MDNA11 demonstrates durable anti-tumor activity in phase-2 eligible expansion cohorts, enriched for immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H and TMB-H cancers, in each case exceeding objective response rate (ORR) benchmarks in these difficult to treat populations  In the monotherapy expansion cohorts, irrespective of tumor type, patients treated with MDNA11, as the next treatment following progression on immune checkpoint inhibitors (ICI), had an ORR of 42% and a disease control r ...

TORONTO and HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines for the treatment of cancer as well as autoimmune and inflammatory diseases is pleased to announce that it will host a live webinar on December 10, 2025 at 08:30 AM Eastern Time. As previously announced, Medicenna will present updated clinical data from the ABILITY-1 Phase 1/2 Study, evalu ...

Core Insights - Medicenna Therapeutics is advancing its clinical programs, particularly focusing on MDNA11 and MDNA113, with significant updates expected at the ESMO Immuno-Oncology Congress in December 2025 [1][5][2] MDNA11: IL-2 Superkine Program - The updated clinical data from the Phase 1/2 ABILITY-1 Study for MDNA11 will be presented, showcasing its potential as a leading IL-2 therapy [5] - A new clinical trial, NEO-CYT, will evaluate MDNA11 in combination with checkpoint inhibitors for high-risk melanoma patients prior to surgery [1][5] - The primary endpoint of the NEO-CYT trial is Major Pathologic Response (MPR), which is predictive of long-term survival outcomes [5] MDNA113: First-in-Class Anti-PD-1-IL-2 Bispecific Superkine - MDNA113 is being evaluated in non-human primate studies, with plans for a first-in-human clinical trial to start in 2026 [1][12] - The bispecific therapy is designed to enhance safety and efficacy through proprietary technologies [12] - Preclinical data presented at AACR 2025 supports its development potential in cancers affecting over 2 million patients annually [5][12] Intellectual Property Update - Six new patents have been issued or allowed across multiple jurisdictions, protecting various superkine assets, including the anti-PD1 x IL-2 program [1][7] Financial Overview - As of September 30, 2025, the company reported cash and cash equivalents of $15.7 million, providing a runway into at least mid-2026 [8] - Total operating costs for the quarter were $5.5 million, consistent with the previous year, with a noted increase in R&D expenses to $4.1 million due to expanded clinical activities [9][11] - The net loss for the quarter was $4.9 million, compared to a loss of $4.2 million in the same period last year [10]

Core Insights - Medicenna Therapeutics Corp. is set to present updated clinical data for MDNA11 at the ESMO Immuno-Oncology Congress 2025 in London from December 10-12, 2025 [1][2] - The presentation will focus on the Phase 1/2 ABILITY-1 Study, evaluating MDNA11 as a monotherapy and in combination with pembrolizumab for advanced solid tumors [2] Company Overview - Medicenna is a clinical-stage immunotherapy company specializing in the development of Superkines targeting cancer and autoimmune diseases [1][3] - The company’s lead product, MDNA11, is a long-acting IL-2 Superkine designed to preferentially stimulate cancer-killing effector T cells and NK cells [3] - Medicenna is also developing MDNA113, a bispecific targeting PD-1 and IL-2 for solid tumors, utilizing proprietary platforms BiSKITs™ and T-MASK™ [3] - Bizaxofusp, an IL-4 Empowered Superkine, has been studied in five clinical trials with over 130 patients and has received FastTrack and Orphan Drug status from the FDA and EMA [3]

