Medicenna Therapeutics Corp. has announced encouraging results from its ongoing Phase 1/2 ABILITY-1 trial, demonstrating significant therapeutic potential for its novel immunotherapy combinations in treating advanced solid tumors.
The combination therapy arm, pairing MDNA11 with Merck's KEYTRUDA® (pembrolizumab), achieved a remarkable 78% disease control rate among nine patients. This included one complete response, one partial response, and five cases of stable disease. Notably, a 70-year-old patient with advanced chemo-refractory anal cancer achieved a complete response within just eight weeks of treatment.
Strong Monotherapy Performance
In the monotherapy arm, MDNA11 demonstrated impressive single-agent activity with a 30% objective response rate (3 out of 10 patients) in the dose expansion cohort. These results are particularly significant as they were observed in patients who had previously failed checkpoint inhibitor therapies.
"Our excitement is driven by the impressive response rates seen in the ABILITY-1 trial, particularly in the monotherapy arm where 5 patients responded to MDNA11 out of 20 patients with heavily pre-treated advanced solid tumors, including one complete response, despite all of them having failed prior checkpoint inhibitor therapies," stated Dr. Fahar Merchant, President and CEO of Medicenna.
Financial Position and Future Development
The company maintains a strong financial position with $30 million in cash and equivalents, providing runway through mid-2026. This funding will support the completion of the MDNA11 ABILITY-1 study and other planned developments.
Operating costs for the quarter ending December 31, 2024, totaled $5.1 million, reflecting increased clinical trial activities and expansion to new sites. R&D expenses rose to $3.4 million, primarily due to the expanded ABILITY-1 study and the addition of the combination therapy arm.
Upcoming Milestones
Medicenna has outlined several key objectives for 2025, including:
- Presentation of PK/PD data from the ABILITY-1 trial at the AACR-Immuno-Oncology Conference in February 2025
- Completion of enrollment for both the monotherapy dose expansion arm and combination dose escalation arm by mid-2025
- Initiation of the combination dose expansion arm in Q2 2025
- Advancement of MDNA113, a first-in-class targeted bispecific anti-PD1-IL2 immunotherapy, toward IND-enabling studies
Pipeline Development
Beyond MDNA11, the company is advancing MDNA113 as a novel immunotherapy candidate. This program represents the only 'β-enhanced' anti-PD1-IL2 bi-specific molecule currently in development, highlighting Medicenna's innovative approach to cancer treatment.
Dr. Merchant emphasized the significance of recent developments: "The strong financial support we received from RA Capital last year validates and reinforces confidence in our innovative approach and positions us well to execute on a robust clinical development program for MDNA11 to support its use across a range of tumor types."
