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Medscape
23-06-2025
- Health
- Medscape
NHL: 2nd Generation CAR T Shows Benefit
GLPG5101, a second-generation anti-CD19/4-1BB CAR T-cell therapy, shows high complete response rates in the treatment of high-risk indolent relapsed/refractory (r/r) non-Hodgkin lymphoma, with a notably shortened vein-to-vein time, or time from leukapheresis (the separation and collection of cells) to infusion, compared with other CAR T products. 'The short vein-to-vein time of GLPG5101 eliminated the need for bridging therapy and the dropout rate was low, which potentially facilitated treatment of patients who would not otherwise be able to receive CAR T-cell therapy,' said first author Maria T. Kuipers, MD, PhD, of the Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands, in presenting the findings at 18th International Conference on Malignant Lymphoma (ICML) 2025. Though indolent cancers grow slowly by nature, that slow growth can occur in early or advanced cancers, including r/r non-Hodgkin lymphoma, and in such cases, remission times can become shorter with each subsequent line of therapy, Kuipers explained. CD19-targeted CAR T-cell therapies have shown favorable outcomes in r/r non-Hodgkin lymphoma, and in the ongoing phase 1/2 ATALANTA trial, Kuipers and her colleagues previously reported that GLPG5101 had high complete response (CR) and molecular residual disease (MRD) negativity among those patients who were heavily pretreated. By utilizing a decentralized platform with GLPG5101, the vein-to-vein time, which can take weeks in some situations, was achieved in 91.5% (43 of 47 patients) in the ATALANTA trial in just 7 days. At ICML, Kuipers reported the results from the cohort of patients from the study who had indolent r/r non-Hodgkin lymphoma, specifically those with follicular lymphoma (n = 27) and marginal zone lymphoma (MZL; n = 5). Of the patients, 32 of the 34 were infused after leukapheresis, and 30 of those received a fresh product. Importantly, 28 of the 30 patients (93%) had a 7-day vein-to-vein time and none required bridging therapy. The remaining two patients received a cryopreserved product in a 13-day vein-to-vein time. The patients, who had a median age of 64 years, had a median range of prior systemic lines of therapy of three, ranging from two to as many as six, and 31% had a prior allogeneic stem cell transplant. Nineteen of the 32 patients (59%) had experienced a progression of disease within 24 months from starting their first-line therapy. Among those with follicular lymphoma, 16 of 26 (62%) had high-risk follicular lymphoma international prognostic index scores, while none of the patients with MZL had the high-risk scores. As of month 9, of 13 patients who were evaluable, all had persisting CAR T cells, and CAR T cells were detected for up to 21 months. The responses were durable — with a median follow-up of 12.3 months, no disease progression was observed, and all responses were complete responses. Overall, the objective response rate (ORR) and CR rate (CRR) per investigator's assessment were 97% for each. Among 27 patients in the follicular lymphoma group, the ORR and CRR were 96% each (26 of 27) and the corresponding rates in the five patients with MZL were 100%. In addition, 31 of the 32 patients who were infused (97%) had a CR. And all eight patients who were evaluable for MRD were MRD-negative at the time of CR. The 12-month progression-free survival rate overall was 97%, which Kuipers said is notably high in relation to published studies of patients with indolent non-Hodgkin lymphoma treated with anti-CD19 CAR T therapies, which range from 67%, 80%, and 83% in the ELARA (tisagenlecleucel), ZUMA 5 (axicabtagene ciloleucel), and TRANSCEND (lisocabtagene maraleucel) trials. Safety Outcomes B-cell aplasia occurred in 26 of 34 patients (77%) on day 7; 30/30 (100%) had occurrence on day 28 and 26 of 27 (96%) at Week 14. In terms of safety, the most common grade 3 or higher adverse events up to 14 weeks post-infusion were hematologic. Cytokine release syndrome occurred in 11 of 32 (34%) patients, with no cases that were grade 3 or higher, and immune effector cell-associated neurotoxicity syndrome in 4 of 32 (13%) patients, with one case being grade 3 or higher. Prolonged grade 3 or higher cytopenia occurred in 11 (34%) patients 30 days post-infusion, in 8 of 29 (28%) at 60 days, and 9 of 28 (32%) at 90 days post-infusion. There were no deaths reported as of the last assessment, at a median follow-up of 9.0 months, ranging from 1 to 26 months. Further commenting to Medscape Medical News , Kuipers noted that, 'although there are no head-to-head comparisons, CAR T-cell therapy offers the advantage of a single treatment, and progression-free survival appears better with this therapy, however, this benefit may be associated with a higher short-term toxicity rate,' she explained. Kuipers noted that bispecific antibodies have the added advantage of being able to start immediately, which is particularly important for patients with progressive disease, and toxicity rates are lower. 