On November 1, 2018 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it will present data from three accepted abstracts related to MEI Pharma’s clinical stage drug development programs at the 2018 ASH (Free ASH Whitepaper) Annual Meeting to be held December 1-4, 2018 in San Diego (Press release, MEI Pharma, NOV 1, 2018, View Source [SID1234530572]).

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Study investigators will present updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma and other indolent B-cell malignancies, as well as results from a preclinical study demonstrating that voruciclib and venetoclax synergistically induce apoptosis in acute myeloid leukemia (AML) cells in vitro. The third abstract will present data from the pracinostat program, being developed in partnership with Helsinn Healthcare, SA, and will highlight an interim analysis of pracinostat in an ongoing Phase 2 study evaluating patients with high/very high-risk myelodysplastic syndrome (MDS).

"Data reported at the ASH (Free ASH Whitepaper) Annual Meeting this year continue to highlight the depth of our clinical pipeline and the progress across multiple programs, each with its own distinct mechanisms for targeting cancer biology," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Notably, the ME-401 data to be reported is supportive of our approach to evaluate both a continuous and intermittent dosing schedule in our Phase 2 study planned to start around year-end in an effort to maximize the utility of the candidate as both a single agent or in combination with other therapies."

Dr. Gold continued: "We also look forward to highlighting the preclinical data demonstrating that our CDK9 inhibitor candidate, voruciclib, synergistically enhances cancer cell death when combined with venetoclax in AML cells in vitro, adding to earlier data showing similar synergies in CLL and DLBCL preclinical models. These results are supportive of possible future studies evaluating voruciclib in combination with venetoclax in relapsed AML."

Poster Presentations at ASH (Free ASH Whitepaper) 2018

Title: Preliminary Safety and Efficacy Results with an Intermittent Schedule of the PI3K delta Inhibitor ME-401 Alone or in Combination with Rituximab for B-Cell Malignancies
Date & Time: December 2, 2018, 6:00 p.m. – 8:00 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 115670
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
Author: Andrew D. Zelenetz, M.D., Ph.D., Medical Director, Quality Informatics at Memorial Sloan Kettering Cancer Center

Title: Voruciclib, an Oral, Selective CDK9 Inhibitor, Enhances Cell Death Induced by the Bcl-2 Selective Inhibitor Venetoclax in Acute Myeloid Leukemia
Date & Time: December 1, 2018, 6:15 p.m. – 8:15 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 118372
Session: 604. Molecular Pharmacology and Drug Resistance in Myeloid Diseases: Poster I
Author: Daniel A. Luedtke, BS, Wayne State University School of Medicine, Cancer Biology Graduate Program

Title: Planned Interim Analysis of a Phase 2 Study Evaluating the Combination of Pracinostat, a Histone Deacetylase Inhibitor (HDACi), and Azacitidine in Patients with High/Very High-Risk Myelodysplastic Syndrome (MDS)
Date & Time: December 3, 2018, 6:00 p.m. – 8:00 p.m.
Location: San Diego Convention Center, Hall GH
Abstract: 112741
Session: 637. Myelodysplastic Syndromes—Clinical Studies: Poster III
Author: Michael Keng, M.D., University of Virginia School of Medicine, Assistant Professor

Abstracts featured as part of the ASH (Free ASH Whitepaper) 2018 program may be found at: View Source

On November 1, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported publication of an abstract on pelareorep to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition taking place December 1-4 in San Diego, California (Press release, Oncolytics Biotech, NOV 1, 2018, View Source [SID1234530637]).

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The abstract, authored by Craig C. Hofmeister, Acting Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine, et al., is titled "Oncolytics Virus Replication Using Pelareorep (Reolysin) and Carfilzomib in Relapsed Myeloma Patients Increases PD-L1 Expression with Clinical Responses".

Because immune checkpoint inhibitors can only be effective when tumors express checkpoints such as PD-L1, an industry-wide effort is underway to identify agents that can upregulate the checkpoints on checkpoint-naked tumor cells. The abstract outlines a two-part study that demonstrated an increase in viral infection, viral replication and PD-L1 expression on the surface of myeloma cells for patients undergoing treatment with pelareorep in combination with carfilzomib (Kyprolis), a proteasome inhibitor, while carfilzomib alone has not been shown to induce PD-L1 expression. In part one of the study, six carfilzomib-sensitive patients showed reovirus infection and replication in the post-treatment bone marrow aspirates. In part two of the study, seven carfilzomib-refractory patients were enrolled, and of the three patients processed to date, reovirus infection was detected in myeloma cells of two patients and endothelial cells of one patient.

