Triumvira Immunologics to Present at the 25th BioCentury Future Leaders Conference

On March 22, 2018-Triumvira Immunologics, a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, reported that it will present at the 25th BioCentury Future Leaders conference at the Millennium Broadway Hotel & Conference Center in New York City (Press release, , 22 22, 2018, View Source [SID1234524954]). Chief Executive Officer and President, Paul Lammers, M.D., M.Sc. will be presenting on March 23 from 8:45-9:00am ET in Presentation Room 508.

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President & CEO of Triumvira Immunologics, Paul Lammers will be presenting at BioCentury’s Future Leaders conference in New York on March 23

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Dr. Lammers will provide an overview of Triumvira and the improvements the company is making over current therapies with its novel immuno-oncology platform T Cell-Antigen Coupler (TAC). Dr. Lammers will also be giving updates on Triumvira’s lead drug, CD19 TAC#921, which is targeted to enter clinical development in Q1 2019 – Phase 1/2 in patients with relapsing/refractory diffuse large B-cell lymphoma (DLBCL).

The Future Leaders conference offers Wall Street and pharma executives the opportunity to assess private and public companies with healthy financial profiles, poised to deliver on milestones that could lead to the next tier of valuations.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Caladrius Biosciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Caladrius Biosciences, 2018, MAR 22, 2018, View Source [SID1234524943]).

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Celyad Reports 2017 Financial and OperatingResults and Expected Key Milestones for 2018

On March 22, 2018 Celyad Reported 2017 Financial and OperatingResults and Expected Key Milestones for 2018 (Press release, Celyad, MAR 22, 2018, View Source(3).pdf [SID1234532496]).

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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Provectus Biopharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Provectus Biopharmaceuticals, 2018, MAR 22, 2018, View Source [SID1234524955]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Astellas Receives Orphan Drug Designation from the Japanese MHLW for Gilteritinib

On March 22, 2018 Astellas Pharma Inc. (President and CEO: Yoshihiko Hatanaka, "Astellas" ) reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation to gilteritinib for the treatment of FLT3mut+ Acute Myeloid Leukemia (AML), the drug’s prospective indication (Press release, Astellas, MAR 22, 2018, View Source [SID1234536693]).

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Orphan drug designation system in Japan aims to support the development of drugs for diseases that, despite there being a significant medical need for treatments, affect only a small number of patients, and for which research and development is virtually nonexistent. As stipulated in Article 77 of the Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act of Japan, the designation is granted by the minister of Health, Labour and Welfare for drugs that meet the designation criteria which include the following: the number of patients who may use the drug is less than 50,000 in Japan; there is no alternative appropriate drug or treatment in Japan; high efficacy or safety is expected compared to existing products. Specific measures to support the development of orphan drugs include subsidies for research and development expenditures, prioritized consultation regarding clinical development, reduced consultation fees, tax incentives, priority review of applications, reduced application fees, and extended registration validity period1

AML is a cancer that impacts the blood and bone marrow, and its incidence increases with age. In Japan, approximately 5,500 patients are diagnosed with AML each year2. Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as FLT3 tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in approximately one-third of patients with AML. Further, gilteritinib has also demonstrated inhibition of the AXL receptor in AML cell lines.

Astellas will continue to develop gilteritinib to provide it to FLT3mut+ AML patients as early as possible.

(1): View Source
(2): KantarHealth. TREATMENT ARCHITECTURE: JAPAN LEUKEMIA, ACUTE MYELOID. CancerMPact Japan, February 2017.