Moleculin Biotech, Inc. · NASDAQ:MBRX
Moleculin Biotech — MSC Symposium September 2022
18 slides from Moleculin Biotech's conference presentation, Sep 9, 2022
Slide 1: Translating Preclinical Research into Clinical Trials
* MOLECULIN OP! Translating Preclinical Research into Clinical Trials Preclinical and Clinical Research with a Novel Anthracycline — Liposomal Annamycin for R/R AML and Soft Tissue Sarcomas With Pulmonary Metastases MSC Symposium September 2022
Slide 2: Disclaimer
Disclaimer All statements contained herein other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements, The words “believe,”
Slide 3: Background
Background pakke Annamycin, ar unique anthrac vel structurally Unique new structure 3'-Deamination and introduction of iodine at C-2' (previously unexplored) Incorporates key structural elements of 3 different clinically used anthracyclines Congener of doxorubicin, epirubicin, and idarubicin Biologi
Slide 4: Annamycin is Significantly More Potent Than Doxorubicin
Annamycin is Significantly More Potent Than Doxorubicin Against Multidrug Resistant Tumor Cell Lines lla Bemorecutin
Slide 5: L-Annamycin is Non-Cardiotoxic in FDA Required Tests
L-Annamycin is Non-Cardiotoxic in FDA Required Tests -<g{MOLECULIN
Slide 6: L-Annamycin is Non-Cardiotoxic in FDA Required Tests
L-Annamycin is Non-Cardiotoxic in FDA Required Tests Annamycin has little to no cardiotoxi preclinically and Clinically in 6 clinical trials to date Cumulative anthracycline doses of >2, ut cardiotoxicity 20 0 mg/m2 have been given MOLECULIN 6
Slide 7: High Efficacy of Liposomal Annamycin in Combination with Cytarabine in AML Mouse Model
High Efficacy of Liposomal Annamycin (L-ANN) in Combination with Cytarabine in Syngeneic p53-Null AML Mouse Model Objective was to evaluate efficacy of L-Annamycin alone and in combination with cytosine arabinoside in an aggressive and clinically relevant AML model Annamycin alone was effective but
Slide 8: Phase I/II Trials in the US and Poland for R/R AML
Phase I/II Trials in the US and Poland for R/R AML Two Phase 1/II clinical trials using L-Annamycin completed First clinical trial in the US proved safety and activity at 120 mg/m2 Second clinical trial begun in Poland at 120 mg/m2 and RP2D was 240 mg/m2 “synergism” between clinical trials with the
Slide 9: Phase I/II Clinical Trial in Europe Initiated with Combination of Annamycin and Ara-C
Comb. Lann Ara-C S:MOLECULIN I/II Clinical Trial in Europe Initiated with ination of amycin and Based on the preclinical data showing greater efficacy adding Ara-C to L-Annamycin, a Phase I/II trial was initiated in Europe Trial beginning in Poland with expansion to other countries going through reg
Slide 10: STS often develops pulmonary metastases and most are unresectable
STS often develops pulmonary metastases and most are unresectable Continued lack of effective chemotherapy Targeting Sanctuary Preclinical experiments demonstrated levels Sites of Canc of Annamycin in lung tissue 6-fold greater than doxorubicin High drug efficacy in lung localized mouse models rangi
Slide 11: Liposomal Lung Penetration of L-Annamycin Versus Doxorubicin
Liposomal Lung Penetration of L-Annamycin Versus Doxorubicin Preclinical data demonstrated a 31% higher pulmon: penetration of L-Annamycin compared to doxorubicin Lungs often a sanctuary site for STS metastases Preclinical experiments demonstrated greater efficacy of L-Annamycin Bmovecuuin un
Slide 12: Results: Tissue-Organ Distribution
Results: Tissue-Organ Distribution Experimental Design:Group of rats CD*IGS [Crl:CD{SD)]; body weights at 20000; dosing ranged from 261-355 g for males and 195-292 g for females} were administered a single IV dose of Liposomal Annamycin (LAN), free annamycin (F-Ann) and free doxorubicin (Dox-HCT). T
Slide 13: Results: Tissue-Organ Distribution
Results: Tissue-Organ Distribution Experimental Design: Group of rats CO {SD dosing ran for fe 2 administered a single IV dose of Liposomal Annamycin (L-ANN), fre (Dox-HCl). The animals were sacrificed at indicated timepoints followed by extraction of plasma and selected organs. T concentration of a
Slide 14: Results: Efficacy of L-ANN in Syngeneic Experimental Metastasis Model of Osteosarcoma: K7M3
Results: Efficacy of L-ANN in Syngeneic Experimental Metastasis Model of Osteosarcoma: K7M3 Survival K7M3 CT image day 58 Lave wetoamie
Slide 15: Preclinical Data Summary
Preclinical Data Summary Annamycin (ANN), a novel non-cardiotoxic anthracycline exhibits very high uptake in the lungs compared to doxorubicin (DOX). Furthermore, ANN’s displays greater potency than DOX in multidrug resistant tumor cell lines and tested sarcoma cell lines High concentration of ANN i
Slide 16: Ongoing Phase I/II Clinical Trials in the US and Poland
Ongoing Phase I/II Clinical Trials in the US and Poland These promising preclinical results led to the initiation of a Phase I/II multicenter sarcoma-specific clinical study in the US for pulmonary metastases on an every 3- week standard regimen A second clinical trial started in Poland for STS with
Slide 17: Conclusions
Conclusions ANN shows dose-and-time-dependent accumulation in cells with increased cytosolic localization and greater potency than DOX in multidrug resistant tumor cell lines The high concentration of ANN in lungs and nanomolar level cytotoxicity against sarcoma cells are responsible for high in viv
Slide 18: Thank You!
Thank You! od, og MOLECULIN Coy