MDNA11 / Medicenna - LARVOL DELTA

A multicenter, randomized phase Ib trial to evaluate neoadjuvant immunotherapy combination of nivolumab alone or plus ipilimumab with the IL-2 superkine MDNA11 alone or with tocilizumab in patients with high-risk, surgically resectable melanoma: The NEO-CYT trial. (ASCO 2026) - "Exploratory analyses will investigate biomarker associations with outcomes to generate hypotheses. The Study schema"

Clinical • IO biomarker • P1 data • Cutaneous Melanoma • Melanoma • Solid Tumor • CD4 • CD8 • IL2 • ISG20

Medicenna and Fondazione Melanoma Onlus Announce First Patient Dosed in the NEO-CYT Study of MDNA11 in Neoadjuvant Melanoma (Investing News Network (INN)) - "The NEO-CYT study is designed to evaluate MDNA11 as neoadjuvant immunotherapy before curative-intent surgery in earlier-stage melanoma patients whose immune systems may be more amenable to immunotherapy and more likely to benefit from treatment."

Trial status • Cutaneous Melanoma

Medicenna and Fondazione Melanoma Onlus Announce Presentation on NEOCYT Trial at ASCO 2026 (The Manila Times) - "The clinical trial is a randomized, investigator‑initiated neoadjuvant Phase 1b trial testing MDNA11, a long‑acting, 'beta‑enhanced not‑alpha' IL‑2 Superkine, in combination with nivolumab (anti‑PD‑1) with or without ipilimumab (anti‑CTLA‑4) for patients with high‑risk, surgically resectable Stage III cutaneous melanoma."

P1 data • Melanoma

Interim results from the phase 1/2 ABILITY-1 study of a long-acting 'beta-enhanced not-alpha' IL-2 superkine in patients with advanced solid tumors (AACR 2025) - P1/2 | "MDNA11 shows a favorable tolerability profile with no DLTs observed up to 120 μg/kg Q2W. Robust evidence of single agent clinical activity include 1 confirmed CR and 4 PR in patients who had progressed on ICI. Monotherapy dose expansion and combination dose escalation with pembrolizumab continue to enrol."

Clinical • Metastases • P1/2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • CD8 • IL2 • MSI

Results from monotherapy dose escalation of MDNA11, a long-acting IL-2 superkine, in a phase 1/2 trial show evidence of single-agent activity in advanced solid tumors (AACR 2024) - P1/2 | "MDNA11 was well-tolerated with no DLTs observed at all dose levels up to 120 μg/kg. With study currently ongoing, single agent clinical activity was evident with an ORR of 7.7% and Clinical Benefit Rate (CBR) of 19.2% (2 PRs + 3 SDs > 6 months) in dose escalation to date. Monotherapy dose expansion at 90 μg/kg and combination dose escalation with pembrolizumab are enrolling."

IO biomarker • Metastases • Monotherapy • P1/2 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Lung Cancer • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • CD8 • ICOS • IL2 • IL2RA • MSI

A Multicentre, Randomised Phase Ib Trial to evaluate Neoadjuvant Immunotherapy Combination of Nivolumab alone or plus Ipilimumab with the IL-2 Superkine MDNA11 alone or with Tocilizumab in Patients with High-Risk, Surgically Resectable Melanoma NEO-CYT (clinicaltrialsregister.eu) - P1 | N=80 | Not yet recruiting | Sponsor: Fondazione Melanoma Onlus

New P1 trial • Melanoma • Oncology • Solid Tumor

NEO-CYT Trial (The Manila Times) - "Medicenna anticipates sharing interim clinical data from this study in neoadjuvant melanoma in H2 2026."

P1 data • Cutaneous Melanoma • Melanoma

MDNA11 Clinical Data Update (The Manila Times) - "On January 16, 2026, Medicenna updated expansion cohort data demonstrating MDNA11’s best-in-class anti-tumor activity. When administered as a 2L/3L systemic treatment or as next line following resistance to checkpoint therapy, MDNA11 achieved a monotherapy objective response rate ('[ORR') of 36% and a disease control rate ('DCR') of 86% (N=14), and when combined with pembrolizumab ORR was 43% and DCR was 72% (N=14)....Medicenna anticipates sharing updated clinical results from the ABILITY-1 study in H2 2026."

