On January 5, 2018 Amgen (NASDAQ:AMGN) and Kite Pharma (NASDAQ:KITE) reported that the two companies have entered into a strategic research collaboration and license agreement to develop and commercialize the next generation of novel Chimeric Antigen Receptor (CAR) T cell immunotherapies based on Kite’s engineered autologous cell therapy (eACT) platform and Amgen’s extensive array of cancer targets (Press release Amgen, JAN 5, 2015, View Source;p=RssLanding&cat=news&id=2002967 [SID1234501267]). The collaboration brings together Amgen’s commitment to and capabilities in advancing new approaches in immuno-oncology and Kite’s industry-leading presence in CAR T cell therapy.

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Under the terms of the agreement, Amgen will contribute cancer targets, and Kite will leverage its proprietary CAR platform, research and development (R&D) and manufacturing capabilities, and expertise. Kite will be responsible for conducting all preclinical research and cell manufacturing and processing through Investigational New Drug (IND) filing. Each company will then be responsible for clinical development and commercialization of their respective CAR therapeutic candidates, including all related expenses. Kite will receive from Amgen an upfront payment of $60 million, as well as funding for R&D costs through IND filing. Kite will be eligible to receive up to $525 million in milestone payments per Amgen program based on the successful completion of regulatory and commercialization milestones, plus tiered high single- to double-digit royalties for sales and the license of Kite’s intellectual property for CAR T cell products. Amgen is eligible to receive up to $525 million in milestone payments per Kite program, plus tiered single-digit sales royalties. Further terms of the agreement are not being disclosed.

"The intersection of immunology and oncology represents one of the most promising approaches to delivering significant impact for patients with cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "With our existing immuno-oncology portfolio of cutting-edge technologies and expertise, we believe joining forces with Kite Pharma will leverage our targets and their leading CAR T cell platform to advance another new promising therapeutic approach to fight cancer."

"Amgen is an ideal partner for us, based on their strong presence in oncology and the company’s broad array of cancer targets optimally suited for combining with our CAR technologies. We are proud to announce this unique collaboration and its validation of our R&D expertise, intellectual property position, and therapeutic manufacturing and processing capabilities," stated Arie Belldegrun, M.D., FACS, Kite Pharma’s president and chief executive officer. "We believe that the therapeutic candidates resulting from the collaboration will have the potential to dramatically transform CAR approaches and to become some of the most powerful therapies for the treatment of cancer."

Conference Call / Webcast Information
Kite Pharma will host a live conference call and webcast today at 4 p.m. ET to discuss the transaction. To access the live webcast or replay, please visit Kite Pharma’s Investor Relations website at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

Alternatively, the dial-in number to access the conference call is (844) 856-8656, or from international locations dial (443) 877-4062. The conference ID number for the live call is 59012654. Telephone replay will be available approximately three hours following the call. To access the replay, please dial (855) 859-2056 (U.S.) or (404) 537-3406 (international). The conference ID number for the replay is 59012654. The telephone replay will remain available until 11:59 p.m. ET, Jan. 12, 2015.

About CAR T Immunotherapies
Kite Pharma’s broadly enabling eACT technology platform allows a patient’s T cells to be genetically modified to express cancer-targeting receptors. Engineered CAR T cells contain a single chain antibody domain, which recognizes and binds to a cell surface tumor antigen, as well as intracellular T cell-activating domains. CAR T cells are designed to traffic directly to tumor sites and become activated upon engagement with the target tumor antigen, selectively eradicating the tumor cells.

On January 15, 2015 Cyclenium Pharma Inc., an emerging pharmaceutical company specializing in the discovery and development of novel drug candidates based on proprietary macrocyclic chemistry and the Institute for Research in Immunology and Cancer — Commercialization of Research (IRICoR) along with Université de Montréal and its Institute for Research in Immunology and Cancer (IRIC) announced today the signing of a collaborative research agreement (Press release, Universite de Montreal, JAN 5/, 2015, View Source [SID1234517247]). The collaboration intends to utilize Cyclenium’s proprietary QUEST Library of next generation macrocyclic molecules and associated hit-to-lead optimization expertise in concert with IRIC’s state-of the-art capabilities in biological target identification, characterization and screening, as well as medicinal chemistry. The objective of the collaboration is to discover and develop new drug candidates in cutting-edge target areas for the treatment of cancer and immunological disorders.

