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Clinical Trial News

Nanobody Platform Enhances Cancer Immunotherapy Through Albumin Hitchhiking and STING Activation

  • Vanderbilt researchers developed albumin-hitchhiking nanobodies that extend circulation time from 5 minutes to 55 hours and achieve 11% injected dose per gram tumor accumulation.
  • The nanobody-STING agonist conjugates demonstrated complete tumor elimination in 100% of breast cancer models and significant efficacy against melanoma metastases.
  • A bivalent nanobody targeting both albumin and PD-L1 showed superior therapeutic outcomes, generating immunological memory that prevented tumor recurrence in 89% of treated mice.
  • The platform activated CD8+ T cells and NK cells as primary antitumor effectors while stimulating antigen-specific memory responses against tumor-associated antigens.

A First Time in Human (FTIH) Study of GSK3745417 Administered to Participants With Advanced Solid Tumors

NCT03843359Active, Not RecruitingPhase 1
GlaxoSmithKline
Posted 3/12/2019

Chiesi Group and Key2Brain Expand Partnership with Worldwide Licensing Deal for Blood-Brain Barrier-Crossing Therapies

  • Chiesi Group and Key2Brain announced a worldwide licensing agreement to develop blood-brain barrier-crossing enzyme replacement therapies for ultra-rare lysosomal storage disorders including alpha-mannosidosis and Krabbe disease.
  • The collaboration builds on a 2022 partnership and positive in vivo proof-of-concept data demonstrating Key2Brain's proprietary BBB-crossing technology platform using engineered VHH antibodies targeting the transferrin receptor.
  • Under the agreement, Chiesi will fund all research, development and commercialization worldwide while Key2Brain receives upfront payments, milestone payments and tiered royalties on potential sales.
  • The partnership addresses significant unmet medical needs in neurodegenerative manifestations of ultra-rare diseases where many families currently have no therapeutic options available.

Cabaletta Bio Launches Public Offering to Fund CAR-T Cell Therapy Development for Autoimmune Diseases

CAR-T
  • Cabaletta Bio announced an underwritten public offering of common stock and warrants on June 11, 2025, with expected closing on June 12, 2025.
  • The clinical-stage biotechnology company is developing the first curative targeted cell therapies specifically designed for patients with autoimmune diseases.
  • The company's lead therapy rese-cel is a fully human CD19-CAR T cell investigational treatment being evaluated in the RESET clinical program.
  • The RESET program spans multiple therapeutic areas including rheumatology, neurology, and dermatology for autoimmune disease treatment.

Graves Disease Pipeline Shows Promise with 10+ Therapies in Development as TED Treatments Gain Regulatory Momentum

Monoclonal AntibodyDrug Approval
  • DelveInsight's 2025 pipeline analysis reveals 8+ key companies are developing 10+ novel Graves Disease treatment therapies across various clinical development phases.
  • Recent regulatory milestones include Amgen's TEPEZZA approval by UK MHRA for thyroid eye disease and FDA's breakthrough therapy designation for Viridian's veligrotug.
  • Emerging therapies targeting IGF-1R pathway show clinical promise, with Sling Therapeutics' linsitinib demonstrating favorable safety profile in over 900 patients across 15 trials.
  • Pipeline includes diverse therapeutic approaches spanning monoclonal antibodies, small molecules, and gene therapy with multiple routes of administration under investigation.

EssilorLuxottica Acquires European Ophthalmology Network Optegra to Advance Med-Tech Strategy

AI
  • EssilorLuxottica has entered into an agreement to acquire Optegra Eye Health Care, a European ophthalmology platform operating over 70 facilities across five markets including the UK, Czech Republic, Poland, Slovakia, and the Netherlands.
  • The acquisition supports EssilorLuxottica's medical technology strategy expansion, combining comprehensive eye care with advanced diagnostics and AI-powered surgical treatments in a unified platform.
  • Optegra's network provides ophthalmic treatments including cataract surgery, glaucoma treatments, age-related macular degeneration therapies, and laser eye surgery with artificial intelligence integration in pre- and post-operative stages.
  • The transaction is expected to close in 2025 pending regulatory approvals and will enable EssilorLuxottica to leverage AI and big data capabilities for personalized patient care and detection of conditions ranging from neurodegenerative diseases to cardiovascular dysfunction.

