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WP1066

Technology Overview

Indications to Treat Pancreatic Cancer

Overview

WP1066 represents a new class of drugs, which WPD calls “Immune/Transcription Modulators”.WP1066 and related analogs have not only demonstrated the ability to directly induce apoptosis (tumor cell death) but also the ability to stimulate an immune response to tumors allowing T-cells to attack tumor cells. These unique drug properties are a result of WP1066’s ability to inhibit the activated form of STAT3, (p-STAT3). Furthermore, our studies demonstrated that these inhibitory effects are extended to downstream targets and include inhibition of antiapoptotic proteins and VEGF, factors responsible for the formation of new blood vessels (angiogenesis); and most importantly the ability to additionally inhibit two key oncogenic transcription factors, HIF-1α, and c-Myc, that were considered either undruggable or very challenging drug targets.

Clinic Development

Currently in a Phase I trial at MD Anderson for GBM and melanoma metastasized to the brain (WP1066 crosses the blood-brain barrier, or BBB); presently in the 3rd cohort of dose escalation evaluating safety and activity; planned surgical expansion to be able to assess tumor tissue directly after administration of WP1066 at the maximum tolerated dose (MTD) for direct confirmation of target inhibition. The future plan is to implement the WP1066 in the treatment of pancreatic cancer since the promising results of the preclinical trials were lately obtained.

Grants / Funding

WP1066 development has received over $8 million and grants and has had $15 million invested in furthering the technology and is expected to receive an additional $3 million in the next 24 months for Phase I and II clinical trials for WP1066 and related analogs.

Regulatory

WP1066 has received an Orphan Drug designation in the US for the treatment of glioblastoma, which provides seven years of marketing exclusivity.

Partners, Affiliations & License

MD Anderson, leading cancer research center in the world

Moleculin Biotech, Inc. – co-development partner

Children’s Healthcare of Atlanta, Pediatric Neuro-Oncology Program, Emory University School of Medicine – Clinical studies of WP1066 in pediatric medulloblastoma, the most common malignant brain tumor in children

Mayo Clinic - Clinical Studies in diffuse intrinsic pontine gliomas (DIPG), a highly aggressive and difficult to treat brain tumor that affects almost exclusively children

WPD owns the exclusive license to 30 countries in Europe and Asia and also Russia.

Market Opportunity

The expected market size is multiple billions.

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