On November 4, 2020 Incyte (Nasdaq: INCY) reported that numerous abstracts highlighting data from its oncology portfolio will be presented at the upcoming 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2020), held virtually December 5–8, 2020 (Press release, Incyte, NOV 4, 2020, View Source [SID1234569880]).

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"We are thankful for the American Society of Hematology (ASH) (Free ASH Whitepaper)’s efforts to hold ASH (Free ASH Whitepaper) 2020 – a key event for the scientific community – virtually, and are proud the Incyte portfolio will be represented in more than 40 abstracts"

"We are thankful for the American Society of Hematology (ASH) (Free ASH Whitepaper)’s efforts to hold ASH (Free ASH Whitepaper) 2020 – a key event for the scientific community – virtually, and are proud the Incyte portfolio will be represented in more than 40 abstracts," said Steven Stein, M.D., Chief Medical Officer, Incyte. "The presentations, including the oral presentation of the Phase 3 REACH3 study for ruxolitinib in chronic graft-versus-host disease (GVHD), reflect the strength of our diverse oncology portfolio and our partnerships, and reinforce our commitment to finding solutions that can improve the lives of patients with multiple rare cancers and serious conditions where there is significant medical need."

Select key abstract presentations from Incyte-developed and partnered programs include:

Oral Presentations

Ruxolitinib: Graft-Versus-Host Disease (GVHD)

Ruxolitinib vs Best Available Therapy in Patients with Steroid-Refractory/Steroid-Dependent Chronic Graft-vs-Host Disease (cGVHD): Primary Findings from the Phase 3, Randomized REACH3 Study1 (Abstract #77, Session: 732. Clinical Allogeneic Transplantation: Results I. Saturday, December 5, 7:30-9:00 a.m. PT)

Ruxolitinib: Myeloproliferative Neoplasms (MPN)

To Treat or Not To Treat? Understanding Treatment Patterns in Patients with Lower-Risk Myelofibrosis Enrolled in the MOST Study (Abstract #152, Session: 904. Outcomes Research – Non-Malignant Conditions: Bleeding, Immune Thrombocytopenia, and Other Hematologic Disorders. Saturday, December 5, 9:30-11:00 a.m. PT)

Mortality and Causes of Death of Patients with Polycythemia Vera: Analysis of the REVEAL Prospective, Observational Study (Abstract #484, Session: 634. Myeloproliferative Syndromes: Clinical: Clinical Trials in Polycythemia Vera. Sunday, December 6, 2:00-3:30 p.m. PT)

Parsaclisib

Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204) (Abstract #338, Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Clinical studies in Waldenstrom’s Macroglobulinemia, Marginal Zone Lymphoma and Hairy Cell Leukemia. Sunday, December 6, 9:30-11:00 a.m. PT)

Ponatinib

Outcome by Mutation Status and Line of Treatment in OPTIC, a Dose-Ranging Study of 3 Starting Doses of Ponatinib in Patients with CP-CML2 (Abstract #48, Session: 632. Chronic Myeloid Leukemia: Therapy—Building The Future CML. Saturday, December 5, 7:30-9:00 a.m. PT)

Efficacy and Safety of Ponatinib (PON) in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Who Failed One or More Second-Generation (2G) Tyrosine Kinase Inhibitors (TKIs): Analyses Based on PACE and OPTIC2 (Abstract #647, Session: 632. Chronic Myeloid Leukemia: Therapy: CML: New and Beyond. Monday, December 7, 11:30 a.m.-1:00 p.m. PT)

Itacitinib

A Single-Arm, Open-Label, Phase 1 Study of Itacitinib (ITA) with Calcineurin Inhibitor (CNI)-Based Interventions for Prophylaxis of Graft-Versus-Host Disease (GVHD; GRAVITAS-119) (Abstract #356, Session: 722. Clinical Allogeneic Transplantation; Acute and Chronic GvHD, Immune Reconstitution: Phase I and II Trials. Sunday, December 6, 9:30-11:00 a.m. PT)

Poster Presentations
All accepted posters in Poster I and Poster II sessions are available from 7:00 a.m.-3:30 p.m. PT on Saturday and Sunday, December 5 and 6. All accepted posters in the Poster III sessions are available from 7:00 a.m.-3:00 p.m. PT on Monday, December 7.

