On December 2, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that preclinical data for its lead drug candidate CB-839, the company’s novel, orally bioavailable glutaminase inhibitor, will be presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held from December 3-6, 2016 in San Diego, California (Press release, Calithera Biosciences, DEC 2, 2016, View Source;p=RssLanding&cat=news&id=2227168 [SID1234516878]). Data to be presented include the following two poster presentations:

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Glutaminase Inhibitor CB-839 Enhances Proteasome Inhibitor Sensitivity in Multiple Myeloma Cells
Presenter: Ravyn Thompson, Nathan Dolloff, Medical University of South Carolina
Oral and Poster Abstracts Session 652: Myeloma: Pathophysiology and Preclinical Studies, Hall GH, Abstract 3294
Sunday, December 4, 2016, 6:00 p.m.-8:00 p.m. PT
Gls Inhibitor CB-839 Modulates Cellular Metabolism in AML and Potently Suppresses AML Cell Growth When Combined with 5-Azacitidine
Presenter: Tianyu Cai, Marina Konopleva, The University of Texas, MD Anderson Cancer Center
Oral and Poster Abstracts Session 616: Acute Myeloid Leukemia: Novel Therapy, Hall GH, Abstract 4064
Monday, December 5, 2016, 6:00 p.m.-8:00 p.m. PT

On December 2, 2016 PIQUR Therapeutics AG, a Swiss clinical-stage pharmaceutical company, reported that
the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to PIQUR’s lead compound PQR309 for the treatment of primary central nervous system lymphoma (PCNSL) (Press release, PIQUR Therapeutics, DEC 2, 2016, View Source [SID1234527272]).

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PCNSL is a very rare and aggressive form of lymphoma involving brain and its linings, eyes or spinal cord. The disease affects less than 1 person in 100,000 in the USA with approximately 7,500 new cases reported annually in the USA, Europe and Japan. Treatment options available for PCNSL are limited, and the prognosis with current therapies is poor.

"We are very pleased to receive FDA orphan drug designation for PQR309 in PCNSL. This is an important regulatory milestone for the company and a significant step towards the clinical advancement of PQR309," said Dr. Ruggero Della Bitta, Chief Medical Officer of PIQUR. "This represents an important step towards addressing a high unmet medical need and bringing a potential treatment to those with this rare and life-threatening disease."

The Orphan Drug Designation Program, administered by the FDA’s Office of Orphan Products Development, is intended to encourage companies to develop therapeutics for diseases that affect fewer than 200,000 people in the USA. The designation provides the company several benefits and incentives, including assistance with clinical study design and drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, as well as a seven-year period of market exclusivity upon regulatory product approval.

About PQR309
PIQUR’s lead compound, PQR309, is an oral, brain-penetrant, dual inhibitor of the PI3K/mTOR pathway, which is activated in 60 – 80% of human cancers. Unlike most of its competitors, PQR309 crosses the blood-brain barrier, expanding its use to malignant diseases involving the brain. Preclinical and Phase 1 studies have shown PQR309 to have a favorable safety, tolerability and pharmacokinetic profile. In addition, PQR309 has shown both preclinical
activity in various tumor models and clinical activity in Phase 1 and 2 studies.

PQR309 is currently being investigated in five Phase 1 and 2 clinical studies in advanced solid tumors (NCT02483858), relapsed or refractory lymphoma (NCT02249429), relapsed or refractory PCNSL (NCT02669511) and progressive glioblastoma multiforme (NCT02850744). In addition, the PIQHASSO Phase 1/2b study investigates PQR309 in combination with Eisai’s Eribulin in metastatic HER2-negative and triple-negative breast cancer (NCT02723877).

On December 1, 2016 Alligator presented the corporate presentation (Presentation, Alligator Bioscience, DEC 1, 2016, View Source [SID1234538696]).

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On December 1, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that Scott Maguire, CEO of Xenetic Biosciences, will present at the LD Micro Main Event 2016 Annual Conference on Wednesday, December 7, 2016 at 4:30 p.m. PT at the Luxe Sunset Boulevard Hotel in Los Angeles (Press release, Xenetic Biosciences, DEC 1, 2016, View Source [SID1234537807]).

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During his presentation, Mr. Maguire will provide a corporate update and discuss the Company’s clinical and regulatory progress for its in-house product candidates, as well as those being developed with Xenetic’s partners. Xenetic’s current in-house product pipeline includes Virexxa (sodium cridanimod), which is being evaluated for the treatment of endometrial cancer and triple negative breast cancer, and ErepoXen, a polysialylated form of erythropoietin (EPO), a hormone created by the kidneys to maintain red blood cell production and address anemia. Xenetic is also currently evaluating OncoHist for the treatment of acute myeloid leukemia (AML) in refractory patients.

Mr. Maguire will also discuss the Company’s up to $100 million license deal with Shire, one of the Company’s largest shareholders, along with the clinical status of their product candidate.

A live webcast of the presentation will be available by accessing the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com). A replay of the webcast will be available for 90 days, starting approximately two hours after the presentation ends.