Tagged News
Avidicure Launches with $50M to Develop Novel Multifunctional Antibody Platform for Cancer
• Netherlands-based Avidicure has secured $50 million in seed financing to develop its AVC-Boosters platform, a novel multifunctional antibody modality designed to harness both innate and adaptive immune responses against cancer.
• The company's lead product, AVC-S-101, targets Trop2 protein and is being developed for non-small cell lung cancer and other indications, with potential to deliver targeted and potent cancer monotherapy with reduced toxicity.
• Avidicure's platform leverages decades of antibody engineering expertise and offers plug-and-play functionality for multiple product development, positioning it to potentially surpass first-generation antibodies, checkpoint inhibitors, and ADCs.
CN Bio and Pharmaron Partner to Advance Organ-on-a-Chip Technology for Drug Development
• CN Bio has formed a strategic partnership with Pharmaron to validate and integrate its PhysioMimix organ-on-a-chip technology across drug discovery applications, reducing reliance on animal testing.
• The collaboration will initially focus on disease modeling, toxicity testing, and ADME studies, with plans to expand into novel applications addressing unmet needs in pharmaceutical R&D.
• This partnership aligns with recent FDA announcements to phase out animal testing requirements for monoclonal antibodies, as the global organ-on-a-chip market is projected to reach $388 million by 2028.
Cemiplimab Shows Significant Survival Benefit in NSCLC Patients with Brain Metastases and High PD-L1 Expression
• First-line cemiplimab (Libtayo) monotherapy demonstrated a remarkable survival advantage over chemotherapy in advanced NSCLC patients with PD-L1 ≥50% and brain metastases, with median OS of 52.4 vs 20.7 months.
• The EMPOWER-Lung 1 trial's 5-year follow-up data confirms cemiplimab's long-term clinical benefits across all PD-L1 expression levels, with the greatest benefit observed in patients with PD-L1 ≥90%.
• Patients receiving cemiplimab experienced fewer grade ≥3 adverse events compared to chemotherapy (18.3% vs 39.9%), while also reporting improved quality of life measures including better emotional functioning and reduced fatigue.
Related Clinical Trials:
Regeneron Pharmaceuticals
Posted 5/29/2017
Annexon's Tanruprubart Shows Rapid and Durable Improvements in Guillain-Barré Syndrome Phase III Trial
• Tanruprubart demonstrated significant functional improvements in Guillain-Barré syndrome patients as early as one week after treatment, with patients 14 times more likely to show improved mobility versus placebo.
• The monoclonal antibody targeting C1q protein maintained durable benefits through 26 weeks, with twice as many treated patients achieving full recovery compared to placebo.
• If approved, tanruprubart could address a significant unmet need for the estimated 7,000 U.S. and 15,000 EU patients diagnosed with GBS annually, potentially representing a $1 billion market opportunity.
Related Clinical Trials:
Annexon, Inc.
Posted 12/17/2020
Uplizna Shows Remarkable Efficacy in Reducing Flares and Glucocorticoid Dependence in IgG4-Related Disease
• Phase III MITIGATE trial demonstrates Uplizna (inebilizumab) significantly reduces flare risk in IgG4-related disease, with only 10% of treated patients experiencing flares compared to 60% in the placebo group.
• The CD19-targeting monoclonal antibody proved particularly effective for patients with pancreatic and biliary manifestations of IgG4-RD, showing even greater benefits than in the overall study population.
• Uplizna treatment led to higher rates of glucocorticoid-free complete remission, potentially establishing a new second-line standard of care following initial glucocorticoid therapy.
Related Clinical Trials:
Amgen
Posted 10/26/2020
New Study Highlights Benefits of Maintaining High Factor VIII Levels in Hemophilia A Patients
• Maintaining high Factor VIII (FVIII) levels in people with hemophilia A provides significant clinical benefits, including reduced bleeding risk and better joint health preservation.
• Despite advances in prophylactic treatment, standard-of-care prophylaxis does not completely prevent joint damage or chronic pain, with approximately 47% of hemophilia patients experiencing ongoing pain.