Ruxolitinib: Graft-Versus-Host Disease (GVHD)

Biomarker Analysis in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease (aGVHD) Treated with Ruxolitinib (RUX) or Best Available Therapy (BAT) in the Randomized, Phase 3 REACH2 Study1 (Abstract #1519, Session: 732. Clinical Allogeneic Transplantation: Results: Poster I. Saturday, December 5)

Ruxolitinib, a JAK1/2 Inhibitor, is Efficacious in a Novel Humanized GVHD Model Characterized by Enhanced NK, NK-T and T-Cell Engraftment (Abstract #1422, Session: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster I. Saturday, December 5)

Safety Analysis of Patients Who Received Ruxolitinib for the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease in an Expanded Access Program (Abstract #1488, Session: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster I. Saturday, December 5)

Safety Analysis of Ruxolitinib (RUX) vs. Best Available Therapy (BAT) in Patients (pts) with Steroid-Refractory (SR) Acute Graft-Versus-Host Disease (aGVHD) in the Randomized Phase 3 REACH2 Study1 (Abstract #2440, Session: 732. Clinical Allogeneic Transplantation: Results: Poster II. Sunday, December 6)

Ruxolitinib: Myeloproliferative Neoplasms (MPN)

An International Multicentric Observational Study on the Use of Ruxolitinib in Patients with Polycythemia Vera Resistant or Intolerant to Hydroxyurea: Results from Interim Analysis1 (Abstract #1256, Session: 634. Myeloproliferative Syndromes: Clinical: Poster I. Saturday, December 5)

Clinical Characteristics and Treatment Patterns by Risk Stratification in Patients with Essential Thrombocythemia: An Analysis of the MOST Study (Abstract #1258, Session: 634. Myeloproliferative Syndromes: Clinical: Poster I. Saturday, December 5)

The Final Analysis of EXPAND: A Phase 1b, Open-Label, Dose-Finding Study of Ruxolitinib (RUX) in Patients (pts) with Myelofibrosis (MF) and Low Platelet (PLT) Count (50 × 109/L to < 100 × 109/L) at Baseline1 (Abstract #1252, Session: 634. Myeloproliferative Syndromes: Clinical: Poster I. Saturday, December 5)

Thrombotic Events and Mortality Risk in Patients Newly Diagnosed with Intermediate- to High-Risk Essential Thrombocythemia in the United States (Abstract #1622, Session: 904. Outcomes Research – Non-Malignant Conditions: Poster I. Saturday, December 5)

Changes in the Incidence and Overall Survival of Patients with Myeloproliferative Neoplasms Between 2002 and 2016 in the United States (Abstract #2160, Session: 634. Myeloproliferative Syndromes: Clinical: Poster II. Sunday, December 6)

Clinical & Economic Implications of Hydroxyurea Intolerance in Polycythemia Vera in Routine Clinical Practice1 (Abstract #2477, Session: 901. Health Services Research-Non-Malignant Conditions: Poster II. Sunday, December 6)

Interactions of Key Hematological Parameters with Red Cell Distribution Width (RDW) are Associated with Incidence of Thromboembolic Events (TEs) in Polycythemia Vera (PV) Patients: A Machine Learning Study (PV-AIM)1 (Abstract #2991, Session: 634. Myeloproliferative Syndromes: Clinical: Poster III. Monday, December 7)

Long-Term Effect of Ruxolitinib (RUX) in Inadequately Controlled Polycythemia Vera (PV) Without Splenomegaly: 5-Year Results from the Phase 3 Response-2 Study1 (Abstract #2987, Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster III. Monday, December 7)

Real-World Survival Among Patients with Intermediate- to High-Risk Myelofibrosis in the United States: Impact of Ruxolitinib Approval (Abstract #3089, Session: 634. Myeloproliferative Syndromes: Clinical: Poster III. Monday, December 7)