'With GLPG5101, we have so far observed a very manageable safety profile,' she added. 'The short vein-to-vein time eliminated the need for bridging therapy, and the dropout rate was low (5.9%), which potentially facilitated treatment of patients who would not otherwise be able to receive CAR T-cell therapy,' she concluded. 'Real signal' of Benefit in Indolent NHL Is Clear Commenting on the study, Samuel Yamshon, MD, director, cellular therapy service, lymphoma program, at the Weill Cornell Medical Center, in New York City, agreed that the study was notable in 'consistently demonstrating responses from the GLPG5101 product in indolent lymphoma, and many of these responses appear to be durable.' 'This was accomplished without bridging and with a rapid turnaround time, which is a potentially exciting development for patients with aggressive disease,' he said. While patients with indolent lymphomas with high risk disease features, such as those who relapse within 24 months of treatment, can be challenging to treat with traditional therapies, 'CAR T-cell therapies so far appear to abrogate this risk somewhat — both the ZUMA-5 study of axi-cel and the TRANSCEND FL study of liso-cel demonstrated similar efficacy in high risk subgroups,' he explained. 'This suggests that this efficacy of the GLPG5101 product in these high-risk subpopulations of indolent non-Hodgkin lymphoma is a real signal.' Regarding the vein-to-vein benefit, Yamshon noted that the turnaround with GLPG101 'is definitely faster than what's currently available on the market — currently, the quickest turnaround time is with axi-cel, which in my experience is about 2 weeks.' However, it's not clear yet how much this really matters, especially in follicular and MZL, he cautioned. 'A short vein-to-vein time can cut both ways: Nobody on this trial received bridging therapy, which we sometimes actually like to do to debulk patients' lymphoma ahead of CAR T,' Yamshon said. 'Trials without bridging therapy can sometimes inadvertently select for more slowly growing lymphomas where we are comfortable proceeding without bridging therapy.' Nevertheless, 'having the flexibility of a quick turnaround is certainly exciting,' he said. Limitations include that the follow-up remains relatively short for some of the patients, Yamshon noted. 'Especially in indolent lymphomas, the real question is not how many patients respond, but how long these responses last. It will remain to be seen how the durability compares to the other approved products in indolent non-Hodgkin lymphoma.'
Malaysian Reserve
10-06-2025
- Health
- Malaysian Reserve
Foresight Diagnostics and Partners to Present Independent Validation Data for its CLARITY™ MRD Assay at the 2025 European Hematology Association (EHA) Congress and International Conference on Malignan
– Data will be presented as an oral presentation at EHA on Thursday, June 12, 2025, and at ICML on Thursday, June 19, 2025 BOULDER, Colo., June 10, 2025 /PRNewswire/ — Foresight Diagnostics, a leading developer of ultra-sensitive minimal residual disease (MRD) detection technologies, today announced that validation data demonstrating the prognostic performance of its CLARITY™ MRD assay in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be featured as encore oral presentations at two upcoming international conferences: the 2025 European Hematology Association (EHA) Congress (June 12–15, in Milan, Italy) and the 18th International Conference on Malignant Lymphoma (ICML) (June 17–21, in Lugano, Switzerland). This multi-center study, conducted in collaboration with Amsterdam University Medical Centers, the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON), and the Netherlands Comprehensive Cancer Organization (IKNL), highlights real-world results using Foresight CLARITY™ MRD on patients who were treated with frontline chemotherapy across over 50 centers in the Netherlands and Belgium. 'We're grateful to present our data at major medical meetings this spring, validating our science and the real-world utility of ultra-sensitive ctDNA-MRD technology,' said David Kurtz, M.D., Ph.D., Chief Medical Officer of Foresight Diagnostics. 