Stemline Therapeutics Highlights Three ELZONRIS Presentations, Including an Oral Presentation in Myelofibrosis, at Upcoming ASH Meeting

On December 6, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that highlighted three upcoming ELZONRIS (tagraxofusp), presentations, including an oral presentation of ELZONRIS clinical data in myelofibrosis, at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, that is being held from December 7-10 in Orlando, FL (Press release, Stemline Therapeutics, DEC 6, 2019, View Source [SID1234551990]).

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Details on the ASH (Free ASH Whitepaper) presentations are as follows:

Myelofibrosis – ELZONRIS monotherapy, clinical; oral presentation
Title: Results from a Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Intermediate, or High Risk, Relapsed/Refractory Myelofibrosis
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 558
Session: 634. Myeloproliferative Syndromes: Clinical: Emerging and Novel Targeted Therapies
Date/Time: Monday, December 9, 2019 8:15 AM ET
Location: Orange County Convention Center, W304EFGH

Multiple Myeloma – ELZONRIS in combination with Pom+Dex, clinical; poster presentation
Title: Results from Phase 1/2 Trial of Tagraxofusp in Combination with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Presenter: Paul G. Richardson, M.D.; Dana-Farber Cancer Institute
Abstract: 3145
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date/Time: Sunday, December 8, 2019 6:00 PM–8:00 PM ET
Location: Orange County Convention Center, Hall B

Myeloproliferative Neoplasms – ELZONRIS in combination with ruxolitinib, preclinical; poster presentation
Title: Evaluation of Tagraxofusp (SL-401) Alone and in Combination with Ruxolitinib for the Treatment of Myeloproliferative Neoplasms
Presenter: Aishwarya Krishnan, MD; Memorial Sloan Kettering Cancer Center
Abstract: 2967
Session: 635. Myeloproliferative Syndromes: Basic Science: Poster II
Date/Time: Sunday, December 8, 2019 6:00 PM–8:00 PM ET
Location: Orange County Convention Center, Hall B

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

MSD and Taiho Pharmaceutical terminate co-promotion contract for anti-PD-1 antibody/anti-cancer drug KEYTRUDA® In Japan

On December 6, 2019 MSD K.K. (president and CEO Jannie Oosthuizen, Chiyoda-ku, Tokyo) and Taiho Pharmaceutical Co., Ltd. (president and CEO Masayuki Kobayashi, Chiyoda-ku, Tokyo) reported that they have agreed to terminate their co-promotion contract in Japan at the end of December 2019 for KEYTRUDA (pembrolizumab [genetical recombination]), anti-PD-1 therapy manufactured and marketed by MSD (Press release, Taiho, DEC 6, 2019, View Source [SID1234551969]).

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KEYTRUDA was launched on February 15, 2017 and has been co-promoted by MSD and Taiho Pharmaceutical in Japan. From January 2020, MSD will continue manufacturing, distribution and promotion of KEYTRUDA.

MSD and Taiho Pharmaceutical believe that they could make a significant contribution to patients and healthcare professionals by providing a novel cancer treatment option through the co-promotion activities. The companies will continue their commitment to the advancement in cancer therapy in the course of their business activities.

MSD and Taiho Pharmaceutical terminate co-promotion contract for anti-PD-1 antibody/anti-cancer drug KEYTRUDA® In Japan

On December 6, 2019 MSD K.K. (president and CEO Jannie Oosthuizen, Chiyoda-ku, Tokyo) and Taiho Pharmaceutical Co., Ltd. (president and CEO Masayuki Kobayashi, Chiyoda-ku, Tokyo) reported that they have agreed to terminate their co-promotion contract in Japan at the end of December 2019 for KEYTRUDA (pembrolizumab [genetical recombination]), anti-PD-1 therapy manufactured and marketed by MSD (Press release, Taiho, DEC 6, 2019, View Source [SID1234551968]).

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KEYTRUDA was launched on February 15, 2017 and has been co-promoted by MSD and Taiho Pharmaceutical in Japan. From January 2020, MSD will continue manufacturing, distribution and promotion of KEYTRUDA.

MSD and Taiho Pharmaceutical believe that they could make a significant contribution to patients and healthcare professionals by providing a novel cancer treatment option through the co-promotion activities. The companies will continue their commitment to the advancement in cancer therapy in the course of their business activities.

BiocurePharm, Korea (“BPK”) Announces Closing of Convertible Debenture Financing

On December 5, 2019 BiocurePharm, Korea ("BPK"), a wholly owned subsidiary of Biocure Technology Corp. (CSE: CURE) (OTCQB: BICTF) ("CURE" or the "Company") reported that it has closed its Convertible Debenture financing. BPK has issued convertible debentures for gross proceeds of Korean Won660,000,000 (CAD732,600) (Press release, Biocure Technology, DEC 5, 2019, View Source [SID1234628753]). Its maturity date is December 5, 2029, with the coupon rate of 3%. The investor has a right to convert to common shares of BPK at CAD12.21 per share three years after the issuance of Convertible Debenture. All dollar values are based on the published Exchange Rate of CAD0.001110/KRW1 on December 4, 2019, Bank of Canada.

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Abbisko Therapeutics Announces the IND Approval of a Novel FGFR4 Inhibitor ABSK011 by the Taiwan FDA

On December 5, 2019 Abbisko Therapeutics, a clinical-stage biopharmaceutical company, reported that it has received the regulatory approval from the Taiwan FDA to initiate Phase 1 clinical trials for ABSK011, a fibroblast growth factor receptor 4 (FGFR4) inhibitor, in patients with hepatocellular carcinoma (HCC) (Press release, Abbisko Therapeutics, DEC 5, 2019, View Source;article_id=134 [SID1234556286]).

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FGFRs, belonging to tyrosine receptor kinase family, comprise four subtypes (FGFR1-4), and their activation play critical roles in cell growth, proliferation, survival and metastasis in multiple advanced tumors. Aberrant activation of FGFR4 signaling pathway is frequently observed in HCC. Blocking its activities represents a potential therapeutic approach for HCC treatment. HCC is one of the most common types of malignant tumors with high prevalence in Asia and strong unmet clinical need. At present, there are no FGFR4-targeted therapeutic drugs available on the market worldwide.

ABSK011 was independently discovered and developed by Abbiskso Therapeutics with global intellectual property rights. It is an orally available, highly potent and selective small molecule inhibitor of FGFR4 with best-in-class potential.

Founded in April 2016, Abbisko Therapeutics Co., Ltd. is a biopharmaceutical company dedicated to discovering and developing innovative therapeutics to treat cancer and other diseases with unmet medical needs. The founders and core team of Abbisko are industrial veterans with strong leadership and managerial experiences from top international pharmaceutical companies. In three years, Abbisko has established a strong oncology pipeline with multiple programs entering the clinic.