Medicenna Q1 Fiscal 2025 Results and First Responder with MDNA11 Monotherapy

Medicenna Therapeutics Corp., a clinical-stage immunotherapy company specializing in Superkines, recently disclosed its financial results and corporate updates for the quarter ending June 30, 2024. The company also provided insights into its ongoing global Phase 1/2 ABILITY-1 study involving MDNA11, an advanced IL-2 Superkine with enhanced beta activity.

A key highlight from the ABILITY-1 study is a melanoma patient who previously did not respond to dual checkpoint inhibitors but achieved a complete response after 52 weeks of MDNA11 treatment, with all lesions regressing. This patient continues on the treatment, marking significant progress. Additionally, a pancreatic cancer patient has exhibited complete regression of all lesions after 115 weeks and remains in remission six months post-treatment. Other patients with partial responses are still undergoing treatment, and the combination dose escalation of MDNA11 with pembrolizumab (KEYTRUDA®) remains active and continues to enroll patients.

The company's financial standing was bolstered by a $20 million investment from RA Capital, extending its cash runway to mid-2026. This financial support enables the expansion of the clinical trial in the EU, following regulatory approval from the EMA in June. Updated data on MDNA11 and other programs will be presented at several medical conferences in the latter half of 2024.

Program updates for MDNA11 include notable advancements. A cutaneous melanoma patient, who had shown partial response at week 12, achieved complete response by week 52, continuing treatment and demonstrating durability for at least 12 months. Similarly, a pancreatic cancer patient has sustained tumor control for over 115 weeks with no further treatment required. Other patients continue to show partial responses, supporting the durability of MDNA11. The dose escalation in combination with KEYTRUDA® is ongoing, with no dose-limiting toxicities reported at 60 µg/kg.

Recent conference presentations highlighted key results for MDNA11, such as a 29% overall response rate and a 50% clinical benefit rate among high-dose Phase 2 eligible patients who had previously failed checkpoint inhibitor therapy. MDNA11 has maintained an acceptable safety profile, with no evidence of vascular leak syndrome. Most treatment-related adverse events (TRAEs) were mild and resolved quickly. Pharmacodynamic analyses demonstrated durable systemic immune activation, showing increases in CD8+ T cells and NK cells, crucial for effective anti-cancer responses. Gene expression analysis indicated that cancer-promoting pathways were downregulated, while immune-related pathways were enhanced during treatment.

The company also shared updates on its IL-4 Superkine Program, bizaxofusp (formerly MDNA55). In June 2024, Medicenna presented significant survival benefits from a Phase 2b study of bizaxofusp in recurrent glioblastoma at the ASCO Annual Meeting, compared to a control group.

Operational achievements included the EMA's approval to expand the Phase 1/2 ABILITY-1 study to Europe and securing $20 million in financing through a private placement with RA Capital Management. 

Financially, as of June 30, 2024, Medicenna had cash and equivalents totaling $35.6 million, an increase from $17.0 million on March 31, 2024. These funds are expected to support the company's expenses through mid-2026. For the quarter ending June 30, 2024, operating costs were $4.0 million, down from $4.5 million in the previous year, primarily due to reduced general and administrative expenses. Research and development expenses remained steady at $2.8 million, while general and administrative expenses decreased to $1.3 million from $1.6 million in the prior period. The company reported a net loss of $3.6 million for the quarter, slightly higher than the $2.8 million loss in the same period last year, attributed to a non-cash gain in the previous year.

In summary, Medicenna continues to advance its innovative therapies with promising clinical results and robust financial support, positioning the company for ongoing success in its immunotherapy endeavors.

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