Medicenna Therapeutics Corp Stock Price, News & Analysis

Medicenna Therapeutics Corp. (TSX: MDNA, OTCQB: MDNAF) has appointed Karim Lalji to its Board of Directors, effective August 14, 2024. Mr. Lalji brings extensive experience in the life sciences sector, including strategic vision and big-pharma partnership expertise. His career highlights include:

- 10 years at Merck & Company, leading global strategies and growing annual sales to over $1 billion
- Vice President role at Sepracor, Inc., contributing to growth from $50 million to over $1 billion in annual sales
- Chief Commercial Officer at Cardiome Pharma Corp., facilitating a $1 billion licensing deal with Merck

Mr. Lalji's appointment is expected to strengthen Medicenna's position in advancing its Superkine platform and pipeline of clinical assets, including MDNA11 for advanced solid tumors and bizaxofusp for brain cancer.

Medicenna Therapeutics Corp. (TSX: MDNA, OTCQB: MDNAF) reported Q1 fiscal 2025 financial results and announced significant progress in its MDNA11 clinical trials. Key highlights include:

1. First complete response in a melanoma patient resistant to dual checkpoint inhibitors

2. Sustained 100% regression in a pancreatic cancer patient at 115 weeks

3. $36 million cash balance after a $20 million investment from RA Capital

4. Cash runway extended to mid-2026

5. Ongoing enrollment in combination therapy with KEYTRUDA®

6. EMA approval to expand ABILITY-1 study to Europe

Financial results show $4.0 million in operating costs and a net loss of $3.6 million ($0.05 per share) for Q1 fiscal 2025. The company anticipates presenting updated data on MDNA11 and other programs at conferences in H2 2024.

Medicenna Therapeutics announced its fiscal year 2024 results, showcasing a robust financial position with an increased cash balance of $37 million due to a $20 million investment by RA Capital. This investment extends the company's operational runway to mid-2026. Notably, MDNA11, an IL-2 Superkine, demonstrated significant anti-tumor activity with a 29% response rate in patients with checkpoint-resistant tumors, and a favorable safety profile. The European Medicines Agency has approved the expansion of the ABILITY-1 study to the EU. Medicenna also reported net loss for the year ended March 31, 2024, at $25.5 million, compared to $10.0 million the previous year, primarily due to increased operating costs and derivative warrant liability. Current cash reserves and the recent investment are expected to sustain operations until mid-2026.

Medicenna Therapeutics announced that the European Medicines Agency (EMA) has approved the Clinical Trial Application for expanding the Phase 1/2 ABILITY-1 study of MDNA11 to Europe. MDNA11, a long-acting IL-2 super-agonist, is currently being tested on patients with advanced solid tumors in the U.S., Canada, Australia, and Korea. The study aims to evaluate MDNA11 as a monotherapy and in combination with KEYTRUDA®. This expansion is expected to expedite patient enrollment and provide key updates on the trial's progress by H2 2024.

Medicenna reported significant survival benefits for recurrent glioblastoma (rGBM) patients treated with bizaxofusp at the 2024 ASCO Annual Meeting.

The Phase 2b study showed that a single treatment increased median overall survival (mOS) by 88% (13.5 vs. 7.2 months, p=0.009) and reduced the risk of death by nearly half (hazard ratio: 0.54, 95% confidence interval: 0.34-0.83) compared to a matched external control arm.

Additionally, bizaxofusp improved one-year and two-year overall survival rates by 180% and 290%, respectively. Importantly, these benefits were observed irrespective of IL-4 receptor expression, broadening the potential patient pool for future studies.

The findings indicate that tumor control could serve as an early surrogate for survival benefits.

Medicenna announced promising results from the Phase 1/2 ABILITY-1 study of MDNA11, showing durable single-agent activity in patients with advanced solid tumors. A pancreatic cancer patient achieved 100% lesion regression over 104 weeks, maintaining remission 4 months post-treatment. A melanoma patient also showed 100% regression of target lesions. No dose-limiting toxicities were observed, even when combined with Keytruda, allowing dose escalation to 90µg/kg. The study reported significant immune activation, particularly in CD8+ T and NK cells, suggesting MDNA11's potential as a next-generation IL-2 super-agonist.

Medicenna Therapeutics Corp., a clinical-stage immunotherapy company, will present updates on the MDNA11 ABILITY-1 Trial at the Sachs 10th Annual Oncology Innovation Forum on May 31, 2024. The event precedes the ASCO Annual Meeting in Chicago, where Medicenna will showcase Phase 1/2 trial data on MDNA11, a long-acting IL-2 super-agonist, in patients with advanced tumors. The study examines MDNA11 as a monotherapy and in combination with pembrolizumab. Medicenna's President and CEO, Dr. Fahar Merchant, will lead the presentation and engage in one-on-one meetings during the event. Additionally, Medicenna will present data on bizaxofusp for recurrent glioblastoma at ASCO 2024.

Medicenna provided an update on its presentations at the 2024 ASCO Annual Meeting, highlighting ASCO's withdrawal of the MDNA11 abstract due to alleged prior publication policy violations. Despite disagreements, Medicenna plans to share high-impact data from the ABILITY-1 trial virtually. The company aims to demonstrate the potential of MDNA11 as an IL-2 super-agonist with promising clinical results.