MSI-H • P1/2 data • Tumor mutational burden • Colorectal Cancer • Cutaneous Melanoma • Endometrial Cancer • Microsatellite Instability • Non Small Cell Lung Cancer

ABILITY-1 Enrollment and Update (The Manila Times) - "...Medicenna is completing enrollment in the expansion portions of the ABILITY-1 study by enrolling patients where MDNA11 will be administered as 2/3L Tx or immediately following checkpoint-resistance...Tumor types currently enrolling are: MSI-H, TMB-H, cutaneous melanoma, endometrial (combination only), non-small cell lung cancer (combination only), and colorectal cancer (mono- and combination in TMB-H and MSI-H cohorts)....Medicenna anticipates completing enrollment of expansion cohorts in the ABILITY-1 study and is planning for an end-of-phase 1 meeting with the FDA, allowing for alignment regarding potential registrational trials."

Enrollment status • MSI-H • Tumor mutational burden • Colorectal Cancer • Cutaneous Melanoma • Endometrial Cancer • Microsatellite Instability • Non Small Cell Lung Cancer

ABILITY-1, a phase I/II study of MDNA11, a next generation IL-2 agonist, alone or with pembrolizumab in advanced solid tumors: Interim analysis (ESMO-IO 2025) - P1/2 | "In addition, 1 confirmed CR (anal SCC) and 1 PR (roll-over, TMB-H neuroendocrine tumor) occurred and not included in the ORR. MDNA11 alone or with pembrolizumab induced sustained lymphocyte expansion (>14 days/dose) and increases in CD8+ T (including TCF1+ stemlike and DNAM1+ effector) and NK cells peaking at 90 μg/kg.Conclusions MDNA11 shows a manageable safety profile and durable clinical activity as monotherapy and with pembrolizumab across multiple refractory malignancies, including ICI-progressed and immunologically 'cold' tumors, supporting continued evaluation in expansion cohorts."

Metastases • P1/2 data • Cutaneous Melanoma • Melanoma • Microsatellite Instability • Neuroendocrine Tumor • Oncology • Solid Tumor • CD8 • IL2 • MSI • TMB

Medicenna Updates MDNA11 Clinical Trial Results at the ESMO-IO Congress 2025, Further Bolstering its Anti-Tumor Activity in Advanced Solid Tumors (GlobeNewswire) - "Monotherapy and combination treatment achieve durable responses in multiple advanced metastatic tumors, including pancreatic, breast, colorectal, endometrial, bladder, anal cancer and melanoma...MDNA11 continues to demonstrate a manageable safety profile both as a single agent and in combination with KEYTRUDA...ORR of 42% (5 of 12) and DCR of 83% (1 CR, 4 PR, 5 SD) amongst patients who were treated with MDNA11 as the next treatment line following progression on a checkpoint inhibitor, highlighting the potential of MDNA11 in earlier treatment settings...In microsatellite stable (MSS) endometrial cancers with secondary resistance to immune checkpoint inhibition, the ORR was 50% (2 of 4) with a DCR of 75% (2 PR, 1 SD); In TMB-H tumors, the ORR was 25% (2 of 8) with a DCR of 88% (2 PR, 5 SD) and tumor regression observed in 6 of 8 patients (75%)."

MSI-H • P1/2 data • Tumor mutational burden • Anal Carcinoma • Bladder Cancer • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Melanoma • Pancreatic Cancer

Medicenna Therapeutics to Host a Live Webinar with Q&A to Discuss Updated MDNA11 Clinical Data (GlobeNewswire) - "As previously announced, Medicenna will present updated clinical data from the ABILITY-1 Phase 1/2 Study, evaluating MDNA11 as a monotherapy and in combination with pembrolizumab, on December 10th at the ESMO Immuno-Oncology Congress 2025. The webinar will have Medicenna’s management team and the presenting Principal Investigator along with commentary from key opinion leaders to discuss the updated data."

