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.

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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])

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.

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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])

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.

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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])

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])

On December 2, 2025 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported top line results from its randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in 99 patients with newly diagnosed glioblastoma (ndGBM). Glioblastoma is a highly aggressive brain cancer with an average life expectancy of just 12 to 15 months, and a five-year survival rate of under six percent. It has been 20 years since the last improvement to the standard of care for the treatment of ndGBM.

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In the trial, patients in the IGV-001 arm had a median overall survival (mOS) of 20.3 months, a difference of 6.3 months, or 45%, compared to a mOS of 14.0 months in the placebo arm. The median follow-up time for all patients in the study was 22 months. There were no drug-related serious adverse events in the treatment arm, and the safety profile seen in the Phase 2b trial is favorable, consistent with that observed in a previous Phase 1b study (n=33). To date, approximately 100 ndGBM patients have received treatment with IGV-001 across two clinical studies. In the study, patients in the IGV-001 arm saw measurable patient benefit across multiple metrics compared to the placebo arm. The Company has informed the U.S. Food and Drug Administration (FDA) that it intends to submit a meeting request to discuss the regulatory pathway for IGV-001.

"The data from this trial are highly encouraging and suggest both a clinically meaningful improvement in overall survival for ndGBM patients and a benign safety profile for the therapy," said J. Bradley Elder, M.D., Director, Neurosurgical Oncology, Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center and the highest enrolling investigator in the Phase 2b trial. "These results represent a potential watershed moment for the treatment of this deadly disease."

"While treatments for many cancers have come a long way, treatments for glioblastoma have not changed much over the years. It is a heartbreaking diagnosis made even harder by how few treatment options there are," said Kelly Sitkin, President and Chief Executive Officer of the American Brain Tumor Association. "Ultimately, what any patient or family member wants is a chance at more time with loved ones, and new treatments for glioblastoma provide that hope for our community."

"Today marks a pivotal moment for both Imvax and for the people affected by ndGBM. For the past decade, the Imvax team has been dedicated to advancing the development of IGV-001, and the results from this Phase 2b study bring us meaningfully closer to achieving that goal. Thanks to the strong support of our investors, Imvax has the resources and expertise to execute on a clear strategy for IGV-001," said John P. Furey, Executive Chair of the Imvax Board of Directors. "We are preparing to meet with FDA to discuss the regulatory pathway for IGV-001 and what we believe is a strongly positive risk-benefit profile, especially given the large unmet medical need in ndGBM. Finally, we are profoundly grateful to the investigators, patients, and their families for their commitment to this study."

About IGV-001 and Glioblastoma

IGV-001 is an autologous biologic-device combination product candidate derived from Imvax’s proprietary Goldspire immuno-oncology platform for solid tumors, which involves a unique approach to inducing a patient-specific, broad, and durable immune response against tumors. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation and Orphan Drug Designation to IGV-001 for the treatment of ndGBM. IGV-001 is an investigational therapy and has not been approved by the FDA or any regulatory body.

Glioblastoma is both the most common and most aggressive malignant brain cancer and has resisted significant advances in treatment for decades. Approximately 14,000 people are diagnosed with glioblastoma each year in the United States, and their average life expectancy is 12 to 15 months with the current standard of care. Under six percent of patients survive for five years after diagnosis. The last significant advance in the treatment of ndGBM was the Stupp trial in 2005, which demonstrated a 2.5-month improvement in median overall survival. More than 20 years later, the Stupp protocol – maximal safe resection followed by adjuvant radiotherapy with concurrent temozolomide and subsequent maintenance temozolomide – remains the current standard of care for ndGBM patients.

About the Phase 2b Trial

The Phase 2b clinical trial is a randomized, multicenter, double-blind, placebo-controlled study (NCT04485949) designed to assess the safety and efficacy of IGV-001, an autologous biologic-device combination product, in ndGBM patients. The trial assessed several endpoints, including progression-free survival (PFS, the primary endpoint), overall survival and safety. The trial did not reach statistical significance on PFS but demonstrated a 6.3 month increase in median overall survival and a favorable safety profile.

The trial enrolled 99 participants in a 2:1 randomization across 19 sites in the United States. Approximately 48 hours after surgical resection of the patient’s malignant tumor, participants in the IGV-001 arm were implanted with biodiffusion chambers containing a combination of personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001); in the placebo arm, the chambers contained an inactive solution only. In both arms, the biodiffusion chambers were explanted approximately 48 hours later, and after six weeks all patients were treated with standard of care (adjuvant concomitant radiotherapy and temozolomide followed by maintenance temozolomide).

(Press release, Imvax, DEC 2, 2025, View Source;utm_medium=rss&utm_campaign=imvax-announces-positive-top-line-data-from-phase-2b-clinical-trial-of-igv-001-in-newly-diagnosed-gbm [SID1234661048])