On January 07, 2016 Kite Pharma, Inc. (NASDAQ:KITE) reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the NCI for the research and clinical development of a fully human anti-CD19 chimeric antigen receptor (CAR) product candidate for the treatment of B-cell lymphomas and leukemias (Press release, Kite Pharma, JAN 7, 2016, View Source [SID:1234508683]). Under the CRADA, Kite will collaborate with James (Jim) N. Kochenderfer, M.D., an investigator in the Experimental Transplantation and Immunology Branch of the NCI, to evaluate this product candidate in a Phase 1 clinical study this year.

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In addition, the newly established CRADA will focus on the development of next-generation CAR programs directed against other novel antigens for the treatment of B-cell lymphomas and leukemias. Kite will also continue to advance multiple CAR and T cell receptor (TCR) programs under its existing CRADA with the Surgery Branch of the NCI, led by Dr. Rosenberg, a recognized pioneer in immuno-oncology and special advisor to Kite.

"We are delighted to expand our partnership with the NCI by working with the Experimental Transplantation and Immunology Branch. Our close collaboration with the Surgery Branch over the past three years has enabled us to advance the science behind T cell therapy and to expand our clinical product candidate portfolio at Kite. The new CRADA is a natural step in our life cycle management strategy to further improve the success of CAR therapy for patients with advanced B-cell malignancies," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer.

"Dr. Kochenderfer is a world renowned expert in T cell therapy who pioneered innovative CAR T therapies for patients with aggressive non-Hodgkin lymphoma," added David Chang, M.D., Ph.D., Chief Medical Officer and Executive Vice President of Research and Development. "His seminal research in anti-CD19 CAR T cell therapy has been instrumental for our lead product candidate, KTE-C19, which is currently in four Kite-sponsored clinical trials in B-cell malignancies. We look forward to expanding our successful collaboration on next generation technologies with Jim."

On January 7, 2016 OncoResponse, an immuno-oncology antibody discovery company, and the Knight Cancer Institute at Oregon Health & Science University reported a collaboration to identify antibodies against novel targets in elite responders to cancer immunotherapy (Press release, OncoResponse, JAN 7, 2016, View Source [SID1234516435]). The agreement provides OncoResponse with access to OHSU patient samples in two cancer indications, prostate cancer and chronic myeloid leukemia (CML), for immune repertoire screening to identify antibodies with exceptional reactivity from patients who have elite responses to cancer immunotherapies.

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"By interrogating the humoral response of patients who have responded exceptionally well to immunotherapy, we can identify rare cancer-fighting antibodies and novel targets that may lead to the development of improved cancer treatments," said Clifford J. Stocks, CEO of OncoResponse. "This collaboration will allow us access to invaluable patient sample sets that will undoubtedly be instrumental to the understanding of the immune response to cancer."

Using a validated platform technology to rapidly screen antibodies made by the human immune system, OncoResponse scientists will identify those with exceptional reactivity and leverage this knowledge to identify potential targets for novel therapeutic development. Financial terms of the agreement were not disclosed.

"We are deeply committed to the development of improved cancer treatments for patients in need," said Tomasz Beer, M.D., deputy director, OHSU Knight Cancer Institute. "This collaboration will provide valuable data that will allow us to develop a better understanding of what makes certain treatments successful and will inform the development of new therapies that have the potential to significantly impact patients’ lives."

On January 7, 2015 Medivation, Inc. (NASDAQ: MDVN) and NanoString Technologies, Inc., (NASDAQ: NSTG) reported they have entered into a collaboration, together with Astellas Pharma Inc., to pursue the translation of a novel gene expression signature algorithm from Medivation into a companion diagnostic assay using NanoString’s nCounter Dx Analysis System (Press release, Medivation, JAN 7, 2016, View Source [SID:1234508684]). Under the terms of the collaboration agreement, NanoString will be responsible for developing and validating the diagnostic test and, if the parties thereafter determine to proceed, NanoString would also be responsible for seeking regulatory approval for and commercializing the diagnostic test. NanoString is eligible to receive up to $22 million for technology access, near-term milestones and development funding, in addition to other potential undisclosed downstream payments.

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Under the Collaboration Agreement, NanoString will modify its PAM50-based Prosigna Breast Cancer Assay for potential use as a companion diagnostic test for enzalutamide for triple negative breast cancer. The modified test will be based upon data from a Phase 2 trial conducted by Medivation and Astellas that evaluated enzalutamide in patients with triple negative breast cancer.

