On November 7, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported data from its ADCETRIS (brentuximab vedotin) clinical development program at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 7-10 in Orlando, Fla (Press release, Seattle Genetics, NOV 7, 2019, View Source [SID1234550654]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma (HL) and expressed on the surface of several types of peripheral T-cell lymphomas. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.

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"At this year’s ASH (Free ASH Whitepaper) meeting, ADCETRIS will be featured in 15 data presentations, including updated analyses from ECHELON-1 and ECHELON-2 phase 3 frontline trials," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are encouraged by the ECHELON-1 update supporting a sustained progression-free survival benefit for ADCETRIS in combination with AVD when compared to ABVD in advanced classical Hodgkin lymphoma and additional analyses from trials evaluating ADCETRIS in combination with nivolumab. We continue to invest in our ADCETRIS clinical development program with the goal of improving outcomes for patients."

Details of oral presentations featured at ASH (Free ASH Whitepaper) include:

Safety and Efficacy of Brentuximab Vedotin in Combination with AVD in Stage II-IV HIV-Associated Classical Hodgkin Lymphoma: Results of the Phase 2 Study, AMC 085
Abstract: 130
Presenter: P. Rubinstein, Rush University Medical Center, Chicago, Ill.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Combination Chemotherapy and Biomarkers of Response in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 10:15 a.m. ET
Location: Tangerine 2 (WF2)

Brentuximab Vedotin in First Refractory/Relapsed Classical Hodgkin Lymphoma Patients Treated By Chemotherapy (ICE) before Autologous Transplantation. Final Analysis of Phase II Study
Abstract: 132
Presenter: A. Stamatoullas, Departement d’Hematologie, Centre Henry Becquerel, Rouen, France
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Combination Chemotherapy and Biomarkers of Response in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 10:45 a.m. ET
Location: Tangerine (WF2)

Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged ≥ 60 Years
Abstract: 237
Presenter: C. Yasenchak, Willamette Valley Cancer Institute and Research Center/US Oncology Research, Eugene, Ore.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Immunotherapy Approaches in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 2:30 p.m. ET
Location: W224

Brentuximab Vedotin and Nivolumab for Relapsed or Refractory Classical Hodgkin Lymphoma: Long-term Follow-up Results from the Single-arm Phase 1/2 Study
Abstract: 238
Presenter: A. Moskowitz, Memorial Sloan Kettering Cancer Center, New York, N.Y.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Immunotherapy Approaches in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 2:45 p.m. ET
Location: W224

A Phase I/II Trial of Brentuximab Vedotin (BV) Plus Rituximab (R) as Frontline Therapy for Patients with Immunosuppression-Associated CD30+ and/or EBV+ Lymphomas
Abstract: 351
Presenter: W. Pearse, Loyola University Medical Center, Maywood, Ill.
Session: Oral presentation Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Optimizing Frontline Chemotherapy
Date and Time: Sunday, December 8, 8:00 a.m. ET
Location: Hall E2

An Exploratory Analysis of Brentuximab Vedotin plus CHP (A+CHP) in the Frontline Treatment of Patients with CD30+ Peripheral T-cell Lymphomas (ECHELON-2): Impact of Consolidative Stem Cell Transplant
Abstract: 464
Presenter: K. Savage, British Columbia Cancer Centre for Lymphoid Cancer, University of British Columbia and the Department of Medical Oncology, Vancouver, B.C., Canada
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Novel Therapies in Peripheral T-cell Lymphomas
Date and Time: Sunday, December 8, 12:15 p.m. ET
Location: Valencia D (W415D)

Details of company-sponsored presentations are as follows:

Patterns of Care and Clinical Outcomes in Peripheral T-Cell Lymphoma Patients Receiving First-Line Treatment in Routine Clinical Practice in France and the United Kingdom
Abstract: 3482
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Real-World Treatment Patterns and Overall Survival Among Medicare Fee-for-Service Beneficiaries Newly Diagnosed with Peripheral T-Cell Lymphoma (PTCL)
Abstract: 3492
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Brentuximab Vedotin with Chemotherapy for Stage III/IV Classical Hodgkin Lymphoma (cHL): Four-Year Update of the ECHELON-1 Study
Abstract: 4026
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

Details of select investigator-sponsored presentations are as follows:

Long-Term Follow-up Confirms Durability of Single-Agent Brentuximab Vedotin as Pre-Transplant Salvage for Hodgkin Lymphoma
Abstract: 1555
Session: Poster Presentation
Date and Time: Saturday, December 7, 5:30-7:30 p.m. ET
Location: Hall B