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"We are delighted to have forged this collaboration with IRICoR and the team of leading investigators at IRIC in two of our therapeutic focus areas," stated Helmut Thomas, Ph.D., President & Chief Executive Officerof Cyclenium. "Combining IRIC’s exquisite research expertise in the understanding of novel pharmacological targets with our CMRT drug discovery technology and our joint experience in the medicinal application of macrocyclic compounds and proven development success in the macrocycle arena offers superb potential for success in the search for new pharmaceuticals in oncology and immunology indications."

"We are extremely pleased to be working with Cyclenium," said Michel Bouvier, Chief Executive Officer of both IRIC and IRICoR. "We clearly see multiple areas of synergy between IRIC’s drug discovery, screening, and medicinal chemistry expertise with Cyclenium’s leadership position in macrocycle-based drug development."

On December 30, 2014 Tikcro Technologies Ltd. (OTC PK: TIKRF) reported that it has entered into a research and license agreement with Yeda Research and Development Company Ltd., the technology transfer arm of the Weizmann Institute of Science in Israel (Press release Tikcro, DEC 30, 2014, View Source [SID:1234501263]). This agreement is for the development of new antibodies originating from specified research at the Weizmann Institute of Science addressing identified targets of cancer immune checkpoints.

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Under the agreement, Tikcro will provide funding for further research at the Weizmann Institute of Science to develop certain antibodies selected and verified in pre-clinical trials. The antibodies may have high selectivity and binding qualities towards cancer immune checkpoints. Further research and development will be required to promote such antibodies as therapeutic candidates for immune modulation in oncology.

Tikcro, alone or through sub-licensees, will have the right to obtain the research results and to pursue development through commercialization. The license consideration due from Tikcro to Yeda includes royalties from net sales, sub-license fees and fixed fees linked to clinical and commercial sales milestones.

On December 29, 2014 Ignyta reported that the U.S. Food and Drug Administration (FDA) has granted both orphan drug designation and rare pediatric disease designation for Ignyta’s lead product candidate entrectinib for the treatment of neuroblastoma (Press release Ignyta, DEC 29, 2014, View Source [SID:1234501251]).

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"We are pleased that the FDA has provided us these designations, which highlight the potential for entrectinib to address unmet needs of patients with rare cancers," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "Although Ignyta is intrinsically motivated to continue to aggressively pursue our clinical development program for entrectinib in solid tumors for the benefit of adult and pediatric cancer patients everywhere, we are pleased that the incentives provided by these designations – including the potential for seven years of marketing exclusivity and the potential to obtain a valuable Pediatric Disease Priority Review Voucher from the FDA – can potentially provide additional avenues for creating value for our stockholders."

On December 26, 2014 Chugai Pharmaceutical reported that it obtained approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) on December 26, 2014, for "unresectable melanoma with BRAF mutation," for an anti-cancer agent, BRAF inhibitor, vemurafenib tablets (brand name: Zelboraf Tablet 240mg (hereafter, "Zelboraf") (Press release Chugai, DEC 25, 2014, View Source [SID:1234501253]).
Also, Roche Diagnostics K.K. [Main Office: Minato-ku, Tokyo. President & CEO: Makoto Ogasawara (hereafter, "Roche Diagnostics")] obtained approval from the MHLW for in vitro diagnostics to detect the BRAF mutation, "cobas 4800 BRAF V600 Mutation Test," as a companion diagnostics for Zelboraf on December 2, 2014.

It is necessary to detect BRAF mutation with cobas 4800 BRAF V600 Mutation Test before use of Zelboraf for patients with unresectable melanoma with BRAF mutation. As just described, medical approach to select an appropriate therapy for each patient before administration of a drug is called personalized healthcare. It enables to avoid a treatment unlikely to show efficacy. Furthermore, since a treatment unlikely to be effective is not given, personalized healthcare increase the benefit in terms of medical economics.

It is reported that each year 1,300 to 1,400 patients (Globocan 2012) in Japan are newly diagnosed as malignant melanoma (all stages), and the number has been growing. Of these patients, 26.7 to 41.8% have the BRAF gene mutation).

Chugai and Roche Diagnostics, members of the Roche Group and pioneers in personalized healthcare, are sure that Zelboraf and cobas 4800 BRAF V600 Mutation Test can contribute to the treatment of "unresectable melanoma with BRAF mutation," a disease with poor prognosis and with high unmet medical needs. We will continue to dedicate ourselves to providing treatment options to suit individual patients.

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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

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