Annamycin:

Next Generation Non-Cardiotoxic and Organotropic Anthracycline

Annamycin is a next-generation anthracycline that has 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. Importantly, Annamycin has also been shown in animal models to have potentially important organotropic (affinity for certain organs) properties, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. We believe that the use of Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently prescribed anthracyclines. As well, we believe it may be more effective than currently prescribed anthracyclines due to its lack of cross-resistance and its ability to accumulate at much higher levels in certain targeted organs (for example: Annamycin has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin).

U.S. FDA Orphan Drug Designation for STS Lung Mets and AML

U.S. FDA Fast Track Status for STS Lung Mets

Ongoing Clinical Studies:

Phase 1b/2

STS Lung Mets

Phase 1/2

AML

Key Highlights:

Demonstrated to be non-cardiotoxic1

Organotropic properties (e.g.: >30x greater accumulation in lungs than doxorubicin)

Ability to overcome multi-drug resistance

Potent topoisomerase-II poison with a wider therapeutic window than doxorubicin2

<10% incidence of alopecia compared with 65%-92% for doxorubicin3,4

Clinically evaluated stable liposomal formulation5

1: Trevino et al, 2004; 2: Based on preclinical and clinical data to date. See Company’s most recent SEC filings; 3: Gonzalez et al. 2018; 4: DOXORUBICIN HYDROCHLORIDE [package insert]. New York, NJ: Pfizer Injectables; 2019; 5: L-ANN, Wetzler et al. 2013

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