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Cyclenium Pharma and IRICoR Announce Collaborative Research Agreement

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."

Amgen and Kite Pharma Announce Strategic Cancer Immunotherapy Collaboration to Advance the Application of Novel Chimeric Antigen Receptor (CAR) T Cell Therapies

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.

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.

8-K – Current report

On December 31, 2014, Kite Pharma entered into a Research Collaboration and License Agreement (the “Agreement”) with Amgen pursuant to which Kite and Amgen expect to develop and commercialize chimeric antigen receptor (“CAR”) T cell immunotherapies based on Kite’s engineered autologous cell therapy (eACT) platform and a number of Amgen cancer targets (Filing 8-K , Kite Pharma, JAN 5, 2015, View Source [SID:1234501272]).

Under the terms of the Agreement, Kite and Amgen will jointly create preclinical development plans through investigational new drug application (“IND”) filing with the U.S. Food and Drug Administration for the research and development of CAR-based product candidates that target certain antigens (each, a “target”) expressed on the cell surface of various cancers. Kite and Amgen expect to progress multiple Amgen programs (“Amgen Programs”), each consisting of the development of one or more CAR-based product candidates directed against a certain Amgen selected target. Kite and Amgen also expect to progress multiple Kite programs (“Kite Programs”), each consisting of the development of one or more CAR-based product candidates directed against a certain Kite selected target. Under certain circumstances, the collaboration may be expanded to include the research and development of other product candidates.

Amgen will fund the research and development costs for all programs with certain limitations through any IND filing. Kite will reimburse Amgen for the research and development costs for any Kite Program that progresses to an 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 be responsible for the manufacturing and processing of Amgen Program product candidates for a certain period following the completion of Phase 2 clinical trials.

Amgen will pay Kite $60.0 million as an upfront payment pursuant to the Agreement. Kite will be eligible to receive up to $525.0 million in milestone payments for each 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 will be eligible to receive up to $525.0 million in regulatory and commercial milestone payments per Kite Program plus tiered single digit sales royalties.

The term of this Agreement will continue on a target-by-target basis until the later of (i) the date on which the product candidates directed against the target are no longer covered by certain intellectual property rights, (ii) the loss of certain regulatory exclusivity and (iii) a defined term from the first commercial sale of the first product candidate directed against the target. Either Kite or Amgen may terminate the Agreement on a target-by-target basis for their respective programs with prior written notice. Either party may also terminate the agreement with written notice upon material breach by the other party, if such breach has not been cured within a defined period of receiving such notice.

The Agreement is subject to customary anti-trust clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

The foregoing description of the Agreement is only a summary and is qualified in its entirety by reference to the Agreement. Kite intends to file a copy of the Agreement as an exhibit to its Annual Report on Form 10-K for its fiscal year ending December 31, 2014, portions of which will be subject to a FOIA Confidential Treatment Request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, for certain portions of the Agreement. The omitted material will be included in the request for confidential treatment.

Tikcro Signs Research and License Agreement Regarding Cancer Immune Checkpoint Antibodies

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.

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.

8-K – Current report

On December 30, 2014 OncoGenex Pharmaceuticals reported that it has executed an initial agreement with Teva Pharmaceutical Industries to regain rights to custirsen, an investigational compound currently being evaluated in Phase 3 clinical development as a treatment for prostate and lung cancers (Filing 8-K , OncoGenex Pharmaceuticals, DEC 30, 2014, View Source [SID:1234501256]). This transfer of rights would occur in connection with the termination of the collaboration agreement between OncoGenex and Teva executed in 2009.

The initial agreement reached by OncoGenex and Teva provides that, following execution of the final agreement to terminate the collaboration between the parties, OncoGenex will receive a $27 million payment from Teva, subject to certain adjustments. In addition, OncoGenex will take over responsibility for all custirsen related expenses, including those related to the ENSPIRIT trial, as well as manufacturing and regulatory activities for custirsen programs, which are currently being managed by Teva. OncoGenex expects that the $27 million payment from Teva will allow for the completion and final results from the AFFINITY trial, as well as continuation of the ENSPIRIT trial through the second interim futility analysis expected in the first half of 2015.

“Teva’s strategic focus has shifted away from oncology research and development. However, OncoGenex remains committed to the continued investigation of custirsen, particularly in patients who have advancing disease despite previous treatments,” said Scott Cormack, President and CEO of OncoGenex. “This agreement provides OncoGenex with greater control of custirsen’s development, including the modification of the ENSPIRIT statistical analysis plan to involve a more rigorous second interim futility analysis to be completed in the second quarter of 2015 that, if passed, would enable the trial to continue with a smaller enrollment requirement, increased confidence in success and shorter time to regulatory submission.”

The Company expects that the $27 million payment from Teva and the Company’s current resources should enable the completion of the AFFINITY trial through data readout in late 2015/early 2016, allow for the continuation of the ENSPIRIT trial through the second interim futility analysis that is expected in the first half of 2015 and the achievement of key apatorsen clinical milestones, such as the completion of patient enrollment in the Borealis-2 trial and final data from the Spruce and Rainier clinical trials.

The Company anticipates a final agreement will be executed in January 2015. Additional terms of the initial agreement with Teva can be found in the Company’s Form 8-K filed today and available at View Source