Daromun (Philogen) is a combination of Darleukin, a human vascular targeting monoclonal antibody (L19) fused to interleukin-2 (IL-2), and Fibromun, the L19 antibody linked to tumor necrosis factor (TNF). Both IL-2 and TNF are cytokines, key signaling molecules that are involved with the coordination of immunity. IL-2 is an approved biopharmaceutical for melanoma; however, the IL-2 and TNF combination is thought to act in concert to modulate the immune response towards fighting tumors.
Philogen is positioning Daromun as a neoadjuvant therapy, a setting where no specific therapy has been approved for melanoma. Although the use of cytokines in melanoma treatment has largely been replaced by newer immuno-oncology drugs, Daromun utilizes direct intratumoral injection and linkage to a vascular targeting monoclonal antibody that together serve to localize the drug to tumors. Data from a Phase II trial studying Daromun suggest that the drug may also have systemic activity, showing effects in melanoma lesions that are uninjected. These characteristics, combined with good tolerability, could make Daromun a viable option in the treatment of melanoma. Results from a Phase III trial that was recently expanded to the US will be crucial in determining the product’s potential.
LIST OF FIGURES
10 Figure 1: Daromun for melanoma – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of Daromun for melanoma
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of Daromun for melanoma
14 Figure 4: Daromun sales for melanoma across the US and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: Daromun drug profile
7 Table 2: Daromun ongoing late-phase clinical trial in melanoma
9 Table 3: Daromun Phase II data in melanoma
15 Table 4: Daromun sales for melanoma across the US and five major EU markets, by country ($m), 2017–26
17 Table 5: Daromun patient numbers for melanoma across the US and five major EU markets, by country, 2017–26
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