On December 5, 2024 Simcha Therapeutics ("Simcha"), a clinical-stage immunobiology company pioneering first-in-class cytokine treatments in cancer, reported the opening of two clinical studies assessing the use of ST-067, Simcha’s decoy-resistant IL-18, in hematological indications (Press release, Simcha Therapeutics, DEC 5, 2024, View Source [SID1234648850]). One study (ClinicalTrials.gov ID NCT06492707) will assess ST-067 in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), while the other study (ClinicalTrials.gov ID NCT06588660) will test ST-067 in combination with teclistamab (TECVAYLI) in patients with multiple myeloma.

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"These two studies, both of which may rapidly generate clinical proof-of-concept data in indications where there is significant need for better therapies, represent a very exciting opportunity for us to explore additional therapeutic areas that have great potential to respond well to treatment with IL-18," said Sanuj Ravindran, M.D., chief executive officer of Simcha. "Emerging data, including those included in our preclinical poster to be presented at ASH (Free ASH Whitepaper), are generating signals that serve as proof-of-concept and point to the therapeutic potential of IL-18 across various hematological cancers, so we are pleased to partner with leading hematologic cancer experts on these trials."

The AML/MDS study, under principal investigator Elizabeth Krakow, M.D., of Fred Hutch Cancer Center, is enrolling patients over 18 years of age who have persistent or recurrent AML or MDS after hematopoietic cell transplantation (HCT), also known as a bone marrow transplant. While HCT is the only curative therapy for most forms of AML or MDS, relapse occurs in approximately one-third of patients and is the most common cause of death following HCT.

The Phase 1, open-label, dose-escalation study will primarily assess dose limiting toxicities and the number of clinical trial subjects who complete four consecutive weeks of treatment with ST-067. Secondary endpoints will assess response rates, overall survival and whether graft-versus-leukemia effects can be elicited without the accompanying graft-versus-host disease.

The study assessing ST-067 in combination with teclistamab, a bi-specific antibody with T cell engagement activity, in patients 18 years of age or older with relapsed or refractory multiple myeloma is occurring under the direction of Rahul Banerjee, M.D., of the University of Washington and Fred Hutch Cancer Center. This open-label Phase 1b study will primarily assess dose-limiting toxicities of ST-067 alone and in combination with teclistamab, as well as optimal dosing and the incidence of adverse events. Secondary endpoints will include overall response rate, duration of response, progression-free survival, overall survival and measurable residual disease negativity.

T-cell directed therapeutics, like teclistamab, other bi-specific antibodies or CAR Ts, have become standards of care for the treatment of relapsed/refractory multiple myeloma. However, they are not curative, as not all patients respond to teclistamab, and relapse can occur in those that do. The multiple myeloma study is based on the hypothesis that ST-067 in combination with teclistamab will promote T-cell fitness and persistence, which could increase the number of patients who respond to teclistamab and lengthen durations of response.

Data to be highlighted at ASH (Free ASH Whitepaper) in a poster presentation demonstrate the therapeutic activity of decoy-resistant IL-18 in multiple mouse models of hematological tumors including B-cell lymphoma, acute myeloid leukemia and plasma cell myeloma. The poster, entitled "Preclinical Efficacy of Decoy-Resistant IL-18 in Hematological Malignancies" will be presented during poster session 802 on Monday, December 9 from 6:00 PM to 8:00 PM.

In addition, a trials in progress poster describing the AML/MDS study will be presented at ASH (Free ASH Whitepaper). The poster, entitled "Trials in Progress: Decoy-Resistant Interleukin-18 (DR-18) for Relapse or Pre-Emptive Treatment of Measurable Residual Disease after Allogeneic Hematopoietic Cell Transplantation in Patients with AML and MDS: DR. DREAM, a Phase I Trial (NCT06492707)" will be presented Monday, December 9 from 6:00 PM to 8:00 PM in poster session 701.

On December 5, 2024 Sarah Cannon Research Institute (SCRI) reported that more than 65 abstracts and presentations have been accepted for the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Sarah Cannon Research Institute, DEC 5, 2024, View Source [SID1234648849]). Hosted in San Diego, Calif., and online from Dec. 7-10, the event is recognized as the premier global hematology conference, drawing experts and researchers from around the world.

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SCRI investigators, including physicians from The US Oncology Network and HCA Healthcare Sarah Cannon Transplant & Cellular Therapy Network, will present pioneering research across a range of topics including malignant and non-malignant blood cancers, blood disorders, CAR T-Cell therapy, innovative immunotherapies and real-world outcomes with a specific focus on results between inpatient and outpatient care.

"We look forward to presenting our latest research findings, which include advancements in the treatment of a wide range of hematologic malignancies," said David Spigel, MD, Chief Scientific Officer for SCRI. "This year’s presentations are a testament to the collective efforts of investigators across our network, highlighting the power of collaboration in advancing clinical research."

