Moleculin Rockets on FDA Nod

Moleculin Biotech, Inc. (NASDAQ: MBRX) rose Tuesday after the company disclosed that its WP1066 drug has received the Food and Drug Administration (FDA) brain tumor IND clearance, in patients with recurrent malignant glioma and brain metastasis from melanoma

Moleculin CEO Walter Klemp said “We are so pleased to now have a second drug enter the clinical stage.

"We believe WP1066 represents a new class of anticancer drugs able to fight tumors on two fronts by directly inhibiting cell signaling supporting tumor activity, and independently stimulating a natural immune response. This constitutes a new approach to treating brain tumors and tumor metastasis to the brain.

Klemp added “Since the discovery of WP1066 … it has now been studied by many independent groups and is widely recognized as a potent inhibitor of the activated form of a protein called STAT3, which has been implicated in many difficult to treat tumors, including brain tumors.

“Animal studies have shown that inhibition of STAT3 directly blocks tumor proliferation and its survival, while most importantly boosting the immune system's ability to fight cancer. We finally have our first opportunity for a clinical proof of concept and confirmation of promising preclinical activity."

The Houston-based Moleculin is a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on discoveries made at M.D. Anderson Cancer Center. Its lead product candidate is Annamycin, an anthracycline being studied for the treatment of relapsed or refractory acute myeloid leukemia

Shares in the company climbed 31 cents, or 17%, by noon ET Tuesday to $2.13.