MDNAF - Medicenna To Present Evidence of Durable Single Agent Activity and Potent Immune Effector Response with MDNA11 in the Dose Escalation Portion of Phase 1/2 ABILITY-1 Study at the 10th Annual Oncology Innovation Forum | Benzinga
MDNA11 demonstrates durable response in pancreatic cancer patient with 100% regression of target and non-target lesions for over 104 weeks and continues to show remission 4 months after stopping treatment
Melanoma patient continues to show sustained 100% regression of target lesions
Dose escalation in combination with KEYTRUDA® is now enrolling at the next higher dose of 90g/kg following absence of any dose limiting toxicities at 60g/kg
MDNA11 shows significant increases in stemness, central and effector memory and markers of enhanced effector function in circulating CD8+ T and NK cells, all of which are critical for achieving meaningful and durable anti-cancer response.
Analysis of gene expression signatures from pretreatment and on-treatment paired biopsies show that cancer promoting pathways were degraded while immune-related pathways against cancer cells were enhanced following MDNA11 treatment.
TORONTO and HOUSTON, May 31, 2024 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX:MDNA, OTCQB:MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines, today announced that comprehensive clinical results from the monotherapy dose escalation portion of the Phase 1/2 ABILITY-1 (A Beta-only IL-2 ImmunoTherapY) study evaluating MDNA11, in patients with advanced solid tumors, will be presented today at the 10th Annual Oncology Innovation Forum being held in Chicago.
"We are encouraged by four partial responses observed in the study to date, especially 2 patients from the dose-escalation cohort where a pancreatic cancer patient is in remission following complete regression of all target and non-target lesions in addition to a melanoma patient that continues to show durable complete response of the target lesions," said Fahar Merchant, Ph.D., President and CEO of Medicenna. "We are particularly pleased to see good tolerability of MDNA11 in combination with Keytruda allowing us to increase its dose to the next higher level which is identical to the MDNA11 dose used in the monotherapy expansion arm. These advances, together with the first ever observation of increases in unique biomarker specific cancer fighting immune cells in the tumor micro-environment, differentiates MDNA11's mechanism relative to other competing IL-2 programs and its potential to be a best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors. We look forward to reporting additional data from the ongoing monotherapy expansion and combination arms of the ABILITY-1 study at medical conferences in the second half of 2024."
Tumor Response:
As reported last month (AACR PR), key findings from the monotherapy dose escalation and expansion portions of the ABILITY-1 study showed a response rate of nearly 29% in Phase 2 eligible patients with aggressive tumor types who had progressed on prior checkpoint inhibitors and treated with MDNA11 at doses of ? 60 µg/kg (N=14). Specifically, in the monotherapy dose escalation cohort:
o A pancreatic ductal adenocarcinoma (PDAC; MSI-H) patient with primary resistance to pembrolizumab was treated with 60 µg/kg MDNA11 and showed 100% resolution of all baseline target and non-target lesions at week 66. A new lymph node lesion that developed while patient was on a 8-week treatment break during vacation was treated with a single course of radiotherapy prior to resumption on MDNA11. At week 88, all baseline lesions remained completely resolved and the new lymph node lesion was reduced to <10 mm in size (considered physiological per RECIST v1.1), at which time MDNA11 ...