Clinical Trial News
Zura Bio Launches Phase II TibuSHIELD Trial for Novel Dual-Inhibitor in Hidradenitis Suppurativa
• Zura Bio has initiated the Phase II TibuSHIELD trial evaluating tibulizumab, a first-of-its-kind dual inhibitor targeting both BAFF and IL-17A pathways in patients with moderate to severe hidradenitis suppurativa.
• The global, randomized, double-blind, placebo-controlled study will enroll approximately 180 patients across the US, Canada, and Europe, with topline efficacy results expected in Q3 2026.
• This trial represents Zura Bio's second Phase II study for tibulizumab, following the December launch of TibuSURE for systemic sclerosis, advancing their portfolio of treatments for severe inflammatory diseases.
FDA Grants IND Clearance for Immunoglobulin Eye Drops to Treat Dry Eye Disease
• The FDA has granted Investigational New Drug clearance for immunoglobulin eye drops (SLG-100/GRF312), developed by Selagine and Grifols, to treat dry eye disease in upcoming Phase II clinical trials.
• The novel treatment offers broad-spectrum anti-inflammatory and immunomodulatory properties, potentially providing mechanistic superiority over current narrow-spectrum therapies that primarily target T-cell inflammation.
• A first-in-human pilot trial demonstrated significant reduction in dry eye symptoms with no difference in tolerability or adverse events compared to vehicle, showing promise for the over 100 million people affected globally.
Bharat Biotech's Oral Cholera Vaccine 'Hillchol' Successfully Completes Phase III Trials
• Bharat Biotech's oral cholera vaccine Hillchol has demonstrated non-inferiority against both Ogawa and Inaba serotypes in Phase III clinical trials involving 1,800 participants across India.
• The successful trial results position Hillchol as a potential solution to the global oral cholera vaccine shortage, with Bharat Biotech's facilities capable of producing up to 200 million doses annually.
• Cholera affects approximately 2.86 million people and causes 95,000 deaths annually worldwide, highlighting the significant public health impact of this vaccine development.
Dementia Discovery Fund Secures $269M in Second Fund to Accelerate Novel Therapeutics Development
• The Dementia Discovery Fund (DDF), managed by SV Health Investors, has closed its second fund with $269 million in commitments, bringing its total raised capital to over $550 million for dementia therapeutics development.
• The fund has secured backing from previous cornerstone investors including AARP, British Business Bank, Gates Frontier, pharmaceutical giants Bristol Myers Squibb, Eli Lilly, and Pfizer, with the Alzheimer's Association joining as a new investor.
• DDF-2 has already invested in four companies and aims to build a portfolio of 10-15 innovative biotech ventures across the UK, Europe, and US, addressing the urgent global challenge of dementia affecting over 50 million people worldwide.
Juvenescence Secures $76M in Series B-1 Funding Led by Abu Dhabi's M42 for Age-Related Disease Therapeutics
• Juvenescence has raised $76 million in the first tranche of its Series B-1 financing round, led by Abu Dhabi's M42, to advance its clinical pipeline targeting age-related diseases.
• The funding is part of a strategic partnership with M42 to establish a drug development hub in Abu Dhabi, combining M42's healthcare data expertise with Juvenescence's AI-enabled discovery technology.
• Juvenescence aims to complete the full financing in Q3 2025, supporting its transition to a clinical-stage biotech company developing novel medicines that target core aging mechanisms.
Delhi High Court Overturns Patent Rejection for Taiho Pharmaceutical's Anticancer Compound
• The Delhi High Court has set aside a Patent Office order that rejected Taiho Pharmaceutical's application for an anticancer compound, citing procedural fairness issues in the original decision.
• The court ruled that the Patent Office failed to identify a specific 'known substance' when rejecting the application under Section 3(d) of the Patents Act, denying the company a fair opportunity to demonstrate enhanced therapeutic efficacy.
• The matter has been remanded back to the Patent Office for fresh consideration, with instructions to provide Taiho Pharmaceutical a new hearing opportunity and properly evaluate any comparative research data submitted.
AstraZeneca Showcases Groundbreaking Cancer Research at ASCO 2025 with Two Plenary Presentations
• AstraZeneca will present over 80 abstracts at ASCO 2025, including two plenary presentations featuring camizestrant for HR-positive breast cancer and IMFINZI for early gastric cancer, marking their seventh consecutive year with plenary data.
• The SERENA-6 trial is the first positive Phase III study for a next-generation oral SERD in first-line HR-positive breast cancer, pioneering the use of circulating tumor DNA to guide treatment decisions.
• DESTINY-Breast09 data shows ENHERTU plus pertuzumab is the first treatment in over a decade to demonstrate superiority over standard care in first-line HER2-positive metastatic breast cancer.
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MSD Expands Opevesostat Clinical Program to Include Breast, Endometrial, and Ovarian Cancers
• MSD has initiated a new Phase 2 clinical trial to evaluate opevesostat (MK-5684) in women's cancers, expanding beyond its current prostate cancer program.
• Opevesostat, an oral, non-steroidal and selective CYP11A1 inhibitor discovered by Orion, will be tested for safety and efficacy in breast, endometrial, and ovarian cancers.
• The expansion represents a significant broadening of potential therapeutic applications for opevesostat, which is already in Phase 3 trials for metastatic castration-resistant prostate cancer.
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Applied StemCell Launches Hypoimmunogenic hiPSC Products to Advance Allogeneic Cell Therapy Development
• Applied StemCell has introduced two new hypoimmunogenic human induced pluripotent stem cell (hiPSC) products designed to overcome immune rejection challenges in allogeneic cell therapy development.
• The products feature B2M/CIITA double knock-out modifications that eliminate HLA class I and II expression, significantly reducing the risk of T cell-mediated immune rejection in transplanted cells.
• Derived from CD34+ umbilical cord blood cells with low mutational burden, these research-use-only tools are isogenic matches to forthcoming GMP-grade versions, offering researchers a seamless transition from early research to clinical development.
Closed Loop Medicine Appoints Kate Woolland as CEO to Drive Precision Dosing Commercialization
• Closed Loop Medicine has appointed Kate Woolland as CEO to lead the company's transition from product development to commercial deployment of its pharmaceutical precision dosing platform.
• The company has built an extensive IP portfolio with over 60 filings across 16 patent families, covering precision dosing technologies for GLP-1 therapies, hypertension, and other therapeutic areas.
• CLM's proprietary approach has demonstrated improved patient medication adherence rates exceeding 90% through personalized titration, positioning the company to pursue strategic partnerships and licensing opportunities.