Core Insights - Medicenna Therapeutics is advancing its clinical pipeline with promising data for MDNA11 and MDNA113, targeting various cancers and autoimmune diseases [2][3][21] Clinical Data and Trials - Updated clinical data from the ABILITY-1 trial shows MDNA11 achieving an objective response rate (ORR) of 36% in monotherapy and 43% when combined with pembrolizumab in patients treated as second or third-line therapy [4][5] - The ABILITY-1 study has expanded to include patients with non-small cell lung cancer (NSCLC) and secondary resistance to checkpoint therapy, addressing a significant unmet need in cancer treatment [4][6] - The NEO-CYT trial will evaluate MDNA11 in combination with nivolumab for high-risk melanoma, with patient enrollment expected to start in H1 2026 and interim data anticipated in H2 2026 [8][10] Product Development - MDNA113, a bifunctional anti-PD-1–IL-2 superkine, is progressing through IND-enabling studies, with plans to submit an IND in H2 2026 after demonstrating a favorable safety profile in non-human primates [3][14] - Bizaxofusp (formerly MDNA55) has shown a significant increase in median overall survival for recurrent glioblastoma patients, with a median overall survival of 13.6 months compared to the standard of care of 7 months [14] Financial Overview - As of December 31, 2025, Medicenna reported cash and cash equivalents of $10.6 million, expected to fund operations into Q3 2026 [16] - The company reported total operating costs of $5.6 million for the quarter, an increase from $5.1 million in the same period the previous year, primarily due to higher R&D expenditures [17][19] - The net loss for the quarter was $4.4 million, a decrease from $5.2 million in the prior year, attributed to an increase in the gain on the fair value of derivative warrant liability [18]

Core Insights - Medicenna Therapeutics is advancing its clinical pipeline with promising data for MDNA11 and MDNA113, aiming for significant milestones in 2026 [2][3] Clinical Data and Trials - The ABILITY-1 trial for MDNA11 shows an objective response rate (ORR) of 36% in monotherapy and 43% when combined with pembrolizumab, with a disease control rate (DCR) of 86% and 72% respectively [3][4] - A new expansion cohort in the ABILITY-1 study will treat patients with non-small cell lung cancer (NSCLC) and secondary resistance to checkpoint therapy [3][5] - The NEO-CYT trial will evaluate MDNA11 in combination with nivolumab for melanoma, with patient enrollment expected to start in H1 2026 and interim data anticipated in H2 2026 [7][9] Product Development - MDNA113, a bifunctional anti-PD-1–IL-2 superkine, is progressing through IND-enabling studies, with plans to submit an IND in H2 2026 [2][12] - Bizaxofusp (formerly MDNA55) has shown a median overall survival (mOS) of 13.6 months in a Phase 2b trial for recurrent glioblastoma, compared to the standard mOS of 7 months [12] Financial Overview - As of December 31, 2025, Medicenna reported cash and cash equivalents of $10.6 million, expected to fund operations into Q3 2026 [14] - The company reported total operating costs of $5.6 million for the quarter, an increase from $5.1 million in the same period the previous year, primarily due to higher R&D expenditures [15][17] - The net loss for the quarter was $4.4 million, a decrease from $5.2 million in the prior year, attributed to a gain on the fair value of derivative warrant liability [16]

TORONTO and HOUSTON, Feb. 13, 2026 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQB: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines, announces that Mr. Richard Sutin and Mr. Angelos Georgakis have been appointed, effective as of February 12, 2026, to the board of directors of the Company (the “Board”). “We are excited to welcome Mr. Richard Sutin and Mr. Angelos Georgakis to the Medicenna board of directors” commented ...

Core Insights - Medicenna Therapeutics is advancing its clinical programs, particularly focusing on MDNA11 and MDNA113, with promising data indicating their potential as best-in-class therapies for cancer treatment [2][3] MDNA11 Developments - In monotherapy expansion cohorts (n=21), the overall response rate (ORR) was 50% for patients treated with MDNA11 in the 2L/3L setting and 42% when MDNA11 was the next treatment post-ICI failure, indicating its best-in-class potential [5][10] - Among all efficacy-evaluable monotherapy patients (n=55) across 18 different cancers, the ORR was 19% for MDNA11 as a 2L/3L treatment and 24% when used post-ICI failure [10] - The ABILITY-1 Phase 1/2 trial has enrolled over 110 safety-evaluable patients, establishing a biologically effective dose range (BEDR) of 60-120 g/kg without dose-limiting toxicities [4][5] MDNA113 Insights - MDNA113, a bifunctional anti-PD1-IL2 superkine, has shown a favorable safety profile in non-human primates at doses up to 30 mg/kg, supporting its potential for human trials [9][16] - The IND submission and initiation of the first-in-human trial for MDNA113 are expected in H2 2026 [9][17] NEO-CYT Study - The NEO-CYT study, in collaboration with Fondazione Melanoma Onlus, will evaluate MDNA11 in front-line therapy for resectable advanced cutaneous melanoma, with patient enrollment planned for H1 2026 and interim data expected in H2 2026 [8][17] Strategic Priorities for 2026 - Medicenna aims to maximize the potential of MDNA11 in earlier-line and neoadjuvant settings, advance MDNA113 as a targeted bifunctional therapy, and progress bizaxofusp through partnerships for recurrent GBM and other brain cancers [14][17] - Key milestones include completing patient enrollment in the ABILITY-1 study, reporting updated clinical data, and securing FDA guidance for registrational trials [17][18]

Core Viewpoint - Medicenna Therapeutics is presenting new clinical data from the ABILITY-1 study evaluating MDNA11, highlighting the company's ongoing commitment to advancing its clinical programs [2]. Group 1: Company Overview - Dr. Fahar Merchant serves as the Founder, Chairman, President, and CEO of Medicenna Therapeutics, leading the company in its clinical research efforts [2]. - The webinar is part of an initiative to share significant developments in the company's research and clinical trials [2]. Group 2: Clinical Study Insights - The ABILITY-1 study focuses on evaluating the efficacy and safety of MDNA11, which is a key component of Medicenna's therapeutic pipeline [2]. - The presentation includes forward-looking statements regarding the potential outcomes of the clinical study, emphasizing the company's expectations and plans for MDNA11 [2][3].

