What is belzupacap sarotalocan?
Belzupacap sarotalocan (bel-sar) is a novel class of virus-like drug conjugate (VDC) therapy with suprachoroidal administration designed to target heparan sulfate proteoglycans (HPSGs) that are overexpressed on cancer cell types. Irradiation activates the photosensitizer to damage the cell membrane of the cancer (ocular melanoma) cell without damaging the surrounding tissue. (via.)
Any prior trials to know about?
Aura recently presented positive interim data from the ongoing phase 2 trial before finalizing the phase 3 trial design. The trial included 20 adult patients receiving up to three cycles of therapy. All patients were evaluated for tumor growth rate, tumor control, and visual acuity preservation.
What did they find?
The results showed a statistically significant reduction in tumor growth rate compared to the original rate at study entry. Phase 2 trials also suggested a generally favorable safety profile of bel-sar. (via.)
Tell me about this phase 3 trial.
The global phase 3 trial has a three-arm randomized and masked design and will enroll an estimated 75 adult patients with early-stage CM with documented tumor growth. It will continue to evaluate the efficacy and safety of bel-sar with suprachoroidal administration as a first-line treatment of early-stage CM. Bel-sar will be compared to sham as the primary analysis.
What comes next?
Favorable results from the phase 3 trial could position bel-sar as the first vision-preserving treatment option for early-stage primary choroidal melanoma. Aura plans to enroll patients in the phase 3 trials while continuing to pursue further development of bel-sar across multiple cancers.