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Genomic Testing Cooperative (GTC) to Share 12 Ground-breaking Abstracts at the 2025 American Society of Hematology (ASH) Annual Meeting in Orlando

On December 2, 2025 Genomic Testing Cooperative (GTC), a leading provider of integrated DNA and RNA next-generation sequencing (NGS) solutions for hematologic tumors and liquid biopsy applications, reported that its work and data will be presented in 12 abstracts at the ASH (Free ASH Whitepaper) 2025 Annual Meeting in Orlando, December 6-9. The work represents novel proprietary approaches using artificial intelligence (AI) for prediction models, transcriptomic signatures, cell-free RNA (cfRNA) analytics, ethnic-ancestry outcomes, circulating cell-free multiple myeloma cells (CMMCs), and more — underscoring GTC’s commitment to innovation in precision hematology.

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"The presented diagnostic innovations provide powerful new tools for stratifying patients and selecting targeted therapy that have the potential of changing the practice of oncology." Said Dr. Maher Albitar the Chief Executive Officer, Chief Medical Officer and Founder of GTC. "The integration of RNA analysis with advanced AI is redefining what precision medicine can achieve. These breakthroughs were made possible by the cooperative business model in diagnostics that was established at the inception of GTC" Dr. Albitar added.

Highlights of the abstracts include:

Liquid-biopsy mutation landscape and its concordance with skin biopsies in cutaneous T-cell lymphoma (abs25-2858)
AI-derived prediction of response and relapse to venetoclax + hypomethylating-agent therapy in acute myeloid leukemia (AML) (abs25-14588)
Integrative clinical and molecular analysis of outcome in elderly African-ancestry AML (abs25-14645)
B- and T-cell clonality using peripheral blood cell-free RNA (cfRNA) in liquid biopsy (abs25-7865)
Somatic mutations and clinical outcomes in primary central nervous system lymphoma among Hispanic and non-Hispanic patients: a study from the UCHMC (University of California Hematologic Malignancies Consortium) (abs25-7950)
Ultra high-risk multiple myeloma with early mortality despite quad-class and BCMA-directed therapies: clinical and molecular insights (abs25-12597)
Real-world validation of the molecular prognostic risk signature in AML treated with hypomethylating agents + BCL-2 inhibitor (abs25-15523)
Developing artificial-intelligence-based transcriptomic signature for selecting patients with HOXA-MEIS1 pathway abnormalities for treatment with menin inhibitors (abs25-4126)
Developing artificial-intelligence-based transcriptomic signature for the diagnosis of dark-zone lymphoma in patients without MYC gene rearrangement (abs25-7855)
Molecular profiling and kinetics of circulating multiple myeloma cells (CMMCs) predict resistance to bispecific antibodies (BsAbs) in relapsed/refractory multiple myeloma (RRMM) (abs25-12216)
Developing transcriptomic signature for IDH1 and IDH2 acute leukemia and the demonstration of high prevalence of these signatures in mutation-negative leukemia (abs25-4127)
Bone marrow microenvironment overlap between VEXAS and myelodysplastic syndrome demonstrated by targeted transcriptomic and artificial intelligence (abs25-7376).
At the ASH (Free ASH Whitepaper) meeting, GTC will highlight how its combined tissue and liquid-biopsy portfolio—including cfDNA and cfRNA analytics, transcriptomic signatures, and AI-driven models—supports clinicians and researchers making more informative decisions in treating their patients.

Details on dates and time of the oral and poster presentations are listed on the ASH (Free ASH Whitepaper) and GTC website. Visit GTC in the exhibition hall at booth 2081.

(Press release, Genomic Testing Cooperative, DEC 2, 2025, View Source [SID1234661047])

Enterome OncoMimics™ immunotherapy EO2401 shows survival benefit in Phase 2 glioblastoma trial

On December 2, 2025 Enterome, a clinical-stage company pioneering OncoMimics peptides, a new class of off-the-shelf, multi-targeted in vivo immune therapies that induce a fast and potent expansion of memory T cells to fight cancer, reported new survival analyses from Cohort 3 of the Phase 1/2 ROSALIE clinical trial. The data were reported at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting. The ROSALIE trial is evaluating Enterome’s OncoMimics immune therapy EO2401 in combination with immune checkpoint inhibitor nivolumab, with or without anti-VEGF therapy bevacizumab, in patients with glioblastoma at first progression/recurrence. Top-line data from the trial had previously been released in November 2023.

The analyses demonstrated a statistically significant survival benefit for patients who underwent a second surgery after their first glioblastoma recurrence when treated with EO2401 in combination with nivolumab and bevacizumab, compared with patients who did not undergo surgery (p = 0.027). Importantly, no survival benefit was observed for the supportive therapies, nivolumab or bevacizumab on a stand-alone basis after surgery, compared with no surgery. The investigators concluded in their poster that: "The data indicate that a randomized study evaluating EO2401 is warranted."