Thrombosis and Risk of Mortality in Newly Diagnosed High-Risk Polycythemia Vera: An Analysis of the Medicare Claims Database in the United States (Abstract #3458, Session: 904. Outcomes Research—Non-Malignant Conditions: Poster III. Monday, December 7)

ADORE: A Randomized, Open-Label, Phase 1/2 Open-Platform Study Evaluating Safety and Efficacy of Novel Ruxolitinib Combinations in Patients with Myelofibrosis1 (Abstract #2997, Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster III. Monday, December 7)

Parsaclisib

Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Mantle Cell Lymphoma Not Previously Treated with a BTK Inhibitor (CITADEL-205) (Abstract #1121, Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I. Saturday, December 5)

Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Mantle Cell Lymphoma Previously Treated with Ibrutinib (CITADEL-205) (Abstract #2044, Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II. Sunday, December 6)

Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Follicular Lymphoma (CITADEL-203) (Abstract #2935, Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III. Monday, December 7)

Ponatinib

Ponatinib Versus Imatinib with Reduced-Intensity Chemotherapy in Patients with Newly Diagnosed Philadelphia Chromosome–Positive (Ph+) Acute Lymphoblastic Leukemia (ALL): PhALLCON Study2 (Abstract #1026, Session: 615. Acute Myeloid Leukemia: Commercially Available Therapy, excluding Transplantation: Poster I. Saturday, December 5)

A Phase 1/2 Study to Evaluate the Safety and Efficacy of Ponatinib with Chemotherapy in Pediatric Patients with Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)2 (Abstract #2842, Session: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster III. Monday, December 7)

Treatment of Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Using Tyrosine Kinase Inhibitors in Combination with Chemotherapy: A Patient-Centered Benefit-Risk Assessment2 (Abstract #3471, Session: 905. Outcomes Research—Malignant Conditions (Lymphoid Disease): Poster III. Monday, December 7)

Tafasitamab

The Combination of Tafasitamab and Rituximab Increases Cytotoxicity Against Lymphoma Cells In Vitro3 (Abstract #2095, Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Poster II. Sunday, December 6)

A Phase 1b, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab (MOR208) or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma: Analysis of the Safety Run-In Phase3 (Abstract #3028, Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III. Monday, December 7)

Long-Term Subgroup Analyses from L-MIND, a Phase 2 Study of Tafasitamab (MOR208) Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma3 (Abstract #3021, Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III. Monday, December 7)

Blockade of the CD47/SIRPα Checkpoint Potentiates the Anti-Tumor Efficacy of Tafasitamab3 (Abstract #3008, Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster III. Monday, December 7)

INCB057643

A Phase 1 Study of INCB057643 Monotherapy in Patients with Relapsed or Refractory Myelofibrosis (INCB57643-103) (Abstract #2166, Session: 634. Myeloproliferative Syndromes: Clinical: Poster II. Sunday, December 6)

INCB000928

A Phase 1/2 Study of INCB000928 as Monotherapy or in Combination with Ruxolitinib in Patients with Anemia Due to Myelofibrosis (INCB00928-104) (Abstract #3000, Session: 634. Myeloproliferative Syndromes: Clinical: Poster III. Monday, December 7)

Characterization of INCB000928, a Potent and Selective ALK2 Inhibitor for the Treatment of Anemia (Abstract #3095, Session: 635. Myeloproliferative Syndromes: Basic Science: Poster III. Monday, December 7)

Full session details and listings for oral presentations and poster sessions are available in the ASH (Free ASH Whitepaper) 2020 program: View Source

About Jakafi (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

About Iclusig (ponatinib) Tablets
Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Iclusig is approved in the U.S., EU, UK, Australia, Switzerland, Israel and Canada. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

About Monjuvi (tafasitamab-cxix)
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi(tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG.
XmAb is a registered trademark of Xencor, Inc.

