2022, at 11:00 AM ET. Management, including CEO Walter V. Kemp, will discuss Annamycin's clinical development and its combination with Cytarabine (AnnAraC). This open-label trial (MB-106) builds on prior safety data from earlier Phase 1 trials. Investors can submit questions and access a live webcast.
Moleculin Biotech, Inc. (Nasdaq: MBRX), a clinical-stage pharmaceutical firm, announced its participation in the 2nd Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care from September 8-10, 2022, at the Roswell Park Comprehensive Cancer Center, Buffalo, NY. Presentations will include The Value of Collaboration in Clinical Development by CEO Walter Klemp and Translating Preclinical Research Into Clinical Trials by Dr. Robert Shepard. The company focuses on drug candidates for resistant tumors, including Annamycin for leukemia and WP1066 for brain tumors.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that CEO Walter Klemp will present at the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022, in New York and virtually. The company focuses on developing treatments for highly resistant tumors and viruses, including its lead program Annamycin, aimed at acute myeloid leukemia. A video webcast of the presentation will be available from September 12 at 7:00 AM ET for 30 days. Management will also conduct virtual one-on-one meetings during the event.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that the FDA granted Orphan Drug Designation for WP1122, aimed at treating Glioblastoma Multiforme (GBM), an aggressive brain tumor. This milestone follows the progress in WP1122's Phase 1 clinical trial and supports its potential in addressing a significant medical need. GBM accounts for 16% of primary brain tumors, with a dire median survival of only 15 months. Orphan Drug Designation offers benefits like financial incentives and up to seven years of market exclusivity upon approval, enhancing Moleculin's strategic position in oncology.
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