Kyowa Kirin and La Jolla Institute Extend 35-Year Research Alliance with Focus on Cell and Gene Therapies
• The 35-year partnership between Kyowa Kirin and La Jolla Institute for Immunology has been renewed for three more years, representing one of the longest-standing industry-academic collaborations in drug discovery.
• The alliance has already produced significant advances in immunology research, including a promising immunotherapy for atopic dermatitis currently in Phase III clinical trials.
• The renewed agreement will prioritize development of cell and gene therapies for diseases with limited treatment options, with preliminary clinical data for several compounds expected in 2025.
NIH Launches First Human Trial of LASSARAB Vaccine for Deadly Lassa Fever
• The NIH has initiated a Phase 1 clinical trial of LASSARAB, a novel vaccine candidate for Lassa fever, a viral hemorrhagic disease that can be fatal and causes permanent hearing loss in up to one-third of patients.
• Developed by researchers at Thomas Jefferson University, LASSARAB demonstrated complete protection in nonhuman primates exposed to lethal doses of Lassa virus, representing a significant advancement in addressing this West African endemic disease.
• The trial will enroll 55 healthy adults to evaluate three different concentrations of the vaccine, which uniquely combines protection against both Lassa fever and rabies through a modified inactivated rabies vaccine platform.
Rocatinlimab Shows Promising Results in Phase 3 Trial for Moderate to Severe Atopic Dermatitis
• Amgen and Kyowa Kirin's Phase 3 IGNITE study of rocatinlimab met all primary and secondary endpoints, with 42.3% of patients in the higher dose group achieving EASI-75 compared to placebo.
• Rocatinlimab, an investigational anti-OX40 monoclonal antibody, works as a T-cell rebalancing therapy targeting a root cause of atopic dermatitis, potentially offering a new mechanism of action for patients.
• The ROCKET clinical program includes multiple studies evaluating rocatinlimab's efficacy, with ongoing trials examining long-term maintenance, durability of response, and effectiveness in adolescent populations.
Immune Signatures Predict Immunotherapy Side Effects, Suggesting New Prevention Strategies
• A new study identifies distinct immune signatures in patients that may predict the development of immune-related adverse events (irAEs) from immune checkpoint inhibitor (ICI) therapy.
• Elevated levels of Th17 and Th2 cell populations, along with increased interleukin-6 (IL-6), correlate with a higher risk of developing severe irAEs.
• Researchers suggest that targeting specific immune pathways, such as IL-6, could mitigate or prevent irAEs without compromising the anti-cancer benefits of ICIs.
• A clinical trial has been launched to investigate whether IL-6 inhibitors can prevent adverse effects in patients restarting immunotherapy after experiencing irAEs.
Rocatinlimab Shows Promise in Phase 3 Trial for Moderate to Severe Atopic Dermatitis
• Rocatinlimab met co-primary endpoints in the Phase 3 ROCKET HORIZON trial, demonstrating significant improvement in skin clearance for atopic dermatitis patients.
• The trial achieved a statistically significant reduction in Eczema Area and Severity Index (EASI-75) scores compared to placebo at week 24.
• Key secondary endpoints, including itch reduction and improved quality of life, also showed statistically significant improvements with rocatinlimab.
• Safety findings in the ROCKET HORIZON trial were consistent with those observed in the Phase 2b study, supporting the drug's tolerability.
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