On November 30, 2018 Eureka Therapeutics, Inc., a clinical stage biopharmaceutical company with the goal of curing cancer by developing novel T-cell therapies that harness the evolutionary power of the immune system, reported that five abstracts, including four oral presentations and one poster discussion, highlighting clinical programs in multiple myeloma and NHL using binding domains developed by Eureka, have been accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 1-4 in San Diego, California (Press release, Eureka Therapeutics, NOV 30, 2018, View Source [SID1234531755]).

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The data presented at this meeting underscores the potential potency of antibodies generated from Eureka’s proprietary E-ALPHA discovery platform, which includes the human BCMA and CD19 binding domains used in the CAR-T and ARTEMIS T-cell therapies presented at ASH (Free ASH Whitepaper). The E-ALPHA platform comprises a highly diverse human-derived antibody phage library, containing over 100 billion clones with unique antibody sequences, and a robust workflow to develop highly specific antibodies against target antigens.

"We are pleased to be working with Eureka on our multiple myeloma programs," said Eric Smith, M.D., Ph.D., Director of Translational Development, Cellular Therapeutics Center at Memorial Sloan Kettering Cancer Center (MSK) and co-inventor of CARs for the targeting of multiple myeloma. "Working with Eureka to identify fully-human BCMA and other multiple myeloma targeted binding domains has the potential to avoid host anti-CAR immunity that may develop when using murine derived antibodies as binders. We look forward to continue working with Eureka on developing the next generation of T-cell therapies."

"We are delighted that data involving Eureka’s assets are being reported in many presentations at ASH (Free ASH Whitepaper) – in particular the exciting clinical data from the BCMA/multiple myeloma programs that we developed in collaboration with Memorial Sloan Kettering in 2012 and licensed to Juno Therapeutics (now Celgene) in 2016," said Dr. Cheng Liu, President and Chief Executive Officer of Eureka Therapeutics. "In addition, the updated data from the 21-patient proof-of-concept study of our ARTEMIS T-cell therapy (ET190L1 ARTEMIS) for CD19-positive r/r NHL continues to show that our ARTEMIS T-cells have been well tolerated with no observed cytokine release syndrome (CRS) or neurotoxicity, validating the potential of our ARTEMIS platform to deliver safer T-cell therapy than the currently available CAR-T therapies."

The accepted abstracts are listed below and are now available on the ASH (Free ASH Whitepaper) website.

Multiple Myeloma

CAR T Cell Therapy Targeting G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D), a Novel Target for the Immunotherapy of Multiple Myeloma
Author: Eric L. Smith, MD, PhD
Abstract #589
Oral Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Development of Novel Immunotherapeutic Approaches in Multiple Myeloma
Monday, December 3, 2018: 7:00 AM, Ballroom 20D
Clinical Responses and Pharmacokinetics of MCARH171, a Human-Derived BCMA Targeted CAR T Cell Therapy in Relapsed/Refractory Multiple Myeloma: Final Results of a Phase I Clinical Trial
Author: Sham Mailankody, MBBS
Abstract #959
Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Immunotherapies in Plasma Cell Disorders
Monday, December 3, 2018: 5:30 PM, Ballroom 20A
JCARH125, Anti-BCMA CAR T-cell Therapy for Relapsed/Refractory Multiple Myeloma: Initial Proof of Concept Results from a Phase 1/2 Multicenter Study (EVOLVE)
Author: Sham Mailankody, MBBS
Abstract #957
Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Immunotherapies in Plasma Cell Disorders
Monday, December 3, 2018: 5:00 PM, Ballroom 20A
Fully Human BCMA Targeted Chimeric Antigen Receptor T Cells Administered in a Defined Composition Demonstrate Potency at Low Doses in Advanced Stage High Risk Multiple Myeloma
Author: Damian J. Green, MD
Abstract #1011
Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Immunotherapy
Monday, December 3, 2018: 6:45 PM, Ballroom 20D
Non-Hodgkin Lymphoma

