On April 8, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that preclinical data of Annamycin tested in syngeneic models of metastatic colorectal cancer established in lungs or liver was accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, being held April 8-13, 2022, in New Orleans, Louisiana (Press release, Moleculin, APR 8, 2022, View Source [SID1234611728]).
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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)
Details of the poster presentation are as follows:
Title: New approach to target metastatic colorectal cancer organotropism with L-Annamycin
Track: Experimental and Molecular Therapeutics
Poster Number: 4048
Session: PO.ET06.05 – New Chemotherapy Agents
Presentation Type: E-Poster presentation
Session Date and Time: Wednesday, April 13, 2022, from 9:00 am – 12:30 p.m. CDT
Section: 27
The objective of this study was to assess the efficacy of Annamycin in experimental colorectal cancer liver and lung metastasis models. The efficacy of Annamycin was tested in syngeneic models of metastatic colorectal cancer established in lungs or liver. For lung metastasis model, CT26-Luc cells were injected intravenously (IV) into Balb/c mice, followed by weekly IV treatment of Annamycin (4 and 6 mg/kg). The liver metastatic model was established using intrasplenic injection protocol. Mice received six weekly IV injections of 4 mg/kg of Annamycin or vehicle. Bioluminescent imaging (BLI), Magnetic Resonance Imaging (MRI) or Computer Tomography (CT) were used to track tumor progression.
Annamycin exhibited robust antitumor activity in both models. In the lung metastasis model, a dose-dependent delay in the tumor progression was visualized by both BLI and CT scan in the Annamycin treated group. The delay correlated with 272% extension of survival in the group receiving 6 mg/kg Annamycin [median survival (MS) 79d for treated vs 29d vehicle, p<0.0001] and 234% for the animals dosed with Annamycin at 4 mg/kg [MS 68d, p=0.0012]. In the liver metastasis model, all vehicle-treated mice showed massive tumors in the liver and peritoneal cavity as monitored by BLI and MRI. In the vehicle group, 13/14 died or were euthanized by 35d (median survival was 34.5d). Yet, no tumors were detected by BLI or MRI in Annamycin treated mice as of 44d and 0/14 mice died (100% survival). This indicates a highly significant (P< 0.0001) extension of survival (ongoing experiment).
"We continue to be encouraged by the growing body of robust preclinical and human clinical data demonstrated by Annamycin. The positive results seen in these preclinical models provide added confidence in the potential follow-on development opportunities we believe Annamycin holds. While metastatic colorectal cancer is not an immediate area of focus for us, this data set continues to provide valuable insight as we advance its clinical development for the treatment of highly resistant tumors," commented Walter Klemp, Chairman and CEO of Moleculin.
In summary, the strategy to develop anticancer agents that imitate metastatic colorectal cancer organotropism appears to be highly promising and is supported by these results. This study demonstrating efficacy of Annamycin in colorectal cancer models provides convincing evidence for further preclinical development aimed at initiation of clinical studies in metastatic colorectal cancer patients.
Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple human clinical trials, including ongoing trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, and the Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently prescribed anthracyclines. Annamycin is currently in development for the treatment of AML and STS lung metastases and the Company believes it may have the potential to treat a number of additional indications.
Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of STS lung metastases, in addition to Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia.
For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.