On June 14, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that ELZONRISTM (tagraxofusp; SL-401) will be the subject of three clinical presentations, including an oral presentation on the pivotal BPDCN program (Press release, Stemline Therapeutics, JUN 14, 2018, View Source [SID1234527314]). Updated data from the ongoing Phase 2 trial in chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF) will also be presented. Presentations will be delivered tomorrow, Friday, June 15th at the 23rdCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden.

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Details on the presentations are listed below. Presentations will be available on the Stemline website (www.stemline.com), Scientific Presentations tab, after their delivery.

Results of Pivotal Phase 2 Trial of SL-401 in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm

Abstract: S116
Session: Miscellaneous Treatments in AML
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Oral Presentation: Friday, June 15; 11:45 – 12:00 CEST (5:45 AM – 6:00 AM ET)
Location: Room A4
Results from Ongoing Phase 1/2 Trial of SL-401 in Patients with Intermediate or High Risk Relapsed/Refractory Myelofibrosis

Abstract: PF618
Session: Myeloproliferative neoplasms – Clinical
Poster Presentation: Friday, June 15; 17:30 – 19:00 CEST (11:30 AM – 1 PM ET)
Location: Poster Area
Results from Ongoing Phase 1/2 Trial of SL-401 in Patients with Relapsed/Refractory CMML

Abstract: PF626
Session: Myeloproliferative neoplasms – Clinical
Poster Presentation: Friday, June 15; 17:30 – 19:00 CEST (11:30 AM – 1 PM ET)
Location: Poster Area
About ELZONRISTM (tagraxofusp; SL-401)
ELZONRISTM (tagraxofusp; SL-401) is a novel targeted therapy directed to CD123, a cell surface receptor expressed on a range of malignancies. ELZONRIS has successfully completed a pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), an indication for which it was granted Breakthrough Therapy Designation (BTD). A rolling Biologics License Application (BLA) submission is underway. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

On June 14, 2018 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management will present at the JMP Securities 2018 Life Sciences Conference in New York, NY on Thursday, June 21, 2018 at 1:00 PM ET (Press release, CTI BioPharma, JUN 14, 2018, View Source;p=RssLanding&cat=news&id=2354543 [SID1234527313]).

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The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma’s website at www.ctibiopharma.com.

On June 14, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) reported that they have entered into a license agreement with CrystalGenomics, Inc. (KOSDAQ:083790) for China rights to CG-806 (including People’s Republic of China, Hong Kong and Macau) (Press release, Aptose Biosciences, JUN 14, 2018, View Source;p=RssLanding&cat=news&id=2354544 [SID1234527312]). Aptose will now own worldwide rights (excluding Korea) to develop and commercialize CG-806, a first-in-class, highly potent oral small molecule being developed for acute myeloid leukemia (AML), B-cell malignancies and other hematologic malignancies.

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Under the agreement, CrystalGenomics will receive an upfront payment of US $3 million and is eligible for development, regulatory and commercial-based milestones, as well as single-digit royalties on product sales in China. Total deal value for the China territory, including the upfront payment, is up to US $125 million.

On May 7, 2018, Aptose exercised its option to obtain the exclusive license from CrystalGenomics to develop and commercialize CG-806 worldwide outside of China and Korea. This new agreement extends that license agreement to include China.

"Licensing rights to CG-806 to include the China territory was a strategic decision," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Our preclinical work with CG-806 has demonstrated its superior activity to other FLT3 inhibitors on AML patient samples, its superior ability to kill B-cell malignancy patient samples relative to ibrutinib, and a favorable safety profile. We believe that CG-806 has the potential to serve as a transformational agent for multiple hematologic cancers, including AML, CLL and others."

"We are pleased to continue our relationship with the Aptose team, which recognized the exciting potential of CG-806 very early in its development," said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics. "They have been laser focused on IND-enabling studies of CG-806, and we look forward to seeing CG-806 enter the clinic."

About CG-806

CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-kinase inhibitor that represents a potential best-in-class therapeutic for patients with AML.

Aptose has been conducting Investigational New Drug (IND) enabling studies with CG-806, as well as numerous preclinical studies. When tested against fresh bone marrow samples from patients with AML, CG-806 demonstrated superior potency and range of activity relative to all other FLT3 inhibitors evaluated. Likewise, CG-806 demonstrated superiority over ibrutinib when tested against samples from CLL patients. The superior potency and breadth of activity against patient-derived hematologic malignancy cells is due to the ability of CG-806 to target wild type (WT) and all known mutant forms of FLT3 and BTK, and to suppress multiple signaling pathways that can rescue hematologic cancers from other agents. Once-daily oral dosing of CG-806 in murine xenograft models of human hematologic malignancies demonstrated tumor eradication in the absence of observable toxicity, and dose range finding studies have shown CG-806 to have a robust safety profile. Aptose expects to submit an IND in late 2018 and initiate clinical trials immediately thereafter.

On June 14, 2018 Kura Oncology, Inc. (Nasdaq:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that Troy Wilson, Ph.D., J.D., Kura’s President and Chief Executive Officer, is scheduled to participate in a fireside chat at the JMP Securities Life Sciences Conference in New York on Thursday, June 21, 2018 at 11:00 a.m. ET / 8:00 a.m. PT (Press release, Kura Oncology, JUN 14, 2018, View Source [SID1234527310]).

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A live audio webcast of the fireside chat will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available for 30 days following the event.

On June 14, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has initiated dosing in its phase 1 clinical trial of TTI-622 (SIRPaFc-IgG4), a checkpoint inhibitor of the innate immune system, in relapsed or refractory lymphoma or myeloma (Press release, Trillium Therapeutics, JUN 14, 2018, View Source [SID1234527309]).

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TTI-622 is a fusion protein that blocks the inhibitory activity of CD47, a molecule that is overexpressed by a wide variety of tumors. CD47 binds to SIRPa on macrophages and delivers a "do not eat" signal that inhibits the ability of macrophages to engulf and destroy cancer cells. Preclinical studies have shown that TTI-622 has anti-tumor activity across a range of hematologic tumors.

TTI-622 is the second SIRPaFc decoy receptor that Trillium has advanced into the clinic. TTI-621 (SIRPaFc-IgG1), which consists of the same CD47-binding domain of human SIRPa as TTI-622 but linked to an IgG1 Fc region, is currently in two multicenter trials and has produced positive signals of activity in mycosis fungoides, Sézary syndrome and diffuse large B-cell lymphoma patients. The different pharmacologic properties of TTI-621 and TTI-622 will allow Trillium to explore the relationships between the level of CD47 blockade, Fc isotype, tolerability and anti-tumor activity in patients.

"This is an exciting time for Trillium as we initiate clinical development with our second CD47 blocking agent," commented Dr. Yaping Shou, Trillium’s Chief Medical Officer. "TTI-622 deepens our presence in the CD47 space, and its minimal binding to human erythrocytes could confer best-in-class status among IgG4-based blocking agents currently in development."

A two-part, multicenter, open-label, phase 1a/1b study of TTI-622 in patients with advanced relapsed or refractory lymphoma or multiple myeloma has been initiated. In the phase 1a dose-escalation part, patients will be enrolled in sequential dose cohorts to receive TTI-622 once weekly to characterize safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose. In the phase 1b part, patients will be treated with TTI-622 in combination with rituximab, a proteasome inhibitor-containing regimen, or a PD-1 inhibitor. Rituximab and proteasome inhibitors may provide additional "eat" signals that could enhance the efficacy of TTI-622. A PD-1 inhibitor may help amplify any anti-tumor T cell response generated by TTI-622.