"With two very good partial responses and two partial responses, the results demonstrate an objective response at the recommended dose, as well as increased viral infection and viral replication," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "Most notably, in these myeloma patients receiving a proteasome inhibitor, systemically delivered pelareorep led to increases in PD-L1 expression, making pelareorep an ideal candidate to use in combination with this drug class."

The complete abstract can be found online at View Source Full details from the poster presentation will be announced after it is presented.

Presentation Number: 2655
Title:
Oncolytics Virus Replication Using Pelareorep (Reolysin) and Carfilzomib in Relapsed Myeloma Patients Increases PD-L1 Expression with Clinical Responses
Date: Sunday, December 2
Lecture Time: 6:00 p.m. PT – 8:00 p.m. PT
Location: San Diego Convention Center, Hall GH
Speakers: Craig Hofmeister
Session:
605. Molecular Pharmacology, Drug Resistance—Lymphoid and Other Diseases: Poster II

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On November 1, 2018 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported that new translational data for NiCord, an investigational cell therapy in Phase 3 clinical development for allogeneic stem cell, or bone marrow, transplant, will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting, which is being held December 1-4 in San Diego, CA (Press release, Gamida Cell, NOV 1, 2018, View Source [SID1234530653]).

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Details about the poster presentation are as follows:
Presentation Time: Saturday, December 1, 2014, 6:15 p.m. – 8:15 p.m. PT
Title: Rapid and Robust CD4+ and CD8+ T-, NK-, B- and Monocyte Cell Reconstitution after Nicotinamide-Expanded Cord Blood Transplantation
Abstract Number: 2123
Lead Author: Jaap Jan Boelens, M.D., Ph.D., Pediatric Blood and Marrow Transplantation Program, University Medical Center Utrecht, Utrecht, Netherlands
Location: San Diego Convention Center, Hall GH

About NiCord
NiCord, the company’s lead clinical program, is under development as a universal bone marrow transplant solution for patients with high-risk hematologic malignancies. NiCord has demonstrated improved efficacy over standard cord blood, including fewer bacterial and fungal infections and a reduction in duration of hospital stays. NiCord has been granted breakthrough status by the U.S. Food and Drug Administration, making it the first bone marrow transplant alternative to receive this designation. It has also received U.S. and EU orphan drug designation. A Phase 3 study evaluating NiCord in patients with leukemia and lymphoma is ongoing in the United States, Europe and Asia (NCT02730299). For more information on NiCord clinical trials, please visit www.clinicaltrials.gov.

On November 1, 2018 Sorrento Therapeutics, Inc. (NASDAQ: SRNE), an innovative immunotherapy company, reported that the first patients were dosed in a Phase 1 study to evaluate the safety and efficacy of CD38 CAR-T therapy in relapsed or refractory multiple myeloma patients at two clinical sites – University of Pennsylvania (UPenn) in Philadelphia and Roger Williams Medical Center in Rhode Island (Press release, Sorrento Therapeutics, NOV 1, 2018, View Source [SID1234532250]). The CD38 CAR-T cells manufactured at both Sorrento cGMP facilities (San Diego, CA and Providence, RI) met all release specifications and were used in the study.

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This study is the first US-based clinical trial targeting CD38 using an autologous CAR-T cell therapy. Details on the study can be found at: www.clinicaltrials.gov : NCT03464916. Phase 1, Open-Label, Dose-Escalation, Pharmacokinetic, and Pharmacodynamic Study of the Safety and Efficacy of CAR2 Anti-CD38 A2 CAR-T Cells in Patients with Relapsed or Refractory Multiple Myeloma.

On November 1, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that 35 abstracts related to Genmab owned and partnered programs have been accepted for presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 1-4 in San Diego, California (Press release, Genmab, NOV 1, 2018, View Source [SID1234530513]). Abstracts accepted for presentation include updates on multiple daratumumab and ofatumumab trials, as well as pre-clinical data from Genmab’s DuoBody-CD3xCD20 and DuoHexaBody-CD37 programs. All abstracts are available on the ASH (Free ASH Whitepaper) website at www.hematology.org. Details regarding the key abstracts to be presented are included below.