'These presentations and the recent incorporation of ctDNA-MRD testing in B-cell lymphoma clinical guidelines give us confidence as we prepare to launch in the clinical market in 2026 and integrate Foresight CLARITY into routine clinical practice.' Lead study authors Steven Wang, M.D., and Martine Chamuleau, M.D., Ph.D., Amsterdam UMC, added: 'Our findings confirm that ultra-sensitive ctDNA-MRD detection provides meaningful prognostic information beyond standard imaging and clinical factors. We believe this assay can support better risk stratification than imaging alone and inform post-treatment management decisions in DLBCL.' Oral presentation details for EHA: Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national trial Presenter: Martine Chamuleau, MD, PhD (Amsterdam UMC) Session: Aggressive Non-Hodgkin lymphoma – Clinical (Observational) Time: Thursday, June 12 | 5:00 p.m. – 5:15 p.m. CEST / 11:00 a.m. – 11:15 a.m. ET Room: Brown Hall 3 Abstract number: S240 Oral presentation details for ICML: Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national HOVON trial Presenter: Martine Chamuleau, MD, PhD (Amsterdam UMC) Session: Session 6: Liquid biopsy for response assessment Time: Thursday, June 19 | 2:15 p.m. – 2:30 p.m. CEST / 8:15 a.m. – 8:30 a.m. ET Room: Polivalente room, East Campus USI Article number: 041 In addition to the oral presentation, Foresight's technology will be highlighted in other presentations, including: Title: Prognostic Value of Circulating Tumor DNA (ctDNA) Detection by PhasED-Seq After Axicabtagene ciloleucel (Axi-cel) Therapy in Relapsed/Refractory Large B-Cell Lymphoma (LBCL) Meeting: EHA 2025 Sponsor: Kite PharmaPresenter: Jeffrey Gregg, MD (Foresight Diagnostics) Session: Poster Session I | Poster HallDate/Time: Friday, June 13 | 6:30 p.m. – 7:30 p.m. CEST / 12:30 p.m. – 1:30 p.m. ET Abstract: #PF1002 Title: The Correlation of Mutational Profiles and Valemetostat Efficacy in Patients With R/R PTCL in the Phase 2 VALENTINE-PTCL01 Trial Meeting: ICML 2025 Sponsor: Daiichi Sankyo Presenter: Pier Luigi Zinzani, MD, PhD (University of Bologna) Session: 'Focus On' Session Biology and Therapy of T-cell Lymphomas | Room B Date/Time: Saturday, June 14 | 10:05 a.m. – 10:15 a.m. CEST / 4:05 a.m. – 4:15 a.m. ET Article Number: 164 About Foresight Diagnostics Foresight Diagnostics is a privately held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million. The improved sensitivity of Foresight CLARITY™ has the potential to provide actionable information to physicians and biopharmaceutical companies to enable personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit and follow us on X, LinkedIn, and Bluesky.
Yahoo
10-06-2025
- Health
- Yahoo
Foresight Diagnostics and Partners to Present Independent Validation Data for its CLARITY™ MRD Assay at the 2025 European Hematology Association (EHA) Congress and International Conference on Malignant Lymphoma (ICML)
- Data will be presented as an oral presentation at EHA on Thursday, June 12, 2025, and at ICML on Thursday, June 19, 2025 BOULDER, Colo., June 10, 2025 /PRNewswire/ -- Foresight Diagnostics, a leading developer of ultra-sensitive minimal residual disease (MRD) detection technologies, today announced that validation data demonstrating the prognostic performance of its CLARITY™ MRD assay in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be featured as encore oral presentations at two upcoming international conferences: the 2025 European Hematology Association (EHA) Congress (June 12–15, in Milan, Italy) and the 18th International Conference on Malignant Lymphoma (ICML) (June 17–21, in Lugano, Switzerland). This multi-center study, conducted in collaboration with Amsterdam University Medical Centers, the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON), and the Netherlands Comprehensive Cancer Organization (IKNL), highlights real-world results using Foresight CLARITY™ MRD on patients who were treated with frontline chemotherapy across over 50 centers in the Netherlands and Belgium. "We're grateful to present our data at major medical meetings this spring, validating our science and the real-world utility of ultra-sensitive ctDNA-MRD technology," said David Kurtz, M.D., Ph.D., Chief Medical Officer of Foresight Diagnostics. "These presentations and the recent incorporation of ctDNA-MRD testing in B-cell lymphoma clinical guidelines give us confidence as we prepare to launch in the clinical market in 2026 and integrate Foresight CLARITY into routine clinical practice." Lead study authors Steven Wang, M.D., and Martine Chamuleau, M.D., Ph.D., Amsterdam UMC, added: "Our findings confirm that ultra-sensitive ctDNA-MRD detection provides meaningful prognostic information beyond standard imaging and clinical factors. We believe this assay can support better risk stratification than imaging alone and inform post-treatment management decisions in DLBCL." Oral presentation details for EHA: Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national trial Presenter: Martine Chamuleau, MD, PhD (Amsterdam UMC) Session: Aggressive Non-Hodgkin lymphoma - Clinical (Observational) Time: Thursday, June 12 | 5:00 p.m. – 5:15 p.m. CEST / 11:00 a.m. – 11:15 a.m. ET Room: Brown Hall 3 Abstract number: S240 Oral presentation details for ICML: Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national