ET190L1-ARTEMIS T Cell Therapy Results in Durable Disease Remissions with No Cytokine Release Syndrome or Neurotoxicity in Patients with Relapsed and Refractory B-Cell Lymphoma
Author: Zhitao Ying, MD, PhD
Abstract #1689
Poster Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster I
Saturday, December 1, 2018, 6:15 PM-8:15 PM, Hall GH
About E-ALPHA Antibody Discovery Platform
Eureka’s proprietary E-ALPHA antibody discovery platform is composed of a highly diverse human-derived antibody phage library, containing over 100 billion clones with unique antibody sequences, and a robust workflow with specificity screens designed to develop highly specific antibodies against target antigens. The E-ALPHA platform is designed to enable Eureka to rapidly discover, iterate upon and improve our antibodies. Eureka’s E-ALPHA platform enables Eureka to develop highly specific antibodies for both conventional targets, such as cell surface markets, and T-cell receptor targets, such as intracellular peptides displayed by the major histocompatibility complex, with the goal of addressing solid tumors.

About ARTEMIS T-cell Receptor Platform
Eureka’s proprietary ARTEMIS T-cell receptor platform was designed to create potentially safer and more effective T-cell therapies. In pre-clinical studies against CD19-positive malignancies, Eureka’s ARTEMIS T-cells matched the cancer killing potency of currently available CAR-T therapies but with a dramatic reduction in the levels of inflammatory cytokines released. Cytokine release syndrome (CRS) and neurotoxicity are serious side effects associated with currently available CAR-T therapies.

On November 30, 2018 bluebird bio, Inc. (Nasdaq: BLUE) reported that the company will host a live webcast of an investor and analyst event being held on Monday, December 3, 2018, during the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, bluebird bio, NOV 30, 2018, View Source [SID1234531754]). Speaker presentations will begin at 8:30 p.m. PST (11:30 p.m. EST) and will review the company’s data being presented at the ASH (Free ASH Whitepaper) meeting.

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To access the live webcast of bluebird bio’s presentation, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source A replay of the webcast will be available on the bluebird bio website for 90 days following the event.

On November 30, 2018 Adaptive Biotechnologies and its collaborators reported it will present 28 studies, including a late-breaker presentation, at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in San Diego, December 1-4, 2018 (Press release, Adaptive Biotechnologies, NOV 30, 2018, View Source [SID1234531753]). The data presented at ASH (Free ASH Whitepaper) builds on the recent FDA clearance of the clonoSEQ Assay to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma or B-cell acute lymphoblastic leukemia (ALL), using DNA from a patient’s bone marrow sample.

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Among the 28 clonoSEQ studies at ASH (Free ASH Whitepaper), new research supports expanded use in myeloma and ALL, efficacy in other blood cancers like chronic lymphocytic leukemia (CLL) and Non-Hodgkin’s Lymphoma (NHL), and ability to detect MRD in blood-based samples. New data generated using clonoSEQ will be presented that demonstrate the value of a highly sensitive, standardized next-generation sequencing MRD test to determine early response to treatment and predict potential relapse in myeloma and ALL patients. Data will also be presented that look at the sensitivity of clonoSEQ and other technologies to assess MRD.

"This year has been a landmark year for minimal residual disease. It’s one of the first new endpoints we’ve seen in hematology clinical trials since progression-free survival," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "The volume and the quality of MRD data being presented at ASH (Free ASH Whitepaper) establish that MRD has firmly taken root as a clinical trial endpoint and biomarker that can help predict patient outcomes. With greater reliance on MRD in clinical trials, as well as a growing focus on monitoring MRD to inform patient care, having access to a highly sensitive, standardized test like clonoSEQ is paramount."

clonoSEQ, the first clinical application of Adaptive’s pioneering immune profiling platform, will be featured in a late-breaker presentation, 12 oral presentations and 15 posters. Data on approved, investigational and research uses will be presented across a range of cancers – 14 multiple myeloma, 4 ALL, 4 CLL, 4 mantle cell lymphoma, 1 diffuse large B-cell lymphoma, and 1 Hodgkin’s lymphoma.

