Sarah Cannon Research Institute to Present Latest Research Insights at the 2023 ASH Annual Meeting & Exposition

On December 7, 2023 Sarah Cannon Research Institute (SCRI) reported that more than 80 abstracts and presentations have been selected for inclusion at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition. Hosted in San Diego and online from Dec. 9-12, the meeting is the year’s most comprehensive global hematology event (Press release, Sarah Cannon Research Institute, DEC 7, 2023, View Source [SID1234638277]).

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At this year’s ASH (Free ASH Whitepaper) Annual Meeting & Exposition, SCRI investigators, including physicians from The US Oncology Network, will discuss groundbreaking research in malignant and non-malignant blood cancer, CAR T-Cell therapy, real-world outcomes, and targeted immunotherapies.

"We look forward to sharing our research insights, including the latest developments in the treatment of sickle cell disease, immune effector cell therapy, and other novel therapies that are advancing the way we treat blood cancers and blood disorders," said Howard A. "Skip" Burris, III, MD, President, SCRI. "We are proud to share these important updates through the work of more than 65 investigators from across our network, which can only be done through the power of collaboration."

In November 2022, McKesson and HCA Healthcare formed a joint venture combining SCRI with former US Oncology Research, the research arm of The US Oncology Network. The collaboration brings together physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. More than 65 investigators from the joint venture will present insights at this year’s Annual Meeting. Separately, Ontada, McKesson’s oncology real-world data and evidence, clinical education, and provider technology business, is also presenting two posters at the conference.

Featured presentations include:

Haydar Frangoul, MD, MS, Sarah Cannon Pediatric Hematology/Oncology & Cellular Therapy Program at TriStar Centennial Medical Center, is first author on an oral presentation titled, "Exagamglogene Autotemcel for Severe Sickle Cell Disease" to be shared on Monday, December 11 at 4:30 p.m. (presentation time 4:45 p.m.) PST.

This presentation will include important updates from CLIMB SCD-121, an ongoing, 24-month, phase 3 trial of exa-cel in patients age 12-35 with sickle cell disease.

Dr. Frangoul is also co-author on an oral presentation titled, "Exagamglogene Autotemcel for Transfusion-Dependent β-Thalassemia" to be shared on Monday, December 11 at 4:30 p.m. (presentation time 5:00 p.m.) PST.

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Chris Yasenchak, MD, Willamette Valley Cancer Institute and Research Center, Jason Melear, MD, Texas Oncology, John M. Burke, MD, Rocky Mountain Cancer Centers, Habte A. Yimer, MD, Texas Oncology, Mihir Raval, MD, New York Oncology Hematology, Miguel Islas-Ohlmayer, MD, St. Elizabeth Healthcare, Mitul Gandhi, MD, Virginia Cancer Specialists, and John Scott Renshaw, MD, Texas Oncology, are co-authors on the oral presentation, "Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine for Advanced Stage Classical Hodgkin Lymphoma: Efficacy and Safety Results from the Single Arm Phase 2 Study" presented on Sunday, December 10 at 4:30 p.m. (presentation time 4:45 p.m.) PST.

John M. Burke, MD, Rocky Mountain Cancer Centers, Mitul Gandhi, MD, Virginia Cancer Specialists, and Christopher A. Yasenchak, MD, Willamette Valley Cancer Institute and Research Center, will highlight "Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine (AN+AD) for Early-Stage Classical Hodgkin Lymphoma (SGN35-027 Part C)" through an oral presentation on Sunday, December 10 at 4:30 p.m. (presentation time 5:30 p.m.) PST.

These studies represent two arms of significant clinical trials exploring treatment advancements in classical Hodgkin Lymphoma (both advanced and early stage).

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Tonya Cox, BSN, Sarah Cannon Transplant & Cellular Therapy Network, is first author alongside seventeen SCRI/Sarah Cannon Transplant & Cellular Therapy Network co-authors on an oral presentation titled, "Standardization of Outpatient Care after CAR-T Therapy Across a Large Cell Therapy Network- Through Technology and Decentralized Virtual Nurses: Preliminary Results" which will be presented on Saturday, December 9 at 2:00 p.m. PST.

This study describes the innovative care model of using remote patient monitoring to provide chimeric antigen receptor T-cell therapies in the outpatient setting across a network of cell therapy centers.