Summary of Medicenna Therapeutics Conference Call Company Overview - Medicenna Therapeutics is a publicly listed company on the TSX main board and OTCQX under the symbol MDNA, focused on developing immunotherapies for late-stage diseases, particularly cancer [1][2] - The company specializes in a class of molecules known as cytokines, aiming to develop enhanced versions called Superkines [1][2] Core Points and Arguments Development and Collaborations - Medicenna licensed the Superkines platform from Stanford University in 2016 and has exclusive worldwide rights [2] - The company has a clinical collaboration with Merck, utilizing Keytruda, the world's best-selling drug, in combination with its own therapies [2][3] Clinical Trials and Data - Medicenna is preparing to provide updates on its Superkine MDNA11, with over 100 patient data points collected [3][6] - The company has received FDA agreement on a phase 3 design for its brain cancer drug, indicating significant progress in its development pipeline [3][5] - MDNA11 has shown promising results, with tumor shrinkage observed in 30% to 50% of patients who have previously failed other therapies [12][14] Market Opportunity - Keytruda, which is set to go off patent in 2028, currently generates nearly $30 billion in annual sales, highlighting a significant market opportunity for alternatives like MDNA11 [11][12] - Medicenna's valuation is approximately $60 million USD, with potential for substantial growth given the response rates observed in clinical trials compared to competitors [18][19] Competitive Landscape - The company is positioned against competitors like Replimune and Iovance, which have higher valuations despite similar response rates [19][20] - Recent multibillion-dollar transactions in the bispecific molecule space, such as the $11.2 billion deal between Takeda and Innovent, indicate a growing interest in this area [21][22] Pipeline and Future Developments - Medicenna is advancing multiple drugs, including MDNA113, a bispecific molecule combining anti-PD-1 and IL-2, with data expected soon [21][23] - The brain cancer program shows potential for significant market impact, with an estimated $4 billion opportunity across various brain cancer types [25][26] Important but Overlooked Content - The company has a strong advisory team, including leading experts in brain cancer and skin cancer, which enhances its credibility and potential for success [4] - Medicenna's approach to IL-2 therapy addresses previous challenges with safety and efficacy, aiming to provide a safer treatment option that effectively shrinks tumors [10][11][13] - The company has a cash runway into Q3 of the following year, allowing it to continue its development efforts without immediate financial pressure [26][40] Upcoming Milestones - Key data readouts are expected by the end of the year, particularly at a major cancer conference in the UK [27][40] - The company plans to meet with regulators to discuss pathways for accelerated approval based on upcoming clinical trial results [28][40]

Summary of Medicenna Therapeutics FY Conference Call Company Overview - Medicenna Therapeutics is a publicly listed clinical-stage immunotherapy company focused on developing "evolutionary superkines" to address unmet needs in oncology [2][24] - The company is listed on the Toronto Stock Exchange and OTCQX [2] Key Programs 1. **MDNA11** - A best-in-class IL-2 superkine, the only long-acting IL-2 super agonist not enhanced by alpha-beta [2] - Demonstrated response rates of 30% to 50% in checkpoint failed patients [3] - Phase 1/2 trials are ongoing, with data expected from over 425 patients by year-end [6][24] - Safety profile shows over 90% of adverse events were grade one or two, with no dose-limiting toxicities observed [12][13] 2. **MDNA113** - A first-in-class targeted anti-PD-1 bispecific, currently in preclinical proof of concept [3] - Combines an anti-PD-1 with the IL-2 superkine from MDNA11, aiming to enhance efficacy [19][20] 3. **Bizaxofusp (MDNA55)** - An IL-4 empowered superkine targeting end-stage recurrent glioblastoma, showing doubled survival rates compared to standard care (from 7 months to nearly 14 months) [3][23] - The company is seeking to partner this asset [4][24] Clinical Data and Expectations - By the end of the year, clinical data from 250 patients with aggressive tumors is expected [4][24] - Completion of the phase 1/2 ability trial and data disclosure on MDNA11 in monotherapy and combination with Keytruda® [4][24] - Non-human primate testing of the bifunctional superkine is also anticipated [24] Market Opportunity - The market for MDNA11 is significant, particularly for patients with recurrent melanoma and MSI-high tumors, who currently have limited treatment options [17] - The combination of MDNA11 with checkpoint inhibitors could potentially improve response rates from 30%-40% to 60%-70% [18] Financial Overview - Medicenna has a cash position of $21 million, projected to last until Q3 of the following year [24] - The company has approximately 83 million shares outstanding, with insiders owning about 22% [24] Conclusion - Medicenna Therapeutics is positioned to make significant advancements in immunotherapy with its innovative superkine platform, particularly in oncology, with multiple programs showing promising clinical data and a strong market opportunity ahead [2][24]

