Clinical Data CMB305: First-in-class Prime-boost Immunotherapy Targeting NY-ESO-1 TumorsData from a completed first-in-human dose-escalation study and an early subset of patients from an expansion study of CMB305 as a single agent in patients with cancers expressing the NY-ESO-1 tumor antigen revealed:

• CMB305 was safe, without dose-limiting toxicities, as reviewed by an independent data safety monitoring board (DSMB);
• A significant subset of CMB305-treated patients had NY-ESO-1-specific CD8 T cell responses that were generated or increased after therapy;
• Patients who did respond immunologically had a greater degree of antigen-specific T cell response than that previously reported in a Phase 1 study of LV305 alone, which is consistent with the intent of the prime-boost approach; and
• Preliminary clinical benefit in the form of progression-free rate (PFR) was observed in patients with soft tissue sarcoma.
  
  LV305: Novel Vector Delivering NY-ESO-1 RNA Specifically to Dendritic Cells in vivo Maintains Safety and Immunogenicity with Improved Clinical Benefit ProfileData from the expansion study following the previously-reported dose escalation study of LV305 in patients with tumors expressing NY-ESO-1 revealed:
  • A consistently favorable safety profile, as reviewed by an independent DSMB;
  • A consistent immune response rate; and
  • An improved clinical benefit profile.
    
    G100: Intratumoral Administration of aTLR4 Agonist Significantly Modifies the Tumor Microenvironment (TME) and Maintains Clinical BenefitNew data from the completed pilot trial of G100 with local radiation in patients with Merkel cell carcinoma revealed:
    • Safety was consistent with that originally reported, demonstrating an acceptable profile alone or in combination with local radiation;
    • G100 significantly altered the TME, causing inflammation and transforming tumors to a "hot" state in G100 responding patients; and
    • Clinical benefit remained constant with the full patient set.