On December 3, 2025 Delcath Systems, Inc. (Nasdaq: DCTH), ("Delcath" or the "Company") an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of a retrospective study by leading interventional radiologists and oncologists from Asklepios Hospital Barmbek in Hamburg, Germany. The study, titled "Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience," was published in the journal Cancers and reports outcomes from 38 consecutive patients with liver-dominant metastatic uveal melanoma (mUM) who underwent 99 procedures using Delcath’s CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP). The article highlights the procedure’s safety and efficacy, demonstrating a median overall survival (OS) of 29.1 months from the first PHP treatment, with improved outcomes associated with additional treatment cycles.

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"The publication of this 10-year experience in Cancers underscores the significant clinical evidence supporting the use of PHP as an effective liver-directed therapy for patients with liver-dominant metastatic uveal melanoma," said Gerard Michel, Chief Executive Officer of Delcath Systems. "These results from a high-volume specialized center show a median OS approaching 2.5 years, surpassing prior reports and reinforcing the potential survival benefits of treatment with repeated PHP cycles. We are pleased to see this data add to the collection of research supporting HEPZATO KIT and CHEMOSAT, which aligns with our commitment to advancing treatment options in interventional oncology."

The retrospective study synthesizes data from consecutive patients treated between April 2014 and March 2024, demonstrating safety and efficacy of CHEMOSAT in a real-world setting. Key highlights include:

Median OS of 29.1 months (95% CI: 18.4–38.9 months) from the first PHP treatment, with 1-, 2-, and 3-year OS rates of 79.5%, 53.2%, and 28.5%, respectively
Numerically improved median OS with ≥3 PHP cycles (29.8 months) versus ≤2 cycles (21.4 months; p=0.058), with each additional cycle associated with a ~40% reduction in risk of death (HR=0.414)
No treatment-related deaths, with procedure-related adverse events graded ≥2 occurring in 10.5% of patients
Patient population with ECOG-PS 0-1, ≤70% liver involvement, and limited extrahepatic disease, reflecting appropriate selection for PHP
Support for institutional experience and volume as factors in optimizing outcomes, providing a reference for novel mUM management strategies
The article is available here: View Source

(Press release, Delcath Systems, DEC 3, 2025, View Source [SID1234661098])

On December 3, 2025 Quadriga BioSciences, a clinical-stage oncology company developing QBS72S (formerly QBS10072S) for the targeted treatment of cancer, reported positive Phase IIa interim clinical data presented at the 7th Quadrennial World Federation of Neuro-Oncology Societies and 30th Annual Meeting of the Society for Neuro-Oncology (WFNOS–SNO), held November 19–23, 2025, at the Hawaii Convention Center in Honolulu, Hawaii. In an oral session, data were presented from a single-arm, open-label study conducted by the Department of Neurosurgery at the Stanford University School of Medicine that evaluated the safety and efficacy of QBS72S, a novel chemotherapeutic designed to cross the blood–brain barrier via the L-type amino acid transporter 1 (LAT1). The results showed that QBS72S produced both radiographic and symptomatic improvement in breast cancer patients with leptomeningeal disease (LMD).

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"The Phase IIa results provide important early clinical signals that reinforce the potential of QBS72S to meaningfully impact outcomes for patients with LMD," said Gordon Ringold, Ph.D., CEO of Quadriga BioSciences. "Seeing radiographic stability alongside improvements in neurologic and physical symptoms, as well as survival beyond 12 months in 4 out of 10 patients, is very encouraging. These findings underscore the promise of our therapeutic approach and strengthen our commitment to advancing QBS72S as a treatment option for patients with LMD, for which there are no approved treatment alternatives."

LMD is a serious complication of advanced breast cancer in which cancer cells spread to the membranes surrounding the brain and spinal cord, leading to significant neurologic symptoms, rapid clinical decline, and a poor prognosis.

"Breast cancer is one of the most common solid tumors to spread to the brain, and LMD represents a serious and challenging complication for patients," said Ron Weitzman, M.D., CMO of Quadriga BioSciences "Available treatment options remain limited, in part due to challenges with drug delivery across the blood-brain barrier. The clinical findings presented at WFNOS–SNO suggest that QBS72S reaches the cancer cells and may offer meaningful benefit for patients with advanced metastatic disease. These data support continued evaluation of QBS72S as a targeted therapeutic candidate for LMD, an area of significant unmet need."

These results reinforce Quadriga Biosciences’ commitment to advancing QBS72S toward a potential therapeutic option for patients with leptomeningeal disease and other central nervous system manifestations of metastatic breast cancer.

