On January 8, 2018 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug Application (IND) for voruciclib, an orally available Cyclin Dependent Kinase 9 (CDK9) inhibitor, for patients with relapsed/refractory B-cell malignancies (Press release, MEI Pharma, JAN 8, 2018, View Source [SID1234523013]). Under this IND, MEI Pharma plans to initiate a Phase 1 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of voruciclib in patients with B-cell malignancies.

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"Inhibiting the function of certain CDK family members has shown significant clinical activity in breast cancer. Voruciclib inhibits CDK9 which controls expression of MCL-1, a known mechanism of resistance to apoptosis. Therefore, voruciclib alone or in combination with a BCL-2 inhibitor such as venetoclax offers a potential novel approach for treatment of B-cell malignancies," said Daniel P. Gold, Ph.D., President and Chief Executive Officer of MEI Pharma. "With the FDA clearance of our IND, we look forward to advancing voruciclib through the clinic in the second quarter of 2018 to demonstrate its clinical and commercial value."

About Voruciclib

Voruciclib (formerly P1446A; ME-522) has been tested in more than 70 patients in multiple solid tumor Phase 1 studies and has been associated with side effects consistent with other drugs in its class, including nausea, vomiting and diarrhea. In pre-clinical studies, voruciclib alone induces cell death in multiple patient-derived chronic lymphocytic leukemia (CLL) samples1. In additional pre-clinical studies, voruciclib shows dose-dependent suppression of MCL-1 at concentrations achievable with doses that appeared to be generally well tolerated in the Phase 1 studies2. Studies have shown that MCL-1 is an established resistance mechanism to the B-cell lymphoma 2 (BCL-2) inhibitor venetoclax (marketed as Venclexta)3.

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.

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On January 8, 2018 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported a $230 million non-dilutive royalty transaction with HealthCare Royalty Partners (HCR) (Press release, Agenus, JAN 8, 2018, View Source [SID1234523003]). The transaction is comprised of $190 million of cash proceeds at closing plus up to $40 million in milestone payments. Agenus will use part of these proceeds to redeem its royalty bond from Oberland and the additional monies to advance its registrational studies with anti-CTLA-4 and anti-PD-1 for planned BLA filings in 2019 and 2020.

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At closing, HCR will receive the rights to royalties on sales of GlaxoSmithKline’s QS-21 containing vaccines. Agenus retains all rights for the development of QS-21 with its entire portfolio of checkpoint antibodies, vaccines, and cellular therapies* with no third party obligation.

Agenus is advancing its QS-21 powered vaccine, AutoSynVax, in combination with validated checkpoint antibodies to generate immune recognition of tumors unresponsive to checkpoint blockade alone.

"This transaction reflects the significant value that can be generated from our assets and our ability to execute non-dilutive transactions to strengthen our balance sheet," said Dr. Garo Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "Part of the proceeds will fund our pivotal programs designed to achieve our near-term goals to become a commercial company with a planned BLA filing by the second half of 2019."

John Urquhart, Principal at HCR commented, "HealthCare Royalty Partners is pleased to partner with Agenus in this royalty financing transaction that recognizes the significant value of the immune-potent QS-21 adjuvant."

After the repurchase of the Oberland obligation, the transaction is expected to yield net proceeds of approximately $28 million to Agenus at closing, plus the potential for up to an additional $40 million of milestone payments. In the event that certain sales milestones are not met, Agenus will owe HCR approximately $26 million in 2021.

Bank of America Merrill Lynch acted as sole structuring advisor to Agenus for the transaction. Goodwin Procter LLP acted as special counsel to Agenus and Cadwalader, Wichersham & Taft LLP represented HCR.

On January 8, 2018 Aclaris Therapeutics presented Corporate Overview Presentation (Presentation, Aclaris Therapeutics, JAN 8, 2018, View Source [SID1234523002]).

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On January 8, 2018 Momenta Pharmaceuticals, Inc. presented at the 36th Annual J.P. Morgan Healthcare Conference (Presentation, Momenta Pharmaceuticals, JAN 8, 2018, View Source [SID1234523014]).

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