Welcome to our dedicated page for Moleculin Biotec news (Ticker: MBRX), a resource for investors and traders seeking the latest updates and insights on Moleculin Biotec stock.
Moleculin Biotech, Inc. (Nasdaq: MBRX) is a Phase 3 clinical stage pharmaceutical company whose news flow is driven by developments in its oncology and virology pipeline. The company regularly issues updates on its lead anthracycline program Annamycin (naxtarubicin), its Immune/Transcription Modulator WP1066, and its antimetabolite portfolio, including WP1122.
News about Moleculin often focuses on clinical trial milestones, particularly for the pivotal, adaptive design Phase 2B/3 MIRACLE trial in relapsed or refractory acute myeloid leukemia (AML). Investors can follow announcements on enrollment progress, interim unblinding plans, trial expansion across multiple countries, and independent assessments of Annamycin’s cardiotoxicity profile. The company has highlighted an independent expert review of 90 Annamycin-treated subjects across five trials with no evidence of cardiotoxicity based on ECG, echocardiography and cardiac biomarkers.
Another key news theme is pipeline expansion. Moleculin reports investigator-initiated and grant-funded research that extends Annamycin into pancreatic cancer and glioblastoma multiforme (GBM), including collaborations with UNC-Chapel Hill and CIC biomaGUNE. Updates also cover externally funded clinical activity for WP1066 in adult GBM at Northwestern University and pediatric brain tumors at Emory University, along with published Phase 1 data showing STAT3 suppression and anti-tumor immune responses in children.
Moleculin’s news stream also includes corporate and regulatory updates such as reverse stock split actions, Nasdaq listing compliance developments, warrant exercises and patent grants, including an Australian patent for preliposomal Annamycin lyophilizate. For investors tracking MBRX, this news page provides a centralized view of scientific, clinical, regulatory and capital markets announcements related to the company’s efforts in hard-to-treat cancers and certain viral infections.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced on July 21, 2020, that independent laboratory tests confirmed the antiviral activity of WP1122 against coronavirus. Conducted by IIT Research Institute, the tests showed that WP1122, a 2-DG prodrug, demonstrated significant effects in a cell viability assay with a focus on realistic glucose levels. CEO Walter Klemp noted the importance of this validation and indicated plans for animal model testing for IND status. The company is also exploring other compounds in its portfolio for viral treatments.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a contract with Sterling Pharma USA LLC for the US production of WP1122, aimed at supporting its development for COVID-19 treatment. This collaboration is expected to enhance preclinical studies and the submission of an Investigational New Drug (IND) application to the FDA. The company is expanding its testing of WP1122 and its analogs against various viruses, yet acknowledges challenges in obtaining in vivo testing due to high demand. The outcomes will also contribute to advancing WP1122 for treating other viral infections and cancers.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a significant update on its Annamycin clinical development for treating relapsed acute myeloid leukemia (AML). Following collaboration with US and European regulators, the company will expand cardiotoxicity testing in its Phase 1 trial. European authorities approved increasing the dose-escalation increment from 30 mg/m2 to 60 mg/m2. The first patient has been treated at 240 mg/m2 without cardiotoxicity. Moleculin anticipates establishing a recommended Phase 2 dose in 2021 and is preparing for a Phase 1 trial for lung metastases by year's end.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a significant advancement in cancer research with the publication of a peer-reviewed article in Clinical Cancer Research. The study demonstrates that the combination of Moleculin's STAT3 inhibitor, WP1066, and whole brain radiation therapy (WBRT) enhances median survival time and induces long-term survival in mice with human brain tumors. The findings suggest an improved therapeutic effect and the potential to develop immune memory, potentially preventing tumor recurrence.
Moleculin Biotech announced significant preclinical findings on Annamycin at the AACR Annual Meeting, which took place from June 22-24, 2020. The poster presentation highlighted Annamycin's ability to achieve high concentrations in lung tissues, leading to superior anti-tumor efficacy against lung-localized tumors in mice. Annamycin demonstrated nearly six times the lung accumulation compared to doxorubicin, indicating potential for improved treatment outcomes in patients with metastatic lung cancer. The company aims to explore Annamycin's clinical applications further.
Moleculin Biotech, Inc. (Nasdaq: MBRX) will present at the virtual Life Sciences Investor Forum on June 25, 2020, from 1:30 PM to 2:00 PM ET. CEO Walter Klemp will lead the presentation, allowing real-time questions from investors. An archived webcast will be available for those who miss the live event. Investors are encouraged to pre-register via the event's page. Moleculin focuses on developing oncology drug candidates targeting resistant tumors, including Annamycin for acute myeloid leukemia, WP1066 for brain tumors, and WP1220 for cutaneous T-cell lymphoma.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced confirmed in vitro testing results demonstrating the antiviral potential of WP1122 against Human Coronavirus 229E, a surrogate for SARS-CoV-2, on June 1, 2020. The company plans to pursue further in vitro and in vivo studies, anticipating an IND filing for COVID-19 treatment by the end of 2020. Moleculin intends to leverage non-GLP toxicology data in its IND submission. The FDA's guidance was received positively, helping shape the company’s clinical development strategy for WP1122.