NIDLEGY^TM (DAROMUN)

NIDLEGY^TM (DAROMUN)

Despite recent advances in therapeutic options for advanced melanoma patients, there is still an unmet medical need for melanoma patients with local recurrence, who are candidates for surgical resection of all metastases. These patients are at a high risk of further recurrences until the disease becomes inoperable (unresectable) or progresses to Stage IV (distant organ involvement), for which the prognosis is particularly grim.

Nidlegy^TM is a combination of the immunocytokines L19IL2 and L19TNF, which is being developed as neoadjuvant intralesional treatment for melanoma patients with locoregional disease. In preclinical melanoma tumor models, the combination has shown strong synergistic effects, dependent on T cell activity, and a clear superiority to each individual immunocytokine used as a single agent in achieving cure of animals. A combination pack for Nidlegy^TM has been approved by EMA.

Aimed at blocking or delaying progression of the disease to stage IV, a phase II study of intralesional treatment with Nidlegy^TM in stage III/IVA melanoma patients (i) showed efficacy in terms of complete and partial response of the injected metastases, (ii) led to a systemic immune response, i.e. non-injected lesions (neighboring or distant) shrank or disappeared upon intralesional injection (bystander effect), (iii) and recorded a decelerated progression to stage IV melanoma of treated patients with respect to historical controls.

ONGOING CLINICAL TRIALS

• Two randomized, controlled phase III registration trials for intralesional application of Nidlegy^TM as a neoadjuvant followed by surgery + eventual adjuvant treatments (standard of care) and compared to standard of care are currently ongoing in Europe (NCT02938299) and in the USA (NCT03567889) in patients with fully resectable stage IIIB/C melanoma.
• A phase II trial in non-melanoma skin cancer (i.e., high-risk patients with Basal Cell Carcinoma and Cutaneous Squamous-Cell Carcinoma) (NCT04362722).
• A phase II trial with Nidlegy^TM (intralesional) in combination with anti-PD-1 (systemic) in patients that have progressed after anti-PD-1 therapy is about to start.