Company Presentation & KOL Webinar MDNA11 Clinical Data Update 10 December 2025 ESMO-IO Congress 2025 Disclaimer Certain statements in this presentation may constitute "forward-looking statements" under applicable securities laws. These forward-looking statements include, but are not limited to, information about possible or assumed future results of the Medicenna Therapeutics Corp's (the "Company" or "Medicenna") business, clinical trials, drug development, financial condition, results of operations, liqui ...

Core Insights - MDNA11 demonstrates durable anti-tumor activity in difficult-to-treat populations, exceeding objective response rate (ORR) benchmarks in immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H, and TMB-H cancers [1] - The monotherapy expansion cohorts show an ORR of 42% and a disease control rate (DCR) of 83% for patients treated with MDNA11 after progression on immune checkpoint inhibitors [1] - Combination therapy with KEYTRUDA shows an ORR of 50% and a DCR of 75% in MSS endometrial cancer, while MSS TMB-H tumors show an ORR of 25% and a DCR of 88% [1] Clinical Data - In monotherapy cohorts, ORR is 38% in melanoma and 22% in MSI-H tumors, with corresponding DCRs of 75% and 78% respectively [1] - Patients with disease control in monotherapy cohorts had a median overall survival (mOS) of 120.2 weeks compared to 28.6 weeks for those without disease control [7] - In combination cohorts, patients with disease control had a median OS that was not yet reached, compared to 26 weeks for those without disease control [10] Safety Profile - MDNA11 shows a manageable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient, resolving typically within 48 hours [4] - No dose-limiting toxicities were observed at doses up to 120 µg/kg in monotherapy or in combination with KEYTRUDA [4] Recommended Dose - The preliminary recommended dose for expansion for both monotherapy and combination arms is established at 90 µg/kg Q2W, with a biological effective dose range set at 60 to 120 µg/kg [5] Future Developments - Medicenna plans to share new and mature data from the ABILITY-1 study and additional studies in the coming weeks and months [3]

Core Insights - MDNA11 demonstrates durable anti-tumor activity in difficult-to-treat populations, exceeding objective response rate (ORR) benchmarks in immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H, and TMB-H cancers [1] - The monotherapy expansion cohorts show an ORR of 42% and a disease control rate (DCR) of 83%, indicating the potential of MDNA11 in earlier lines of treatment [1] - Combination treatment with KEYTRUDA shows promising results, with an ORR of 50% and a DCR of 75% in MSS endometrial cancer [1][9] Clinical Data - In monotherapy expansion cohorts, ORRs are 38% in melanoma and 22% in MSI-H tumors, with corresponding DCRs of 75% and 78% respectively [1] - Patients treated with MDNA11 as the next treatment after immune checkpoint inhibitors had an ORR of 42% [8] - In MSS endometrial cancers, the ORR was 50% with a DCR of 75%, while TMB-H tumors showed an ORR of 25% and a DCR of 88% [9] Safety Profile - MDNA11 exhibits a manageable safety profile, with over 90% of treatment-related adverse events being Grade 1-2 and transient [4] - No dose-limiting toxicities were observed at doses up to 120 µg/kg, and Grade 3-4 events were mainly laboratory abnormalities without clinical sequelae [4] Overall Survival - In monotherapy cohorts, patients with disease control had a median overall survival (mOS) of 120.2 weeks compared to 28.6 weeks for those without disease control [7] - In combination cohorts, patients with disease control had a median OS that was not yet reached, compared to 26 weeks for those without disease control [10] Future Developments - Medicenna plans to share new and mature data from the ABILITY-1 study and additional studies in the coming weeks and months [3] - The NEO-CYT trial provides external validation of MDNA11's approach, suggesting its potential as a de-risked drug candidate for earlier stage cancer patients [3]

Core Insights - Medicenna Therapeutics Corp. is hosting a live webinar on December 10, 2025, at 08:30 AM Eastern Time to discuss updated clinical data from the ABILITY-1 Phase 1/2 Study evaluating MDNA11 [1][2] Company Overview - Medicenna is a clinical-stage immunotherapy company focused on developing Superkines for cancer and autoimmune diseases, with a particular emphasis on long-acting IL-2 Superkine, MDNA11, which has superior affinity toward CD122 and preferentially stimulates cancer-killing T cells and NK cells [5] - The company is also developing MDNA113, a bispecific targeting PD-1 and IL-2 for solid tumors, utilizing proprietary BiSKITs™ and T-MASK™ platforms [5] - 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 [5] Webinar Details - The webinar will feature presentations from Medicenna's executive and scientific advisory team, including Dr. Fahar Merchant, Dr. Arash Yavari, and Dr. André Mansinho, along with commentary from key opinion leaders and a live Q&A session [4][9]

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]