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Stemline Therapeutics In-Licenses Novel Oral Small Molecule Nuclear Transport Inhibitor Targeting XPO1

On January 7, 2015 Stemline Therapeutics reported that it has exclusively licensed from CanBas the rights to develop and commercialize a novel, oral small molecule reversible inhibitor of Exportin-1 (XPO1), a nuclear transport target also known as Chromosome Region Maintenance-1 (CRM1) (Press release Stemline Therapeutics, JAN 7, 2015, View Source [SID:1234501295]). Stemline has acquired worldwide rights with the exception of Japan, Korea, Taiwan and China. Stemline will now refer to the compound as SL-801.

Recent work has demonstrated that XPO1 is a clinically relevant target, and nuclear export inhibitors have emerged as a new approach in cancer treatment with activity in patients across multiple indications. Given that SL-801 is a novel reversible inhibitor of XPO1, we believe it has the potential to offer a broad therapeutic window with dosing and scheduling flexibility. SL-801 has demonstrated preclinical anti-cancer activity, including efficacy and safety in animal models, across a wide array of solid and hematologic cancers. Stemline expects to file an Investigational New Drug (IND) application in 2015.

Eric Rowinsky, M.D., Stemline’s Chief Medical Officer and Head of Research and Development commented, “CanBas’ foundational work created a novel potent inhibitor of XPO1 with a number of unique attributes, including reversibility of XPO1 inhibition, which we believe may enhance clinical efficacy and safety.” Dr. Rowinsky concluded, “As we continue to progress SL-401 and SL-701 through multiple clinical trials, we also plan to advance SL-801 into the clinic in several strategic indications.”

Terminations of Otsuka’s Contract With OncoTherapy Science, Inc. on a Candidate Therapeutic Vaccine for Pancreatic Cancer and Otsuka’s Sublicensing Contract With Fuso Pharmaceutical Industries for the Marketing of a Candidate Therapeutic Vaccine, OTS102

On January 8, 2015 Otsuka Pharmaceutical reported that the exclusive licensing contract that has been in effect with OncoTherapy Science, Inc. (OTS) for the development, manufacture, and marketing of a peptide therapeutic vaccine for the treatment of pancreatic cancer, will be allowed to expire, following 180-day prior notification, at the scheduled end date of the contract period (Press release Otsuka, JAN 8, 2015, View Source [SID:1234501293]). A sublicensing contract which has been in effect with Fuso Pharmaceutical Industries, Ltd. for the manufacture and marketing in Japan of OTS102, a therapeutic vaccine, will also be allowed to expire on the same date.

Otsuka will continue its efforts in oncology as a priority area. This will include the development of the peptide therapeutic vaccine OCV-C02, for which a phase 1 clinical study is currently underway in colon cancer based on a contract with OTS.

Kyowa Hakko Kirin and Syndax Announce an Exclusive License Agreement to Develop and Commercialize Entinostat in Japan and Korea

On January 7, 2015 Kyowa Hakko Kirin and Syndax Phamaceuticals reported that the companies have entered into a license agreement for the exclusive rights to develop and commercialize entinostat in Japan and Korea (Press release Kyowa Hakko Kirin, JAN 7, 2015, View Source [SID:1234501290]). Entinostat is a Class I selective histone deacetylase (HDAC) inhibitor being developed by Syndax in the United States and Europe in combination with hormone therapy for advanced breast cancer and immune therapy combinations in solid tumors.

Under the terms of the agreement, Kyowa Hakko Kirin will pay Syndax a total of up to $100 million including an upfront fee of $25 million with a certain amount of an equity investment and potential development and commercial milestone payments. Syndax will manufacture and supply the product to Kyowa Hakko Kirin during the term of the agreement.

“We are pleased to enter into a partnership with Syndax to develop Entinostat in Japan and Korea. Entinostat has great potential to treat a cancer with a mode of action modifying epigenetics.” stated Masashi Miyamoto, Ph.D., Executive Officer, Director, Strategic Product Portfolio Department of Kyowa Hakko Kirin. “We believe that Entinostat could deliver a lot of benefit to breast and other cancer patients, which lead to strengthen KHK’s future oncology portfolio.”

Arlene Morris, president and chief executive officer of Syndax, said, “Since we have already begun a registration-directed Phase 3 trial in breast cancer in the U.S., it’s important and timely to enter into this agreement with KHK to initiate development in order to bring entinostat to breast cancer patients in Japan and Korea. The expansion of the global development effort further validates the importance of prolonging survival in metastatic breast cancer as observed in our Phase 2 trial and underscored by the FDA designating entinostat a Breakthrough Therapy when combined with exemestane in postmenopausal women with HR+ metastatic breast cancer. Syndax is very pleased to be able to collaborate with KHK, a company with a strong track record of developing important therapeutic products.”

Kyowa Hakko Kirin is planning to initiate clinical trials in 2015.

Gilead Sciences Announces Acquisition of Phenex Pharmaceuticals’ Development Program for Non-Alcoholic Steatohepatitis (NASH) and Other Liver Diseases

On January 06, 2015 Gilead Sciences, Inc. (Nasdaq:GILD) and Phenex Pharmaceuticals AG, a privately-held biotechnology company, reported the signing of a definitive agreement under which Gilead will acquire Phenex’s Farnesoid X Receptor (FXR) program comprising small molecule FXR agonists for the treatment of liver diseases including nonalcoholic steatohepatitis (NASH) (Press release, Gilead Sciences, JAN 6, 2015, View Source [SID1234639733]). Under the terms of the agreement, Gilead will pay Phenex an upfront payment plus additional payments based upon achievement of certain development milestones that may potentially be worth up to $470 million.