A Pilot Study of Brentuximab Vedotin Combined with AVD Chemotherapy and Radiotherapy in Patients with Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Abstract: 2834
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Preliminary Results from a Phase 2 Trial of Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed by BV Consolidation in Patients with CD30-Expressing Peripheral T-cell Lymphomas
Abstract: 4023
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

Details of company-sponsored trials in progress are as follows:

Brentuximab Vedotin in Combination with Nivolumab, Doxorubucin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma
Abstract: 2836
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Brentuximab Vedotin in Front-Line Therapy of Hodgkin Lymphoma (HL) and CD30-Expressing Peripheral T-Cell Lymphoma (PTCL) in Adults Age 60 and Above
Abstract: 2852
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

A Phase 2 Study of Retreatment with Brentuximab Vedotin in Patients with cHL, sALCL or other CD30 Expressing PTCL
Abstract: 4054
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

On November 7, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that the Company will host an R&D event in New York on Tuesday, November 19, 2019 from 12:00 – 3:30 PM EST (Press release, Pieris Pharmaceuticals, NOV 7, 2019, View Source [SID1234550653]).

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The R&D event will feature presentations from management and thought leaders in immuno-oncology and respiratory diseases, including:

Michael A. Curran, PhD, Associate Professor, Department of Immunology and Scientific Director, ORBIT Platform, The UT MD Anderson Cancer Center
Geoffrey Y. Ku, MD, Assistant Attending Physician and Head, Esophagogastric Section, Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering
Anuradha Ray, PhD, Professor of Medicine, Department of Immunology and UPMC Endowed Chair in Lung Immunology Medicine, University of Pittsburgh
Sally E. Wenzel, MD, Professor of Medicine, Department of Medicine; Chair, Department of Occupational & Environmental Health; Acting Director, Asthma Environmental Lung Health Institute and UPMC Endowed Chair of Translational Airway Biology, University of Pittsburgh
Presentations will include expert discussant perspectives on recently presented data for PRS-343 and PRS-060, emerging data from the ongoing PRS-343 combination trial with atezolizumab, and perspectives on how these drug candidates could best fit into the emerging landscapes of asthma and immuno-oncology.

The event will be accessible via a live webcast through this link beginning at 12:30 PM EST on November 19, 2019.

In-person attendance is by invitation only. For more information, please contact [email protected].

On November 7, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported financial results for the third quarter of 2019 and recent business highlights (Press release, Atara Biotherapeutics, NOV 7, 2019, View Source [SID1234550652]).

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"I am pleased with our recent clinical, operational and strategic progress," said Pascal Touchon, President and Chief Executive Officer of Atara Biotherapeutics. "Following a comprehensive strategic portfolio review, we will focus our resources going forward on innovative off-the-shelf, allogeneic T-cell immunotherapy programs, specifically tab-cel, ATA188, ATA2271/ATA3271 and ATA3219. In parallel, we will continue to leverage the capabilities and expertise of external partners for development of autologous CAR T immunotherapies."

Following a six-month assessment of patients with progressive multiple sclerosis (MS) enrolled in cohort 3 of an ATA188 Phase 1a study, Atara selected this cohort 3 dose to initiate the randomized, double-blind, placebo-controlled Phase 1b part of this study.

"We are encouraged by the safety profile and early findings of potential efficacy for people living with progressive MS, as shown in our Phase 1a study data presented at ECTRIMS in September," said AJ Joshi, MD, Senior Vice President and Chief Medical Officer of Atara Biotherapeutics. "The decision to initiate the Phase 1b was based on achieving in cohort 3 our pre-determined criteria of a continued well-tolerated safety profile and at least 50 percent of patients achieving clinical improvement from more than one clinical study site using the criteria we defined at ECTRIMS. Recognizing these are early data, and incorporating input from external experts, we believe these results merit the acceleration of ATA188 development for progressive MS patients who have limited treatment options and in whom continual clinical decline is expected."

