On November 3, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, reported that it will support 30 data presentations, including seven oral presentations in large B-cell lymphoma (LBCL), and two oral presentations on investigator-sponsored studies in acute myeloid leukemia (AML) during the 64th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (December 10-13) (Press release, Gilead Sciences, NOV 3, 2022, View Source [SID1234623032]).

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"Every year, we see more patients benefitting in profound ways from CAR T-cell therapy," said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite. "The breadth of real-world evidence and multi-year follow-up in pivotal studies we present this year can reinforce physicians’ confidence in the durability and reliability of Kite’s CAR T-cell therapies."

Key presentations for Kite’s CAR T-cell therapies include three-year results from ZUMA-5 in indolent non-Hodgkin lymphoma (iNHL) and exploratory data from the three-year results from ZUMA-2 in mantle cell lymphoma (MCL) and two-year results from ZUMA-3 in B-cell acute lymphoblastic leukemia (ALL). Additional Kite research will focus on new sub-analyses of ZUMA-7 in LBCL, and real-world experience studying the impact of time from leukapheresis to infusion on patient outcomes.

"We continue to grow the body of evidence for new therapeutic options that improve how we treat blood cancers, which include some of the most challenging tumors," said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. "With our recently announced collaboration with MacroGenics to develop their second-generation CD123 bispecific antibody, we are excited about our presence at ASH (Free ASH Whitepaper) and the potential of our pipeline to improve patient outcomes across a variety of hematologic cancers."

An oral presentation showcasing results from a Phase 1/2 study of our investigational, anti-CD47 immunotherapy, in combination with azacitidine and venetoclax in patients with newly diagnosed older/unfit AML and relapsed/refractory AML also will be presented.

On November 3, 2022 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, reported that new preclinical data on its CDC7 inhibitor, SGR-2921, will be presented during a poster session at the American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting taking place virtually and in New Orleans, Louisiana, December 10-13, 2022 (Press release, Schrodinger, NOV 3, 2022, View Source [SID1234623031]).

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CDC7 is a cell cycle kinase involved in DNA replication and is an important activator of replication stress and DNA damage responses. CDC7 inhibition is considered a promising therapeutic approach for the treatment of cancers, including acute myeloid leukemia (AML). Schrödinger is advancing SGR-2921 through investigational new drug (IND)-enabling studies with plans to initiate a Phase 1 trial in patients with relapsed/refractory acute myeloid leukemia (AML) in the second half of 2023.

On November 3, 2022 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported that three abstracts highlighting data and information from the clinical development program evaluating the intermittent dosing of zandelisib, an investigational phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor for the treatment of B-cell malignancies, will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2022 Annual Meeting to be held December 10 – 13, 2022 (Press release, MEI Pharma, NOV 3, 2022, View Source [SID1234623030]).

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On November 3, 2022 Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, reported that new clinical data will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 10-13 (Press release, Orca Bio, NOV 3, 2022, View Source [SID1234623029]). Specifically, an oral presentation will include new data on relapse-free survival with Orca Bio’s lead investigational high-precision cell therapy, Orca-T. Additionally, results from Orca Bio’s Phase 1 clinical trial of its second investigational cell therapy, Orca-Q, in patients with haploidentical donors will be presented for the first time in an oral presentation.

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Orca Bio will also share two poster presentations featuring data on immune reconstitution and elevated regulatory T cell frequencies in patients treated with Orca-T, as well as an analysis of the cost burden of allogeneic hematopoietic cell transplants and the potential value of addressing this unmet need.

ASH abstracts are now available at www.hematology.org. Details of the Orca Bio presentations follow:

Oral Presentations:

Title: Precision-Engineered Cell Therapy Orca-T Demonstrates High Relapse-Free Survival at 1 Year While Reducing Graft-Versus-Host Disease and Toxicity
Abstract Number: 265
Date and Time: Saturday, December 10, 2022, at 2 p.m. CST
Location: 391-392, Ernest N. Morial Convention Center
Presenter: Everett Meyer, M.D., Ph.D., Associate Professor of Medicine, Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford Health Care

Title: Orca-Q Demonstrates Favorable GvHD-and Relapse-Free Survival in Haploidentical Transplants without Post-Transplant Cyclophosphamide
Abstract Number: 769
Date and Time: Monday, December 12, 2022, at 10:30 a.m. CST
Location: 252-254, Ernest N. Morial Convention Center
Presenter: Amandeep Salhotra, M.D., Associate Professor, Division of Leukemia, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope

Poster Presentations:

Title: Rapid Immune Reconstitution and Elevated Regulatory T Cell Frequencies in Patients Treated with Orca-T
Abstract Number: 3408
Date and Time: Sunday, December 11, 2022, from 6 p.m. – 8 p.m. CST
Location: Hall D, Ernest N. Morial Convention Center

Title: Estimating the Lifetime Medical Cost Burden of an Allogeneic Hematopoietic Cell Transplantation Patient and the Value of Addressing the Unmet Need
Abstract Number: 4865
Date and Time: Monday, December 12, 2022, from 6 p.m. – 8 p.m. CST
Location: Hall D, Ernest N. Morial Convention Center

About Orca-T

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

On November 3, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported an upcoming presentation highlighting key features of WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, that support its application for the treatment of relapsed/refractory (R/R) acute myelogenous leukemia (AML) and elucidate predictors of therapeutic response to cytokine-induced memory-like (CIML) NK cell therapy (Press release, Wugen, NOV 3, 2022, View Source [SID1234623028]). The data will be presented at the 64th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) taking place December 10 – 13, 2022 in New Orleans, Louisiana.

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Compared to conventional NK cells, WU-NK-101 demonstrated enhanced trafficking to the bone marrow, robust anti-tumor activity, and an adaptive metabolic profile consistent with aerobic glycolysis, which may support resilience in an immunosuppressive tumor microenvironment (TME). Together, these data demonstrate WU-NK-101 may represent an effective treatment modality for R/R AML.

Further analysis also identified an 8-gene TME signature score that was significantly higher at baseline in patients with R/R AML that responded to CIML NK cell therapy. The TME signature also correlated with response duration.

The details of Wugen’s presentation at ASH (Free ASH Whitepaper) are as follows:

Title: Putative Predictors of Response to WU-NK-101, an Allogeneic, Enhanced Memory (ML)
Natural Killer (NK) Cell Therapy Product, for Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
Publication Number: 3294
Session Name: 703. Cellular Immunotherapies: Basic and Translational: Poster II
Session Date and Time: Sunday, December 11, 2022 from 6:00 p.m. – 8:00 p.m. CT
Location: Ernest N. Morial Convention Center, Hall D
Presenting Author: Sergio Rutella, M.D., Ph.D., FRCPath, FRSB, Nottingham Trent University

Additional meeting information can be found at View Source

About WU-NK-101
WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary Moneta platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.