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NASH is a common, serious chronic liver disease characterized by inflammation and excessive fat accumulation in the liver and may lead to progressive fibrosis, cirrhosis and liver failure. NASH is estimated to affect 10 to 20 percent of people in the developed world. There are currently no approved therapies to treat NASH. FXR is a nuclear hormone receptor that regulates bile acid, lipid and glucose homeostasis, which can help reduce liver steatosis and inflammation, and may help prevent liver fibrosis.

"This agreement represents a significant milestone for our company and for the field of liver disease research," said Dr. Claus Kremoser, CEO of Phenex Pharmaceuticals AG. "After 15 years of research, FXR is now one of the few clinically validated targets for NASH and we are delighted that Gilead will be continuing the research necessary to more fully realize its potential for advanced liver disease."

"The acquisition of Phenex’s FXR program represents an important opportunity to accelerate Gilead’s efforts to develop new treatment options that address fibrotic liver diseases," said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. "We look forward to working closely with Phenex’s research and development team to advance the FXR program into clinical development as quickly as possible to explore its potential in areas of significant unmet need."

Cardio3 BioSciences enters immuno-oncology space with acquisition of oncyte car T-CELL portfolio from celdara medical

On January 6, 2015 Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of cell therapies, reported the acquisition of OnCyte, the oncology division of privately-held U.S. biotechnology company Celdara Medical, and its portfolio of immuno-oncology product candidates (Press release, Celyad, JAN 6, 2015, View Source [SID1234516407]). The acquisition marks Cardio3 Biosciences’ entry into the rapidly growing and very promising field of immuno-oncology, positioning the Company at the forefront of the CAR T-Cell space and represents a significant step towards the Company’s strategic objective of developing into a world leader in cell therapy.

Cardio3 BioSciences acquires OnCyte for an upfront payment of USD 10 million, of which USD 4 million will be paid in C3BS shares. For the successful development of the most advanced product CM-CS1, Celdara could receive up to USD 50 million in development and regulatory milestones until market approval. Celdara will be eligible to additional payments on the other products upon achievement of development and regulatory milestones totalling up to USD 21 million per product. In addition, Celdara will receive up to USD 80 million in sales milestones when net sales will exceed USD 1 billion and royalties ranging from 5 to 8%.

The Chimeric Antigen Receptor (CAR) technology developed by OnCyte uses human Natural Killer cell (NK cell) receptors which, unlike traditional CAR technologies, have the potential to target a broad range of liquid and solid cancers via a human natural receptor that targets ligands present on most tumor types. The research underlying this technology was originally conducted by Dartmouth College Professor Charles Sentman, and has been published in numerous peer-reviewed publications such as Journal of Immunology, Cancer Research and Blood.

OnCyte’s most advanced autologous CAR T-Cell drug candidate, CM-CS1, uses a specific human Natural Killer cell receptor, NKG2D, that targets tumor antigens expressed in most liquid and solid cancers. CM-CS1 has an active Investigational New Drug (IND) clearance with the U.S. Food and Drug Administration (FDA) for a Phase I clinical trial in hematologic malignancies and the Company plans to begin enrolling patients in Q1 2015. The CM-CS1 Phase I study is expected to be completed in the second quarter of 2016. The Company expects to report interim data from this trial throughout the enrolment period. In addition to CM-CS1, OnCyte has two CAR T-Cell programs targeting other cancer cell ligands in pre-clinical development, as well as an allogeneic T-Cell platform, which enables almost any CAR T-Cell therapy to be made into an "off-the-shelf" product.

Dr. Christian Homsy, CEO of Cardio3 BioSciences, commented: "We are thrilled to add the OnCyte clinical development program and CAR T-Cell platform to our portfolio of world-class assets. Building on the strong foundation of our lead cardiac product, C-Cure, this acquisition positions us in a second therapeutic area characterized by significant unmet medical need, while allowing us to leverage our leading cell therapy capabilities to drive the development of this potentially gamechanging immuno-oncology technology. We look forward to initiating the Phase I trial of CM-CS1 and advancing the other OnCyte assets to create value for patients, the medical community and other key Cardio3 BioSciences stakeholders."

Dr. Jake Reder, Co-founder and Chief Executive Officer of Celdara Medical, added: "We are extremely proud of everything that the OnCyte team has accomplished to date. The product candidates they have developed could have a tremendous impact on the field of immuno-oncology, and we believe that Cardio3 BioSciences is the optimal partner to lead the further advancement of this groundbreaking technology. Cardio3 BioSciences possesses the right scientific, manufacturing, and clinical expertise to continue developing these therapies and to realize their full potential."

Recognized by experts as one of the most exciting fields in the treatment of cancer, immunooncology, and more specifically CAR T-Cell therapies, represents an innovative approach to treat cancers by leveraging the body’s own immune system.

Dr. Christian Homsy, CEO of Cardio3 BioSciences, further added: "Like our cardiopoietic platform for C-Cure, the OnCyte CAR T-Cell portfolio and development platform represent potential breakthroughs in cancer therapy that could offer transformational treatment options for patients. We believe that this new technology will become a strong asset of Cardio3 BioSciences’ product portfolio as we develop it further."

Cardio3 BioSciences intends to progress the various candidate products acquired from current preclinical stage to human clinical trials over the next months and years. Further information on CAR T-Cell therapies and OnCyte’s technology platform is available at www.c3bs.com/immuno-oncology