Endocrine Cancer Drug

helping patients with adrenal gland malignancies

While most cancers have decreased, the incidence of deaths from endocrine cancers has increased dramatically. Specifically, adrenal cancers are extremely challenging to successfully treat because of a lack of durable therapies and significant drub toxicities. New treatments are needed to help patients leader longer, healthier lives.

University of Michigan Medical School faculty Mark Cohen, M.D. and College of Pharmacy faculty Anna Schwendeman, Ph.D. took a unique approach to addressing this problem. The duo has developed a new adrenal cancer treatment that offers improved drug potency and minimal toxicity through a combination of a naturally occurring cancer therapeutic and a synthetic HDL nanoparticle that targets the SR-B1 receptor found in adrenal tissues.

Significant Need

It is a difficult challenge to effectively treat malignancies of endocrine system organs. Scarab offers a novel drug that is selective against adrenocortical carcinomas (ACCs), carries a better safety and tolerability profile, and has more durable efficacy than current standard of care. In addition, the HDL-nanoparticle delivery platform improves the effectiveness of the withanolides.

Compelling Science

Combining a novel naturally-derived withanolide with a patented HDL-nanoparticle delivery platform improves drug delivery and potency.

Competitive Advantage

The current standard of care lacks durable efficacy and often limits dosing because of possible drug toxicity issues. This new adrenal cancer treatment shows highly favorable safety profiles in pre-clinical studies.

Overall Commercialization

  • Intellectual Property – Invention disclosure filed – additional patents to be filed.
  • Commercialization Strategy – License withanolide to a major pharmaceutical company, with ongoing validation of synthetic development.
  • Regulatory Pathway – Accelerate clinical trial entry by utilizing an orphan drug Investigational New Drug pathway. Demonstrate efficacy and toxicology profile.
  • Product Launch Strategy – Start a biotechnology company that will license the technology – the final product launch would be determined by licensee.

Milestones

  • Optimization, analytical characterization and stability testing of the HDL-TA-WGA particle
  • In vitro drug uptake and cytotoxicity studies in cancer vs. normal cells
  • Non-GLP pharmacokinetics and MTD testing
  • Non-GLP efficacy and drug distribution imaging in ACC xenografts (solid tumor model)
  • Non-GLP efficacy and drug distribution imaging in ACC xenografts (metastatic disease tumor model)
  • Non-GLP single dose toxicology and histology studies
  • Q316 Update: $2,500 follow-on funding, Scarab Therapeutics (startup)

May 2, 2017
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