Clinical Trial News
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.
FDA Grants Rare Pediatric Disease Designation to Relief Therapeutics' EB Treatment RLF-TD011
• The FDA has granted Rare Pediatric Disease designation to Relief Therapeutics' RLF-TD011 for epidermolysis bullosa, a rare genetic skin disorder affecting approximately 500,000 people worldwide.
• RLF-TD011 is a hypotonic acid-oxidizing solution with hypochlorous acid that provides antimicrobial and anti-inflammatory properties while creating a wound microenvironment conducive to healing.
• The designation could potentially lead to a Priority Review Voucher upon approval, which has significant value as demonstrated by a recent EB treatment voucher that sold for $155 million.
Related Clinical Trials:
Northwestern University
Posted 2/6/2023
AnnJi Pharmaceutical Reports Promising Phase 1/2a Results for AJ201 in SBMA, a Rare Neuromuscular Disease
• AnnJi Pharmaceutical's AJ201 demonstrated positive results in a Phase 1/2a trial for Spinal and Bulbar Muscular Atrophy (SBMA), showing improvements in physical function and muscle biomarkers after 12 weeks of treatment.
• The investigational drug reduced mutant androgen receptor levels by more than 50% in over half of treated patients and activated the Nrf2 pathway, supporting its proposed mechanism of action.
• With no FDA-approved treatments currently available for SBMA, AnnJi plans to advance AJ201 to Phase 3 trials, potentially offering hope for approximately 1 in 40,000 males affected by this rare genetic disorder.
Related Clinical Trials:
AnnJi Pharmaceutical Co., Ltd.
Posted 2/28/2023
Samsung Biologics to Spin Off Biosimilar Business to Focus on Core CDMO Services
• Samsung Biologics announced plans to establish Samsung Epis Holdings, which will incorporate Samsung Bioepis as a wholly owned subsidiary, separating its biosimilar development from CDMO operations.
• The strategic spinoff aims to streamline operations by allowing each business to focus on their different revenue models, with final shareholder approval scheduled for September 16.
• As one of the world's leading CDMO firms, Samsung Biologics reported impressive financial performance with $3.3 billion in sales and $1 billion in net profit in 2024.
International R&D Partnerships Drive Innovation and Accessibility in Generic Drug Development
• International research and development collaborations are becoming increasingly vital for generic drug manufacturers to overcome complex challenges in bringing affordable medications to market.
• These cross-border partnerships facilitate knowledge sharing, resource pooling, and technology access, resulting in accelerated development timelines and improved product quality.
• By addressing key obstacles such as intellectual property protection, regulatory compliance, and supply chain logistics, these collaborations are expanding global access to essential medicines.
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.
Sanofi to Acquire Vigil Neuroscience for Up to $600 Million, Expanding Alzheimer's Disease Pipeline
• Sanofi has entered into a definitive merger agreement to acquire Vigil Neuroscience for $8.00 per share in cash upfront, with an additional $2.00 per share contingent value right tied to VG-3927's first commercial sale.
• The acquisition strengthens Sanofi's neurology pipeline with VG-3927, a Phase 2-ready oral small molecule TREM2 agonist being developed for Alzheimer's disease, targeting microglial dysfunction in neurodegenerative disorders.
• The transaction, valued at approximately $600 million including the potential CVR payment, is expected to close in the third quarter of 2025, with Vigil's monoclonal antibody program iluzanebart not included in the acquisition.
ONWARD Medical Advances Brain-Computer Interface Technology with Fifth Successful Implant for Spinal Cord Injury Patients
• ONWARD Medical has successfully implanted its ARC-BCI® Therapy in two additional patients, bringing the total to five individuals with spinal cord injuries who can now potentially control movement through thought.
• The innovative DigitalBridge™ system creates a wireless connection between brain and spinal cord, using AI to decode neural signals and translate intention into movement, bypassing damaged neural pathways.
• With FDA Breakthrough Device Designation and growing clinical evidence, ONWARD's less invasive BCI approach is positioning the company as a leader in neurotechnology for restoring function after paralysis.
ReproNovo Secures $65 Million Series A Funding to Advance Novel Reproductive Medicine Therapies
• ReproNovo has raised $65 million in Series A financing led by Jeito Capital to advance two Phase 2-ready compounds targeting male infertility, adenomyosis, and embryo implantation success.
• The company's lead candidates include RPN-001 (leflutrozole) for male infertility due to low testosterone levels and RPN-002 (nolasiban) for adenomyosis treatment and improving assisted reproductive technology outcomes.
• This investment addresses critical gaps in reproductive medicine amid declining global fertility rates, with male sperm counts having fallen by 50-60% over the past four decades.
California's AB 824 Pharmaceutical Patent Settlement Law Faces Permanent Injunction Limiting Enforcement
• A federal court has issued a permanent injunction limiting California's AB 824 law, which presumes pharmaceutical "reverse payment" patent settlements are anticompetitive, to agreements negotiated or entered within California's borders.
• AB 824 differs significantly from federal standards by creating a presumption of illegality for settlements where generic manufacturers receive "anything of value" while delaying market entry, with potential penalties of $20 million or more.
• Pharmaceutical companies must carefully consider where settlement discussions occur and document procompetitive rationales, as questions remain about enforcement when parties have California connections or when agreements affect in-state sales.