Reference: Abstract ID: CTNI-71, Oral Presentation

Title: Interim analysis of a phase IIa trial of LAT1-targeted QBS72S in breast cancer leptomeningeal disease
Authors: Brandon Carlson-Clarke, Sahara Rout, Meaghan Roy-O’Reilly, Rukayat Taiwo, Paul M. Harary, Monica Granucci, Sophia B. Chernikova, Thy T.H. Trinh, Sophie Bertrand, Kate Therkelsen, Summer Han, Bo Gu, Gordon Ringold, Jaymes Holland, Ron Weitzman, Seema Nagpal, Melanie Hayden Gephart

About QBS72S
QBS72S is a novel, first-in-class chemotherapeutic agent that mimics an aromatic amino acid for cellular uptake by the amino acid transporter LAT1 (L-type amino acid transporter 1) thereby enabling the drug to cross the blood brain barrier (BBB) as well as to selectively target numerous types of rapidly growing cancer cells. Once inside the cell QBS72S causes double-stranded DNA breaks resulting in cell death. Most aggressive cancers express high LAT1, which is commonly associated with poor prognoses.1

About the Study
The Phase 2 open-label clinical trial is designed to assess the safety, tolerability and efficacy of QBS72S in patients with brain metastases from breast cancer. The study will recruit up to 35 patients with the primary objective of determining preliminary efficacy through overall response rate. Secondary endpoints include measurement of progression free survival, overall survival, duration of response, and adverse events.

Please refer to www.clinicaltrials.gov [NCT05305365] for additional clinical trial details.

(Press release, Quadriga BioSciences, DEC 3, 2025, View Source [SID1234661116])

On December 3, 2025 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the final analysis of its Phase 3 CARES-310 study was published in The Lancet Oncology. The study assessed the efficacy and safety of the combination of Elevar’s drug candidate rivoceranib, an oral TKI, and camrelizumab, a PD-1 inhibitor, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC).

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In the randomized, open-label, international trial (NCT03764293), which included 543 patients at 95 study sites across 13 countries/regions, camrelizumab plus rivoceranib continued to show clinically meaningful survival improvement versus sorafenib (median overall survival of 23.8 vs. 15.2 months), a standard first-line treatment for uHCC, and a manageable safety profile.

Elevar plans resubmission of a New Drug Application to the U.S. Food and Drug Administration for the combination therapy of camrelizumab and rivoceranib in January 2026.

"Having our Phase 3 study final analysis published in a prestigious journal such as The Lancet Oncology is momentous for Elevar Therapeutics and, even more so, for the global liver cancer patient community," said Bryan Kim, chief executive officer of Elevar. "The data clearly showed the potential of our combination treatment of camrelizumab and rivoceranib, as it significantly improved survival compared to the standard treatment option. This is evidence that our hard work developing better therapies for patients with few options is paying off. We’re proud of everyone on our team and our partners for hitting this milestone, and we’re focused on getting this promising treatment to patients everywhere as soon as possible."

Findings:

Between June 28, 2019, and March 24, 2021, 543 patients (457 [84%] males; 450 [83%] were Asian) were randomly assigned to receive camrelizumab-rivoceranib (n=272) or sorafenib (n=271). At final analysis on June 14, 2023, the median follow-up was 22.1 months (IQR 11.9-30.3) in the camrelizumab-rivoceranib group and 14.9 months (7.2-28.3) in the sorafenib group. Median overall survival was 23.8 months (95% CI 20.6-27.2) with camrelizumab-rivoceranib and 15.2 months (13.2-18.5) with sorafenib (hazard ratio [HR] 0.64 [95% CI 0.52-0.79]; one-sided p<0.0001). Median progression-free survival was 5.6 months (95% CI 5.5-7.4) with camrelizumab-rivoceranib and 3.7 months (95% CI 3.1-3.7) with sorafenib (HR 0.54 [95% CI 0.44-0.67]; one-sided p<0.0001).

The most common grade 3 or 4 treatment-related adverse events were hypertension (104 [39%] of 272 patients in the camrelizumab-rivoceranib group vs. 40 [15%] of 269 patients in the sorafenib group), palmar-plantar erythrodysesthesia syndrome (33 [12%] vs. 42 [16%]), increased aspartate aminotransferase (47 [17%] vs. 14 [5%]), and increased alanine aminotransferase (38 [14%] vs. 8 [3%]). Treatment-related serious adverse events were reported in 69 (25%) patients in the camrelizumab-rivoceranib group and 18 (7%) patients in the sorafenib group. Treatment-related deaths occurred in one patient each in the camrelizumab-rivoceranib group (multiple organ dysfunction syndrome) and sorafenib group (respiratory failure and circulatory collapse).

About Hepatocellular Carcinoma

Hepatocellular Carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation, which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. More than 800,000 people worldwide are diagnosed with liver cancer each year and it is also a leading cause of cancer deaths, accounting for more than 700,000 annually, according to the American Cancer Society.

About Rivoceranib

Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor (VEGFR), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as a first-line treatment for uHCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer and breast cancer, etc.) and treatment settings. Camrelizumab, under the brand name AiRuiKa, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for uHCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the EMA in August 2024.

In October 2023, Elevar licensed camrelizumab, an anti-PD-1 antibody, for commercialization from Hengrui Pharma worldwide excluding Greater China and Korea.