Simtra BioPharma Solutions and MilliporeSigma Form Strategic Alliance to Streamline ADC Manufacturing

Monoclonal Antibody
  • Simtra BioPharma Solutions and MilliporeSigma have established a five-year strategic alliance to create a turnkey offering for antibody-drug conjugate manufacturing and bioconjugation services.
  • The partnership aims to address the complexity of ADC manufacturing by creating a seamless value chain where MilliporeSigma handles drug substance conjugation and Simtra manages fill-finish operations.
  • With over 200 ADCs currently in clinical trials and the ADC manufacturing market expected to grow from $1.79 billion to $7 billion by 2035, the alliance targets significant industry demand.
  • The collaboration is designed to reduce development timelines and complexity for biopharmaceutical companies, allowing them to focus on drug discovery while ensuring quality standards.

Elkedonia Raises €11.25 Million to Develop Novel Neuroplastogen Therapy for Treatment-Resistant Depression

Precision Medicine
  • Elkedonia closed an oversubscribed €11.25 million seed funding round to advance first-in-class neuroplastogen therapeutics targeting the Elk1 protein for treatment-resistant depression.
  • The company's approach targets neuroplasticity restoration without the side effects of psychedelics or ketamine, addressing the needs of approximately 100 million patients globally who don't respond to current treatments.
  • The Franco-Belgian startup leverages research from Sorbonne University and plans to develop precision medicine biomarkers alongside small molecule inhibitors of the intracellular Elk1 target.
  • Major depressive disorder affects 300 million people worldwide, with suicide being the third leading cause of death among 15-29 year-olds, highlighting the urgent need for innovative therapeutic solutions.

Harmony Biosciences' BP1.15205 Shows Breakthrough Potential as Best-in-Class Narcolepsy Treatment

  • Harmony Biosciences presented preclinical data for BP1.15205, a highly potent orexin 2 receptor agonist that demonstrated significant wake-promoting and cataplexy-suppressing effects in narcolepsy mouse models.
  • The investigational drug showed exceptional selectivity with >600-fold preference for OX2R over OX1R receptors and produced statistically significant effects at very low oral doses starting at 0.03 mg/kg.
  • A first-in-human study is planned for the second half of 2025 with topline data expected in 2026, following completion of regulatory applications to both European and U.S. authorities.
  • The compound demonstrated favorable safety profile with no adverse events observed in 3-month toxicology studies at doses up to 300 mg/kg/day across two species.

Walnut Hill Medical Selected as FDA TAP Program Advisor to Accelerate Medical Device Patient Access

  • Walnut Hill Medical has been selected as an advisor to the FDA's Total Product Life Cycle Advisory Program (TAP), launched in 2023 to transform how breakthrough medical devices reach patients.
  • The TAP program addresses delays in patient access to clinically promising medical technologies by connecting innovators with FDA experts and external advisors to streamline regulatory review and align evidence generation with payer expectations.
  • As a TAP advisor, Walnut Hill Medical will provide expertise in reimbursement strategy and market access to help companies design faster commercialization pathways for breakthrough-designated medical devices.
  • The program aims to solve persistent gaps in the innovation ecosystem where medical technologies face delays due to misaligned regulatory, coverage, and reimbursement pathways.

SeaStar Medical's SCD Therapy Receives $2 Million DoD Grant for Military Burn and Sepsis Research

  • The AREVA Institute secured a prestigious $2 million Department of Defense grant to evaluate SeaStar Medical's Selective Cytopheretic Device therapy for treating severe burns, inhalation injury, and sepsis in warfighters.
  • The three-year study, beginning July 2025, was selected as one of only four projects from 160 submissions to the Military Burn Research Program, highlighting the innovative potential of extracorporeal immunomodulation.
  • SeaStar Medical's SCD therapy is designed to neutralize destructive hyperinflammation and cytokine storms, potentially improving survival rates in both combat casualties and civilian patients with severe trauma and infection.
  • The device works alongside continuous renal replacement therapy to selectively target inflammatory immune cells and may reduce the need for dialysis while promoting long-term organ recovery.

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