Recent Highlights and Anticipated Upcoming Milestones

61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting

Announced four abstracts highlighting robust off-the-shelf, allogeneic T-cell immunotherapy pipeline and next-generation CAR T technologies to be presented at the 61st ASH (Free ASH Whitepaper) Annual Meeting, December 7-10, 2019 in Orlando, Florida
Among these data are tab-cel long-term clinical outcomes from a multicenter expanded access protocol (EAP) study for patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD)
— 26 relapsed/refractory EBV+ PTLD patients were treated in a multicenter tab-cel EAP study including a subgroup of 22 patients who would have likely met eligibility criteria for Atara’s ongoing tab-cel Phase 3 studies
— An overall response rate (ORR) of 55 and 82 percent was observed in this subgroup of patients with EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT) and solid organ transplant (SOT), respectively
— Estimated 2-year overall survival (OS) in this subgroup was 79 and 81 percent for HCT and SOT, respectively
Atara will present additional findings describing the hospitalization burden of patients with EBV+ PTLD
Atara’s Moffitt Cancer Center collaborators to present two abstracts detailing next-generation CAR T technologies
Tab-cel (tabelecleucel)

Atara continues to progress tab-cel Phase 3 development for patients with EBV+ PTLD
— Atara remains on track to initiate a tab-cel biologics license application (BLA) submission for patients with EBV+ PTLD in the second half of 2020
— In the U.S. and Australia, 35 sites are available for enrollment and the company is preparing to open additional sites in the U.S. and Canada
— Atara plans to submit a clinical trial application (CTA) to several European countries by the end of 2019 to enable opening EU clinical sites next year
Atara continues to see strong tab-cel investigator, physician and patient interest, and in cases where the company is not able to enroll patients in its EBV+ PTLD Phase 3 clinical studies, Atara is providing tab-cel to patients in need under its early access and single patient use programs
Atara is in discussions with the European Medicines Agency (EMA) and the outcome of these discussions will determine the timing of the tab-cel EU conditional marketing authorization (CMA) application for patients with EBV+ PTLD
Studies supporting potential additional tab-cel indications are also advancing
— A Phase 1/2 clinical study of tab-cel in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC) is currently enrolling
— Atara expects to initiate enrollment in a Phase 2 multi-cohort study including patients with other EBV+ cancers in the second half of 2020
ATA188 for Multiple Sclerosis (MS)

Following a six-month assessment of patients with progressive MS enrolled in cohort 3 of an ATA188 Phase 1a study, Atara selected this dose to initiate the randomized, double-blind, placebo-controlled Phase 1b part of this study
In September, Atara presented safety and early findings of potential efficacy from a Phase 1a study of ATA188 in patients with progressive MS at the 35thCongress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)
— Completed enrollment in the fourth and final planned Phase 1 dose escalation cohort
— Atara expects to present additional efficacy and safety results from this study in 2020, including six and twelve-month assessments from cohorts 3 and 4
— Safety results showed across the 4 planned dose cohorts, ATA188 was well tolerated in patients with progressive forms of MS with no evidence of cytokine release syndrome, graft versus host disease or dose-limiting toxicities
Atara will not initiate a randomized study of autologous ATA190 in progressive MS at this time and will evaluate strategic options for this program
— Atara’s ATA190 portfolio decision is based on continued encouraging ATA188 results, acceleration of the ATA188 randomized Phase 1b study and the Company’s strategic focus on off-the-shelf, allogeneic T-cell immunotherapies
ATA2271/ATA3271 and ATA3219 CAR T Programs

Atara is developing a mesothelin-targeted autologous CAR T (ATA2271) for patients with advanced mesothelioma with an IND planned in 2020
— ATA2271 is designed using a novel 1XX CAR co-stimulatory domain and PD-1 dominant negative receptor (DNR) intrinsic checkpoint inhibition technology
Atara is also developing off-the-shelf, allogeneic CAR T immunotherapies targeting mesothelin (ATA3271) and CD19 (ATA3219) using its next generation technologies and EBV T cell platform
Operational

Facility commissioning and qualification activities to support clinical development at ATOM (Atara T-cell Operations and Manufacturing) are complete
— Commercial production qualification activities are progressing well and, together with our contracted manufacturing partner, are aligned with our planned commercial strategy
The Company is focused on aligning the current leadership to the Company’s new strategic priorities and actively searching for a new Global Head of Research and Development, Head of Commercial and General Counsel
Third Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments as of September 30, 2019 totaled $282.9 million, which includes $140.7 million in net proceeds from an underwritten public offering completed in July 2019
The Company believes that its current cash, cash equivalents and short-term investments are sufficient to fund planned operations into 2021
The Company reported a net loss of $71.9 million, or $1.31 per share, for the third quarter of 2019 as compared to $58.4 million, or $1.29 per share, for the same period in 2018
Total operating expenses include non-cash stock-based compensation and depreciation and amortization expenses of $13.9 million for the third quarter of 2019 as compared to $10.4 million for the same period in 2018
Research and development expenses were $53.5 million for the third quarter of 2019 as compared to $43.4 million for the same period in 2018. The increase in the third quarter of 2019 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
— Clinical study, manufacturing and outside service costs related to our MS programs
— Research and process development costs related to our CAR T programs
— Higher employee-related and overhead costs from increased headcount and operations
Research and development expenses include $7.0 million of non-cash stock-based compensation expense for the third quarter of 2019 as compared to $4.7 million for the same period in 2018
General and administrative expenses were $19.0 million for the third quarter of 2019 as compared to $16.9 million for the same period in 2018. The increase in the third quarter of 2019 was primarily due to increases in employee-related costs driven by increased headcount to support the Company’s expanding operations
General and administrative expenses include $5.1 million of non-cash stock-based compensation expense for the third quarter of 2019 as compared to $4.6 million for the same period in 2018
Conference Call and Webcast Information

