Tagged News
GenVivo Reports Promising Phase 1 Data for GEN2 and Preclinical Results for GEN-1013 Cancer Immunotherapies at ASGCT 2025
• GenVivo's lead candidate GEN2, a non-replicating mRNA vector therapy, demonstrates favorable safety profile with minimal toxicity and encouraging pharmacodynamic activity in Phase 1 trials for solid tumors.
• GEN-1013, the company's preclinical IL-12 encoding therapy, showed remarkable efficacy in murine cancer models with 89% of treated animals reaching study endpoints compared to just 11% in control groups.
• Both therapies leverage GenVivo's innovative vector platform that activates patients' immune systems against their own tumor antigens, with GEN-1013 advancing toward IND filing by mid-2026.
Related Clinical Trials:
GenVivo, Inc.
Posted 3/4/2024
Colorectal Cancer Leads in Real-World Data Volume, But Oncology Trials Need Modernization
• Phesi's analysis of 167 million patient records reveals colorectal cancer has the largest volume of real-world data with nearly six million records, outpacing breast, lung, liver, and prostate cancers.
• Despite the wealth of available data, oncology clinical trials continue to suffer from inefficiencies, with trial design and execution failing to keep pace with advances in biomarker science and patient profiling.
• Experts urge a shift toward "precision oncology" using AI and clinical data science to optimize patient profiles, programs, protocols, and operations plans to accelerate drug development.
Intermountain Health Pioneers First Remote CAR-T Cell Collection Site in Southern Utah
• Intermountain Health has established the nation's first remote CAR-T cell collection site at St. George Regional Hospital, bringing advanced cancer treatment closer to patients in Southern Utah and Nevada.
• The innovative satellite clinic eliminates the need for patients to travel hundreds of miles to Salt Lake City for initial collection procedures, significantly improving accessibility to this cutting-edge immunotherapy.
• CAR-T cell therapy, which reprograms patients' immune cells to target and destroy cancer cells, has shown remarkable success in treating various hematologic cancers including leukemia, lymphoma, and multiple myeloma.
STEERLife Unveils Solvent-Free Melt Fusion Technology for Potent Drug Development
• STEERLife has introduced a groundbreaking solvent-free melt fusion technology that eliminates harmful organic solvents in pharmaceutical manufacturing, enhancing safety and efficiency.
• The company has initiated development of generic versions of several high-potency drugs including Apalutamide, Enzalutamide, Venetoclax, and Olaparib, with market releases planned from 2026.
• Through strategic partnerships, STEERLife aims to serve pharmaceutical markets across multiple regions including the United States, Europe, Latin America, and Asia.
Elucent Medical's EnVisio X1 Surgical Navigation System Receives FDA Breakthrough Device Designation
• Elucent Medical's EnVisio X1 In-Body Spatial Intelligence System has received FDA Breakthrough Device Designation, potentially accelerating its path to market for soft tissue surgical navigation.
• The system features permanently implantable SmartClip markers and real-time 3D guidance technology that wirelessly tracks surgical instruments, enhancing precision during thoracic and abdominal soft tissue excisions.
• This innovative technology aims to improve surgical outcomes by enabling more precise excisions, reducing positive margins, and minimizing the need for repeat procedures in cancer surgeries.
Narmafotinib Combination Shows Superior Response in Pancreatic Cancer ACCENT Trial
• Amplia Therapeutics' Phase 1b/2a ACCENT trial has recorded 15 confirmed partial responses in pancreatic cancer patients receiving narmafotinib combined with standard chemotherapy.
• The trial results demonstrate that adding narmafotinib, a highly selective FAK inhibitor, to gemcitabine and Abraxane chemotherapy is superior to chemotherapy alone in advanced pancreatic cancer.
• With 21 of 55 enrolled patients still on study, researchers anticipate additional partial responses may be observed before final data readout expected in mid-Q3 2025.
Telisotuzumab Vedotin Plus Osimertinib Shows Promise in TKI-Resistant NSCLC with c-MET Overexpression
• The combination of telisotuzumab vedotin and osimertinib demonstrated a 50% objective response rate in patients with EGFR-mutant NSCLC who had progressed after prior osimertinib treatment.
• All patients experienced at least one treatment-emergent adverse event, with peripheral sensory neuropathy (50%) and peripheral edema (32%) being most common, though no dose-limiting toxicities were reported.
• The promising efficacy data, including a median progression-free survival of 7.4 months, suggests this combination could address an unmet medical need in patients with c-MET protein overexpression-mediated resistance to EGFR TKIs.
Related Clinical Trials:
AbbVie
Posted 10/10/2018
AbbVie
Posted 1/15/2014
Ibrutinib/Nivolumab Combination Shows Promising 77.8% Response Rate in Relapsed CNS Lymphoma Trial
• A phase 2 trial of ibrutinib plus nivolumab demonstrated a high objective response rate of 77.8% in patients with relapsed/refractory central nervous system lymphoma, with 50% achieving complete responses.
• At a median follow-up of 31 months, the median overall survival was 21 months, with 17% of patients experiencing durable remissions lasting more than two years without additional treatment.
• The combination therapy was well-tolerated with manageable side effects, though 50% of patients experienced at least one grade 3-4 treatment-related adverse event, most commonly neutropenia and oral mucositis.
Related Clinical Trials:
M.D. Anderson Cancer Center
Posted 2/15/2019
Merck KGaA Joins Peregrine Ventures' Incentive Incubator as Strategic Partner
• Merck KGaA has become a strategic partner in Peregrine Ventures' Incentive Incubator, gaining early access to startups in bioconvergence, pharma, and biotechnology fields.
• The collaboration will focus on ventures with significant market potential aligned with Merck's three global divisions: Healthcare, Life Science, and Electronics, with priority given to bioconvergence ventures.
• Through this partnership, eligible startups will receive support including investments, regulatory guidance, business development assistance, and potentially early-phase trial planning.
Exelixis Initiates Phase 1 Trial of XB628, a Novel Bispecific NK Cell Engager for Advanced Solid Tumors
• Exelixis has begun dose-escalation in a first-in-human Phase 1 trial of XB628, a first-in-class bispecific antibody targeting both NKG2A and PD-L1 in patients with recurrent advanced or metastatic solid tumors.
• XB628 represents a novel immunotherapy approach by engaging natural killer cells through dual targeting of an inhibitory receptor (NKG2A) and the immune checkpoint protein PD-L1.
• The investigational therapy was developed through a collaboration between Exelixis and Invenra, leveraging Invenra's proprietary B-Body® platform for creating multispecific antibodies with superior biophysical properties.