HOVON trial Presenter: Martine Chamuleau, MD, PhD (Amsterdam UMC) Session: Session 6: Liquid biopsy for response assessment Time: Thursday, June 19 | 2:15 p.m. – 2:30 p.m. CEST / 8:15 a.m. – 8:30 a.m. ET Room: Polivalente room, East Campus USI Article number: 041 In addition to the oral presentation, Foresight's technology will be highlighted in other presentations, including: Title: Prognostic Value of Circulating Tumor DNA (ctDNA) Detection by PhasED-Seq After Axicabtagene ciloleucel (Axi-cel) Therapy in Relapsed/Refractory Large B-Cell Lymphoma (LBCL) Meeting: EHA 2025 Sponsor: Kite PharmaPresenter: Jeffrey Gregg, MD (Foresight Diagnostics) Session: Poster Session I | Poster HallDate/Time: Friday, June 13 | 6:30 p.m. – 7:30 p.m. CEST / 12:30 p.m. – 1:30 p.m. ET Abstract: #PF1002 Title: The Correlation of Mutational Profiles and Valemetostat Efficacy in Patients With R/R PTCL in the Phase 2 VALENTINE-PTCL01 Trial Meeting: ICML 2025 Sponsor: Daiichi Sankyo Presenter: Pier Luigi Zinzani, MD, PhD (University of Bologna) Session: "Focus On" Session Biology and Therapy of T-cell Lymphomas | Room B Date/Time: Saturday, June 14 | 10:05 a.m. – 10:15 a.m. CEST / 4:05 a.m. – 4:15 a.m. ET Article Number: 164 About Foresight Diagnostics Foresight Diagnostics is a privately held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million. The improved sensitivity of Foresight CLARITY™ has the potential to provide actionable information to physicians and biopharmaceutical companies to enable personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit and follow us on X, LinkedIn, and Bluesky. View original content to download multimedia: SOURCE Foresight Diagnostics, Inc.
Associated Press
13-05-2025
- Business
- Associated Press
Renovaro and Amsterdam University Medical Center Announce Exclusive Collaboration to Advance Blood Platelet RNA Diagnostics
LOS ANGELES, May 13, 2025 (GLOBE NEWSWIRE) -- Renovaro Inc. (NASDAQ: RENB), a TechBio leader focused on next-generation diagnostics, drug discovery, and genetically enhanced cancer therapies, today agreed on terms for an exclusive collaboration agreement with Amsterdam University Medical Center ('Amsterdam UMC') to jointly evaluate and develop blood platelet RNA diagnostics. This partnership marks an important step forward in the clinical validation and advancement of a promising new approach to disease detection and monitoring. The collaboration will focus on assessing the clinical utility of blood platelet RNA signatures as a powerful biomarker source. This effort will leverage the unique Artificial Intelligence ('AI')/Machine Learning ('ML') capabilities of Renovaro as well as the newly announced compute resources provided through their agreement with Nebul, to uncover subtle disease-specific signals from blood samples and is aimed at transforming diagnostic and prognostic approaches across multiple cancer types. Under the terms of the agreement, Renovaro and Amsterdam UMC will work together to refine and improve predictive performance, aiming for a high degree of clinical accuracy. The project will involve collection and analysis of blood samples, data integration from multiple modalities, and the development of sophisticated deep learning models. 'We are excited to partner with Amsterdam UMC, a leader in translational research, to advance this promising technology,' said David Weinstein, CEO of Renovaro. 'By combining their clinical expertise with our technological capabilities, we believe we can significantly accelerate the translation of blood platelet RNA diagnostics into clinical practice.' Both organizations have committed to jointly manage the intellectual property arising from the collaboration and plan to establish a dedicated company in the Netherlands to further develop and commercialize resulting diagnostics. The initial term of the collaboration is four years, with the possibility of extension by mutual agreement. About Amsterdam UMC Amsterdam UMC is a leading medical center that combines complex high-quality patient care, innovative scientific research, and education of the next generation health care professionals. We believe that health care practice, research and education belong together, with each shaping and informing the other. With over 16,000 people, the two locations of Amsterdam UMC work together to provide good and accessible care. Amsterdam UMC is focused on a future where diseases can be prevented and where patients receive the best treatments. The emphasis is on the complex treatment of rare disorders. About Renovaro Renovaro aims to accelerate precision and personalized medicine for longevity powered by mutually reinforcing AI and biotechnology platforms for early diagnosis, better-targeted treatments, and drug discovery. Renovaro Inc. includes RenovaroBio with its advanced cell-gene immunotherapy company and