"We are excited about the partnership with NanoString given their expertise in diagnostic development and that the Prosigna assay has regulatory clearance in the U.S. and European Union," said Amy Peterson, M.D., vice president, clinical development at Medivation. "Triple negative breast cancer has no recognized target and standard therapy is therefore cytotoxic chemotherapy. This diagnostic has the potential to identify patients with triple negative breast cancer appropriate for treatment with enzalutamide. We look forward to generating additional clinical data that validates this potential in a severely underserved patient population."

"We’re excited to work with Medivation and Astellas to translate their discoveries and Phase 2 findings into a potential label expansion for enzalutamide with a companion diagnostic," said Brad Gray, president and chief executive officer of NanoString Technologies. "We’re also pleased to have the opportunity to leverage our PAM50-based Prosigna breast cancer franchise, potentially expanding its role in informing breast cancer treatment decisions and enhancing the description of the intrinsic biology of breast cancer to aid in therapeutic treatment decisions. Furthermore, we believe this collaboration will provide additional validation of our nCounter Dx Analysis System as the platform-of-choice for development of multiplexed companion diagnostic assays."

XTANDI (enzalutamide) capsules is currently approved for the treatment of metastatic castration-resistant prostate cancer; it is not approved for use in women and is contraindicated in women who may become pregnant. Enzalutamide is not approved for women with advanced triple negative breast cancer. See Important Safety Information below.

About the Prosigna Breast Cancer Prognostic Gene Signature Assay
The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma. The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.

In the United States, the Prosigna Assay has 510K clearance and is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand and Hong Kong.

In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as: (1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes. For more information, please visit www.prosigna.com.

On January 7, 2016 C4 Therapeutics reported that it has launched from Dana-Farber Cancer Institute with the closing of a $73 million Series A round of financing (Press release, C4 Therapeutics, JAN 7, 2016, View Source;series-a.html [SID:1234508695]).

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The Company is developing novel treatments in the field of targeted protein degradation using proprietary Degronimid technology. The Degronimid platform technology was pioneered since 2010 by researchers in the Bradner Lab at Dana-Farber Cancer Institute and described in a seminal paper published in the Journal Science in June 2015. Degronimids represent a new class of small molecule targeted protein degradation (TPD) therapeutics that target disease-causing proteins and facilitate their rapid destruction and clearance from the cell. The Company has executed a license agreement with Dana-Farber that provides worldwide exclusivity for all applications of the Degronimid technology.

The groundbreaking Degronimid platform utilizes an innovative, all-chemical solution for potent, targeted and rapid protein degradation. Degronimids are novel chemical adapters that are conjugated with selective small molecules designed to recruit the cell’s ubiquitin/proteasome system (UPS) in order to "naturally" degrade targeted proteins. Degronimids offer a promising solution for the removal of previously undruggable proteins, including those that are known to develop resistance to inhibitors.

"We are building a word-class team of pioneers in the field of targeted protein degradation who are dedicated to our mission of developing a new class of therapeutics that will have a profound effect on many diseases," said Marc Cohen, Co-founder and Executive Chairman of C4 Therapeutics. "The use of Degronimids as a strategy for targeting traditionally undruggable proteins and overcoming resistance is extremely promising. By removing the need for ongoing target inhibition from the therapeutic equation, TPD therapeutics represent a new paradigm in drug development. C4 is a company that will develop many drugs over time in proprietary and partnered development programs."

C4 Therapeutics was co-founded by Ken Anderson, M.D., Kraft Family Professor of Medicine, Harvard Medical School, Director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics at Dana-Farber, and a world-renowned expert in protein degradation and multiple myeloma; Nathanael Gray, Ph.D., Professor of Biological Chemistry and Molecular Pharmacology, Harvard Medical School, Principal Investigator at Dana-Farber and an expert in kinase inhibitors and drug discovery; software and biotech entrepreneur Marc Cohen; and James "Jay" E. Bradner, M.D., former Associate Professor of Medicine, Harvard Medical School and former Investigator at Dana-Farber. With Dr. Bradner’s new role at Novartis Institutes for BioMedical Research, he will no longer have involvement with the Company. C4 will be located at Mass Innovation Labs in Kendall Square, Cambridge. Cobro Ventures led the Series A round, with additional investments from Cormorant Asset Management, The Kraft Group, EG Capital Group, and angel investors. Other investors include Roche and Novartis.