Featured presentations include:

Tonya Cox, BSN, HCA Healthcare Sarah Cannon Transplant & Cellular Therapy Network (SCTCTN), is first author alongside thirteen SCTCTN co-authors on a poster presentation titled, "Comparison of 15- Vs. 30-Day Remote Patient Monitoring for Outpatient Chimeric Antigen Receptor T-Cell Therapy across a Large Health System" to be shared on Saturday, December 7 at 5:30 p.m. PST.

Navneet Majhail, MD, MS, FASTCT, Physician-in-Chief of Blood Cancers for HCA Healthcare Sarah Cannon Cancer Network, and five SCTCTN physicians are co-authors on an oral presentation titled, "Efficacy and Safety of Brexucabtagene Autoleucel for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in Patients Aged 60 and Above." The oral presentation takes place on Sunday, December 8 at 9:30 a.m. PST.

Minoo Battiwalla, MD, SCRI at TriStar Centennial, is first author alongside eleven SCTCTN co-authors on a poster presentation titled, "The Patient Journey and Treatment Outcomes Comparing Inpatient Versus Outpatient Axicabtagene Ciloleucel in Non-Hodgkin’s Lymphoma – a Large, Multicenter Study" to be shared on Sunday, December 8 at 6:00 p.m. PST.

Jeff P. Sharman, MD, SCRI at Willamette Valley Cancer Institute & Research Center is first author alongside co-author John M. Burke, MD, SCRI at Rocky Mountain Cancer Centers on an oral presentation titled, "BRUIN CLL-321: Randomized Phase III Trial of Pirtobrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma." The oral presentation will take place on Monday, December 9 at 3:30 p.m. PST.

Haydar Frangoul, MD, SCRI at TriStar Centennial Children’s Hospital, is first author on a poster presentation titled, "Durable Clinical Benefits with Exagamglogene Autotemcel for Severe Sickle Cell Disease" to be shared on Monday, December 9 at 6:00 p.m. PST.

On December 5, 2024 Mission Bio, a leader in single-cell multiomics solutions for precision medicine, reported the full list of presentations by leading researchers and clinicians spanning multiple indications of blood cancer, leveraging the Tapestri Platform to advance therapeutic research and development at the 66th ASH (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Mission Bio, DEC 5, 2024, View Source [SID1234648848]). More than 20 presentations at the event, which takes place Dec. 7-10 in San Diego, will shine a spotlight on how Mission Bio’s customers are using Tapestri and associated products to gain a broader and deeper understanding of Multiple Myeloma, AML, Lymphoma, and CAR-T therapy development.

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Among these presentations, Mission Bio will showcase new datasets for the first time, demonstrating how the Tapestri Single-cell Multiple Myeloma Multiomics Solution, which became commercially available this year, can be used to integrate genomic, immunophenotypic, and clonotypic assessment to pinpoint disease-driving clones in Multiple Myeloma (MM). The team behind the data was led by Mission Bio CTO and co-founder Adam Sciambi.

"Our ongoing mission is to provide scientists with the means to understand hard-to-treat diseases like MM in ways that will lead to new, more effective treatments," Sciambi said. "We’re looking forward to sharing our findings on the role of rare clones in the progression from precursor conditions like monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) to full-blown MM, as well as the comprehensive clonal architecture underlying relapse and treatment resistance. We’re equally excited to see what our customers are doing to advance research into other forms of cancer."

A new study from Heidelberg University Hospital will showcase the value of single-cell DNA+protein multiomics sequencing to refine minimal residual disease (MRD) assessment in acute myeloid leukemia (AML). Presented under the title "Clonal Dynamics of Leukemic and Clonal Hematopoiesis Mutations Predict Relapse in Single Cell MRD Analysis of AML in First Complete Remission," the research uses patient samples to demonstrate how this approach offers greater precision than current techniques, potentially establishing a way to redefine AML MRD.

Researchers from the University of Cincinnati will also introduce the first-ever data demonstrating the feasibility of integrating DNA and fusion profiling at the single-cell level as a multiomic approach. The presentation, titled "Single-Cell Multi-Omic Analysis of KMT2A-Rearranged Pediatric Acute Leukemia Clonal Evolution," is the first of its kind to utilize the combination of simultaneous molecular profiling and fusion identification at the single-cell level for pediatric leukemia.

Following a recent publication in the New England Journal of Medicine, new findings from Stanford University highlight the power of single-cell DNA sequencing to uncover critical genomic insights in chimeric antigen receptor (CAR) T-cell therapy, revealing myeloid predominance for TP53 clonal hematopoiesis in post-CAR therapy myeloid neoplasms (tMN) among non-Hodgkin lymphoma patients. These findings, presented under the title "Single Institution Analysis of Lymphoma Treatment Related Post-CAR Myeloid Neoplasms," underscore the potential of single-cell DNA sequencing to inform CAR T therapy development, enabling safer treatments by addressing risks tied to therapy-induced molecular changes.

