On January 8, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, and Mirati Therapeutics (NASDAQ:MRTX), a clinical-stage targeted oncology company, reported an exclusive license agreement for the development, manufacturing and commercialization of Mirati’s sitravatinib in Asia (excluding Japan), Australia, and New Zealand (Press release, BeiGene, JAN 8, 2018, View Source;p=RssLanding&cat=news&id=2325285 [SID1234523004]). Mirati will retain exclusive rights for the development, manufacturing and commercialization of sitravatinib for the rest of world.

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Sitravatinib is an investigational tyrosine kinase inhibitor that has demonstrated potent inhibition of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET. It is being evaluated by Mirati as a single agent in a Phase 1b expansion trial in patients whose tumors harbor specific genetic alterations in non-small cell lung cancer (NSCLC) and other tumors types. Sitravatinib has shown encouraging interim results in an ongoing Phase 2 trial in combination with nivolumab in NSCLC patients who have progressed after prior treatment with a checkpoint inhibitor.

"We are delighted to enter into this exclusive clinical development and commercialization agreement for sitravantinib and look forward to working with the experienced team at Mirati. Sitravatinib is an exciting compound that has demonstrated a unique tyrosine kinase inhibition profile and promising clinical activity both as a single agent and in combination with a checkpoint inhibitor in non-small cell lung cancer. This collaboration complements our portfolio and will allow us to investigate sitravatinib in combination with tislelizumab, our investigational anti-PD-1 antibody, in China and the rest of the licensed territory," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"We are excited to begin a partnership with BeiGene, which has built a world-class global development organization with a strong presence in Asia-Pacific, as well as an established commercial organization in China. They have demonstrated an ability to enroll patients quickly in a variety of indications which will augment our development capabilities and expand the evaluation of sitravatinib to additional tumor types for patients who are checkpoint inhibitor naïve or who have been previously treated with a checkpoint inhibitor," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati Therapeutics.

Under the agreement Mirati will receive an upfront cash payment of $10 million from BeiGene. Additionally, Mirati is eligible to receive up to $123 million of additional payments based upon the achievement of certain development, regulatory and sales milestones as well as significant royalties on future sales of sitravatinib in the licensed territory.

About Sitravatinib

Sitravatinib (MGCD-0516) is a spectrum-selective kinase inhibitor which potently inhibits receptor tyrosine kinases (RTKs) including RET, TAM family receptors (TYRO3, Axl, MER), and split family receptors (VEGFR2, KIT). Sitravatinib is being evaluated as a single agent in a Phase 1b expansion trial enrolling patients that harbor RET, CHR4Q12, and CBL genetic alterations in NSCLC and other tumors.

As an immuno-oncology agent, sitravatinib is being tested in combination with anti PD-1 checkpoint inhibitor nivolumab in NSCLC patients who have progressed after prior treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family receptors may help overcome resistance to checkpoint inhibitor therapy through enhancement of dendric cell-dependent antigen presentation, targeted depletion of immunosuppressive T regulatory cells and myeloid-derived suppressor cells, and conversion of tumor associated macrophages to an immune-enhancing Type I composition, in the tumor microenvironment.

About Tislelizumab (BGB-A317)

Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).

On January 8, 2018 Incyte Corporation (NASDAQ:INCY) and Syros Pharmaceuticals, Inc. (NASDAQ:SYRS) reported that the companies have entered into a target discovery, research collaboration and option agreement (Press release, Syros Pharmaceuticals, JAN 8, 2018, View Source [SID1234523027]). Under the agreement, Syros will use its proprietary gene control platform to identify novel therapeutic targets with a focus in myeloproliferative neoplasms (MPNs), and Incyte will receive options to obtain exclusive worldwide rights to intellectual property resulting from the collaboration for up to seven validated targets. Incyte will have exclusive worldwide rights to develop and commercialize any therapies under the collaboration that modulate those validated targets.

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"The discovery and development of novel therapeutic approaches to treat MPNs is an important area of focus at Incyte," said Reid Huber, Ph.D., Chief Scientific Officer of Incyte. "Through this collaboration, we believe that Syros’ gene control platform will allow us to advance our understanding of the underlying biology of MPNs and potentially uncover new molecular targets for drug discovery."