On November 4, 2020 PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that data reflecting five years of experience with ropeginterferon alfa-2b in polycythemia vera (PV) will be presented during the virtual 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, PharmaEssentia, NOV 4, 2020, View Source [SID1234569879]).

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Findings from "Long-Term Use of Ropeginterferon Alpha-2b in Polycythemia Vera: 5-Year Results from a Randomized Controlled Study and Its Extension" (Presentation 481 in Session 634) will be featured as an oral presentation on Sunday, December 6th at 2:30 PM PT.

"We look forward to contributing to the scientific dialogue around opportunities to improve care in the area of myeloproliferative neoplasms, and specifically in PV, during the virtual ASH (Free ASH Whitepaper) meeting," said Meredith Manning, U.S. General Manager for PharmaEssentia. "Our robust research offers a new, innovative perspective in this category and illustrates our goal to reset expectations and improve patient outcomes."

PharmaEssentia has focused its efforts on therapeutic innovation in the category of myeloproliferative neoplasms (MPNs), which are caused by specific genetic mutations that lead to overproduction of blood components including white or red blood cells, or platelets. In PV, the vast majority of which is caused by a JAK2 V617F mutation, the bone marrow produces excessive red blood cells, causing the blood to be thicker than normal and potentially leading to a range of complications.1,2 PV is estimated to affect more than 160,000 people in the U.S. alone,1 who have progressively burdensome symptoms. Without proper management, the disease can progress into myelofibrosis and malignancies including acute myeloid leukemia.3

Follow PharmaEssentia on LinkedIn to get news and updates on our activity at the virtual ASH (Free ASH Whitepaper) Annual Meeting.

About Ropeginterferon alfa-2b

Ropeginterferon alfa-2b is a novel, long-acting, mono-pegylated proline interferon that has been engineered with an optimized profile to support improved pharmacokinetic properties, tolerability and convenience. It is designed for administration once every two weeks, or once every four weeks during long-term maintenance. Ropeginterferon alfa-2b has Orphan Drug designation for treatment of polycythemia vera (PV) in the United States. Marketed as Besremi in Europe, the product was approved by the European Medicines Agency (EMA) in 2019. Ropeginterferon alfa-2b was discovered and is manufactured by PharmaEssentia in its Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018.

About Polycythemia Vera

Polycythemia Vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. This condition may result in cardiovascular complications such as thrombosis and embolism, as well as transformation to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.3

On November 4, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that three abstracts including data from the Company’s clinical and research portfolio have been accepted for oral presentations and two abstracts have been accepted for poster presentations at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held virtually December 5-8, 2020 .

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Of particular note are primary and key secondary endpoint data from additional analysis of the Phase 3 RESET study evaluating the efficacy of rivipansel in VOC. These findings point to the potential benefits, clinical improvements and improved outcomes associated with early treatment with GlycoMimetics’ wholly-owned product candidate, which include shorter hospital stays for patients and reduced need for IV opioids to treat pain.

A second presentation includes data from two different preclinical models of VOC using GlycoMimetics’ highly potent and specific E-selectin antagonist, GMI-1687. This presentation will highlight the product candidate’s potential for intravenous and subcutaneous administration to treat VOC by inhibiting occlusions and restoring blood flow.

A third presentation discloses how targeting E-selectin with uproleselan may help patients with AML overcome resistance to venetoclax combined with hypomethylating agent (HMA) based therapy.

Poster presentations convey how GMI-1359, a rationally-designed small molecule that inhibits E-selectin and CXCR4 (a chemokine receptor), enhances sorafenib’s anti-leukemia effect in pre-clinical AML models; and how GMI-1359 can uniquely generate motility-enhancing signals in AML cells and deplete AML cells from protective vascular niches in the bone marrow.

"GlycoMimetics is honored to have five abstracts from across our product candidate portfolio selected for presentations at this year’s ASH (Free ASH Whitepaper) meeting. The data convey new insights into the critical role of E-selectin in both malignant and inflammatory, adhesion-mediated conditions, suggesting novel treatment options for unmet need in sickle cell disease and AML," said Helen Thackray, MD, FAAP, GlycoMimetics’ Chief Medical Officer.