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Jeffrey Matous, MD, Colorado Blood Cancer Institute, is first author on an oral presentation titled, "Talquetamab + Pomalidomide in Patients with Relapsed/Refractory Multiple Myeloma: Safety and Preliminary Efficacy Results from the Phase 1b MonumenTAL-2 Study" which will be shared on Monday, December 11 at 4:30 p.m. PST.

This presentation will offer an update out of a Phase I study for patients with relapsed/refractory multiple myeloma.

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Paul Shaughnessy, MD, Sarah Cannon Transplant & Cellular Therapy Program at Methodist Hospital, is a co-author on a late-breaking oral presentation, titled, "Reduced Intensity Haploidentical Bone Marrow Transplantation in Adults with Severe Sickle Cell Disease: BMT CTN 1507" which will be presented on Tuesday, December 12 at 9:00 a.m. PST.

This presentation presents the results of a Phase II multi-center single-arm prospective clinical trial of haploidentical transplantation in adults with severe sickle cell disease.

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A full list of presentations can be found here. Investigators highlighting research at this year’s ASH (Free ASH Whitepaper) Annual Meeting & Exposition represent studies being conducted across SCRI, Sarah Cannon Transplant & Cellular Therapy Network, and partners from The US Oncology Network and Ontada.

Seres Therapeutics Announces Presentation of Preliminary PK/PD and Safety Data for Investigational Microbiome Therapeutic SER-155 at ASH 2023

On December 7, 2023 Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, reported that preliminary clinical data from a currently enrolling Phase 1b study of SER-155 study in adult patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT) will be presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting held from December 9-12, 2023, in San Diego, California, USA (Press release, Seres Therapeutics, DEC 7, 2023, View Source [SID1234638276]). SER-155 is an oral, cultivated live bacterial consortia investigational therapeutic designed to prevent enteric-derived infections and resulting blood stream infections, as well as reduce the incidence of graft-versus-host disease (GvHD) by modulating immune responses in the gastrointestinal tract.

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Poster Presentation Details:
Poster Title: Impact of Investigational Microbiome Therapeutic SER-155 on Pathogen Domination: Initial Results from a Phase 1b Study in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT)
Poster number: 2198
Presenter: Jonathan Peled, MD, PhD, Memorial Sloan Kettering Cancer Center, New York, NY
Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster I
Session Date/Time: Saturday, December 9, 2023: 5:30pm – 7:30pm EST
Location: San Diego Convention Center, Halls G-H

About SER-155
SER-155 is a consortium of bacterial strains selected using Seres’ reverse translation discovery and development platform technologies. SER-155 design incorporated microbiome biomarker data from human clinical data and preclinical data from human cell-based assays and in vivo disease models. SER-155 is intended to restructure the gastrointestinal microbiome by decreasing the abundance of bacterial pathogens that can harbor antibiotic resistance, and introducing bacteria that provide immunomodulatory metabolites that can improve mucosal barrier integrity and reduce local GI inflammation. These effects are hypothesized to reduce the likelihood of pathogen translocation and subsequent bloodstream infection and GvHD.

Aura Biosciences Announces First Patient Dosed in Global Phase 3 CoMpass Trial Evaluating the Safety and Efficacy of Belzupacap Sarotalocan (Bel-sar) for First-Line Treatment of Early-Stage Choroidal Melanoma

On December 7, 2023 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported the first patient has been dosed in the global Phase 3 CoMpass trial evaluating the safety and efficacy of bel-sar for the first-line treatment of adult patients with early-stage choroidal melanoma (Press release, Aura Biosciences, DEC 7, 2023, View Source [SID1234638275]).

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"Dosing of the first patient in this global Phase 3 trial is a major milestone for Aura, and for patients with early-stage choroidal melanoma, a life-threatening rare disease with no approved targeted therapies," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "With the SPA agreement from the FDA, and a strong endorsement from the ocular oncology community, we continue to move bel-sar closer to potentially being approved as a first-line vision preserving treatment for patients living with this disease."