"Our gene control platform has broad applicability across diseases," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "By working with Incyte, a leader in the discovery, development and commercialization of therapies for MPNs, we aim to leverage the promise of our platform to benefit patients with diseases beyond our current areas of focus. Meanwhile, we can continue advancing our own pipeline to achieve our long-term goal of building a fully integrated company with therapies that make a profound difference for patients."

Terms of the Agreement

Under the terms of the agreement, Incyte will pay Syros $10 million upfront – including $2.5 million in cash and $7.5 million in prepaid research and development (R&D) – and purchase a total of $10 million in Syros common stock at $12.61 per share.

Should Incyte exercise all of its options under the agreement, Syros could receive up to $54 million from Incyte in target selection and option exercise fees. For products resulting from the collaboration against each of the up to seven selected and validated targets, Syros could receive up to $50 million in development and regulatory milestones, as well as up to $65 million in commercial milestones. Syros would also be eligible to receive low single-digit royalties on sales of products resulting from the collaboration.

The transaction is effective immediately.

About Incyte Corporation

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at View Source

On January 8, 2018 Pieris Pharmaceuticals, Inc. presented Investor Presentation of dated January 2018 (Press release, Pieris Pharmaceuticals, JAN 8, 2018, View Source [SID1234522946]).

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On January 8, 2018 Aduro Biotech, Inc. presented Investor Presentation (Press release, Aduro Biotech, JAN 8, 2018, View Source [SID1234522993]).

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On January 8, 2018 Exelixis, Inc. (NASDAQ: EXEL) reported that it has entered into an exclusive collaboration and license agreement with StemSynergy Therapeutics, Inc., (StemSynergy) for the discovery and development of novel oncology compounds targeting Casein Kinase 1 alpha (CK1α), a component of the Wnt signaling pathway implicated in key oncogenic processes (Press release, Exelixis, JAN 8, 2018, View Source;p=RssLanding&cat=news&id=2325370 [SID1234523005]). The agreement is part of Exelixis’ ongoing strategy to build an innovative pipeline beyond its two internally-discovered, commercially available compounds, cabozantinib and cobimetinib.

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Under the terms of the agreement, Exelixis will partner with StemSynergy to conduct preclinical and clinical studies with compounds from StemSynergy’s CK1α Activator Program. Exelixis will pay StemSynergy an upfront payment of $3M and up to $3.5M in initial research and development funding. StemSynergy will be eligible for a variety of milestones for the first product to emerge from the collaboration, including preclinical and clinical development and regulatory milestone payments, commercial milestones, as well as single-digit royalties on worldwide sales. Exelixis will be solely responsible for the commercialization of products that arise from the collaboration.

"Supported by revenues from its commercial products and collaborations, Exelixis is on a growth trajectory and now actively focused on augmenting our pipeline both through targeted business development and internal drug discovery activities," said Peter Lamb, Ph.D., Executive Vice President, Discovery Research and Chief Scientific Officer of Exelixis. "CK1α activation is an underexplored and intriguing mechanism for addressing the Wnt/β-catenin axis, a major pathway deregulated in multiple cancers. We look forward to working with StemSynergy to advance this compelling program as we build the next generation of Exelixis medicines."

The CK1α Activator Program is representative of StemSynergy’s focus on treating cancer by targeting developmental processes that are reactivated in cancer cells. The Wnt signaling pathway is a prominent example of this process: the pathway plays an important role in embryonic development, but can support oncogenic processes when deregulated in adult tissues. Activation of β-catenin, a key downstream component of the pathway, is increased in multiple tumors, including a majority of colorectal cancers, where mutations in the APC gene that result in beta-catenin stabilization are prevalent. CK1α Activator Program compounds have been shown to induce degradation of β-catenin and pygopus, another member of the pathway, in preclinical CRC models, and to inhibit the growth of tumors. Importantly, their GI-sparing qualities may help overcome limitations of other approaches targeting the Wnt pathway.

"StemSynergy is developing compounds that can specifically address developmental pathways reactivated in cancer cells to potentially deliver greater benefit to patients," said Anthony J. Capobianco, Ph.D., President and Co-Founder of StemSynergy. "Our CK1α Activator Program has been supported in part by the National Cancer Institute through the SBIR program. With deep drug discovery and development expertise and a proven track record of successfully bringing medicines to market, Exelixis is a natural partner for our CK1α Activator Program as it advances. We look forward to collaborating with the experienced Exelixis team to move the program forward."