FRED HUTCHINSON CANCER CENTER
🇺🇸United States
HIV Vaccine Breakthrough: Clinical Trials Show Promise for Broadly Neutralizing Antibody Development
• Two phase 1 clinical trials demonstrate successful activation of rare immune cells needed to develop broadly neutralizing antibodies against HIV, marking significant progress in vaccine development.
• The innovative stepwise vaccination strategy using mRNA technology showed 100% success rate in generating VRC01-class antibody responses in participants who received both prime and boost doses.
• Results from trials conducted in North America and Africa showed similar immune responses, supporting the potential for a globally effective HIV vaccine targeting regions most affected by the pandemic.
CDC Confirms Concerning Mutations in First Severe U.S. Bird Flu Case
• A Louisiana patient hospitalized with H5N1 avian influenza marks the first severe human case in the United States, with genetic analysis revealing mutations that could enhance the virus's ability to infect human cells.
• The mutations developed during infection and were not present in the backyard poultry that transmitted the virus, suggesting adaptation to the human host rather than widespread circulation in nature.
• Despite 66 other mild H5N1 cases reported across the U.S. since April, primarily among poultry and dairy workers, CDC officials maintain that the risk of person-to-person transmission remains low.
Omeros Forms Elite Clinical Steering Committee to Advance Novel AML Therapeutic Program
• Omeros Corporation has established an Oncology Clinical Steering Committee comprising eight distinguished leukemia experts from leading cancer centers to guide its OncotoX-AML program development.
• The OncotoX-AML therapeutic has demonstrated superior efficacy to current standard treatments in preclinical studies, effectively targeting 90% of common AML mutations while showing excellent tolerability at high doses.
• The novel engineered molecules, approximately half the size of antibodies, selectively kill dividing cancer cells including treatment-resistant leukemia stem cells, addressing a significant unmet need in AML treatment.
Lupus Research Alliance Awards $4.5 Million to Pioneer Next-Generation Cell Therapies for Lupus
• The Lupus Research Alliance has launched its Targeted Research Program on Engineered Cell Therapies for Lupus (TRP-ECT), awarding grants to 11 researchers developing innovative cellular treatments.
• Funded projects include faster CAR T cell production methods, selective targeting of harmful B cells while sparing protective ones, and novel approaches using regulatory T cells and natural killer cells.
• The initiative builds on promising clinical results where CD19 CAR T cell therapy induced complete remission in lupus patients who had failed previous treatments, potentially offering a path to drug-free disease management.
Fortress Biotech and Partex Form Strategic AI Partnership to Accelerate Drug Discovery and Development
• Fortress Biotech and Partex NV have announced a strategic collaboration leveraging Partex's proprietary AI platform to identify and evaluate biopharmaceutical compounds for potential acquisition or licensing.
• The partnership aims to expedite target identification, indication expansion, and molecular profiling, ultimately accelerating the process of bringing innovative therapeutics to market more efficiently.
• Fortress Biotech, with seven marketed products and over 20 programs in development, expects this AI-driven approach to enhance their business model of acquiring and advancing assets to create long-term shareholder value.
Groundbreaking CAR T-Cell and Transplantation Research Unveiled at 2025 Tandem Meeting
• Novel trial combining idecabtagene vicleucel with lenalidomide maintenance shows promise for multiple myeloma patients following autologous stem cell transplantation.
• Real-world analysis reveals potential benefits of second-line CAR T-cell therapy in large B-cell lymphoma, though larger studies needed for statistical confirmation.
• Researchers challenge current post-CAR T driving restrictions, suggesting unnecessary limitations after week 4 based on US Multiple Myeloma Immunotherapy Consortium data.
CELESTIAL and COSMIC-312 Trials Shape Future of HCC Treatment Landscape
• CELESTIAL trial establishes cabozantinib as standard second and third-line treatment for HCC, demonstrating improved overall survival of 10.2 months vs 8.0 months with placebo.
• COSMIC-312 trial shows mixed results with cabozantinib-atezolizumab combination, achieving PFS benefits but failing to meet OS endpoints in first-line HCC treatment.