RenovaroCube that is leveraging AI for multi-omic diagnostics and drug development, and BioSymetrics which specializes in contingent AI for precision neurology. For more information, visit Forward-Looking Statements This press release contains statements by Renovaro Biosciences Inc. ('Renovaro', 'we', 'us', 'our' or the 'Company') that are not historical facts and are considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may address, among other things, our prospects, plans, business strategy and expected financial and operational results. You can identify these statements by the use of words such as 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'should,' 'will,' 'would', 'could', 'project', 'plan', 'potential', 'designed', 'seek', 'target', variations of these terms, the negatives of such terms and similar expressions. These statements are based on certain assumptions that we have made in light of our experience in our industry as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate in these circumstances. These forward-looking statements are based on our current expectations and beliefs concerning future developments and their potential effect on us. You should not rely on forward-looking statements because our actual results may differ materially from those indicated by forward-looking statements as a result of a number of important factors. These factors include, but are not limited to: the success or efficacy of our pipeline, platform and fundraising; our ability to successfully integrate business that we have acquired, including BioSymetrics, or that we may acquire; our ability to achieve the benefits that we expect to realize as a result of our acquisitions, including BioSymetrics; and those other risks and uncertainties discussed in the reports we have filed with the Securities and Exchange Commission (the 'SEC'), such as our most recent Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. All forward-looking statements are qualified in their entirety by this cautionary statement. Forward-looking statements speak only as of the date the statements were made. We do not undertake any obligation to update forward-looking information, except to the extent required by applicable law. Investor Relations Chris Tyson Executive Vice President MZ Group - MZ North America 949-491-8235 [email protected] For media inquiries, please contact: [email protected]
Web Release
24-04-2025
- Health
- Web Release
Imricor Commences VISABL-VT Trial
By Editor_wr On Apr 24, 2025 Imricor Medical Systems, Inc. (Company or Imricor) (ASX: IMR) is pleased to announce that it has commenced the VISABL-VT clinical trial by completing the first-in-human ventricular ablation guided by real-time MRI with the Company's NorthStar Mapping System. The procedure was performed by the team at the Amsterdam University Medical Centre (AUMC), ranked in 2025 by Newsweek as the best hospital in The Netherlands, and in the top 35 worldwide. The procedure marked several world firsts. It was the first ventricular ablation to be guided by real-time MRI, and it was the first left-sided ablation to be performed under real-time MRI guidance. The patient was treated for right-sided and left-sided premature ventricular complexes (PVCs). 'During ablation, MRI-images provide a better view of the anatomy of the heart and the instruments used for treatment, but also of the changes made to the treated cardiac tissue. Unlike X-ray images, the entire area surrounding the heart can be seen, including the blood vessels and valves. And the MRI offers the opportunity during the procedure to visualize the effects of the treatment on the myocardial tissue,' says Marco Götte, imaging cardiologist at Amsterdam UMC, initiator and project leader of the cardiac intervention MRI research program. Amsterdam UMC has a long history with the development of MRI-guided cardiac interventions, with numerous firsts and this is yet another an important milestone. 'The patient is doing well; the procedure went according to plan and the arrhythmia has been eliminated. We are therefore extremely proud that with our years of preparation, we have now reached the point where we are the first in the world to be able to treat complex forms of cardiac arrhythmias in an MRI scanner,' says Cor Allaart, Professor of Electrophysiology and cardiologist at Amsterdam UMC. Imricor's Chair and CEO, Steve Wedan, commented, 'We formed Imricor in 2006 with the goal of delivering MRI-compatible catheters and systems that would enable real-time MRI guidance of complex ventricular and atrial ablation procedures, where the power of MRI has the potential to deliver better, faster, safer, and less expensive treatment for patients suffering from irregular heartbeats. This achievement is a huge milestone for both Imricor and Amsterdam UMC.' Imricor Commences VISABL-VT Trial Comments are closed.