The CoMpass trial is designed as a superiority trial comparing bel-sar versus a sham control. The trial is a global Phase 3, randomized, multi-center, masked study, intended to enroll approximately 100 patients randomized 2:1:2 to receive high dose regimen of bel-sar, low dose regimen of bel-sar with suprachoroidal (SC) administration or a sham control. Aura received written agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the overall design of the CoMpass trial.

Medidata Unveils Multi-Sector Research Alliance at the 65th ASH Annual Meeting and Exposition

On December 7, 2023 Medidata, a Dassault Systèmes company and leading provider of clinical trial solutions to the life sciences industry, reported the launch of the Medidata Research Alliance (Press release, Medidata, DEC 7, 2023, View Source [SID1234638274]). This unique consortium brings together leading clinician-researchers and key opinion leaders from academia, non-profit organizations, and the life sciences industry to leverage Medidata’s expertise in Artificial Intelligence (AI) capabilities and clinical trial data to drive cutting-edge research into innovative treatments.

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The Medidata Research Alliance bridges insights from data into clinical practice, fostering scientific exploration that can be applied across multiple therapeutic areas.

"This initiative combines the deep expertise of physician-scientists with Medidata AI and data-driven research to help advance medical breakthroughs – ultimately supporting patients and the broader healthcare and life sciences communities," said Fareed Melhem, SVP, Medidata AI, Medidata. "Our collective ambition is to drive medical progress by drawing insights from the volume, depth, and richness of our historical clinical trial data."

One significant area of focus for the Research Alliance is providing a greater understanding of Chimeric antigen receptor T (CAR-T) cell therapy, a promising new therapeutic approach to treat cancer. CAR-T clinical developers face a number of challenges, including life-threatening side effects and a lack of relevant data. Medidata and academic researchers can now partner and leverage the insights from an exclusive CAR-T dataset, generated through the Medidata Data Collaboration Program. And through this effort, collaborators explore clinically impactful hypotheses and jointly conduct research that provides tangible improvements in patient care.

"It’s been a dream come true to partner with such a great group of people at Medidata and to utilize such a robust dataset to explore these hypotheses in a more granular and highly statistically powered way than a single institution may otherwise be able to," said Theodore Scott Nowicki, MD, PhD, Assistant Professor of Pediatric Hematology/Oncology at the David Geffen School of Medicine, UCLA.

Results from the Research Alliance collaborations will be presented in poster sessions at the 65th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held from December 9-12, 2023:

Poster 3626: The association of phosphorus disruption and neurotoxicity in patients undergoing CAR-T therapy
Poster 3629: Significant CRS risk model with T-cell engaging therapies
Poster 5018: Machine learning-based decision tree for clinical management of neurotoxicity in patients undergoing CAR-T therapy

NextPoint Therapeutics Announces IND Clearance from the FDA to Advance NPX887, a Novel Therapeutic Targeting HHLA2 to Reactivate Exhausted T and NK Cells in HHLA2+ Solid Tumors

On December 7, 2023 NextPoint Therapeutics, a clinical-stage biotechnology company developing precision immuno-oncology therapeutics targeting the novel HHLA2 pathway, reported the acceptance of its investigational new drug (IND) application by the U.S. Food & Drug Administration (FDA) for NPX887 (Press release, NextPoint Therapeutics, DEC 7, 2023, View Source [SID1234638273]). The company plans to initiate a first-in-human Phase I clinical trial in early 2024 evaluating NPX887 in patients with solid tumors known to express HHLA2, a tumor antigen strongly upregulated in many human cancers.

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"NPX887 represents our second clinical program targeting the HHLA2 checkpoint axis. NextPoint’s approach is to advance therapeutics targeting this axis from different angles to prevent tumors from cloaking themselves from the immune system," said Leena Gandhi, MD, PhD, Chief Medical Officer of NextPoint Therapeutics. "This important milestone allows us to advance our clinical evaluation of NPX887 and brings us one step closer to our goal of expanding treatment options for patients with cancer."

About NPX887

NPX887 is a fully human monoclonal antibody targeting HHLA2 (B7-H7), a novel immune checkpoint and tumor target antigen highly expressed in many cancers independently of PD-L1. NPX887 is designed to prevent immune escape in solid tumors by blocking KIR3DL3-mediated immunosuppression upon binding to HHLA2. Treatment with NPX887 is believed to promote T and NK cell antitumor activity within the tumor microenvironment.