RedHill Biopharma Announces Collaboration With Germany's Fraunhofer Institute

RedHill Biopharma Ltd. recently announced a research collaboration with Leipzig-based Fraunhofer Institute for Cell Therapy and Immunology (IZI), a research unit of the Fraunhofer Society for the evaluation of RedHill’s Phase II-stage oncology drug candidate, RP101.

The research collaboration tests 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. RP101 is a proprietary, first-in-class, orally administered, heat shock protein 27 (Hsp27) inhibitor intended to prevent the induction of resistance to chemotherapy (chemo-resistance), thus maintaining sensitivity of the tumor to chemotherapy and potentially enhancing patient survival. RP101 has completed several clinical studies, including a Phase II study in pancreatic cancer and has been granted Orphan Drug Designation for the adjunct treatment of pancreatic cancer by the US FDA and the European Medicines Agency (EMA).

As part of the collaboration, Fraunhofer IZI is conducting 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. The preclinical program is intended to support the existing Phase I and Phase II clinical data with RP101 and to assess the drug’s clinical development path.

In August 2014, RedHill entered into an exclusive option agreement with RESprotect GmbH, a privately held Germany-based biotech company, under which 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. RedHill announced in July 2015 that it had extended the term of the exclusive option agreement for an additional year.

RP101 is a nucleoside analogue found by Prof. Rudolf Fahrig at the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) in Hannover, Germany, to inhibit development of chemo-resistance in various cancer models. It is an orally administered, patent-protected small molecule which binds to heat shock protein 27 (Hsp27) and inhibits its anti-apoptotic effects. Hsp27 is a chaperone protein which is found in abnormally high levels in cancer cells. The overexpression of Hsp27, which results in anti-apoptotic effects, has been linked to tumor resistance to cytotoxic drugs and the development of metastasis. By inhibiting Hsp27, RP101 may prevent the induction of resistance to chemotherapy (chemo-resistance) and maintain sensitivity of tumors to chemotherapy, thus potentially enhancing patient survival. RP101 has been studied in several Phase I and Phase II clinical studies with a total of 249 subjects treated, including a Phase II study in pancreatic cancer. RP101 has been granted Orphan Drug Designation for the adjunct treatment of pancreatic cancer by the US FDA and the EMA.

RedHill Biopharma Ltd. is an emerging Israeli biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally administered, small molecule drugs for the treatment of inflammatory and gastrointestinal diseases, including cancer.

The Fraunhofer Institute for Cell Therapy and Immunology IZI investigates and develops specific problem solutions at the interfaces of medicine, life sciences, and engineering. The Institute practices contract research for biotechnological, pharmaceutical, and medical-technological companies, hospitals, diagnostic laboratories, and research facilities. The Institute’s core competencies are located in the field of Regenerative Medicine, in particular in the indication areas of oncology, ischemia, and autoimmune, inflammatory, and infectious diseases. The Institute is clinically oriented and conducts quality checks and the GMP-compliant manufacture of investigational medicinal products. Moreover, the Institute provides support in obtaining manufacturing authorizations and approvals. For more information, visit www.izi.fraunhofer.de.