Atara will host a live conference call and webcast today at 8:00 a.m. EST to discuss the Company’s financial results and recent operational highlights. Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 6069034. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.

On November 7, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), reported that five abstracts relating to the Company’s lead product candidate, rigosertib, were accepted for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, FL, which takes place December 7-10, 2019 (Press release, Onconova, NOV 7, 2019, View Source [SID1234550651]).

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Oral Presentation:

1.Phase II Study of Oral Rigosertib Combined with Azacitidine (AZA) As First Line Therapy in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Combination Therapies
Abstract: 566
Date: Monday, December 9, 2019
Presentation Time: 7:00 AM – 8:30 AM
Location: W311 EFGH (Orange County Convention Center)
Presenter: Shyamala C. Navada, MD, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY
Poster Presentations:

2.Genomic Profiling in Patients with Higher-Risk Myelodysplastic Syndrome (HR-MDS) Following HMA Failure: Baseline Results from the INSPIRE Study (04-30)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster II
Abstract: 3015
Date: Sunday, December 8, 2019
Session Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Guillermo Garcia-Manero, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

3.The INSPIRE Study in Higher-Risk Myelodysplastic Syndrome (HR-MDS): A Novel Phase 3 Study Adaptive Design for Hematological Malignancies in Adults
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster III
Abstract: 4249
Date: Monday, December 9, 2019
Presentation Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Anna Jonasova, MD, General University Hospital in Prague, 1st Internal Clinic – Clinic of Hematology, Prague, Czech Republic

4.Phase 3, Multi-Center, International, Randomized, Double-Blind, Placebo Controlled Study of Oral Rigosertib + Injectable Azacitidine (AZA) Versus Injectable Azacitidine in Treatment-Naïve Patients with Higher-Risk Myelodysplastic Syndrome (HR-MDS)
Session Name: 637. Myelodysplastic Syndromes – Clinical Studies: Poster III
Abstract: 4268
Date: Monday, December 9, 2019
Session Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Guillermo Garcia-Manero, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

5.The Sequenced Combination of Rigosertib and Azacitidine Has Modulatory Effects on CXCL8, RIG-I like Receptor (RLR) and Wnt/β-Catenin Signaling and Downstream Hematopoiesis Pathways in an in Vitro Model of the Myelodysplastic Syndrome
Session Name: 636. Myelodysplastic Syndromes – Basic and Translational Studies: Poster III
Abstract: 4231
Date: Monday, December 9, 2019
Session Time: 6:00 PM – 8:00 PM
Location: Hall B (Orange County Convention Center)
Presenter: Richa Rai, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY

On November 7, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of an abstract highlighting the pre-clinical results of combining pelareorep with the proteasome inhibitor carfilzomib in the treatment of multiple myeloma (Press release, Oncolytics Biotech, NOV 7, 2019, View Source [SID1234550650]). The abstract was published online as part of the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exhibition.

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The abstract, titled, "Proteasome Inhibitors Impair the Innate Antiviral Immune Response and Potentiate Pelareorep-Based Viral Therapy in Multiple Myeloma" describes the synergies between proteasome inhibitors and pelareorep concerning immuno-cellular changes and response in multiple myeloma patients.

The abstract was authored by Dr. Flavia Pichiorri, Associate Professor in the Judy and Bernard Briskin Center for Multiple Myeloma Research within the Hematologic Malignancies and Stem Cell Transplantation Institute at the City of Hope, et al. The publication of the abstract can be found on the website for the ASH (Free ASH Whitepaper) Annual Meeting at www.hematology.org/Annual-Meeting.

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.