Trial of Cutaneous T-cell Lymphoma Therapy WP1220 Fully Enrolled

A Phase 2 clinical trial of WP1220, a potential topical treatment of cutaneous T-cell lymphoma (CTCL) lesions, has reached full patient enrollment.

Developed by Moleculin Biotech, WP1220 is an inhibitor of phospho (p)-STAT3, the activated form of a transcription factor key for cancer cell growth and survival. Increased activity of p-STAT3 has been demonstrated in patients with CTCL. (Of note, transcription factors are small molecules that regulate gene expression.)

WP1220 is an analog compound of WP1066  being developed as a treatment for brain tumors, pancreatic cancer, and blood cancers. Work in a mouse model of melanoma showed that WP1066 extended the animals’ survival and killed tumor cells by both direct effects in these cells and by boosting the anti-tumor immune response.

A previous clinical trial (NCT01826201) found that WP1022 has limited effectiveness in the treatment of psoriasis, an immune-mediated skin disease. However, preclinical data suggest that WP1220 may be effective in suppressing CTCL, according to Moleculin.

This Phase 2 study will be conducted in Poland, where Moleculin has been collaborating with a local company to develop WP1220. The first two patients were enrolled earlier this year.

“We are pleased with how quickly this trial reached full recruitment and we are hopeful to be able to announce results from this trial yet this year,” Walter Klemp, Moleculin’s chairman and CEO, said in a press release.

“We believe there continues to be an unmet need for an improved topical therapy for Stage I–III [early-stage to locally advanced] CTCL skin lesions, especially one that may avoid significant unwanted side effects,” he said.

“This proof of concept [trial], if successful, could be an important first demonstration of a therapeutic effect in humans from such a p-STAT3 inhibitor,” Klemp added. “We believe showing activity with one of our STAT3 inhibitors, within our WP1066 family of molecules, could be an indicator of both the value of p-STAT3 as a target and the potential for our drugs in other cancers where STAT3 is highly activated.”

Three other trials testing Moleculin’s molecules are underway, Kemp noted. The company also is assessing annamycin, which was designed to avoid multi-drug resistance while having little to no cardiac toxicity in the treatment of relapsed or refractory acute myeloid leukemia. Annamycin is expected to enter Phase 2b stage soon, Moleculin says.