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

Title: Restoration of Normal Blood Flow in Mouse Models of Sickle Cell Vaso-occlusion Following Intravenous or Subcutaneous Administration of a Highly Potent E-Selectin Specific Inhibitor.
Presenters: Madhan Thamilarasan, William E. Fogler, John L. Magnani and Rahima Zennadi.
Session: 113 Hemoglobinopathies, Excluding Thalassemia—New Genetic Approaches to Sickle Cell Disease: New Insights Into Sickle Cell Disease Pathophysiology.
Date and Time: December 5, 2020. 2:00 – 3:30 p.m. EST
Presentation Time: 2:45 p.m.

Title: Targeting E-selectin with GMI-1271 Overcomes Microenvironment-mediated Resistance to Venetoclax/HMA Therapy.
Presenters: Kyung Hee Chang, Muharrem Muftuoglu, Weiguo Zhang, Mahesh Basyal, Lauren Ostermann, William E. Fogler, John L. Magnani and Michael Andreeff.
Session: 604 Molecular Pharmacology and Drug Resistance in Myeloid Diseases.
Date and Time: Saturday, December 5, 2020. 2:00 – 3:30 p.m.
Presentation Time: 3:15 p.m.

Title: Dual CXCR4 and E-selectin Inhibition (GMI-1359) Rapidly Increases AML Cellular Motility Prior to Intravasation and Vascular Niche Depletion Observed by Intravital Bone Marrow 2-Photon Microscopy.
Presenters: Tomasz Zal, M. Anna Zal, Mateusz Rytelewski, Kyung Hee Chang, Rodrigo Jacamo, William E. Fogler, John L. Magnani and Michael Andreeff.
Session: 616 Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II.
Date: Sunday, December 6, 2020.
Virtual Poster Hall: 7 a.m. – 3:30 p.m.

Title: Combined Blockage of E-selectin and CXCR4 (GMI-1359) Enhances Anti-Leukemia Effect of FLT3 Inhibition (Sorafenib) and Protects Hematopoiesis in Pre-clinical AML Models.
Presenters: Weiguo Zhang, Kyung Hee Chang, Mahesh Basyal, Yannan Jia, Lauren Ostermann, William E. Fogler, John L. Magnani, M. Anna Zal, Tomasz Zal and Michael Andreeff.
Session: 616 Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III.
Date: Monday, December 7, 2020.
Virtual Poster Hall: 7 a.m. – 3:30 p.m.

Title: Early Initiation of Treatment with Rivipansel for Acute Vaso-Occlusive Crisis in Sickle Cell Disease (SCD) Achieves Earlier Discontinuation of IV Opioids and Shorter Hospital Stay: Reset Clinical Trial Analysis
Presenter: Helen Thackray
Session Name: 114 Hemoglobinopathies, Excluding Thalassemia—Clinical: Novel Treatments for Sickle Cell Disease
Date and Time: Monday, December 7, 2020. 1:30 – 3:00 p.m.
Presentation Time: 1:45 p.m.

The accepted abstracts are available online through the ASH (Free ASH Whitepaper) meeting website, View Source

About Rivipansel

Rivipansel, the company’s wholly-owned glycomimetic drug candidate that binds to all three members of the selectin family (E-, P- and L-selectin), was GlycoMimetics’ first candidate to enter clinical development. After the Phase 3 RESET trial conducted by Pfizer, GlycoMimetics’ former collaborator, did not meet its primary or key secondary efficacy endpoints in 2019, new efficacy data from an additional analysis of rivipansel were published in June 2020 and subsequently presented at the Foundation for Sickle Cell Disease Research Meeting in September 2020. GlycoMimetics is engaging with the FDA to identify what, if any, next steps to take, with a focus on determining if there is a potential streamlined path forward for this asset in sickle cell disease.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly-targeted, highly-potent E-selectin antagonist. It has been shown in preclinical studies to be bioavailable via subcutaneous administration. At the 2018 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), data presented in a poster about GMI-1687 pointed to the potential for a life-cycle extension for GlycoMimetics’ uproleselan. The investigational drug has also been shown to represent a more highly-potent and subcutaneously bioavailable potential life-cycle extension for rivipansel.

