On July 10, 2018 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported that it will host a key opinion leader (KOL) breakfast symposium focused on the unmet need, treatment landscape and opportunity for new combination approaches in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) from 8:30-10:30 a.m. ET on Tuesday, July 17, 2018 in New York City (Press release, Syros Pharmaceuticals, JUL 10, 2018, View Source [SID1234527702]). Syros is currently evaluating SY-1425, its first-in-class, selective retinoic acid receptor alpha (RARα) agonist, in a Phase 2 clinical trial in combination with standard-of-care and targeted therapies in genomically defined subsets of AML and MDS patients.

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The event will feature presentations from Rachel J. Cook, M.D., M.S., Assistant Professor of Medicine and Site Director for Acute Leukemia at the Knight Cancer Institute, Oregon Health and Science University and Eytan M. Stein, M.D., Assistant Professor of Medicine; Leukemia Service, Department of Medicine at Memorial Sloan Kettering Cancer Center. Additionally, members of Syros’ management will provide an overview of SY-1425 and review preclinical and clinical data supporting its combination strategy with SY-1425.

A live webcast of the event will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following each presentation.

On July 10, 2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO) (TSX:APS), reported that the Japan Patent Office has issued Japanese Patent No. 6325573 for CG-806 (Press release, Aptose Biosciences, JUL 10, 2018, View Source;p=RssLanding&cat=news&id=2357553 [SID1234527629]). The granted patent claims various compounds, including the CG-806 compound, pharmaceutical compositions comprising the CG-806 compound, and uses for the treatment of various diseases, such as cancer. The patent is expected to provide protection until the end of 2033.

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"This newly issued patent extends the CG-806 patent protection into an important market and is a welcome addition to the US patent that was issued last year," stated Dr. William G. Rice, Chairman, President and Chief Executive Officer of Aptose. "As noted previously, we plan to continue expansion of the patent portfolio through additional findings and applications."

About CG-806

CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors.

On July 10, 2018 CSPC Pharmaceutical Group Limited (the "Company") is reported that the Company has entered into a product co-development and strategic collaboration agreement (the "Agreement") with Shanghai Junshi Biosciences Co., Ltd. ("Junshi") in relation to the clinical development, registration and commercialization of PD-1 (the anti-PD-1 monoclonal antibody exclusively supplied by Junshi) in combination with albumin-bound paclitaxel for the treatment of breast cancer (the "Product") (Press release, CSPC Pharmaceutical, JUL 10, 2018, View Source [SID1234532266]).

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Pursuant to the Agreement, the Company and Junshi shall form a joint research committee to (1) formulate clinical strategy for the development of the Product; (2) establish and monitor the clinical trials timeline and progress; (3) ensure the full access of clinical data by both parties; (4) discuss and make decision on combination studies of PD-1 with albumin-bound paclitaxel and other chemotherapeutic agents; and (5) resolve any issues that arise during the process of the development and registration of the Product.

The Company shall be responsible for (1) designing and executing clinical trials for the Product; (2) supplying albumin-bound paclitaxel to conduct clinical trials of the Product in the People’s Republic of China (including Hong Kong, Taiwan and Macau) (the "Territory"); (3) applying and securing approval of the Product in the Territory; and (4) commercialization of the Product in the Territory.

Junshi shall be responsible for (1) securing approval of PD-1 single entity in the Territory; (2) supplying PD-1 for the Company to conduct clinical trials for the Product in the Territory; (3) supplying PD-1 to the Company for sales of the Product in the Territory according to a supply agreement to be mutually agreed between the parties.

Junshi grants to the Company a royalty-bearing exclusive license to commercialize the Product in the Territory for a term commencing from the date of the Agreement until 20 years from the receipt of the relevant regulatory approval in the Territory (the "Term"), which allows the Company during the Term to (1) perform clinical and non-clinical studies of the Product; (2) apply for and obtain approvals of the Products in the Territory; and (3) market and sell the Product in the Territory.

Junshi and its affiliates shall not grant any right or license of its PD-1 to any third party for the purpose of development and commercialization of the Product in the Territory. The Company and its affiliates shall only collaborate with Junshi to develop and commercialize the Product.

The Company agrees to pay to Junshi a milestone payment of RMB30,000,000 at each of the five milestone events (i.e. up to an aggregate of RMB150,000,000) leading to the product approval and issuance of product licence by the China Drug Administration for the Product.

All intellectual property rights related to the Product, to the extent solely discovered, invented or developed under the Agreement, shall be jointly owned by the Company and Junshi.

On July 10, 2018 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying mechanistic modeling, simulation, and analysis to de-risk and accelerate drug research and development, reported a collaboration with Revitope for an in-vitro and human mechanistic PK/PD modeling of Revitope’s bispecific T Cell Engaging Antibody Circuits (TEAC) targeting solid tumors (Press release, Applied BioMath, JUL 10, 2018, View Source [SID1234633659]). "TEAC are designed to increase tumor specificity and launch an immune activation only when bound to the cancer cell surface. This innovative engineering approach has the potential to unleash potent immune responses that are focused entirely on the tumor," said Werner Meier, CSO and acting CEO of Revitope Oncology. "Our goal in this collaboration is to leverage Applied BioMath’s modeling and analyses capabilities to identify TEAC drug properties that drive the potential for a better therapeutic index and ideally more efficacy in immuno-oncology."

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Applied BioMath employs a rigorous fit-for-purpose model development process, referred to as Model-Aided Drug Invention (MADI), which aims to quantitatively integrate knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their MADI approach employs proprietary algorithms and software that were designed specifically for mechanistic PK/PD modeling. "Our mechanistic modeling approach allows our collaborators to assess the feasibility of their therapeutic much more quickly than if they were to rely on experiments alone," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "They’ll be able to quickly answer strategic questions about the ideal properties for their therapeutic concept and help accelerate development in Lead Generation and by prioritizing experiments, thus helping them get into the clinical faster and for less money with potentially a BIC therapeutic, giving themselves a much higher chance of clinical success and maximizing R&D ROI."

On July 9, 2018 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) in the U.S., for BENDEKA (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride (Press release, Eagle Pharmaceuticals, JUL 9, 2018, View Source [SID1234527608]).

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As a result, and consistent with the order issued by the U.S. District Court for the District of Columbia (the Court) on June 8, 2018, the FDA will not approve any drug applications referencing BENDEKA until the ODE expires in December 2022. Additionally, on July 7, 2018, the FDA filed a motion with the Court asking it to clarify that the order was not intended to affect applications referencing TREANDA. Eagle continues to believe that an appropriate application of ODE would first allow generic TREANDA entrants in December 2022, rather than November 2019, and expects to vigorously defend the scope of its exclusivity grant.