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Syndax Pharmaceuticals Announces Presentations at the 60th American Society of Hematology Annual Meeting

On November 1, 2018 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that the Company’s Menin-MLLr program will be featured during two presentations at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 1-4, 2018 in San Diego, California (Press release, Syndax, NOV 1, 2018, View Source [SID1234530531]).

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Oral Presentation Details:

Title: MLL-Menin Inhibition Reverses Pre-Leukemic Progenitor Self-Renewal Induced By NPM1 Mutations and Prevents AML Development
Presenter: Hannah Uckelmann, Ph.D., Dana-Farber Cancer Institute
Session Name: 602. Disordered Gene Expression in Hematologic Malignancy, including Disordered Epigenetic Regulation: Single Cell Profiling/Actionable Leukemia Targets
Session Date: Monday, December 3, 2018
Session Time: 7:00 a.m. – 8:30 a.m. PT
Presentation Time: 8:15 a.m. PT
Publication Number: 546
Location:San Diego Convention Center, Room 9

Scientific Spotlight Session Details:

Title: Targeting Chromatin Complexes in MLL Rearranged Leukemia
Presenter: Scott Armstrong, M.D., Ph.D., Dana-Farber Cancer Institute
Session Name: Biochemical and Genetic Insights Into MLL/11q23 Translocation Leukemia
Session Date: Sunday, December 2, 2018
Session Time: 4:30 p.m. – 6:00 p.m. PT
Location: San Diego Convention Center, Room 9

About MLL Rearranged Leukemias

Rearrangements of the MLL gene give rise to an acute leukemia, MLL-r. MLL-r occurs in ~80% of infant acute leukemias and up to 10% of adult acute leukemias. It is associated with a poor prognosis, with less than 40% of infants with MLL-r surviving past 5 years. MLL rearrangements produce fusion proteins that require interaction with a protein called Menin in order to drive leukemic cancer growth. Disruption of the Menin-MLL-r interaction has been shown to halt the growth of MLL-r leukemic cells. MLL-r leukemias are routinely diagnosed through currently available cytogenetic screening techniques in leukemic cells, but there are currently no approved therapies indicated for MLL-r leukemias.

About NPM1c Acute Myeloid Leukemia

NPM1c represents another discrete form of acute myeloid leukemia (AML) distinguished by point mutations in the NPM1 gene that drives the leukemic phenotype. NPM1c is the most common type of cytogenetically normal AML and represents ~30% of all diagnosed AML. This subtype of AML has a poor prognosis, with a 5-year overall survival rate of ~50%. Similar to MLL-r leukemias, NPM1c AML is highly dependent on the expression of specific developmental genes, shown to be negatively impacted by inhibitors of the menin-MLL1 interaction. NPM1c AML is routinely diagnosed through currently available screening techniques in leukemic cells, but there are currently no approved therapies indicated for NPM1c AML.

Spectrum Pharmaceuticals Announces Third Quarter 2018 Financial Results Teleconference and Webcast

On November 1, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported it will host a teleconference and webcast with management to discuss the third quarter 2018 financial results, provide an update on the company’s business, and discuss expectations for the future on Thursday, November 8, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, NOV 1, 2018, View Source [SID1234530530]).

Conference Call

Thursday, November 8, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 3075918
International: (973) 796-5077, Conference ID# 3075918
For interested individuals unable to join the call, a replay will be available from November 8, 2018 @ 7:30 p.m. ET/4:30 p.m. PT through November 15, 2018 until 11:59 p.m. ET/8:59 p.m. PT.

Domestic Replay: (855) 859-2056, Conference ID# 3075918
International Replay: (404) 537-3406, Conference ID# 3075918
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on November 8, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

Sierra Oncology to Report Clinical Data at ASH 2018 from Translational Biology Study of Momelotinib in Transfusion Dependent Patients

On November 1, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that clinical data from a translational biology study of momelotinib in 41 transfusion dependent patients with myelofibrosis (MF) will be reported in a poster at ASH (Free ASH Whitepaper) 2018 (Press release, Sierra Oncology, NOV 1, 2018, View Source [SID1234530529]). The impact of momelotinib on serum hepcidin, along with markers of iron storage and availability, erythropoiesis and inflammation were investigated to explore the biological mechanisms underlying the favorable effects of momelotinib on MF-associated anemia.