Key highlights include:

Abstract Title Date, Time, Location
Multiple myeloma and ALL
Abstract #LBA-2, Late-Breaker Presentation

LBA-2: Phase 3 Randomized Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant (MAIA) Tuesday, December 4, 7:30 AM PT, Hall AB, San Diego Convention Center
Abstract #156, Oral Presentation

One-Year Update of a Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) in Patients (Pts) with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (NDMM): Alcyone Saturday, December 1, 1:15 PM PT, Grand Ballroom 7, Marriott Marquis San Diego Marina
Abstract #123, Oral Presentation

Ixazomib-Lenalidomide-Dexamethasone (IRd) Consolidation Following Autologous Stem Cell Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Large Multi-Center Phase II Trial Saturday, December 1, 10:00 AM PT, Grand Hall C, Manchester Grand Hyatt San Diego
Abstract #281, Oral Presentation

Multivariable Modeling of Disease and Treatment Characteristics of Adults with B-ALL in MRD-Negative CR after CD19 CAR-T Cells Identifies Factors Impacting Disease-Free Survival Sunday, December 2, 8:30 AM PT, Ballroom 20D, San Diego Convention Center
Abstract #1551, Poster Presentation

Molecular Detection of Minimal Residual Disease Precedes Morphological Relapse and Could be Used to Identify Relapse in Pediatric and Young Adult B-Cell Acute Lymphoblastic Leukemia Patients Treated with Tisagenlecleucel Saturday, December 1,
6:15 PM PT, Hall GH, San Diego Convention Center

Abstract #3272, Poster Presentation

Evaluation of Sustained Minimal Residual Disease (MRD) Negativity in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (Pts) Treated with Daratumumab in Combination with Lenalidomide Plus Dexamethasone (D-Rd) or Bortezomib Plus Dexamethasone (D-Vd): Analysis of Pollux and Castor Sunday, December 2, 6:00 PM PT, Hall GH, San Diego Convention Center
Blood-based MRD Monitoring
Abstract #147, Oral Presentation

Circulating Tumor DNA Dynamics during Therapy Predict Outcomes in Mantle Cell Lymphoma Saturday, December 1, 12:30 PM PT, Pacific Ballroom 20, Marriott Marquis San Diego Marina
Abstract #3137, Poster Presentation

Undetectable-Minimal Residual Disease (U-MRD6) (10-6 sensitivity) Is Associated with Best Progression-Free Survival for Patients Who Achieve Bone Marrow Undetectable MRD4 (10-4 sensitivity) with First-Line FCR Sunday, December 2, 6:00 PM PT, Hall GH, San Diego Convention Center
About Minimal Residual Disease

Minimal residual disease (MRD), also referred to as measurable residual disease, refers to cancer cells that remain in the body after treatment for patients with lymphoid cancers. These cells can be present at levels undetectable by traditional morphologic methods, microscopic examination of blood, or a bone marrow or a lymph node biopsy.

MRD is used by physicians to detect and monitor disease burden in patients and to inform their treatment decisions. Clinical practice guidelines recommend assessing MRD at multiple time points during treatment and maintenance in MM and ALL, and guidelines for both diseases include NGS as a recommended testing method. The prognostic value of MRD assessment has been demonstrated in multiple lymphoid cancers. Controlled trials have shown that even small amounts of disease are profoundly significant for predicting a patient’s long-term clinical outcomes. Therefore, highly sensitive, standardized molecular technologies are needed for reliable detection of MRD.

Measurement of MRD is currently being evaluated as a way to measure efficacy in drug trials, with the potential to expedite the approval of emerging therapies.

