Clinical Trial News
Regeneron Develops Novel Antibody Approaches to Enable AAV Gene Therapy Redosing
• Regeneron has demonstrated successful AAV gene therapy redosing in non-human primates using two antibody-based strategies designed to suppress neutralizing antibody formation.
• The company's approaches include a CD40 blockade method and a CD20xCD3 bispecific antibody that depletes B-cells in lymph nodes and spleen, both showing superior efficacy compared to conventional rituximab.
• These transient immunomodulation techniques could potentially overcome one of gene therapy's major limitations by allowing patients to receive multiple doses of AAV-based treatments.
VERAXA Biotech Appoints Oncology Veteran Rick Austin as Chief Scientific Officer to Advance Novel Cancer Therapies
• Dr. Rick Austin, with over 25 years of oncology drug development experience, joins VERAXA Biotech as Chief Scientific Officer to advance the company's BiTAC platform and clinical-stage pipeline.
• Austin brings extensive expertise from leadership roles at Harpoon Therapeutics, Amgen, and Tularik, where he led tumor immunology projects and enabled numerous IND filings and first-in-human studies.
• VERAXA, an emerging leader in novel cancer therapies and proposed acquisition target of Voyager Acquisition Corp., aims to leverage Austin's expertise to expand therapeutic windows for antibody drug conjugates and T-cell engagers.
New Global Review Reveals Comprehensive Landscape of Interstitial Cystitis Clinical Trials in 2025
• A newly released global clinical trials review provides extensive data on Interstitial Cystitis research, tracking trial numbers and enrollment trends across major countries worldwide.
• The report categorizes trials by region, phase, status, and sponsorship, highlighting key pharmaceutical companies including Astellas Pharma, AbbVie, Johnson & Johnson, and Pfizer as prominent sponsors.
• This comprehensive analysis serves as a strategic resource for stakeholders making investment decisions in IC research, offering insights into trial success rates and identifying optimal locations for clinical studies.
Pfizer Enters $6 Billion Licensing Deal with China's 3SBio for Novel Cancer Drug
• Pfizer has secured global rights (excluding China) to 3SBio's experimental cancer drug SSGJ-707 for $1.25 billion upfront, with potential additional payments of up to $4.8 billion based on developmental milestones.
• SSGJ-707 is currently being evaluated for multiple cancer types including non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors, with Phase III trials in China planned to begin this year.
• The deal includes a $100 million equity investment in 3SBio by Pfizer, with manufacturing planned at Pfizer's facilities in North Carolina and Kansas following FDA clearance of the Investigational New Drug application.
Gabapentin Shows Promise in Extending Survival for Glioblastoma Patients, Mass General Brigham Study Reveals
• A retrospective analysis by Mass General Brigham and UCSF researchers found that glioblastoma patients taking gabapentin lived 4-6 months longer than those who didn't receive the medication.
• The common anti-seizure and pain medication appears to interfere with thrombospondin-1 (TSP-1), a protein that gliomas use to integrate into neural circuits and fuel tumor growth.
• Researchers observed lower levels of TSP-1 in the blood of gabapentin-treated patients, suggesting a biologically plausible mechanism that could lead to randomized clinical trials.
BioMed X and Boehringer Ingelheim Launch Initiative to Revolutionize Retinal Drug Delivery
• BioMed X and Boehringer Ingelheim have announced a global call for proposals to develop next-generation intraocular biologics, marking their second research initiative at the XSeed Labs incubator in Ridgefield, Connecticut.
• The collaboration aims to address a critical challenge in retinal disease treatment by creating biologics with extended intraocular half-life and improved retinal penetration, potentially reducing the burden of frequent injections for patients.
• Selected researchers will develop a novel screening platform for biologics, explore innovative design principles, and validate promising technologies to significantly improve patient adherence and treatment outcomes.
FDA Approves Teal Wand: First At-Home HPV Self-Collection Device for Cervical Cancer Screening
• Teal Health's Wand device has received FDA approval as the first prescription device for at-home self-collection of vaginal samples for HPV-based cervical cancer screening.
• The pivotal SELF-CERV study published in JAMA Network Open demonstrated 95% positive agreement for high-risk HPV detection and 96% sensitivity for precancerous lesions, matching clinician-collected samples.
• With an estimated 21 million women under- or unscreened for cervical cancer in the US, the Teal Wand aims to increase screening rates by offering a preferred at-home alternative without compromising clinical accuracy.
Reunion Neuroscience Completes Patient Dosing in Phase 2 RECONNECT Trial of RE104 for Postpartum Depression
• Reunion Neuroscience has completed patient dosing in its Phase 2 RECONNECT clinical trial evaluating RE104, a novel serotonergic psychedelic compound, for postpartum depression.
• The trial enrolled 40 patients across multiple sites in the United States, with topline results expected to be announced in the fourth quarter of 2023.
• RE104 (isoprocin hydrobromide) is designed as a faster-acting, shorter-duration psychedelic treatment option with potential advantages over existing therapies for postpartum depression.
FDA Approves First Blood Test for Alzheimer's Diagnosis, Boosting Roche and BioArctic Shares
• The U.S. Food and Drug Administration has approved the first blood test for diagnosing Alzheimer's disease, potentially revolutionizing patient identification and treatment pathways.
• The diagnostic breakthrough is expected to drive market activity for pharmaceutical companies Roche and BioArctic, whose shares showed positive movement following the regulatory announcement.
• This blood test could significantly streamline the Alzheimer's diagnostic process, making it more accessible and efficient compared to traditional methods that rely on expensive brain scans and invasive procedures.
New Guidelines and Therapies Reshape Acne Treatment Approach in 2025
• The American Academy of Dermatology's 2024 updated acne guidelines recommend limiting systemic antibiotic use and emphasize treating all four pillars of acne pathogenesis simultaneously.
• Several new FDA-approved acne medications since 2019 have expanded treatment options, including Winlevi (clascoterone), the only topical therapy effective for excessive sebum production.
• Dermatology experts now recommend simpler treatment regimens with fewer products that address multiple pathogenic factors, with a growing focus on early intervention to prevent scarring.