Additional institutions included among the presentations at ASH (Free ASH Whitepaper) include the National Institutes of Health, Weill Cornell Medical College, University of Pennsylvania, Berlin Institute of Health, Oxford University Hospitals, University of Miami Miller School of Medicine, and University of Toronto. For the full list of poster and oral presentations, or to schedule a one-on-one meeting with the Mission Bio team at the 2024 ASH (Free ASH Whitepaper) Annual Meeting, please visit View Source Attendees can also learn more about the Tapestri Platform and all of Mission Bio’s multiomics solutions by visiting booth #2112.

On December 5, 2024 Foresight Diagnostics, a leader in ultra-sensitive minimal residual disease (MRD) detection technology, reported the launch of SHORTEN-ctDNA, a clinical trial at Columbia University (Press release, Foresight Diagnostics, DEC 5, 2024, View Source [SID1234648847]). The study aims to evaluate the ability to utilize Foresight CLARITY MRD detection to enable real-time treatment optimization for patients with diffuse large B-cell lymphoma (DLBCL).

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Currently the standard treatment for newly diagnosed DLBCL requires six cycles of combination rituximab and chemotherapy regardless of individual patient response. This one-size-fits-all approach leaves little room for personalization, potentially exposing patients to unnecessary treatment. The SHORTEN-ctDNA trial will investigate whether patients who achieve early clearance of circulating tumor DNA (ctDNA) can safely receive fewer cycles of chemotherapy while maintaining long-term survival outcomes.

"Although PET scans remain our standard tool for monitoring lymphoma treatment, their inconsistent results in identifying active disease limit our ability to make real-time treatment decisions," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "Foresight CLARITY’s detection of residual disease could be the game-changer we need, potentially allowing us to confidently adjust therapy based on each patient’s actual response to treatment with a more dynamic and sensitive tool than imaging."

The study will enroll approximately 32 newly diagnosed DLBCL patients. After three cycles of R-CHOP or pola-R-CHP therapy, participants will undergo ctDNA testing. Those with detectable disease (MRD-positive) will continue with rituximab plus chemotherapy for their remaining cycles, while patients who achieve undetectable ctDNA levels (MRD-negative) will de-escalate to rituximab alone for their final two cycles.

"Recent evidence suggests many patients achieve very deep remissions earlier in their R-chemo treatment than previously thought," said Hua-Jay Cherng, MD, assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and Principal Investigator of the study. "By using next-generation, ultra-sensitive ctDNA technology, SHORTEN-ctDNA aims to identify these early responders and personalize their treatment strategy, potentially reducing treatment duration and associated toxicity and hopefully getting patients back to their normal lives sooner."

On December 5, 2024 Pixelgen Technologies, a leader in cell surface proteomics for single cells, reported upcoming participation at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper) in San Diego, Calif. from Dec. 7-10 at the San Diego Convention Center (Press release, Pixelgen Technologies, DEC 5, 2024, View Source [SID1234648846]). New data from collaborators will support the application of Pixelgen’s patented Molecular Pixelation (MPX) technology and kit across a broad range of scientific research, as the company expands into hematology.

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"With spatial mapping of cell surface proteins, hematology researchers can gain unprecedented insights into the organization and function of protein and protein complexes critical to blood cell function and disease," said Pixelgen CEO Simon Fredriksson, Ph.D. "This capability promises to advance diagnostics, enable personalized therapeutics, and support the development of next-generation treatments for blood cancers, immune dysregulation, and hematopoietic disorders. We’re excited to be participating in ASH (Free ASH Whitepaper) for the first time and sharing our groundbreaking technology with the hematology community."

Pixelgen will be featured in two sessions:

Dr. Fredriksson will give an industry presentation titled "The Spatial Organization of Surface Proteins of Single Cells in Myelodysplastic Syndrome for Diagnostics and Drug Target Discovery By Molecular Pixelation," featuring data from Dr. Aaron Viny, Columbia University, on Dec. 7 from 3:30-3:45 p.m., in Room 5B. Dr. Fredriksson will be joined by Dr. Viny.
Dr. Jessica Nordlund, Associate Professor at the Molecular Precision Medicine research group at Uppsala University, along with Dr. Maria Globisch, has a poster titled "Mapping the Spatial Proteome of Individual Leukemia Cells Undergoing Fludarabine Treatment," from 5:30-9:30 p.m. on Dec. 7, session number 803, in Halls G-H.
Pixelgen will be at Booth #2852 showcasing its product and technology. Representatives will be available to discuss the company’s latest data on identifying CAR-T cells and mapping their cell surface proteome for detailed mechanism of action studies. To support the company’s work in hematology, Pixelgen has developed an Application Note, in collaboration with Illumina, looking at cancer specific protein patterns of blood cancer cells.