RedHill Biopharma said today it will partner with the Fraunhofer Institute for Cell Therapy and Immunology (IZI) in a collaboration designed to evaluate the company’s Phase II–stage oncology drug candidate RP101.
The research collaboration will assess RP101 in preclinical oncology models—including pancreatic cancer—in combination with standard-of-care chemotherapies to support existing Phase I and Phase II clinical data and assess the drug’s clinical development path, RedHill said.
As part of the collaboration, the company added, Fraunhofer IZI will conduct real-time monitoring of tumor engraftment, tumoricidal efficacy, and response to treatment with RP101 in combination with standard-of-care chemotherapies. Results from the studies are expected during the first half of 2016.
Fraunhofer IZI is a research unit of the Fraunhofer Society, one of the world’s largest applied research organizations.
RP101 is a first-in-class, oral heat shock protein 27 (Hsp27) inhibitor intended to prevent the induction of chemoresistance, thus maintaining sensitivity of the tumor to chemotherapy and potentially enhancing patient survival. RP101 is a nucleoside analog found by Rudolf Fahrig, Ph.D., at the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) to inhibit development of chemoresistance in various cancer models.
According to RedHill, RP101 has been studied in several Phase I and II clinical studies with a total of 249 patients treated, including a Phase II study in pancreatic cancer. The drug candidate has been granted orphan drug designations for the adjunct treatment of pancreatic cancer by the FDA and the European Medicines Agency.
In 2014, RedHill obtained the option to acquire the worldwide exclusive rights to RP101 for all indications—other than for the pancreatic cancer indication in South Korea—by entering into an exclusive option agreement with RESprotect, a Fraunhofer Society spinout whose CEO and founder is Dr. Fahrig. Last year, RedHill said it had extended the term of the exclusive option agreement for an additional year.