Agios Announces Revised Starting Time of 8:00am ET for Investor Day and First Quarter 2018 Financial Results Webcast on Friday, May 4, 2018

On April 27, 2018 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company will webcast presentations from its Investor Day, including first quarter financial results, on Friday, May 4, 2018 at 8:00 a.m. ET in New York (Press release, Agios Pharmaceuticals, APR 27, 2018, View Source [SID1234525778]).

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Presentations will be given by members of Agios’ leadership team and external speakers including:

David Schenkein, M.D., Chief Executive Officer
Scott Biller, Ph.D., Chief Scientific Officer
Chris Bowden, M.D., Chief Medical Officer
Andrew Hirsch, Chief Financial Officer and Head of Corporate Development
Steve Hoerter, Chief Commercial Officer
Darrin Miles, Vice President, IDH Program Management
Susan Pandya, M.D., Senior Medical Director, Clinical Development
Kevin Marks, Ph.D., Senior Director, Head of Cancer Biology
Maeve Lowery, M.B., B.Ch., B.A.O, Trinity College Dublin
A live webcast of the presentations can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The presentations are scheduled to begin at 8:00 a.m. ET and conclude at 12:00 p.m. ET. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

AACR 2018

On April 27, 2018 Innate Pharma reported that it presented new data at the AACR (Free AACR Whitepaper) Annual Meeting, April 14-18, in Chicago, including preliminary data suggesting promising anti-tumor activity of the combination of monalizumab and cetuximab in patients with platinum pretreated SCCHN (Press release, Innate Pharma, APR 27, 2018, View Source [SID1234525774]).

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ONO Submits an Application for Manufacturing and Marketing Approval for Metyrosine (ONO-5371), a Tyrosine Hydroxylase Inhibitor, for Improvement of Status of Catecholamine Excess Secretion and its Accompanying Symptoms in Patients with Pheochromocytoma in Japan

On April 26, 2018 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; "ONO") reported that it submitted an application for manufacturing and marketing approval of metyrosine (ONO-5371), a tyrosine hydroxylase inhibitor, for the improvement of status of catecholamine excess secretion and its accompanying symptoms in patients with pheochromocytoma in Japan (Press release, Ono, APR 26, 2018, View Source [SID1234584588]).

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This application is based on a multi-center, open-label, non-comparative study and its
accompanying continuous administration study, Phase I/II study (ONO-5371-02), in patients with the symptoms associated with catecholamine excess secretion of pheochromocytoma, conducted in Japan.

Pheochromocytoma (PC) is a neuroendocrine tumor deriving from the adrenal medulla or the extraadrenal gland ganglion with 2,920 patients estimated in Japan. Catecholamine excessively produced from PC causes various symptoms, such as tachycardia, headache, palpitation, sweating, constipation,including hypertension. Sympatholytic drugs, α-blocker and β-blocker, for control of blood pressure and heart rate have been usually used to improve these symptoms. As there aremany cases where surgical removal of tumors is not applicable in patients with locally invasive or metastatic malignant PC, a long-term therapy, such as radiotherapy and chemotherapy is required. The chronic continuation of catecholamine excess secretion may increase a risk of causing cardiovascular-related adverse events such as heart failure or fatal arrhythmia.

Metyrosine is a product for which development companies were recruited in Japan at the "Review Committee on Unapproved or Off-label Drugs with High Medical Needs", established by the Ministry of Health, Labour and Welfare (MHLW). Further, in May 2015, the product was designated for the orphan drug by the MHLW for the indication of "Improvement of status of catecholamine excess secretion and its accompanying symptoms in patients with PC".

ONO obtained exclusive rights to develop and commercialize metyrosine in Japan for the
prevention, treatment and diagnosis of PC (and conditions and symptoms related thereto), in accordance with the license agreement concluded in October 2013 with Valeant Pharmaceuticals North America LLC (Valeant), an affiliate of Valeant Pharmaceuticals International, Inc. In the US, Valeant markets metyrosine under the tradename of "Demser" in the indication of PC.

Methyrosine
Metyrosine inhibits tyrosine hydroxylase related to the production of catecholamine, reduces catecholamine extremely produced from PC, and alleviates symptoms due to catecholamine excess secretion. Therefore, metyrosine is a promising drug with an efficacy in the improvement of the symptoms in patients who are not able to sufficiently control the symptoms with sympatholytic drugs.

10-Q – Quarterly report [Sections 13 or 15(d)]

Seattle Genetics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Moleculin Announces New Data for Immuno-Stimulating Drug to be Presented at International Conference

On April 26, 2018 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that Dr. Waldemar Priebe, Chair of the Company’s Scientific Advisory Board, has been selected to present findings on Moleculin’s STAT3 inhibitor and immuno-stimulating agent, WP1066, at the Global Academic Programs 2018 in Stockholm, Sweden in May of this year (Press release, Moleculin, APR 26, 2018, View Source [SID1234525745]).

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The Global Academic Programs ("GAP") 2018 is being hosted in Stockholm, Sweden from May 15 to 17, 2018. The annual GAP Conference provides a forum for faculty from MD Anderson and its Sister Institutions to develop collaborations and exchange research results and ideas. Sessions are formed around topics of interest to the members of the Sister Institution Network. The GAP 2018 Conference is being sponsored by a prestigious list of major pharmaceutical companies, including Roche, Bayer, Bristol-Meyers Squibb, AstraZeneca, Novartis, Merck and Pfizer.

"We are eager to share our important findings with regard to WP1066 and its effects on pancreatic cancer that include the ability to suppress activation of STAT3 in vitro and in vivo and simultaneously producing strong anticancer effects in this most deadly type of cancer," commented Dr. Waldemar Priebe, Chair of Moleculin’s Scientific Advisory Board. "In addition to pancreatic cancer, WP1066 appears to produce significant anticancer effects in animal models of other difficult to treat tumors, including brain cancers like glioblastoma. Moleculin has already announced an approved IND for brain tumors. We hope our continuation of the in vivo evaluation of WP1066 in different tumor models will provide a strong basis for the initiation of additional clinical trials in the future."