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.

Mission Bio Announces Over 20 Presentations Demonstrating the Utility of Tapestri Across AML, Multiple Myeloma, and Lymphoma at the 2023 ASH Annual Meeting

On December 7, 2023 Mission Bio, a leader in single-cell multiomic solutions for precision medicine, reported new data generated by clinical researchers from leading biopharma companies and top academic institutions will be showcased at the 65th ASH (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Mission Bio, DEC 7, 2023, View Source [SID1234638272]). This announcement follows on the heels of the successful launch of the company’s scMRD Assay, to which the latest data on 48 samples from the Clínica Universidad de Navarra will be featured in a poster presentation at the conference. The widespread adoption of Tapestri for hematological research and therapeutic development signifies the importance of single-cell multi-omic data and indicates a potential new gold standard in precision medicine.

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At the American Society of Hematology (ASH) (Free ASH Whitepaper) conference, being held in San Diego on December 9-12, world-leading scientists will present results demonstrating Tapestri’s capabilities to uncover critical insights into clonal dynamics, therapeutic response mechanisms, and clones driving disease persistence and relapse, reflecting the platform’s unique capabilities and position in the market.

Included among the presentations is the first data demonstrating the potential actionability of Mission Bio’s Tapestri Single-Cell MRD (scMRD) AML Multiomics Assay, which will be presented from the lab of Felipe Prosper, MD, PhD, Co-director of the Hematology and Cell Therapy Unit at the Clínica Universidad de Navarra, highlighting its feasibility for assessing MRD in AML patients.

"Understanding the genetic heterogeneity at the single-cell level is crucial to the discovery and development of safer and more effective treatments for blood cancers," said Todd Druley, MD, PhD, Chief Medical Officer of Mission Bio. "We’re excited to see so many of our customers leverage Tapestri, validating the scientific merit of our technology, demonstrating its practical application in a clinical setting, and substantiating the impact of single-cell data to potentially transform care by guiding more personalized treatments in AML, multiple myeloma (MM), and other blood cancers."

Among the ASH (Free ASH Whitepaper) presentations, researchers from Dr. Prosper’s lab will present results demonstrating the concordance between Mission Bio’s scMRD assay and the gold-standard techniques for MRD, such as PCR and multiparameter flow cytometry (MFC), in AML patient samples. The data suggest the scMRD Multiomics Assay’s potential role in advancing targeted therapeutic approaches and its influence on treatment paradigms in the future.

In the presentation, "Minimal Residual Disease Detection By Single Cell DNA Sequencing Technology: A Feasible Approach for Clinical Application and Identification of the Landscape of MRD Clones," the researchers showed that Mission Bio’s scMRD AML Multiomics Assay:

Identified rare leukemic clones that were missed by conventional assays.
Distinguished clonality of clinically actionable mutations, compared to MFC and PCR data, which only designated MRD status.
Detected MRD-positive patients, which were deemed negative by MFC and PCR,
Differentiated between clonal hematopoiesis (CH) clones and leukemic clones.
"Patients suffering from relapsed AML have poor overall survival, necessitating more effective methods for MRD monitoring and detection to better understand the genomic landscape of clonal evolution," said Dr. Prosper. "This impressive data is a significant step towards demonstrating the feasibility of Mission Bio’s assay to detect and monitor MRD in AML patients, to ultimately enable more effective therapeutic strategies, including combination and targeted therapies, based on insights from single-cell DNA and protein multiomics for improved patient outcomes in the future."

These results follow Mission Bio’s successful commercial launch of the scMRD AML Multiomics Assay, designed to offer deep genotypic and immunophenotypic insights into MRD signatures within individual cells.

"Multiple Myeloma therapy, similarly to other blood cancers like AML, remains a challenge and huge unmet medical need because of the poor prognosis and high relapse rate. Tapestri’s ability to combine SNVs, CNVs, and surface protein expression at a single-cell level will be crucial to myeloma surveillance and understanding clonal evolution, and our ability to fully realize precision medicine," said Cedric Dos Santos, PhD, Director AML/MDS/MM, Translational Medicine, at Genentech.

Data from other blood cancer studies will be presented by leading researchers in over 24 presentations leveraging Mission Bio’s Tapestri Platform, showcasing its broad application in hematology. These studies from institutions including Genentech, Merck, MD Anderson Cancer Center, Broad Institute of MIT and Harvard, and St. Jude Children’s Research Hospital embody Mission Bio’s commitment to advancing hematological research. For a complete list of ASH (Free ASH Whitepaper) presentations using Tapestri, please visit our website.