Medicenna Therapeutics (MDNA.TO) reported Tuesday that the first patient has been dosed in a Phase 1b trial evaluating its candidate MDNA11, in patients with stage 3 melanoma.
The NEO-CYT study will evaluate MDNA 11 with an immunotherapy combination of nivolumab, with or without ipilimumab, as neoadjuvant immunotherapy before surgery in earlier-stage melanoma patients.
The rationale is that these patients' immune systems may be more amenable to immunotherapy and more likely to benefit from treatment, Medicenna said.
"Dosing the first patient in the NEO-CYT study represents an important milestone in the continued clinical development of MDNA11 and expands our evaluation of this next-generation IL-2 Superkine into the neoadjuvant setting," said Dr. Nageatte Ibrahim, Medicenna chief medical officer.
"MDNA11 has already demonstrated encouraging anti-tumor activity and a manageable safety profile in heavily pretreated patients with advanced metastatic cancers in the ongoing ABILITY-1 study. NEO-CYT allows us to evaluate MDNA11 earlier in the treatment paradigm, where the immune system may be more intact and where pathologic response can provide an early and rigorous signal of clinical activity."
The trial is being conducted at up to 12 centres in Italy.
Medicenna shares closed up $0.03, to $0.66, on Monday on the Toronto Stock Exchange.