Tagged News
Comac Medical Group Acquires ILIFE Consulting to Strengthen Oncology and Early-Phase Trial Capabilities
• UK-based Comac Medical Group has acquired Paris-based ILIFE Consulting, expanding its pan-European footprint and deepening expertise in oncology and rare disease clinical trials.
• The strategic acquisition enhances Comac's service portfolio with ILIFE's specialized capabilities in early-phase biotech trials, creating a more comprehensive offering for small and medium-sized biopharma clients.
• ILIFE founder Marina Iché will retain her leadership role and become a significant shareholder in the Group, ensuring continuity while supporting the combined entity's growth initiatives across Europe.
Replimune's RP1 Melanoma Therapy Nears FDA Decision with July PDUFA Date as Commercial Infrastructure Readies for Launch
• Replimune's BLA for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma is proceeding on schedule with a PDUFA date of July 22, 2025, following completed manufacturing inspections and late cycle review.
• The company has fully established its commercial infrastructure ahead of potential launch, targeting approximately 13,000 annual U.S. patients who progress on PD-1 treatment, with an estimated 80% eligible for RP1 therapy.
• Replimune maintains a strong financial position with $483.8 million in cash, cash equivalents and short-term investments as of March 31, 2025, providing runway into Q4 2026 to support commercialization efforts.
UCLA Study Reveals SSRIs May Enhance Immune Response Against Cancer
• UCLA researchers discovered that selective serotonin reuptake inhibitors (SSRIs) can enhance T cells' ability to fight cancer, reducing tumor size by more than half in multiple cancer models.
• The study, published in Cell, demonstrated SSRIs' effectiveness against melanoma, breast, prostate, colon, and bladder cancers in both mouse and human tumor models.
• Combining SSRIs with existing cancer immunotherapies showed promising results, suggesting potential for repurposing these widely used antidepressants as cancer treatments.
Elicera's iTANK-Armed CAR T-Cell Therapy Shows Complete Response in Lymphoma Patients
• Elicera Therapeutics reports that two out of three patients in the first cohort of the CARMA study achieved complete metabolic response with ELC-301, an iTANK-armed CD20-targeting CAR T-cell therapy.
• The promising results were achieved despite using only one-tenth of the planned maximum dose in a challenging patient population, including one patient who had previously failed standard CD19 CAR T-cell therapy.
• The Phase I/IIa CARMA study has already progressed to its second cohort, where patients are receiving a dose three times higher than the initial cohort, with further data expected as the trial advances.
Dual mTORC1/2 Inhibitor BI 860585 Shows Promise in Phase I Breast Cancer Trial
• A Phase I study of BI 860585, a novel dual mTORC1/2 inhibitor, demonstrated manageable safety profile and preliminary efficacy in advanced breast cancer patients.
• The trial evaluated BI 860585 both as monotherapy and in combination with exemestane or paclitaxel, showing potential for overcoming resistance mechanisms in hormone receptor-positive breast cancer.
• Researchers observed dose-dependent target inhibition and disease stabilization in several patients, supporting further investigation in larger clinical trials.
Related Clinical Trials:
Boehringer Ingelheim
Posted 9/5/2013
NUS Researchers Develop NExT: A Revolutionary Gene Delivery Platform for Cancer Immunotherapy
• Researchers at the National University of Singapore have developed Nanostraw Electro-actuated Transfection (NExT), a non-viral technology that efficiently delivers genetic material into immune cells with minimal disruption.
• The NExT platform can transfect over 14 million immune cells in a single run with up to 94% efficiency for proteins and 80% for mRNA, while maintaining essential tumor-fighting characteristics.
• This breakthrough could significantly reduce manufacturing costs and improve accessibility of CAR-T cell therapies, which currently cost approximately S$670,000 per infusion in Singapore.
FDA Clears Avenzo Therapeutics' IND for AVZO-023, a Novel CDK4 Selective Inhibitor for Advanced Breast Cancer
• Avenzo Therapeutics has received FDA clearance for its investigational new drug application for AVZO-023, a highly selective CDK4 inhibitor with potential best-in-class properties for treating HR+/HER2- breast cancer.
• The company plans to initiate a Phase 1/2 clinical trial in Q3 2025, evaluating AVZO-023 as monotherapy and in combination with endocrine therapy and their CDK2 inhibitor AVZO-021.
• Preclinical data presented at AACR 2025 demonstrated AVZO-023's sub-nanomolar potency against CDK4 with high selectivity over CDK6, potentially reducing hematologic toxicity common with current CDK inhibitors.
New AI Blood Test ARTEMIS-DELFI Shows Promise for Monitoring Pancreatic Cancer Treatment Response
• Johns Hopkins researchers have developed ARTEMIS-DELFI, an AI-powered blood test that detects tumor DNA fragments to monitor pancreatic cancer treatment response more effectively than traditional imaging methods.
• The new technique outperformed conventional methods in two clinical trials, identifying patient responses as early as four weeks after treatment initiation, potentially allowing for faster therapy adjustments.
• ARTEMIS-DELFI offers significant advantages over other approaches as it doesn't require tumor samples, works with more patients, and provides a simpler, potentially less expensive monitoring solution for pancreatic cancer patients.
OSE Immunotherapeutics Leads €1.3 Million Consortium to Advance mRNA Therapeutics Using Lipid Nanoparticle Technology
• OSE Immunotherapeutics has secured €1.3 million in non-dilutive funding to lead the 36-month "HexARN" program focused on advancing mRNA therapeutics delivered via lipid nanoparticles.
• The strategic collaboration brings together OSE Immunotherapeutics, Inside Therapeutics, and MiNT Laboratory to overcome challenges in RNA therapy selectivity, safety, target expansion, and manufacturing scalability.
• The consortium aims to develop novel RNA therapeutics for inflammatory disorders and autoimmune diseases, leveraging advantages over conventional antibody approaches while improving delivery methods.
BioDlink Secures Brazil GMP Certification, Expanding Global Reach for Bevacizumab Biosimilar
• BioDlink has successfully passed its first on-site GMP inspection by Brazil's ANVISA, a PIC/S member, marking a significant regulatory milestone for the company's Suzhou manufacturing facility.
• The inspection specifically reviewed production of Pusintin® (bevacizumab), a biosimilar antibody treating non-small cell lung cancer and metastatic colorectal cancer, receiving full approval with no observations.
• With regulatory certifications now in five countries including Brazil, Indonesia, Egypt, Colombia, and Argentina, BioDlink aims to expand access to affordable oncology biologics across emerging markets.