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"We are elated that out of the over eighty-five ongoing daratumumab clinical studies, a record thirty abstracts containing daratumumab data in multiple myeloma and other indications were accepted for presentation at this year’s ASH (Free ASH Whitepaper) Annual Meeting. We are also thrilled that three abstracts related to pre-clinical data from wholly owned Genmab programs were accepted for inclusion at this prestigious event, including the first proprietary DuoBody program, DuoBody-CD3xCD20, and the first ever DuoHexaBody therapeutic program, DuoHexaBody-CD37," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Late breaking abstracts are not yet available.

Genmab Pre-Clinical Abstracts

DuoBody-CD3xCD20 Shows Unique and Potent Preclinical Anti-Tumor Activity In Vitro and In Vivo, and is Being Evaluated Clinically in Patients with B-Cell Malignancies – Poster presentation, Saturday, December 1

DuoHexaBody-CD37 a Novel Bispecific Antibody with a Hexamerization enhancing Mutation Targeting CD37, Demonstrates Superior CDC in Preclinical B-Cell Malignancy Models – Poster presentation, Monday, December 3

Targeting CD37 in B-Cell Malignancies Using the Novel Therapeutic Ab DuoHexaBody-CD37 Results in Efficient Killing of Tumor B-Cells Ex Vivo via CDC, Even in Relapsed and/or Refractory Patient Samples – Poster presentation, Monday, December 3

Daratumumab Abstracts Sponsored by Janssen Biotech, Inc.

Oral Presentations:
Efficacy and Updated Safety Analysis of a Safety Run-in Cohort from GRIFFIN, a Phase 2 Randomized Study of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide, and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Eligible for High-Dose Therapy and Autologous Stem Cell Transplantation – Oral presentation, Saturday, December 1

LYRA – A Phase 2 Study of Daratumumab Plus Cycolphosphamide, Bortezomib, and Dexamethasone in Newly Diagnosed and Relapsed Patients with Multiple Myeloma – Oral presentation, Saturday, December 1

One-Year Update of a Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma: ALCYONE – Oral presentation, Saturday, December 1

Poster Presentations:
Three-Year Follow Up of the Phase 3 POLLUX Study of Daratumumab Plus Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone in Relapsed or Refractory Multiple Myeloma – Poster presentation, Saturday, December 1

Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Safety and Efficacy Update of the Open-label, Multicenter, Phase 1b Study (PAVO) – Poster presentation, Saturday, December 1

Pharmacokinetics of Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Primary Clinical Pharmacology Analysis of the Open-label, Multicenter, Phase 1b Study (PAVO) – Poster presentation, Saturday, December 1

Split First Dose Administration of Daratumumab for the Treatment of Patients with Multiple Myeloma: Clinical Pharmacology and Population Pharmacokinetic Analyses – Poster presentation, Saturday, December 1

Updated Results from the Phase 2 CENTAURUS Study of Daratumumab Monotherapy in Patients with Intermediate-risk or High-risk Smoldering Multiple Myeloma – Poster presentation, Saturday, December 1

Daratumumab Monotherapy for Patients with Relapsed or Refractory Natural Killer/T-cell Lymphoma (NKTCL), Nasal Type: An Open-label, Single-arm, Multicenter Phase 2 Study – Poster presentation, Saturday, December 1

Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib, and Dexamethasone in First Relapse Patients: Two-Year Update of CASTOR – Poster presentation, Sunday, December 2

Evaluation of Sustained Minimal Residual Disease Negativity in Relapsed / Refractory Multiple Myeloma Patients Treated with Daratumumab in Combination with Lenalidomide Plus Dexamethasone or Bortezomib Plus Dexamethasone: Analysis of POLLUX and CASTOR – Poster presentation, Sunday, December 2

Efficacy of Daratumumab in Combination with Standard of Care Regimens in Lenalidomide-Exposed or Refractory Patients with Relapsed / Refractory Multiple Myeloma: Analysis of CASTOR, POLLUX and MMY1001 Studies – Poster presentation, Sunday, December 2

Ofatumumab Abstracts Sponsored by Novartis

Oral Presentation:
Results of the Primary Analysis of COMPLEMENT A+B: A Phase III Study of Ofatumumab in Combination with Bendamustine Versus Bendamustine Alone in Patients with Indolent Non-Hodgkin’s Lymphoma That is Unresponsive or Relapsed Following Rituximab or Rituximab-containing Regimen – Oral presentation, Sunday, December 2

Poster Presentation:
Long-Term Evaluation of Efficacy and Safety of Ofatumumab Added to Fludarabine & Cyclophosphamide in Subjects with Relapsed Chronic Lymphocytic Leukemia: Final Analysis of COMPLEMENT 2 Trial – Poster presentation, Sunday, December 2