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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 ImmunSYS, Inc. reported that Chairman & CEO Eamonn Hobbs presented on October 31st at the 2018 NYC Oncology Investor Conference, held at Rockefeller Center in Manhattan (Press release, ImmunSYS, NOV 1,2018, View Source [SID1234577208]). ImmunSYS was one of 31 companies accepted to present to investors attending the conference.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The NYC Oncology Investor Conference 2018 hosted by OneMed Forum, and sponsored by the National Foundation for Cancer Research, the International Cancer Impact Fund, Klosters Innovation Partners, Venable LLP, Torreya Partners, and Marcum is the leading conference for early-stage private and public cancer investing.

Meeting attendees included leading life science and oncology venture capitalists, family offices, lawyers, pharma executives, startup public and private cancer companies, and cancer foundations. The conference provides a forum for discussion of trends, opportunities, and risks in oncology investing, corporate presentations by a select group of public and private oncology companies, and updates on cutting edge science.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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