The poster was presented at SNO by the lead investigator of the trial, David Reardon M.D., and Professor of Medicine at Harvard Medical School and Clinical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, under the title: "EO2401 peptide immunotherapy + nivolumab +/- bevacizumab in first recurrent glioblastoma: treatment strategy optimization in the phase 1/2 study EOGBM1-18 / ROSALIE (NCT04116658)". The poster will be made available on the Enterome website.

ROSALIE is a multicenter, open-label, first-in-human study of EO2401 in 100 patients with glioblastoma. EO2401 / nivolumab +/- bevacizumab was well tolerated with a safety profile consistent with the safety profile of nivolumab, and when applicable bevacizumab, except the addition of local administration site reactions. EO2401 plus nivolumab generated fast, strong, and durable specific CD8 T cell immune responses against the EO2401-mimic peptides and target epitopes on tumor associated antigens. Furthermore, the investigators wrote in their poster that the addition of bevacizumab (to EO2401/nivolumab), which exerts strong antiedema properties, and putatively counteracts immunosuppression by VEGF, increased treatment duration and efficacy.

"This finding from the ROSALIE trial in this incredibly challenging patient population is another strong indication of the potential benefit that OncoMimics peptides can offer patients across a broad range of cancers," said Pierre Belichard, Chief Executive Officer of Enterome. "This, and the earlier clinical results make clear that larger, randomized studies of EO2401 are warranted."

EO2401 is an innovative, off-the-shelf OncoMimics multi-targeted in vivo immune therapy composed of three synthetically produced, short non-self HLA-A2 peptides with sequences derived from gut-bacteria (EO2316, EO2317, and EO2318). It is designed to rapidly expand – through peptide molecular mimicry – pre-existing CD8 T cells that cross-react with key glioblastoma tumor associated antigens (TAAs; IL13Ra2, BIRC5/survivin, and FOXM1). EO2401 also includes a universal CD4 helper epitope, UCP2 derived from hTERT, to support and enhance the immune response.

OncoMimics peptides consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs). These antigens induce a fast and potent in vivo expansion of cytotoxic memory CD8+ T cells that were primed by gut bacteria, and are cross-reactive with TAAs. Because the peptides are "non-self", OncoMimics peptides avoid the self-tolerance that limits many cancer immunotherapies, enabling rapid, potent, and durable responses. The synthetically produced peptides are designed in silico, mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple high-affinity peptides to broaden target coverage and mitigate tumor heterogeneity.

OncoMimics peptides are easy to manufacture, store, distribute and administer as an "off-the-shelf" subcutaneous injection. OncoMimics peptides have achieved rapid and potent responses in clinical testing in over 230 patients to date, with a benign safety profile.

(Press release, Enterome, DEC 2, 2025, View Source [SID1234661046])

Electra Therapeutics Presents SURPASS Pivotal ELA026 Study Design and Highlights the Critical Unmet Need in Secondary Hemophagocytic Lymphohistiocytosis (sHLH) at the ASH 2025 Annual Meeting

On December 2, 2025 Electra Therapeutics, a clinical stage biotechnology company pioneering therapies against novel targets for diseases in immunology and cancer, reported it will present two posters on the ELA026 clinical program in secondary hemophagocytic lymphohistiocytosis (sHLH) at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6-9 in Orlando, Florida.

A trial-in-progress poster, presented by Dr. Swaminathan Iyer (MD Anderson Cancer Center), will highlight the SURPASS Phase 2/3 pivotal clinical study, which is evaluating the safety, efficacy, pharmacokinetics, and pharmacodynamics of ELA026 in newly diagnosed, treatment‑naïve adult and pediatric patients with sHLH. ELA026 is the first investigational therapy designed to treat sHLH regardless of underlying trigger, leveraging a novel mechanism of action that targets signal regulatory proteins (SIRP) on immune cells. By selectively depleting pathological myeloid cells and T lymphocytes that drive the cytokine storm and disease severity, ELA026 has the potential to reset the hyperinflammatory cascade at its source. The SURPASS study is actively enrolling at academic medical centers across the U.S. and Europe. Additional information is available at clinicaltrials.gov (NCT05416307).

A second poster, presented by Dr. Catherine Broome (MedStar Georgetown University) and Dr. Daniel Hausrath (Vanderbilt University Medical Center), in collaboration with EpidStrategies, will share results from an Electra-sponsored natural history study characterizing the disease burden and unmet need in patients with sHLH. This study identified a cohort of 232 adult patients over a 16‑year period through electronic health record queries to assess prognostic factors, clinical features, treatment patterns, healthcare utilization, and survival outcomes. The analysis underscored the life-threatening nature of sHLH, its high mortality, and the limited effectiveness of currently available therapies, reinforcing the significant unmet need for improved treatment options.

"We are delighted to connect with the scientific community at ASH (Free ASH Whitepaper) and share the clinical development progress of ELA026 in sHLH," said Kim-Hien Dao, DO, PhD, Chief Medical Officer of Electra Therapeutics. "Every day, patients with sHLH around the world face a devastating prognosis and very limited treatment options. We are committed to generating pivotal data to demonstrate ELA026’s potential to meaningfully improve outcomes for these patients."

