RedHill options Phase 2 pancreatic cancer drug
RP101 has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by FDA and EMA
TEL AVIV, Israel—RedHill Biopharma Ltd., an Israeli biopharmaceutical company focused on late-clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, and RESprotect GmbH, a privately held biotech company located in Dresden, Germany, have entered into an exclusive binding option agreement for the acquisition of the oncology drug candidate RP101 and next-generation compounds.
RP101 is a proprietary, first-in-class, heat shock protein 27 (Hsp27) inhibitor, administered orally, which may prevent the induction of resistance to chemotherapy, thus maintaining sensitivity of the tumor to chemotherapy and potentially enhancing patient survival.
Under the terms of the agreement, RedHill has the option to acquire the worldwide exclusive rights to RP101 for all indications, other than the pancreatic cancer indication in South Korea. RedHill has agreed to pay RESprotect for a one-year option, which may be extended by RedHill under certain agreed terms. During the option period, RedHill may, at its discretion, conduct development activities with RP101. If RedHill elects to exercise the option, it will acquire the exclusive rights to RP101 for a total payment, for both the option and the acquisition of the rights, of $100,000, as well as potential milestone payments and tiered royalties on net revenues, ranging from single-digit to mid-teens.
In response to DDNews follow-up questions, a RedHill spokesperson noted that, “We have just completed the option transaction and have yet to provide the elaborated information which you are seeking. As a publically traded company, we will provide additional information to the public as [a] whole in due course. I’m sure you understand that we work under strict regulatory constraints and therefore we cannot provide any information beyond that which is publicly available.”
RP101 is an orally administered, patent-protected small molecule which binds to Hsp27, a chaperone protein which is found in abnormally high levels in cancer cells, and inhibits its activity. The overexpression of Hsp27, which results in the amplification of a multidrug-resistance gene, has been linked to tumor resistance to cytotoxic drugs and the development of metastasis. By inhibiting Hsp27, RP101 may prevent chemoresistance and enhance the sensitivity of tumors to chemotherapy. RP101 is based on a new mechanism of action of the anti-viral drug brivudine, a nucleoside analogue approved and marketed in several European countries for the treatment of herpes zoster.
Dror Ben-Asher, RedHill’s CEO, said: “[The] acquisition of an option for the Hsp27 inhibitor RP101 reflects RedHill’s increasing strategic focus on new, clinical-stage, orally administered treatments for patients suffering from gastrointestinal and inflammatory diseases, including pancreatic cancer and other gastrointestinal cancers, where there is a particularly strong need for better therapeutic options. Across several clinical studies, pancreatic cancer patients co-treated with RP101 and one or more chemotherapy agents were found to have longer overall survival than historical control pancreatic cancer patients treated with chemotherapy alone.”
A scientific advice meeting with Germany’s BfArM (the Federal Institute for Drugs and Medical Devices—in German: Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM) provided a possible pathway forward for the development of RP101, Ben-Asher added.
Prof. Rudolf Fahrig, RESprotect’s CEO, said: “We are delighted to sign this option agreement with RedHill Biopharma and look forward to work with our new partners at RedHill on the development of RP101.”
RP101 was invented by Fahrig at the Fraunhofer Institute for Toxicology and Experimental Medicine in Hannover, Germany. RP101 has completed several Phase 1 and Phase 2 clinical studies with a total of 249 subjects treated, including Phase 2 studies in pancreatic cancer.
RedHill Biopharma, established in 2009, is an emerging Israeli biopharmaceutical company.
RESprotect GmbH specializes in the development of drugs for the prevention and treatment of chemotherapeutic drug resistance and radiation therapy resistance.
Approximately 65 percent of all cancer patients—some three million newly diagnosed patients per year in the United States and Europe alone—are treated with cytotoxic agents with the objective of killing tumor cells. Unfortunately, treatment success with cytotoxic drugs is confounded by the acquisition of resistance to these drugs by some tumor cells. Consequently, these resistant tumor cells grow once again, leading to disease progression, subsequent metastases and eventual death.