About Uproleselan (GMI-1271)

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The Duke University Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug’s activity. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States.

On November 4, 2020 Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA) inventor of Cellvizio, the multidisciplinary probe and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform, reported the publication of a peer-reviewed meta-analysis and of an international Delphi consensus report based on a systematic, evidence-based review of endoscopic ultrasound (EUS) guided needle-based confocal laser endomicroscopy for pancreatic cystic lesion (PCL) evaluation (Press release, Mauna Kea Technologies, NOV 4, 2020, View Source [SID1234569877]).

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The first publication entitled "Needle-based Confocal Laser Endomicroscopy in Pancreatic Cysts: a Meta-Analysis", was published in the European Journal of Gastroenterology & Hepatology (2020, DOI: 10.1097/MEG.0000000000001728). Ten studies enrolling 536 patients were included and the authors evaluated diagnostic accuracy, pooled sensitivity, specificity, and mean procedural time. The meta-analysis concluded that confocal laser endomicroscopy "clearly outperformed" endoscopic ultrasound fine-needle aspiration (EUS-FNA) in terms of diagnostic accuracy (odds ratio 3.94, 1.58–9.82; P = 0.003) and supports the use of needle-based confocal laser endomicroscopy as a safe and effective tool in the diagnostic algorithm of pancreatic cysts.

The second publication entitled "Confocal Endomicroscopy for the Evaluation of Pancreatic Cystic Lesions: A Systematic Review and an International Delphi Consensus Report", was published in the peer-reviewed journal Endoscopy International Open (2020, DOI: 10.1055/a-1229-4156) and was based on consensus statements from an international panel of 15 experts in pancreatic disease that conducted evidence-based reviews of the applications, outcomes, procedural processes, indications, training, and credentialing of EUS-nCLE in the management of PCLs. The consensus report reflected a high level of agreement pertaining to expert consensus statements and established that EUS-guided nCLE is a minimally invasive procedure that improves evaluation of PCLs and "should be systematically considered when EUS-FNA is indicated for PCL evaluation."

The consensus report also concluded that the use of nCLE as an adjunct to standard EUS-FNA could positively impact patient management and improve healthcare resource utilization by reducing the number of misdiagnoses and preventing redundant follow-up investigations and unnecessary surgery.

"The new meta-analysis and consensus report provide further support that Cellvizio plays a key role in the evaluation of pancreatic cysts and can significantly improve the speed and accuracy of reaching a conclusive diagnosis," said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. "The level of clinical evidence and support suggests that hospitals performing endoscopic evaluation of pancreatic cysts would benefit their patients by incorporating Cellvizio as part of the management of their patients. This represents approximately 75,000 procedures in the US alone. We look forward to the growing adoption of Cellvizio for this important application."

On November 4, 2020 ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported that eight abstracts have been selected for presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held virtually from December 5-8, 2020 (Press release, ADC Therapeutics, NOV 4, 2020, View Source [SID1234569876]). Presentations will feature data on three of the Company’s pyrrolobenzodiazepine (PBD)-based ADCs – loncastuximab tesirine (Lonca), camidanlumab tesirine (Cami) and ADCT-602.

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"The breadth of data that will be presented at the ASH (Free ASH Whitepaper) Annual Meeting reflects the potential of our product candidates and speaks to our leadership in the development of next-generation ADCs to improve outcomes for patients with blood cancers," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "Notably, we look forward to sharing subgroup data from the Lonca LOTIS 2 pivotal trial in relapsed or refractory diffuse large B-cell lymphoma, interim results from our LOTIS 3 trial evaluating Lonca in combination with ibrutinib in patients with advanced diffuse large B-cell lymphoma or mantle cell lymphoma, as well as preliminary results from our pivotal Phase 2 trial of Cami in patients with relapsed or refractory Hodgkin lymphoma."