"The results from this translational biology clinical study provide further evidence for momelotinib’s unique anemia benefit," said Dr. Christian Hassig, Chief Scientific Officer of Sierra Oncology. "Moreover, the findings provide clinical evidence that reinforce the differentiated profile of momelotinib as a potent inhibitor of ACVR1, a principal driver of hepcidin production in the liver. As with many inflammatory diseases associated with chronic anemia, myelofibrosis is characterized by high hepcidin, resulting in functional iron deficiency. In myelofibrosis, high levels of hepcidin are inversely correlated with survival. The observed reduction in hepcidin and restoration of iron homeostasis, coupled with net increases in various measures of erythropoiesis, provide important translational biomarker data accounting for the compelling transfusion-independence rates of 34-39% achieved in this transfusion dependent study population."

"As noted in our recent KOL call* featuring Dr. Srdan Verstovsek, one of the investigators in this clinical study, almost every myelofibrosis patient develops anemia and it typically becomes worse over time, often leading to transfusion dependency, yet there are no approved therapies to treat this facet of the disease," stated Dr. Nick Glover, President and Chief Executive Officer of Sierra Oncology. "Momelotinib inhibits JAK1, JAK2 and ACVR1, and is therefore uniquely positioned to address disease-related cytopenia in myelofibrosis, including anemia and transfusion dependency, while also improving splenomegaly and constitutional symptoms."

Sierra is currently preparing for discussions with regulators to determine the registration path for momelotinib and anticipates reporting next steps in the first half of 2019.

*KOL call featuring Dr. Srdan Verstovsek:
View Source

About the study (ClinicalTrials.gov Identifier NCT02515630):
In this Phase 2 open-label, translational biology study 41 transfusion-dependent (TD; ≥4 units red blood cells [RBC] transfusion in the 8 weeks prior to first dose of momelotinib) patients with primary or post-ET/PV MF (platelets ≥50 K) received 200 mg momelotinib once daily for 24 weeks.

By week 24, 14 (34.1%, 90% CI: 22.0–48.1%) patients had a ≥12-week transfusion-independent response (TI-R) and 39.0% had no RBC transfusion for ≥8 weeks at any time (90% CI: 26.2-53.1%).
At every study visit, median blood hepcidin decreased 6 hours after dosing with momelotinib. Serum iron, transferrin, hemoglobin, reticulocytes, and hematocrit increased at week 2 in patients with TI-R. Following this peak, serum iron decreased while hemoglobin, hematocrit and platelet count increased through week 24.
Adverse events (AEs) were consistent with previous studies of momelotinib in myelofibrosis, with cough, diarrhea, nausea, and fatigue as the most common. AEs ≥Gr 3 were experienced by 21 patients, most commonly anemia and neutropenia.
Title: Hepcidin Suppression by Momelotinib Is Associated with Increased Iron Availability and Erythropoiesis in Transfusion-Dependent Myelofibrosis Patient

Authors: Stephen T. Oh, Moshe Talpaz, Aaron T. Gerds, Vikas Gupta, Srdan Verstovsek, Ruben Mesa, Carole Miller, Candido Rivera, Angela Fleischman, Swati Goel, Mark Heaney, Casey O’Connell, Murat Arcasoy, Yafeng Zhang, Jun Kawashima, Tomas Ganz, Carrie Baker Brachmann

Selecta Biosciences to Report Third Quarter 2018 Financial Results and Update on SEL-212 Development Strategy, including Planned Head-to-Head Study versus Krystexxa

On November 1, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that it plans to issue its third quarter 2018 financial results before the open of the U.S. financial markets on Thursday, November 08, 2018 (Press release, Selecta Biosciences, NOV 1, 2018, View Source [SID1234530528]). The management team also plans to provide an update on the development strategy for SEL-212, the company’s lead product candidate for the treatment of chronic severe gout, including plans to conduct a head-to-head clinical trial of SEL-212 compared to the current FDA-approved uricase therapy, Krystexxa.

