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- The European Medicines Agency has recommended marketing authorization for Nobivac NXT HCPChFeLV, marking the first veterinary vaccine in the EU to utilize self-amplifying RNA technology. - The vaccine provides comprehensive protection against five major feline pathogens including feline herpesvirus, calicivirus, panleucopenia virus, leukaemia virus, and Chlamydia felis. - Clinical studies involving 142 cats demonstrated adequate immune responses with immunity beginning one week after vaccination and lasting up to three years for certain pathogens. - The innovative RNA technology enables temporary multiplication in cells to produce viral proteins that trigger protective immune responses against feline leukaemia virus.
- CuraCell has received approval from Germany's Paul-Ehrlich-Institut to begin a Phase I/IIa clinical trial of CC-38, an autologous tumor-infiltrating lymphocyte therapy for metastatic colorectal and prostate cancers. - The open-label study will enroll up to 16 patients with advanced solid tumors at Krankenhaus Nordwest in Frankfurt, with primary objectives focused on assessing safety and tolerability. - CC-38 is based on CuraCell's CytoPLY platform, which aims to improve tumor-specific T-cell functionality and diversity compared to conventional interleukin-2-based approaches. - The trial will also evaluate preliminary anti-tumor activity, immune responses, and the feasibility of repeated CC-38 administration.
- Alys Pharmaceuticals has submitted a Clinical Trial Application to Germany's Paul-Ehrlich-Institut for ALY-301, a first-in-class bispecific antibody targeting c-Kit and CD-203c with mast cell selectivity. - The Phase 1/1b study will evaluate ALY-301's safety and efficacy in healthy volunteers and patients with Cold Urticaria, a subtype of Chronic Inducible Urticaria. - ALY-301's selective targeting approach is designed to enable safe chronic dosing by avoiding off-target effects associated with conventional c-Kit inhibitors. - The trial represents the first clinical program from Alys' Granular platform and could potentially address multiple mast cell-mediated diseases beyond urticaria.
