Author: [email protected]

8-K – Current report

On January 6, 2015 Argos Therapeutics reported a collaboration with Saint-Gobain’s Performance Plastics division, a leader in high-performance components and solutions using engineered polymers (Filing 8-K , Argos Therapeutics, JAN 7, 2015, View Source [SID:1234501282]). Under the terms of the agreement, Saint-Gobain will partner with Argos to design, integrate and scale production of a range of disposables for use in the automated manufacturing of Argos’ lead product candidate, AGS-003, currently being tested in a Phase III clinical trial for the treatment of metastatic renal cell carcinoma (mRCC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We believe Saint-Gobain is the ideal partner to provide us with disposables that meet the technical specifications we need in the manufacturing of our personalized immunotherapies," says Jeff Abbey, president and CEO of Argos. "Their commitment to this development program and to Argos is a critical step in our effort to bring together all of the high quality resources and expertise we need to support the potential future commercialization of AGS-003. The utilization of their disposables with our automated production technology positions us to maximize throughput while processing biomaterials from multiple patients simultaneously in the same automated manufacturing suite."

"Argos’ Arcelis technology platform shows clear potential to support development of a range of autologous cell therapies that could change the future of patient care in cancer and infectious diseases. We are excited about the opportunity to partner with the Argos team to develop and supply the essential range of disposables that will be required to advance AGS-003 through late stage development and on to commercialization," says Steve Maddox, General Manager of Saint-Gobain Performance Plastics’ Life Sciences business unit.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."