At 8.30 a.m. ET that day, Selecta Biosciences will host a conference call via live webcast to discuss these results and provide a corporate update. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10124090.

Portola Pharmaceuticals to Present New Interim Phase 2 Results for Cerdulatinib During an Oral Session at the 60th American Society of Hematology (ASH) Annual Meeting

On November 1, 2018 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported that new interim results from the Company’s ongoing Phase 2a study of cerdulatinib in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL), will be presented during an oral session at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 1-4, 2018 in San Diego, California (Press release, Portola Pharmaceuticals, NOV 1, 2018, View Source;p=RssLanding&cat=news&id=2374918 [SID1234530526]).

The Company also will present new outcomes-based research on the burden of hospital readmissions for venous thromboembolism among patients with cancer during an oral session on Sunday, December 2, and two investigator-initiated animal studies highlighting the anticoagulant reversal agent Andexxa [coagulation Factor Xa (recombinant), inactivated-zhzo] will be presented in poster sessions.

"As shown at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) meetings earlier this year, cerdulatinib has shown encouraging results across a range of B- and T-cell malignancies and we look forward to presenting new data specifically focused on patients with PTCL and CTCL," said John Curnutte, M.D., Ph.D., head of research and development for Portola. "These data also will serve as a basis for further discussions with regulatory agencies regarding the potential regulatory path forward for cerdulatinib in certain tumor subtypes."

Cerdulatinib is an investigational oral, dual Syk/JAK kinase inhibitor that uniquely inhibits two key cell signaling pathways that promote cancer cell growth in certain hematologic malignancies. It is being developed for the treatment of resistant or relapsed hematologic cancer.

Oral Presentations

1001. The Novel Syk/JAK Inhibitor Cerdulatinib Demonstrates Good Tolerability and Clinical Response in a Phase 2a Study in Relapsed/Refractory Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma
Abstract: View Source
Session: 624 (Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: T Cell Lymphoma: Chemotherapy and Targeted Approaches)
Presenter: Steven M. Horwitz, M.D., Memorial Sloan-Kettering Cancer Center
Date: Monday, December 3, 2018 at 7:15 p.m. PST; Room 6F

365. Burden of Hospital Readmissions for Venous Thromboembolism Among Patients with Cancer
Abstract: View Source
Session: 901 (Health Services Research—Non-Malignant Conditions: Thrombosis and Anticoagulation
Hematology Disease Topics & Pathways)
Presenter: Alpesh Amin, M.D., M.B.A., UC Irvine
Date: Sunday, December 2, 2018 at 10:30 a.m. PST; Room 8
Poster Presentations

2456. Reversal of Apixaban Anticoagulation with Reduced Doses of Andexanet Alfa in a Porcine Polytrauma Model
Abstract: View Source
Session: 321 (Blood Coagulation and Fibrinolytic Factors: Poster II Hematology Disease Topics & Pathways)
Presenter: Oliver Grottke, M.D., Ph.D., M.P.H., University Hospital RWTH Aachen, Germany
Date: Sunday, December 2, 2018 from 6:00 – 8:00 p.m. PST; Hall GH

3778. Comparison of Second and First Generation of Andexanet Alfa in a Porcine Polytrauma Model with Apixaban Anticoagulation
Abstract: View Source
Session: 321 (Blood Coagulation and Fibrinolytic Factors: Poster II Hematology Disease Topics & Pathways)
Presenter: Oliver Grottke, M.D., Ph.D., M.P.H., University Hospital RWTH Aachen, Germany
Date: Monday, December 3, 2018 from 6:00 – 8:00 p.m. PST; Hall GH