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])

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 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])

On December 2, 2025 Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., reported that 11 studies featuring the Breast Cancer Index (BCI) Test will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS). Findings from these studies support the company’s ongoing commitment to help inform personalized treatment recommendations for patients with early-stage, hormone receptor-positive (HR+) breast cancer. Building on the test’s established position as the only guideline-recognized and most extensively validated test to predict which patients are likely to benefit from extended endocrine therapy,1-7 these new insights explore potential expanded utility in premenopausal women and comparison to the 21-gene assay for extended endocrine therapy treatment decisions.

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"These data reinforce Hologic’s continued commitment to oncology innovation and advancing precision diagnostics in breast cancer care," said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. "This impressive volume of evidence provides deeper insight into premenopausal patient populations, supports more nuanced endocrine therapy decision-making and highlights the consistency of the BCI Test’s performance across diverse patient subgroups and sample types."

Among the new findings to be presented, one study, "Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]," explores the BCI Test’s potential ability to identify a group of premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence. Results from this translational analysis of the two largest landmark ovarian function suppression (OFS) trials, Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT), support the potential utility of BCI Testing in identifying premenopausal women who may forgo the addition of OFS therapy to primary adjuvant endocrine therapy.8^*

"As we observe an increasing number of women being diagnosed with breast cancer at a younger age, it is imperative to balance the need for effective recurrence prevention with the preservation of patient quality of life," said primary study author Dr. Ruth O’Regan, MD. "The ability to accurately identify premenopausal women who can safely avoid more aggressive treatment regimens would represent a significant advancement in the field of personalized medicine, allowing us to tailor therapies to individual patient needs while minimizing unnecessary side effects."

A full list of studies to be presented at the 2025 SABCS conference includes:

Poster Session 2: December 10, 2025, 5:00pm – 6:30pm CST
Endocrine Sensitivity and Predicted Benefit of Extended Endocrine Therapy Based on Breast Cancer Index (BCI) in BRCA1, BRCA2 and CHEK2 Pathogenic Variant Carriers with ER+/HER2– Breast Cancer [#PS2-08-25]: Examines how BCI Testing may help identify differences in hormone-therapy benefit among women with inherited BRCA1, BRCA2 or CHEK2 gene variants.9*
Poster Session 3: December 11, 2025, 12:30pm – 2pm CST
Breast Cancer Index Re-stratifies 21-Gene Assay Risk Groups for Risk of Recurrence and Extended Endocrine Therapy Benefit: Final Analysis of the BCI Registry Study [#PS3-07-24]: Demonstrates that BCI Testing provides added insight for doctors already using other genomic tests to guide treatment planning and emphasizes the need to use the right test for each clinical decision.10*
Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index [#PS3-07-27]: Highlights the BCI Test’s ability to identify premenopausal patients with early-stage, HR+ breast cancer who are at minimal risk of experiencing metastatic recurrence.8^*
Prognostic Performance of Breast Cancer Index in Patients with Early-Stage HR+ HER2+ Breast Cancer Treated with Adjuvant Trastuzumab: NCCTG N9831 (Alliance) [#PS3-07-28]: Supports the BCI Test’s ability to assess recurrence risk in patients with HER2+ disease.11*
Comparative Analysis of Breast Cancer Index Testing in Hispanic and Non-Hispanic Populations [#PS3-08-07]: Evaluates ethnicity-based differences in BCI Results and treatment patterns.12*
Comparison of Breast Cancer Index Scores from Core-Needle Biopsies Versus Surgical Excisions in Early-Stage Breast Cancer [#PS3-08-26]: Demonstrates that BCI Testing delivers consistent results from both biopsies and surgical tissue samples.13*
Five additional studies featuring data on the clinical utility of the BCI Test will be presented by external investigators at 2025 SABCS, including:

Poster Session 3: December 11, 2025, 12:30pm – 2pm CST
Guidelines for Breast Cancer Index Test before and after Epic software enhancement [#PS3-03-18]14
Higher Breast Tumor Grades Could More Likely Benefit from Extended Adjuvant Endocrine Therapy [#PS3-09-10]15
Correlation Between Breast Cancer Index (BCI) and RSClin Late in Assessing 5-10 Year Recurrence Risk in Early-Stage Hormone Receptor-Positive Breast Cancer [#PS3-09-19]16
Retrospective study on breast cancer index testing in a community hospital and analyzing its impact on physician-decision making for extended endocrine therapy in early breast cancer [#PS3-10-23]17
Poster Session 4: December 11, 2025, 5:00pm – 6:30pm CST
Spatial transcriptomics of TNBCs show an association between HOXB13 expression and formation of a plasmablast-rich neighborhood [#PS4-07-08]18
"The research to be presented at 2025 SABCS continues to offer insight into expanded clinical applications of the BCI Test," said Schneiders. "With more than a decade of clinical use by over 9,000 providers, and its proven ability to influence extended endocrine therapy decisions, it’s encouraging to see additional real-world and independent data reinforcing the BCI Test’s impact. These findings underscore our ongoing commitment to help clinicians deliver more personalized, confident care for patients."

About the Breast Cancer Index Test

The Breast Cancer Index Test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment.

The Breast Cancer Index Test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO (Free ASCO Whitepaper) Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) acknowledge the Breast Cancer Index Test as a biomarker to help inform extended endocrine treatment decisions.6,7 It is the only test recognized by guidelines to predict which early-stage, HR+ breast cancer patients are likely to benefit from extended endocrine therapy.6,7

The Breast Cancer Index Test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a sole-source laboratory-developed test (LDT) performed by Biotheranostics, Inc., a CLIA-certified and CAP-accredited diagnostic laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit www.breastcancerindex.com.

(Press release, Hologic, DEC 2, 2025, View Source [SID1234661067])