Welcome to our dedicated page for Medicenna Therapeutics news (Ticker: MDNAF), a resource for investors and traders seeking the latest updates and insights on Medicenna Therapeutics stock.
Medicenna Therapeutics Corp. (MDNAF) is a clinical-stage immunotherapy company whose news flow is closely tied to the progress of its Superkine pipeline. Company updates consistently highlight advances in MDNA11, a long-acting IL-2 Superkine in the Phase 1/2 ABILITY-1 trial for advanced solid tumors, as well as developments in MDNA113, a tumor-anchored and conditionally activated PD-1 x IL-2 bifunctional Superkine, and bizaxofusp (MDNA55), an IL-4 Empowered Superkine for recurrent glioblastoma.
On this page, readers can follow MDNAF news related to clinical data readouts, new trial announcements and corporate milestones. Recent releases describe updated MDNA11 results in monotherapy and in combination with pembrolizumab, including activity in checkpoint inhibitor-resistant melanoma, MSS endometrial cancer, MSI-H and TMB-H tumors, as well as plans to complete enrollment in ABILITY-1 and prepare for potential registrational studies. News also covers the NEO-CYT neoadjuvant trial in high-risk, surgically resectable Stage III melanoma, sponsored by Fondazione Melanoma Onlus, which will evaluate MDNA11 in combination with nivolumab with or without ipilimumab.
Investors and clinicians can also track preclinical and non-human primate updates for MDNA113, including safety and pharmacodynamic findings that Medicenna reports as supporting its advancement toward first-in-human trials. Additional news items address partnering efforts and data presentations for bizaxofusp in recurrent glioblastoma, patent issuances protecting IL-2 and IL-4 Superkine assets, and participation in scientific and investor conferences.
By reviewing the MDNAF news feed, users can see how Medicenna communicates new clinical results, outlines expected milestones, and provides context on the scientific rationale behind its Superkine programs, while also including standard cautions about the risks and uncertainties inherent in drug development.
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.
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