Potentially expanding its gastrointestinal-focused pipeline, RedHill has secured an option to acquire RP101 from Dresden-based RESprotect GmbH, a spin-off from the Fraunhofer-Society

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RP101 has completed several Phase I and Phase II clinical studies

RP101 has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)

On August 13, 2014 RedHill Biopharma Ltd. (NASDAQ: RDHL; TASE: RDHL) (the "Company" or "RedHill"), an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, and RESprotect GmbH ("RESprotect"), a privately-held biotech company located in Dresden, Germany, reported that they have entered into a binding exclusive option agreement for the acquisition of the oncology drug candidate RP101 and next generation compounds (Press release, RedHill Biopharma, AUG 13, 2014, View Source;LNGID=1&GID=663 [SID:1234506357]). RP101 is a proprietary, first-in-class, heat shock protein 27 (Hsp27) inhibitor, administered orally, which may prevent the induction of resistance to chemotherapy (chemoresistance), 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 to 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.

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 (MDR) gene, has been linked to tumor resistance to cytotoxic drugs and the development of metastasis. Chemoresistance limits the effectiveness of chemotherapy and can ultimately lead to treatment failure. 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. RP101 has completed several clinical studies, including Phase II studies in pancreatic cancer. RP101 has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Dror Ben-Asher, RedHill’s CEO, said: "Today’s 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. In a randomized, placebo-controlled Phase II pancreatic cancer study, median overall survival was longer in patients receiving chemotherapy plus RP101 than in those receiving chemotherapy plus placebo in a subset of patients with high body surface area in the U.S. A scientific advice meeting with Germany’s BfArM provided a possible pathway forward for the development of RP101." Mr. Ben-Asher added: "there are many government and other research and development grants available for gastrointestinal cancers and specifically for pancreatic cancer which we could potentially pursue, and there is also potential for regulatory designation of RP101 as an expedited program for a serious condition and unmet medical need. We are looking forward to exploring further development of RP101 with our new partners at RESprotect."

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."

About RP101 :

RP101, invented by Prof. Rudolf Fahrig at the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) in Hannover, Germany, is an orally administered, patent-protected small molecule which binds to heat shock protein 27 (Hsp27) and inhibits its multidrug-resistance gene amplification activity. Hsp27 is a chaperone protein which is found in abnormally high levels in cancer cells and plays a key role in the development of therapy resistance and metastases. By inhibiting Hsp27, RP101 may prevent the induction of resistance to chemotherapy (chemoresistance) and maintain sensitivity of tumors to chemotherapy, thus potentially enhancing patient survival. RP101 has completed several Phase I and Phase II clinical studies with a total of 249 subjects treated, including Phase II studies in pancreatic cancer. RP101 has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

On August 13, 2014 CrystalGenomics, Inc. (www.cgxinc.com), a clinical stage biopharmaceutical company headquartered in Korea, has reported a positive outcome from an investigational preclinical research conducted, in part, at the University of Texas MD Anderson Cancer Center by Dr. Raymond N. DuBois’ laboratory where the purpose of the research was to explore the potential anti-tumor effects of polmacoxib (formerly CG100649), CrystalGenomics’ novel Non-Steroidal Anti-Inflammatory Drug (NSAID) candidate with its NDA pending for an approval by the MFDS of South Korea for the relief of signs and symptoms of osteoarthritis (Press release, CrystalGenomics, AUG 13, 2014, View Source;id=1314&page=5&num=83&nowpos=646&type=&sermun=&qu=&tb_name=eng_news&rt_page=/en/news/news.php [SID1234539169]). On December 1, 2012 Dr. DuBois Laboratory on Inflammation and Cancer relocated to the Biodesign Institute at Arizona State University in Tempe, Arizona.

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The preclinical research was designed to examine the possible use of polmacoxib for both prevention and treatment of colorectal cancer (CRC). For the first part of the research, a premalignant mouse model was used to determine efficacy of polmacoxib in polyp reduction and it was observed that polmacoxib was effective in reducing the polyp number and size in both the small and large intestines in the prevention study. In the treatment study, polmacoxib demonstrated significant growth suppression of established polyps in the small intestine and also, reduction of the polyp growth in the colon. These results suggested that polmacoxib would be effective in prevention and treatment of polyps.

The second part of the study examined polmacoxib’s ability to suppress growth of human colorectal carcinoma in the subcutaneous and orthotopic xenograft mouse models. With the subcutaneous model, it was observed that treatment with polmacoxib lead to significant reduction of subcutaneous tumor growth. Similarly, it was observed that treatment with polmacoxib inhibited CRC growth in an orthotopic xenograft mouse model. Overall results from both mouse models lead to a conclusion that polmacoxib could be effective in not only prevention of CRC through reduction of premalignant polyp number and size but also, treatment of CRC by suppressing growth of malignant colonic lesions in humans. More detailed results of this preclinical research have been published in the August edition of the Investigational New Drugs Journal.

The preclinical research was conducted at the laboratory of Dr. Raymond DuBois, an internationally renowned investigator and researcher in the field of cancer, especially in the link between colorectal cancer, arthritis drugs and the cyclooxygenase-2 (COX-2) enzyme. His group was the first to demonstrate elevation of COX-2 expression in colorectal adenomas and carcinomas. Dr. DuBois had previously served as the president of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), provost and executive vice president of MD Anderson and currently is the Executive Director of the Biodesign Institute at Arizona State University (View Source).

Chairman & CEO of CrystalGenomics, Dr. Joong Myung Cho said, "We are extremely pleased with the outcome of this preclinical study as it provides tremendous potential for polmacoxib to become a widely prescribed drug for not only pain & inflammation associated conditions but also for oncology. It was quite exciting to work with a world renowned cancer center and to have the research led by a premier investigator. Although further clinical studies will be required for the oncology applications should we choose to pursue that path, we believe that polmacoxib is capable of making a significant contribution in the improvement of human health as there still are great unmet medical needs in the both areas of osteoarthritis and colorectal cancer."

On August 12, 2014 CRT reported that it’s research reagents team has been commercialising reagents for the past 30 years (Press release, Cancer Research Technology, AUG 12, 2014, View Source [SID1234523518]). Recently CRT has expanded into commercialising Small Molecules as Tool Compounds. CRT is uniquely placed to commercialise these Small Molecules thanks to our in-house production, handling and storage facilities and can take all responsibility for maintenance and distribution.

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Over the past year, CRT has commercialised a total of 14 Small Molecules generated in collaboration with five universities. These compounds are now widely available to the life sciences research community via four global reagents companies: Abcam, Tocris, BioVision and Kerafast.

The commercialisation of these compounds has led to further academic collaborations, compound sharing and increased visibility of the originating research groups. One of the compounds is currently being reconsidered for clinical trials due to the new data generated by sharing the compound via CRT’s commercialisation model.

We’re looking for published or unpublished small molecules that can be used by other research groups as tool compounds for their own studies:

Compounds impacting cancer as well as non-cancer research
Compounds that exhibit good potency and selectivity
Compounds generated from current or old/de-prioritised projects
Compounds for which you routinely get MTA requests
Compounds do not always need to be towards a novel target or the lead candidate in your discovery programme
The research group should be happy to share details (structure, technical and production data) about the compounds on a non-confidential basis.

If you are interested in finding out more, please contact [email protected]. Further information about CRT’s research reagents business can be found here.

Dendreon has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Dendreon has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing 10-Q , Dendreon, AUG 11, 2014, View Source [SID1234500693]).

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