About the clonoSEQ Assay

The Adaptive Biotechnologies clonoSEQ Assay has been granted De Novo designation by the FDA as an in vitro diagnostic (IVD) to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from bone marrow samples. It identifies and quantifies specific DNA sequences found in malignant cells, allowing clinicians to monitor patients for changes in disease burden during and after treatment. This robust assay provides sensitive and accurate measurement of residual disease that allows physicians to predict patient outcomes, assess response to therapy over time, monitor patients during remission and detect potential relapse. The clonoSEQ Assay is a single-site assay performed at Adaptive Biotechnologies. It is also available as a CLIA-regulated laboratory developed test (LDT) service for use in other lymphoid cancers.

clonoSEQ was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk novel devices for which there is no legally marketed predicate device.

For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary

On November 30, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that further correlative data from the Phase 2b trial of nelipepimut-S (NPS, NeuVax) in combination with trastuzumab (Herceptin) for the treatment of women with triple-negative breast cancer (TNBC) will be presented in a poster presentation at the 2018 San Antonio Breast Cancer Symposium (SABCS), taking place December 4-8, 2018 in San Antonio, TX (Press release, Sellas Life Sciences, NOV 30, 2018, View Source;Herceptin-at-the-2018-San-Antonio-Breast-Cancer-Symposium/default.aspx [SID1234531752]). The data will include efficacy results from analysis of key predefined subgroups and the difference in the patterns of disease relapse between the active (NPS plus trastuzumab) versus the control (trastuzumab) arms.

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Details for the presentation are as follows:

Title: Subgroups analysis of a multicenter, prospective, randomized, blinded phase 2b trial of trastuzumab + nelipeptimut-S (NeuVax) vs trastuzumab for prevention of recurrence in breast cancer patients

Poster Session 2: Treatment: Immunotherapy (clinical)

Poster Hall Location: Hall 1

Poster Hall Hours: Thursday, December 6, 2018; 8:30 – 10:00 am ET

Abstract ID: P2-09-01

SELLAS previously announced that the full dataset, as well as correlations between clinical response and HLA type, from the Phase 2b trial of nelipepimut-S in combination with trastuzumab were presented in an oral presentation at the 2018 Annual Meeting of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) on October 22, 2018 in Munich, Germany, and in a poster presentation at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 9 and 10, 2018 in Washington, D.C., respectively

On November 30, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) Application for FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line (Press release, Fate Therapeutics, NOV 30, 2018, View Source [SID1234531751]). The clinical trial of FT500 is expected to be the first-ever clinical investigation in the U.S. of an iPSC-derived cell product.

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"The clearance by the FDA of our FT500 IND is a significant milestone and marks the beginning of an exciting new era for the clinical development of cell products," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "Clonal master iPSC lines are a renewable cell source that can uniquely produce cell products which are uniformly engineered and well characterized, can be mass produced in a cost-effective manner, and can be delivered off-the-shelf to treat many patients. This revolutionary paradigm overcomes significant challenges that limit both patient- and donor-derived cell therapy, where heterogeneous populations of primary cells are repeatedly sourced, engineered, expanded and characterized on a batch-by-batch basis resulting in cell therapies with substantial variability in quality, consistency and potency."

The Company plans to initiate first-in-human clinical testing of FT500 in combination with checkpoint inhibitor therapy for the treatment of advanced solid tumors. This study is expected to evaluate the safety and tolerability of multiple doses of FT500, in multiple dosing cycles with nivolumab, pembrolizumab or atezolizumab, in subjects that have progressed or failed on checkpoint inhibitor therapy.

On Monday, December 3, an oral presentation at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition will feature new preclinical data demonstrating that FT500 has enhanced anti-tumor cytotoxicity and promotes T-cell activation and homing. Moreover, in an in vitro three-dimensional tumor spheroid model, FT500 in combination with activated T cells and an anti-PD1 antibody significantly enhance the elimination of target cancer cells, as compared to FT500 or activated T cells alone. Additional iPSC-derived, off-the-shelf cell product candidates from the Company’s iPSC product platform, including its first iPSC-derived chimeric antigen receptor (CAR) T-cell (FT819) and CAR NK cell (FT596) product candidates, will also be highlighted at ASH (Free ASH Whitepaper).

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary iPSC product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event, and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf to treat many patients. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.