Core Insights - Medicenna Therapeutics is encouraged by positive clinical results from the MDNA11 program, demonstrating best-in-class potential in treating checkpoint-resistant tumors [1][2] - The company is on track to complete enrollment in the Phase 1/2 ABILITY-1 trial and expects to provide top-line clinical data in the second half of 2025 [1][5] - Recent patent grants strengthen Medicenna's intellectual property position, with a total of 86 granted or allowed patents [6][7] Clinical Development - MDNA11 has shown durable efficacy with complete responses in pancreatic and melanoma cancer patients, remaining cancer-free for 18 and 6 months, respectively [1] - The company is advancing its MDNA113 candidate, a bispecific anti-PD1-IL2 Superkine, which has shown promising preclinical data [2][5] - Bizaxofusp, the IL-4 Superkine program, is seeking partnership opportunities for recurrent glioblastoma [4] Financial Overview - Medicenna reported cash and cash equivalents of $20.5 million as of June 30, 2025, providing a runway through mid-2026 [8] - Total operating costs for the quarter were $5.5 million, an increase from $4.0 million in the same quarter of the previous year, primarily due to higher R&D spending [9] - The net loss for the quarter was $4.9 million, compared to a net loss of $3.6 million in the prior year, attributed to increased R&D expenses and foreign exchange losses [10][11]

Core Insights - Medicenna Therapeutics is advancing its MDNA11 program, demonstrating significant anti-tumor activity in difficult-to-treat solid tumors, with response rates between 30-50% in various cohorts [1][5] - The company plans to solidify its Phase 2b development strategy for MDNA11 by the end of 2025, including strategies for accelerated approval [12] - Medicenna's MDNA113, a first-in-class PD-1 x IL-2 bispecific Superkine, is progressing to non-human primate studies in the second half of 2025 [1][12] Clinical Development - MDNA11 is currently in a Phase 1/2 clinical trial, with a recommended dose of 90 µg/kg administered intravenously every two weeks [4] - A pancreatic cancer patient treated with MDNA11 has remained in remission for at least 18 months without further treatment, showcasing the drug's potential [2][5] - The company aims to complete enrollment in the Phase 1/2 ABILITY-1 trial and report top-line data from both monotherapy and combination arms by the end of 2025 [2][12] Financial Performance - For the fiscal year ended March 31, 2025, Medicenna reported total operating costs of $20.4 million, an increase from $18.7 million in the previous year, primarily due to higher research and development expenses [9][11] - The net loss for the year was $11.8 million, a decrease from $25.5 million in the prior year, attributed to a reduction in the fair value of the derivative warrant liability [10] - Medicenna ended the fiscal year with cash and cash equivalents of $24.8 million, expected to fund operations through mid-2026 [8] Research and Development - Research and development expenses increased to $14.4 million for the year ended March 31, 2025, driven by expanded clinical costs and the inclusion of combination studies with KEYTRUDA [11] - The company is pursuing partnership opportunities for its phase-3 ready IL-4 Superkine, Bizaxofusp, which has received FastTrack and Orphan Drug status from the FDA [7] - MDNA113 is designed to address safety issues associated with current anti-PD-1 candidates while maintaining efficacy in challenging tumor types [2][12]

Core Insights - Medicenna Therapeutics is advancing MDNA113, a novel IL-13Rα2 tumor-targeted and "masked" anti-PD-1-IL-2 Superkine, aimed at treating immunologically cold tumors with high unmet needs, such as pancreatic, liver, brain, breast, colon, and prostate cancers, affecting over 2 million patients annually worldwide [1][7] - The company presented new pre-clinical data at the 2025 AACR Annual Meeting, highlighting MDNA113's differentiated approach compared to existing anti-PD-1-IL-2 therapies, showcasing its optimized safety and efficacy profile [1][2] Company Overview - Medicenna is a clinical-stage immunotherapy company focused on developing Superkines targeting cancer and autoimmune diseases, with MDNA113 being the first candidate from its BiSKIT platform [1][8] - The company also has other candidates in development, including MDNA11, a long-acting IL-2 super agonist, which has shown durable anti-tumor activity in ongoing clinical studies [2][8] Product Highlights - MDNA113 is designed to selectively bind to IL-13Rα2, which is overexpressed in various solid tumors, while avoiding binding to the functional IL-13R⍺1, enhancing its therapeutic potential [5][6] - The product demonstrates promising pre-clinical results, including significant anti-tumor activity, enhanced memory responses, and preferential localization in the tumor microenvironment for at least 72 hours [6][2] Market Context - There is growing commercial interest in bi-specific anti-PD-1 therapies, with recent transactions validating this emerging class of immunotherapies, indicating potential for MDNA113 to offer new hope to cancer patients [2][6]