• New research initiatives explore innovative combinations including novel immune checkpoint inhibitors, radiation therapy, and emerging cellular therapies like GPC3-targeted CAR T-cells.
Clinical Trial Diversity Crisis: Black Patients Severely Underrepresented in Multiple Myeloma Studies
• Recent phase 3 trials IMROZ and PERSEUS for multiple myeloma treatments showed alarming diversity gaps, with Black patients comprising only 0.9% and 1.3% of participants despite representing 20% of new myeloma cases.
• FDA study of 32,000 clinical trial participants reveals significant racial disparities, with non-Hispanic Whites overrepresented at 75% while Hispanic and Black populations remain underrepresented relative to US demographics.
• Real-world multiple myeloma patients show 44% worse progression-free survival compared to clinical trial participants, highlighting the consequences of non-representative trial populations.
Oncology Workforce Crisis Drives Push for Enhanced Collaboration and Value-Based Care
• Experts project a 40% increase in cancer care demand amid growing oncologist shortages, emphasizing the critical need for streamlined collaboration between healthcare providers and payers.
• Fred Hutchinson Cancer Center demonstrates success with multidisciplinary care model, expanding from 3 to 13 team members and implementing innovative outpatient-specific approaches to improve patient care delivery.
• Healthcare leaders stress the importance of balancing clinical guidelines with personalized care while highlighting the potential of emerging treatments like TIL therapy in addressing complex cancer cases.
Peri-Transplant Ruxolitinib Significantly Reduces GVHD Risk in Myelofibrosis Patients
• A phase 2 study at Fred Hutchinson Cancer Center demonstrates that peri-transplant ruxolitinib combined with standard GVHD prophylaxis reduces acute GVHD incidence to 32%, compared to 71% with pre-transplant treatment.
• The trial showed impressive survival rates, with 100% overall survival at 1 year and 87% at 2 years, while maintaining low chronic GVHD rates of 12% at 1 year.
• The study validates ruxolitinib's role in GVHD prevention without compromising patient outcomes, showing minimal impact on infection rates and transfusion requirements.
Phase 2 Trial Shows Promising Results for Cord Blood Transplantation in Blood Cancer Patients
• Unrelated umbilical cord blood transplantation demonstrated a 74% two-year overall survival rate in patients with hematologic malignancies, with particularly strong outcomes in pediatric patients.
• The study showed notably low relapse rates of 11% in patients with minimal residual disease-positive acute leukemia, highlighting cord blood's unique benefits as a donor source.
• The clinical trial enrolled 132 patients and tested both high-intensity and intermediate-intensity conditioning regimens, with a median follow-up of 3.5 years.
Study Reveals Clinical Trials Underestimate Quality of Life Impact in Relapsed/Refractory Multiple Myeloma
• A systematic literature review presented at ASH 2024 demonstrates that clinical trials significantly underestimate the health-related quality of life burden in relapsed/refractory multiple myeloma patients compared to real-world settings.
• Analysis of 175 records shows multiple myeloma patients experience notably lower quality of life scores across physical, cognitive, and social functioning compared to the general population, with significant differences in fatigue, pain, and financial difficulties.
• Research confirms that quality of life burden increases with additional lines of treatment, highlighting the cumulative impact of therapy on patient wellbeing in real-world settings.
Fortress Biotech's Triplex Enters Phase 2 Trial for CMV Prevention in Stem Cell Transplant Recipients
• Fortress Biotech and Helocyte have dosed the first subject in a Phase 2 trial of Triplex, a CMV vaccine, for stem cell transplant recipients.
• The trial aims to minimize CMV events by vaccinating HLA-matched stem cell donors, transferring immunity to recipients.
• Triplex is designed to induce a CMV-specific immune response in donors, offering earlier and more robust protection post-transplant.
• The NCI-funded trial builds on positive Phase 1 results and will also assess Triplex in higher-risk, partially HLA-matched transplant recipients.
Historical Redlining Linked to Higher Cancer Mortality Risk in Young Patients, Study Reveals
• Young cancer patients living in historically redlined areas show significantly lower 5-year survival rates (85.1%) compared to those in non-redlined areas (90.3%), according to a new study in Seattle and Tacoma.
