TEL AVIV, Israel—Biopharmaceutical company RedHill Biopharma Ltd. has reached out across the Mediterranean to partner with Leipzig, Germany-based Fraunhofer Institute for Cell Therapy and Immunology (IZI), a research unit of the Fraunhofer Society, one of the world's largest, most prominent applied research organizations. The two have struck up a research collaboration to evaluate RP101, RedHill's Phase 2-stage oncology drug candidate. No financial details were disclosed.
The compound is a nucleoside analogue found by Prof. Rudolf Fahrig at the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) in Hannover, Germany. It has been shown to be capable of inhibiting the development of chemoresistance in various cancer models. RP101 is an orally administered, patent-protected small molecule that binds to heat shock protein 27 (Hsp27)—a chaperone protein found in abnormally high levels in cancer cells—and inhibits its anti-apoptotic effects. The overexpression of Hsp27, which results in anti-apoptotic effects, has been linked to tumor resistance to cytotoxic drugs as well as the development of metastasis. By inhibiting Hsp27, it's thought that RP101 may prevent the onset of chemoresistance and keep tumors sensitive to chemotherapy.
So far, RP101 has been evaluated in a number of Phase 1 and 2 clinical studies, including a Phase 2 study in pancreatic cancer, and has been tested in 249 patients. The U.S. Food and Drug Administration and the European Medicines Agency have both granted RP101 Orphan Drug Designation for the adjunct treatment of pancreatic cancer.
This collaboration will evaluate RP101 in preclinical oncology models, including pancreatic cancer, in combination with standard-of-care chemotherapies to support existing Phase 1 and Phase 2 clinical data and determine the compound's clinical development path. Under the terms of the deal, 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 these studies are expected during the first half of 2016.
RedHill established an exclusive option agreement with privately held biotech company RESprotect GmbH in August 2014, under which RedHill obtained the option to acquire the worldwide exclusive rights to RP101 for all indications, with the exception of the pancreatic cancer indication in South Korea. Last July, the company announced that it had extended the term of the exclusive option agreement for an additional year.
In other recent news for RedHill's pipeline, the company announced at the end of November that it had completed the last dosing and scheduled follow-up patient visit ahead of top-line interim analysis in its Phase 2a proof-of-concept clinical study evaluating RHB-104 in patients treated for relapsing-remitting multiple sclerosis (RRMS). RHB-104 is a proprietary antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
The study—CEASE-MS study—evaluated RHB-104's safety and efficacy in RRMS patients as an add-on therapy to inteferon beta-1a. The primary endpoint is the number of combined unique active lesions after 24 weeks of treatment with RHB-104, compared to baseline, and top-line interim results are expected to be announced early in the first quarter of this year, with a full analysis and the final Clinical Study Report expected sometime in the second quarter.