FDA Grants Annamycin Orphan Drug Status for Soft Tissue Sarcomas

Walter Klemp, Moleculin

The FDA has granted an orphan drug designation to Annamycin for the treatment of patients with soft tissue sarcomas.

"This is now the second orphan drug designation for Annamycin, as Annamycin previously received [this status] for the treatment of relapsed or refractory acute myeloid leukemia," said Walter Klemp, chairman and CEO of Moleculin, the manufacturer of Annamycin. "We believe this continues to show how the breadth of our pipeline affords us 'multiple shots on goal' and therefore multiple opportunities to create shareholder value."

Recently, Moleculin announced that the FDA had permitted its request to give the agent, which is a type of anthracycline, Investigational New Drug (IND) status, which allowed the company to initiate a phase 1B/2 trial for patients with soft tissue sarcoma that has lung metastases following frontline therapy.

Preclinical data of Annamycin were presented at the virtual 2020 AACR Annual Meeting II, as well as data from an independent laboratory announced in October 2020, demonstrated that Annamycin is capable of reaching 6 to 34-fold higher levels of accumulation in the lungs versus that of doxorubicin, Moleculin stated.

Moreover, results showed that Annamycin was not linked with cardiotoxicity and also harbors the ability to avoid multidrug resistance mechanisms, both components that are associated with anthracycline effects in this setting, the company stated.

Annamycin is also being developed for the treatment of patients with relapsed or refractory acute myeloid leukemia.

Reference

1. Moleculin announces Annamycin receives FDA orphan drug designation for soft tissue sarcomas. Moleculin. News release. December 29, 2020. Accessed December 29, 2020. https://prn.to/2L3KioK