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 Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, reported that it will present details from its first-in-human Phase 1 clinical trial of STX-0712, the company’s novel CCR2-CyTAC (Chemokine Receptor Type 2 Cytotoxicity Targeting Chimera) for the treatment of chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) in a poster session at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 6–9, 2025, in Orlando, Florida.

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The poster will highlight the design of the ongoing Phase 1, open-label, multicenter study, which is evaluating STX-0712 as monotherapy in patients with refractory or resistant CMML and relapsed or refractory monocytic or monocytic-predominant AML. Primary objectives include safety, determination of dose limiting toxicities, and determination of recommended Phase 2 dose. Secondary objectives include pharmacokinetic and pharmacodynamic characterization of STX-0712, tolerability, and preliminary evidence of antitumor activity. Key elements of the study design include dose escalation using a Bayesian Optimal Interval approach, planned dose expansion, and exploratory analyses assessing CCR2+ cell depletion, biomarkers, immune cell profiling and patient-reported outcomes.

STX-0712 is a CyTAC targeting the G-Protein Coupled Receptor CCR2, a selective marker expressed at high levels on malignant monocytes in these indications, which are key drivers in certain hematologic cancers. By targeting CCR2, STX-0712 is designed to selectively eliminate these malignant cells.

Presentation Details:
Abstract Title: A First-in-Human Study of STX-0712, a CCR2+ Cytotoxicity Targeting Chimera (CyTAC), in Patients with Chronic Myelomonocytic Leukemia (CMML) and Acute Myeloid Leukemia (AML)
Presenter: Guillermo Montalban Bravo, M.D., Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center
Date: Sunday, December 7, 2025
Time: 6:00pm-8:00pm EST
Location: Room OCCC- West Halls B3-B4
Session: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster II
Abstract Number: 14421

(Press release, Solu Therapeutics, DEC 2, 2025, View Source [SID1234661065])

On December 2, 2025 Kytopen and TQ Therapeutics GmbH (TQx), a pioneer in modular, target-cell–specific gene modification for the generation and direct delivery of in vivo cell therapies, reported a joint agreement granting TQx access to Kytopen’s Flowfect cellular engineering technology through the company’s Technology Access Program (TAP). This latest TAP partnership marks another significant milestone in Kytopen’s expanding presence across Europe.

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A key driver of TQ Therapeutics’ decision to join the TAP program was the opportunity to evaluate a next-generation, non-viral cellular engineering technology that can be uniquely integrated into its proprietary EXiVO approach—an extracorporeal genetherapy process that precisely modifies T cells directly from patients’ unprocessed whole blood using the company’s FABfinity cell-selection technology. As part of the collaboration, the Flowfect technology will be incorporated exclusively as a core module of TQx’s CELLfinity platform, enabling highly efficient delivery of genetic material into defined target cell populations. By combining TQx’s in vivo therapeutic approach with Kytopen’s continuous flow transfection technology—which applies mechanical, electrical, and chemical forces to rapidly engineer hundreds of billions of healthy cells in minutes—the companies aim to advance a new generation of autologous mRNA T-cell therapies designed to revolutionize treatment across multiple disease areas.

Through TAP, TQ Therapeutics will receive comprehensive proof-of-concept and process-development support with Flowfect technology. Kytopen will install the Flowfect Tx system on-site and provide dedicated guidance from its Field Applications Team. In addition, TQ Therapeutics will gain access to the Flowfect Discover 96-well optimization platform, accelerating the progression from early feasibility testing through process optimization and into clinical and commercial manufacturing scale.

"Our partnership with TQ Therapeutics represents a shared vision to transform the landscape of engineered cell therapies," said Kevin Gutshall, Chief Commercial Officer at Kytopen. "By integrating Flowfect technology with TQx’s groundbreaking in vivo CELLfinity platform, we are not just advancing technology—we are opening the door to entirely new therapeutic possibilities that have the potential to redefine patient care."

We are delighted to partner with Kytopen and to integrate the Flowfect technology into our TQx platform," said Christian Stemberger, Chief Scientific Officer at TQ Therapeutics. "The seamless compatibility of the Flowfect Tx system with our extracorporeal in vivo cell therapy approach enhances our ability to efficiently engineer cells with high precision and safety. Access to the Flowfect Discover platform further accelerates our development pathway—from rapid optimization through to clinical readiness—strengthening our mission to deliver transformative therapies to patients.

(Press release, TQ Therapeutics, DEC 2, 2025, View Source [SID1234662194])

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 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that the China National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application for the Phase Ib/II CLINCH-2 study evaluating ATG-022 (CLDN18.2 antibody-drug conjugate [ADC]) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as well as ATG-022 in combination with pembrolizumab and chemotherapy.

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CLINCH-2 is a Phase Ib/II study that will be led by its principal investigator Prof. Lin Shen at Beijing Cancer Hospital, the lead trial center. The study is designed to evaluate two combination regimens in patients with CLDN18.2-positive, HER2-negative, and PD-L1-positive (CPS≥1) unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC): ATG-022 in combination with pembrolizumab (A+P); and ATG-022 in combination with pembrolizumab plus the CAPOX chemotherapy regimen (A+P+C). The primary objective of the study is to assess the safety and tolerability of the two combination regimens, while the secondary objectives include evaluating the regimens’ preliminary antitumor activity, assessing ATG-022’s immunogenicity, and characterizing its pharmacokinetic (PK) profile.

Antengene released updated clinical data from the Phase I/II CLINCH study of ATG-022 monotherapy in patients with advanced GC/GEJC at the European Society for Medical Oncology Congress 2025 (ESMO 2025). For details of the dataset, please refer to the press release published on October 20, 2025 (View Source). The results demonstrated clear differentiation for ATG-022 in both safety and efficacy. In the 1.8 mg/kg dose cohort, the incidence of grade 3 or higher treatment-related adverse events was only 18.2%. Moreover, the study did not observe any ocular toxicity or interstitial lung disease, and the incidence of peripheral neuropathy reported in the study was relatively low. The efficacious doses (1.8mg/kg and 2.4mg/kg) have both demonstrated an objective response rate (ORR) of 40%. This is a strong validation of ATG-022’s potential in combination with pembrolizumab and chemotherapy in the frontline setting. In addition, antitumor activity was observed across high, medium, and low CLDN18.2 expression levels, supporting the use of IHC 1+ ≥1% as the enrollment threshold for frontline combination therapy, indicating potential applicability to a much broader patient population compared to other CLDN18.2-targeting therapies. Furthermore, in the basket cohort of other CLDN18.2+ tumor types, efficacy was observed in a gynecologic tumor subtype, providing early proof of concept for potential expansion into tumor types beyond gastric cancer.

Antengene will continue to advance both the ongoing CLINCH study and the newly approved CLINCH-2 study, with plans to share updated results at upcoming medical conferences to further demonstrate the clinical potential of ATG-022.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ATG-022

ATG-022 is a CLDN18.2-targeted antibody-drug conjugate (ADC) with sub-nM affinity and fast internalization. Using a VC-MMAE linker-payload (DAR 4), ATG-022 has demonstrated potent activity across tumors with high, low, and ultra-low CLDN18.2 expression.

ATG-022 has been granted two Orphan Drug designations (ODDs) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer, and obtained Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA) for treating CLDN18.2-positive, HER-2 negative unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received at least two prior lines of therapy.

(Press release, Antengene, DEC 2, 2025, View Source;chemotherapy-302630024.html [SID1234661066])