Poster Details:

The SURPASS Trial: A Phase 2/3 Registrational Trial of ELA026 in Subjects with Treatment-Naïve Secondary Hemophagocytic Lymphohistiocytosis

Session Number and Name: 201. Granulocytes, Monocytes, and Macrophages: Poster I
Session Date and Time: Saturday, December 6, 5:30 – 7:30 p.m. EST
Location:West Halls B3-B4
Publication Number:#1223

Survival Outcomes of Patients with Secondary Hemophagocytic Lymphohistiocytosis (sHLH) at Two Academic Medical Centers in the United States

Session Number and Name: 905. Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies: Poster III
Session Date and Time: Monday, December 8, 6:00 – 8:00 p.m. EST
Location:West Halls B3-B4
Publication Number:#6243

ELA026 is the first investigational therapy to receive U.S. Food and Drug Administration Breakthrough Designation (BTD) and European Medicines Agency Priority Medicines (PRIME) designation for sHLH, reflecting its potential to address this life-threatening condition with significant unmet medical need.

About Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Secondary hemophagocytic lymphohistiocytosis (sHLH) is a rare, life-threatening hyperinflammatory disease with a lack of treatment options. It can be triggered by cancer, infection, autoimmune disease, or immunotherapy. sHLH is associated with a severe inflammatory response that requires immediate intervention. Without effective treatment, patients may experience multiorgan failure and death. sHLH is associated with high mortality early in the disease course, with malignancy-associated HLH (mHLH) patients having a mortality rate of approximately 50% at two months with available therapies.

(Press release, Electra Therapeutics, DEC 2, 2025, View Source [SID1234661045])

CytoAgents Announces Poster Presentation of New CTO1681 Clinical Data at the 67th American Society of Hematology Annual Meeting

On December 2, 2025 CytoAgents, Inc., a clinical-stage biotechnology company developing CTO1681, a novel, steroid sparing inhibitor of prostaglandin mediated inflammation, reported that preliminary safety data from its Phase 1b/2a clinical trial for its lead drug candidate, CTO1681, will be presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6-9, 2025, in Orlando, Florida.

CTO1681 is an oral, small molecule immune modulator that uses a novel approach to prevent and mitigate both inflammation in the tumor microenvironment as well as toxicity frequently seen with lymphoma patients receiving CAR T-Cell Therapy. CytoAgents is currently enrolling patients in a Phase 1b/2a clinical trial evaluating CTO1681 in lymphoma patients receiving CAR T-Cell Therapy at risk for inflammatory driven toxicities.

At ASH (Free ASH Whitepaper), the company will present preliminary safety data from the first patient cohort of the Phase 1b/2a clinical trial. Among the key findings to be presented, CTO1681 was shown to be well tolerated at the 10μg three times a day (TID) dose. Importantly, no dose-limiting toxicities and no drug-related serious adverse events were observed in the cohort. Based on these positive findings, CytoAgents is currently enrolling the second cohort of the trial, an escalated dosage of 20μg TID.

"New approaches to treat inflammation in the tumor microenvironment as well as black box warning toxicities, Cytokine Release Syndrome (CRS) and the neurotoxicity ICANS, continues to be an area of significant unmet medical need, with the majority of cancer patients undergoing CAR T treatment experiencing CRS and associated neurotoxicity," said Teresa Whalen, Chief Executive Officer at CytoAgents. "We look forward to sharing this initial positive safety data for CTO1681 at ASH (Free ASH Whitepaper) and to continuing our advancement of CTO1681."

Poster Presentation Details

Title: A phase 1b/2a study of CTO1681 for the prevention of cytokine release syndrome in patients with diffuse large B-cell lymphoma receiving chimeric antigen receptor T-cell therapy
Presenter: Jordan Gauthier, MD, MSc, Associate Professor, Clinical Research Division, Fred Hutchinson Cancer Center, Clinical Research Division, Seattle, WA, USA
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
Publication Number: 5955
Session Date and Time: Sunday, December 7, 2025, 6:00 PM – 8:00 PM ET
Location: Orange County Convention Center – West Halls B3-B4

CytoAgents also announced that research from its Phase 1 study evaluating the safety, tolerability and pharmacokinetics of CTO1681 in healthy adult participants has been selected by ASH (Free ASH Whitepaper) for online publication. The abstract, entitled "A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of CTO1681 (GP1681) in Healthy Adult Participants", will be published online in the November supplemental issue of Blood and will become part of the permanent ASH (Free ASH Whitepaper) and Blood abstracts archive.

(Press release, CytoAgents, DEC 2, 2025, View Source [SID1234661044])

Black Diamond Therapeutics to Host Webcast Presentation Highlighting Silevertinib Phase 2 Clinical Trial Results and Program Update

On December 2, 2025 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported it will host a webcast to present results from its Phase 2 clinical trial of silevertinib and provide a program update on Wednesday, December 3, 2025, at 8:00am ET.

Webcast information

The webcast can be accessed under "Events and Presentations" on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com. A replay of the webcast will be available following the completion of the event.

(Press release, Black Diamond Therapeutics, DEC 2, 2025, View Source [SID1234661042])