• Recent innovations in hemophilia treatment, including extended half-life therapies, non-factor replacement options, and gene therapy, offer new approaches to sustaining higher FVIII levels and improving patient outcomes.
Related Clinical Trials:
Hoffmann-La Roche
Posted 11/18/2015
Bioverativ, a Sanofi company
Posted 11/19/2019
Hoffmann-La Roche
Posted 1/30/2017
Hoffmann-La Roche
Posted 7/22/2016
Hoffmann-La Roche
Posted 9/27/2016
Baxalta now part of Shire
Posted 1/4/2006
Bevacizumab Benefits in Colorectal Cancer Limited to Two-Year Window, New Analysis Reveals
• A comprehensive review presented at the 2025 ASCO Gastrointestinal Cancers Symposium reveals bevacizumab (Avastin) provides survival benefits in colorectal cancer patients for approximately two years after initial administration.
• Researchers found that after 20-24 months, the initial survival benefit from bevacizumab diminishes, potentially explaining the crossover of survival curves observed in the PARADIGM trial compared to panitumumab (Vectibix).
• The study suggests bevacizumab treatment may lead to selection of more aggressive tumor clones over time, characterized by accelerated growth and invasiveness after the initial period of tumor stasis and shrinkage.
Related Clinical Trials:
Takeda
Posted 5/29/2015
Hoffmann-La Roche
Posted 12/1/2004
Alliance for Clinical Trials in Oncology
Posted 11/1/2005
National Cancer Institute (NCI)
Posted 9/15/2004
PD Dr. med. Volker Heinemann
Posted 1/1/2007
FDA Approves Tevimbra-Chemotherapy Combination for First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma
• The FDA has approved BeiGene's Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
• In the pivotal RATIONALE-306 trial, patients treated with Tevimbra plus chemotherapy demonstrated a median overall survival of 16.8 months compared to 9.6 months with chemotherapy alone, representing a 34% reduction in risk of death.
• This marks BeiGene's third FDA approval in less than a year, following previous approvals for Tevimbra in second-line ESCC and first-line gastric/gastroesophageal junction cancers, highlighting the company's expanding oncology portfolio.
Related Clinical Trials:
BeiGene
Posted 7/22/2019
BeiGene
Posted 1/26/2018
Galderma's Phase III OLYMPIA 1 Trial Results Show Nemolizumab Significantly Improves Prurigo Nodularis Symptoms
• Newly published results in JAMA Dermatology demonstrate nemolizumab monotherapy significantly improved itch intensity and skin lesions in patients with moderate-to-severe prurigo nodularis compared to placebo.
• The OLYMPIA 1 trial showed rapid response as early as Week 4, with over six times more nemolizumab-treated patients achieving itch response and twenty times more reaching an itch-free or nearly itch-free state compared to placebo.
• Based on the OLYMPIA clinical trial program, nemolizumab (Nemluvio®) received FDA approval for adult prurigo nodularis in August 2024, with additional regulatory reviews ongoing worldwide.
Related Clinical Trials:
Galderma R&D
Posted 8/11/2020
Galderma R&D
Posted 9/11/2020
Roche's PiaSky Approved in EU as First Monthly Self-Administered Treatment for Paroxysmal Nocturnal Haemoglobinuria
• The European Commission has approved PiaSky (crovalimab), the first monthly subcutaneous treatment for paroxysmal nocturnal haemoglobinuria (PNH), offering patients the option to self-administer following training.
• PiaSky utilizes innovative recycling antibody technology developed by Chugai Pharmaceutical, allowing it to bind to C5 protein multiple times and remain effective longer with a small volume of medicine.
• Clinical trials demonstrated PiaSky's non-inferiority to eculizumab, the current standard of care, while potentially reducing treatment burden through less frequent administration and eliminating the need for regular clinic visits.
Related Clinical Trials:
Hoffmann-La Roche
Posted 10/22/2021
Hoffmann-La Roche
Posted 9/30/2020
Hoffmann-La Roche
Posted 10/8/2020
Hoffmann-La Roche
Posted 11/17/2021