(Press release, Elevar Therapeutics, DEC 3, 2025, View Source [SID1234661099])

On December 3, 2025 Foresight Diagnostics, a leader in ultrasensitive minimal residual disease (MRD) detection technology, reported the presentation of multiple lymphoma studies featuring Foresight CLARITY (PhasED-Seq) minimal residual disease (MRD) analysis at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 6–9, 2025, in Orlando, Florida.

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This year’s presentations reflect the growing integration of highly sensitive, circulating tumor DNA (ctDNA)-based MRD testing into clinical studies across hematologic malignancies. Academic groups and pharmaceutical partners are increasingly deploying MRD not only for retrospective assessment but also prospectively within MRD-guided trial designs, exploratory endpoints, and therapeutic development programs.

"Across industry and academic collaborators, we’re seeing a meaningful shift in how ctDNA-MRD is being used in lymphoma," said David Kurtz, MD, PhD, Chief Medical Officer and Co-founder of Foresight Diagnostics. "Ultrasensitive MRD analysis is moving beyond feasibility studies and into clinical trial frameworks, where molecular response has the opportunity to inform patient care decisions. At Foresight Diagnostics, we’re proud to support this next phase of MRD-driven innovation in lymphoma."

Information on presentations and posters featuring Foresight CLARITY (PhasED-Seq) MRD analysis can be found below. To meet with Foresight Diagnostics, visit booth #2165 or contact us at [email protected].

Saturday, December 6

Response-adapted Phase 2 study of acalabrutinib window prior to frontline chemotherapy in untreated large B-cell lymphoma: Molecular correlates of response to acalabrutinib | Mark Roschewski, MD (NCI/NIH) | 9:45-10:00 AM EST | Oral presentation
First-in-human, open-label, Phase 1 study of a novel CD30-directed antibody-drug conjugate with a topoisomerase 1 inhibitor payload, PF-08046044 (35C), in patients with Relapsed/Refractory lymphomas: Updated safety, PK, preliminary efficacy and ctDNA analysis from dose escalation | Swetha Thiruvengadam, MD (City of Hope) | 1:00-1:15 PM EST | Oral presentation
Spatial anatomical genomic heterogeneity and aberrant somatic hypermutation define clonal evolution pathways that predict treatment resistance in aggressive B-cell lymphomas | Jordan Goldstein, MD, MSc (Stanford University) | 5:15-5:30 PM EST | Oral presentation
Sunday, December 7

Golcadomide (GOLCA), a potential, first-in-class, oral CELMoD agent, plus R-CHOP in patients (Pts) with previously untreated aggressive B-cell lymphoma (a-BCL): 24-month efficacy results | Grzegorz Nowakowski, MD (Bristol Myers Squibb) | 9:45-10:00 AM EST | Oral presentation
Primary analysis of the SMART STOP trial: Lenalidomide, tafasitamab, rituximab, and acalabrutinib alone and with combination chemotherapy in newly diagnosed diffuse large B-cell lymphoma | Jason Westin, MD (MD Anderson Cancer Center) | 10:00-10:15 AM EST | Oral presentation
Longitudinal circulating tumor DNA dynamics during & after first-line therapy in a national cohort of large B-cell lymphomas | Steven Wang, MD (Stanford University; formerly UMC Amsterdam) | 10:45-11:00 AM EST | Oral presentation
Response-adapted treatment with mosunetuzumab with or without obinutuzumab and polatuzumab vedotin in treatment naïve follicular and marginal zone lymphoma: Final results and phased-seq MRD analysis | Ryan Lynch, MD (Fred Hutch/University of Washington) | 6:00-8:00 PM EST | Poster
Pembrolizumab + GVD with ctDNA-guided consolidation for relapsed/refractory classic Hodgkin lymphoma: A multicenter phase 2 Study of the University of California hematologic malignancies consortium | Michael Randall, MD (UCSF) | 6:00-8:00 PM EST | Poster
First-line consolidation with cemacabtagene ansegedleucel (cema-cel) in patients with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy: The pivotal, randomized, open label Phase 2 ALPHA3 study | John M. Burke, MD (Rocky Mountain Cancer Centers) | 6:00-8:00 PM EST | Poster
Golseek-1: A Phase 3, double-blind, randomized study of golcadomide (GOLCA), a potential, first-in-class, oral CELMoD agent, + R-CHOP vs placebo + R-CHOP in patients with previously untreated, high-risk, large B-cell lymphoma | Jason Westin, MD (MD Anderson Cancer Center) | 6:00-8:00 PM EST | Poster
Monday, December 8

Precise-HL trial: Personalized reduction of chemotherapy intensity through ctDNA evaluation in advanced Hodgkin lymphoma | Ryan Lynch, MD (Fred Hutch/University of Washington) | 6:00-8:00 PM EST | Poster

(Press release, Foresight Diagnostics, DEC 3, 2025, View Source [SID1234661117])

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])