"Drug discovery research around the ubiquitin/proteasome system is an exciting and growing field, and the discovery of Degronimids represents the first all-chemical solution to ligand-mediated protein degradation," said Dr. Nathanael Gray. "The Dana-Farber Cancer Institute has a strong track record of fostering the advancement of groundbreaking discoveries in numerous oncology applications. By licensing these technologies to companies such as C4, we are supporting the further development of highly promising therapeutic candidates for the betterment of human health."
In conjunction with the Series A financing, C4 announced the appointment of Jason Fisherman, M.D., as Chief Executive Officer of the Company and Member of the Board of Directors. Dr. Fisherman has an extensive track record of building companies as a venture investor at Synthesis Capital and Advent International, a global private equity firm, where his team led or managed over 35 investments in biotechnology, medical technology and healthcare information services. Prior to joining Advent International, Dr. Fisherman had over ten years of drug research and clinical development experience in biopharmaceutical companies, academia, and at the National Cancer Institute. Dr. Fisherman received a B.A. in Molecular Biophysics and Biochemistry from Yale, an M.D. from the University of Pennsylvania and an M.B.A. from the Wharton School of the University of Pennsylvania.

"We are pleased to have Dr. Fisherman join our growing team and believe that C4 will greatly benefit from his extensive financial, business and clinical development expertise," said Cohen. "Dr. Fisherman has 30 years of professional experience within the healthcare and life science industry and will help build our leading Degronimid pharmacology platform."

About C4 Therapeutics
C4 Therapeutics is developing a new class of targeted protein degradation (TPD) therapeutics for the treatment of a broad range of diseases. Our Degronimid platform incorporates highly selective small molecule binders to target disease-causing proteins and facilitate their rapid destruction and clearance from the cell through the natural ubiquitin/proteasome system (UPS). Because of this distinctive mechanism, Degronimids are capable of hitting many more targets, including those previously thought to be undruggable, while reducing the potential for drug resistance. The broad applicability of Degronimids, and our chemical biology platform designed for accelerated validation, have the potential to make an unprecedented impact across many diseases through multiple industry collaborations as well as proprietary programs.

On January 7, 2016 Eureka Therapeutics, Inc. reported that Memorial Sloan Kettering Cancer Center and Juno Therapeutics, Inc. (Nasdaq: JUNO) have entered into an exclusive license agreement for a novel, fully-human binding domain targeting MUC16 to be used for the potential development and commercialization of chimeric antigen receptor (CAR) cell therapies for patients with MUC16 positive cancers, including ovarian, fallopian tube, and primary peritoneal cancers (Press release, Eureka Therapeutics, JAN 7, 2016, View Source [SID:SID1234515201]). The binder was developed under a collaboration agreement between Eureka Therapeutics and Memorial Sloan Kettering Cancer Center.

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"We are excited that Juno Therapeutics, a leader in CAR and TCR technologies, will pursue the development of this binding domain as a CAR cell therapy," said Dr. Cheng Liu, President and Chief Executive Officer of Eureka Therapeutics. "CAR cell therapy has shown promising potential for treating hematologic malignancies, and Eureka is working to accelerate the potential of the technology in a broader array of patients by developing antibodies that can recognize solid tumor antigens with the stringency required for CAR immunotherapy."

"We are pleased to enter into this agreement, as we continue to pursue the development of fully-human binding domains, with the goal of optimizing cell persistence and potential patient benefit of our engineered cells," said Mark Frohlich, M.D., Juno’s Executive Vice President, Development and Portfolio Strategy. "We opened a Phase I trial for our MUC16/IL-12 armored CAR product candidate in 2015, and if the safety and efficacy results are promising, this collaboration will allow us to more rapidly transition from the current murine binding domain to a fully-human binding domain."

Under the terms of the exclusive license agreement, Memorial Sloan Kettering granted Juno Therapeutics an exclusive, worldwide license, under both Memorial Sloan Kettering’s and Eureka’s rights to certain MUC16 binding domains, to develop and commercialize the MUC16 binding domains as part of CAR cell therapies for all indications. In return, Memorial Sloan Kettering will receive an upfront payment and potential future payments upon achievement of certain development, regulatory, and sales milestones, and annual net sales royalty payments. Pursuant to the collaboration agreement between Eureka and Memorial Sloan Kettering, Eureka will receive a portion of these payments from Memorial Sloan Kettering. Juno will fund additional development and commercialization activities.