• Research demonstrates that structural racism, manifested through historical redlining practices, continues to impact health outcomes with a 32% higher mortality risk for cancer patients in redlined neighborhoods.
• The study, analyzing over 4,300 cancer cases between 2000-2019, found disparities particularly affecting Hispanic and Black patients, who were more frequently residing in redlined areas.
Fecal Microbiota Transplantation Shows Promise in Preventing Graft-versus-Host Disease After Stem Cell Transplants
• A phase 2 clinical trial demonstrates that oral fecal microbiota transplantation (FMT) is a safe and feasible approach to prevent graft-versus-host disease (GVHD) in stem cell transplant recipients.
• The study identifies donor-specific effects, with FMT from Donor 3 showing the highest microbiota engraftment rate and a favorable safety profile.
• Lower pre-FMT microbiota diversity in patients was associated with better donor microbiota engraftment, suggesting a more receptive gut environment for transplanted microbes.
• The ongoing randomized phase of the trial will further investigate FMT's impact on reducing severe GVHD, improving quality of life, and increasing survival rates.
Reduced Dexamethasone Dosing Shows Comparable Survival Outcomes in Multiple Myeloma Treatment
• A pooled analysis of SWOG trials reveals that reducing dexamethasone doses below 40-60mg weekly does not negatively impact survival outcomes in newly diagnosed multiple myeloma patients.
• The study, published in Blood, found no significant difference in progression-free and overall survival between patients receiving full-dose versus lower-dose dexamethasone during induction therapy.
• Researchers suggest future clinical trials should prospectively investigate lower-dose dexamethasone strategies, as dose reductions were common even in clinical trial settings.
FDA Approves New Vial Sizes of Niktimvo for Chronic Graft-Versus-Host Disease
• The FDA has approved Niktimvo (axatilimab-csfr) in 9 mg and 22 mg vial sizes for chronic graft-versus-host disease (GVHD) after two prior systemic therapies.
• Niktimvo is the first FDA-approved treatment targeting CSF-1R to reduce inflammation and fibrosis in chronic GVHD, offering a novel approach for patients.
• AGAVE-201 trial data showed a 75% response rate at six months with the 0.3 mg/kg dose, demonstrating durable responses across various organs.
• Incyte and Syndax anticipate Niktimvo will be available in early February, with patient support programs to ensure access and financial assistance.
J&J Seeks FDA Approval for TAR-200 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
• Johnson & Johnson has initiated a New Drug Application (NDA) submission to the FDA for TAR-200.
• TAR-200 is intended for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
• Phase 2b SunRISe-1 study data showed an 83.5% complete response rate with TAR-200 monotherapy.
• The FDA is reviewing the application under the Real-Time Oncology Review (RTOR) program to expedite potential approval.
Ibrutinib and Rituximab Combination Shows Promise in Chronic Graft-vs-Host Disease
• Combination therapy with ibrutinib and rituximab is being explored to improve outcomes in chronic graft-vs-host disease (cGVHD).
• Rituximab enhances the therapeutic effects of ibrutinib in treating cGVHD, potentially leading to better patient responses.
• Recent trials have demonstrated promising efficacy and safety data for the ibrutinib and rituximab combination in cGVHD.
• Clinical practice may shift towards incorporating this combination to optimize treatment strategies for cGVHD patients.
EsoBiotec's In Vivo BCMA CAR-T Therapy, ESO-T01, Enters Clinical Trials for Multiple Myeloma
• EsoBiotec's ESO-T01, an in vivo BCMA CAR-T therapy, has dosed its first patient in a Phase 1 investigator-initiated trial in China for relapsed/refractory multiple myeloma.
• Initial observations suggest a favorable safety profile and promising efficacy at the starting dose of ESO-T01, with no cancer cells detected in bone marrow after 28 days.
• ESO-T01 leverages EsoBiotec's ENaBL platform to reprogram T cells in vivo, offering a potential off-the-shelf, cost-effective treatment option without requiring lymphodepletion.
• The multi-center, open-label, dose-escalation trial (NCT06691685) will evaluate the safety, tolerability, and preliminary clinical activity of ESO-T01 in up to 24 patients.
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