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 Nordic Nanovector ASA (OSE: NANO) reported that an abstract reporting updated results from its LYMRIT 37-01 Phase 1/2 clinical study of Betalutin (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma (iNHL) has been published ahead of its presentation in a poster at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (1-4 December 2018 in San Diego, CA, USA) (Press release, Nordic Nanovector, NOV 1, 2018, View Source [SID1234553490]).

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The published dataset (as of 22 June 2018) includes 74 evaluable patients; all patients received Betalutin as a single administration and have six or more months of follow-up. The complete dataset will be presented at ASH (Free ASH Whitepaper).

The conclusions from the updated study results are that Betalutin is well-tolerated and has promising anti-tumour activity in recurrent iNHL, especially in follicular lymphoma (FL) patients. Key results are:

Patients Number of patients (n) Overall Response Rate (ORR) Complete Responses (CR)
All iNHL patients 74 61 % 26 %
FL patients 57 65 % 24 %
3L FL patients (≥2 prior therapies) 37 70 % 27 %
FL patients in Arm 1
(40 mg lilotomab followed by 15 MBq/kg Betalutin) 25 64 % 28 %
FL patients in Arm 4
(100 mg/m2 lilotomab followed by 20 MBq/kg Betalutin) 16 69 % 19 %
The median duration of response (mDoR), when treated with a single administration of Betalutin, was 13.3 months for all patients (20.5 months for those with a CR) based on a median follow-up of 9.1 months (range 4.9-49.5 months). Twenty-six patients (35%) have remained free of disease progression for more than 12 months.

Betalutin therapy was well tolerated with no unexpected safety findings and the safety profile is both predictable and manageable.

The data continue to highlight the encouraging clinical profile of single-agent Betalutin therapy in iNHL patients, particularly in those with FL, the primary NHL population for which Betalutin is being developed.

Two recommended Phase 2 doses were identified from this study and are now being compared in the pivotal, randomised Phase 2b PARADIGME trial in relapsed, anti-CD20 refractory FL patients who have received two or more prior therapies.

Arne Kolstad, lead investigator of LYMRIT 37-01 and senior consultant in medical oncology and radiotherapy, Oslo University Hospital Radiumhospitalet, said: "Patients with relapsed/refractory follicular lymphoma have a need for effective treatment options that improve their quality of life, especially elderly patients. The clinical profile that Betalutin is consistently showing in this patient population is very encouraging."

Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: "We are very pleased with the clinical data. The results from Arm 4 further support the decision to compare the 100 mg/m2 lilotomab + 20 MBq/kg Betalutin dosing regimen from Arm 4 with the 40 mg lilotomab + 15 MBq/kg regimen from Arm 1 in the pivotal phase 2b PARADIGME trial. The emerging data on the durability of the responses together with the safety profile of Betalutin and the convenience of a single administration underscore the potential of Betalutin for the treatment of patients with advanced-stage follicular lymphoma."

Poster details

Abstract 2879

Abstract title: LYMRIT 37-01: A phase I/II study of 177Lu-lilotomab satetraxetan (Betalutin) antibody-radionuclide-conjugate (ARC) for the treatment of relapsed non-Hodgkin’s lymphoma (NHL) – Analysis with 6-month follow-up

Authors: A. Kolstad, A et al.

Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II

Date: Sunday, 2 December 2018

Presentation Time: 6:00 PM – 8:00 PM Pacific time

Location: San Diego Convention Center, Hall GH

The abstract is available at View Source and the poster will be published on the Nordic Nanovector website to coincide with the session.

About ASH (Free ASH Whitepaper)

The ASH (Free ASH Whitepaper) annual meeting is the premier event for scientific exchange in the field of haematology, attracting more than 20,000 attendees from all over the world. Typically, more than 5,000 scientific abstracts are submitted each year, and more than 3,000 abstracts are accepted for oral and poster presentations through an extensive peer review process.

About LYMRIT 37-01

LYMRIT 37-01 is a Phase 1/2 dose-escalation study to determine the safety, pharmacokinetics and preliminary efficacy of a single dose of Betalutin in patients with relapsed iNHL, and to establish a recommended Phase 2 dose for the global, randomised Phase 2b PARADIGME trial.

LYMRIT 37-01 recruited 74 pts [57 follicular (FL), 7 mantle cell (MCL), 9 marginal zone (MZL), 1 small lymphocytic (SLL)] at 13 sites between December 2012 and February 2018. Median age was 68 years (range 38-87; 55% ≥ 65); the median number of prior therapies was 3 (range 1-9); 48 pts (65%) received 2 or more prior therapies.

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.