Lonca Presentations

Efficacy and Safety of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Abstract: 1183
Date and Time: Saturday, December 5, 2020, 7 a.m. – 3:30 p.m. PST
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster I
Presenter: Paolo F. Caimi, MD, Case Comprehensive Cancer Center, Case Western Reserve University

Characteristics and Treatment Patterns of Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Who Received ≥3 Lines of Therapies
Abstract: 1651
Date and Time: Saturday, December 5, 2020, 7 a.m. – 3:30 p.m. PST
Session: 905. Outcomes Research—Malignant Conditions (Lymphoid Disease): Poster I
Presenter: Jipan Xie, MD, PhD, Analysis Group, Inc.

Interim Results of Loncastuximab Tesirine Combined with Ibrutinib in Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (LOTIS-3)
Abstract: 2099
Date and Time: Sunday, December 6, 2020, 7 a.m. – 3:30 p.m. PST
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster II
Presenter: Julien Depaus, MD, CHU UCL Namur

Safety and Antitumor Activity Study Evaluating Loncastuximab Tesirine and Rituximab Versus Immunochemotherapy in Diffuse Large B-Cell Lymphoma
Abstract: 2107
Date and Time: Sunday, December 6, 2020, 7 a.m. – 3:30 p.m. PST
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster II
Presenter: Yuliya Linhares, MD, Miami Cancer Institute, Baptist Health South Florida

Cami Presentations

Preliminary Results of a Phase 2 Study of Camidanlumab Tesirine (Cami), a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Patients with Relapsed or Refractory Hodgkin Lymphoma
Abstract: 474
Date and Time: Sunday, December 6, 2020, 3 p.m. PST
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Clinical Studies in Hodgkin Lymphoma
Presenter: Alex Herrera, MD, City of Hope Medical Center

Pharmacokinetic and Pharmacodynamic Correlates from the Phase 1 Study of Camidanlumab Tesirine (Cami) in Patients with Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Abstract: 2981
Date and Time: Monday, December 7, 2020, 7 a.m. – 3:30 p.m. PST
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster III
Presenter: Joseph Boni, ADC Therapeutics

Combination of Camidanlumab Tesirine, a CD25-Targeted ADC, with Gemcitabine Elicits Synergistic Anti-Tumor Activity in Preclinical Tumor Models
Abstract: 1178
Date and Time: Saturday, December 5, 2020, 7 a.m. – 3:30 p.m. PST
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster I
Presenter: Francesca Zammarchi, ADC Therapeutics

ADCT-602 Presentation

Analysis of Adct-602 Pre-Clinical Activity in B-Cell Lymphoma Models and Identification of Potential Biomarkers for Its Activity
Abstract: 3011
Date and Time: Monday, December 7, 2020, 7 a.m. – 3:30 p.m. PST
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster III
Presenter: Francesco Bertoni, MD, Institute of Oncology Research, Università della Svizzera italiana

Online Publication in November Supplemental Issue of Blood
Symptoms, Health-Related Quality of Life, and Tolerability of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma
Abstract Number: 3919

The abstracts are available through the ASH (Free ASH Whitepaper) online meeting program and will be published in the November supplemental issue of Blood.

About Loncastuximab Tesirine (Lonca)

Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.

In September 2020, ADC Therapeutics submitted a Biologics License Application to the U.S. Food and Drug Administration seeking accelerated approval for Lonca for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Lonca is being evaluated in LOTIS 2, a pivotal Phase 2 clinical trial in patients with relapsed or refractory DLBCL, LOTIS 3, a Phase 1/2 clinical trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma, and LOTIS 5, a Phase 3 confirmatory clinical trial in combination with rituximab in patients with relapsed or refractory DLBCL.

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead killing the cell. This applies to CD25-expressing tumor cells, and also to CD25-expressing Tregs. The intra-tumoral release of its PBD warhead may also cause bystander killing of neighboring tumor cells and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity. Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (HL), as well as in a Phase 1a/1b clinical trial in patients with relapsed or refractory HL and non-Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.