P1/2 data • Solid Tumor

Medicenna and Fondazione Melanoma Onlus Collaborate to Advance MDNA11 Before First-Line Therapy in a Randomized Neoadjuvant Combination Trial, “NEO-CYT”, in High-Risk, Surgically Resectable Stage III Melanoma (GlobeNewswire) - "NEO‑CYT is designed to produce early, actionable neoadjuvant data to support clinical positioning of MDNA11 in melanoma and significantly broaden the use case for MDNA11 immunotherapy, expanding its addressable market to include the earliest line of systemic therapy for solid tumors with the potential to treat a large patient population with high-risk melanoma....'We look forward to sharing updated clinical data from the on-going ABILITY study with MDNA11 at the upcoming ESMO-IO congress and results from the NEO-CYT study throughout 2026.'"

Clinical data • Commercial • New trial • Melanoma • Solid Tumor

Updated MDNA11 Clinical Data from the ABILITY-1 Study to be Presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025 (GlobeNewswire) - "Updated clinical data from the Phase 1/2 ABILITY-1 Study evaluating MDNA11, an emerging best-in-class IL-2 therapy, as a monotherapy and in combination with pembrolizumab, will be presented by Dr. André Mansinho, a principal investigator of the study."

P1/2 data • Solid Tumor

Medicenna Therapeutics Reports First Quarter Fiscal 2026 Financial Results and Operational Highlights (GlobeNewswire) - "Company remains on track to complete enrollment in the Phase 1/2 ABILITY-1 monotherapy and combination arms and provide top-line clinical data readouts in calendar H2 2025."

P1/2 data • Oncology • Solid Tumor

Medicenna Strengthens Intellectual Property Portfolio with Five Patents Granted for its IL-2 and IL-4 Superkines (GlobeNewswire) - "Medicenna Therapeutics...announced grant of five patents covering the Company’s IL-2 and IL-4 Superkine platforms....The newly granted patents cover composition, formulation, combination, use, and therapeutic applications of IL-2 and IL-4 Superkines. Newly granted patents span major markets, with anticipated expiration dates ranging from 2033 to 2040 depending on the specific case and local rules, without accounting for any potential extensions....Notably, the patent covering IL-2 superagonists in combination with anti-PD1 antibodies provides important coverage for MDNA11....Furthermore, protection granted to a novel formulation of bizaxofusp (MDNA55), used in the Phase 2b recurrent glioblastoma clinical trial, solidifies its commercial exclusivity for treatment of brain cancers....'We look forward to sharing additional clinical data from the ABILITY-1 clinical trial during the balance of this calendar year'."

P1/2 data • Patent • Glioblastoma • Solid Tumor

Clinical Activity of MDNA11 in Combination with KEYTRUDA during Dose Escalation (GlobeNewswire) - P1/2 | N=115 | ABILITY-1 (NCT05086692) | Sponsor: Medicenna Therapeutics, Inc. | "5 objective responses (1 CR and 4 PRs) among heavily pre-treated patients, including two previously reported objective responses in...70-year-old male with anal squamous cell carcinoma (SCC) who previously progressed on two prior lines of chemotherapy achieved a CR on the first study evaluable imaging scan (week 8); patient continues on combination treatment following a confirmed CR; 52-year-old female with TMB-H/MSS colorectal cancer who previously progressed on two prior lines of chemotherapy achieved a confirmed PR. While off-study for 4 months, the patient continues to show deepening of the tumor response in the absence of any treatment....Objective response rate (ORR) of 31% (4 of 13) in patients with cancers planned for the Phase 2 combination expansion cohort, including cutaneous melanoma, MSI-H/dMMR, and TMB-H tumors, and an ORR of 36% (5 of 14) when including the virally-derived cancers."

dMMR • MSI-H • P1/2 data • Anal Squamous Cell Carcinoma • Colorectal Cancer • Cutaneous Melanoma • Microsatellite Instability • Solid Tumor • Squamous Cell Carcinoma

Monotherapy Tumor Response in Immune Checkpoint Inhibitor-Resistant Patients (GlobeNewswire) - P1/2 | N=115 | ABILITY-1 (NCT05086692) | Sponsor: Medicenna Therapeutics, Inc. | "ORR of 40% in the monotherapy dose escalation (treated at ≥ 60 μg/kg) and expansion arm (1 confirmed CR, 1 confirmed PR and 2 unconfirmed PRs) among 10 patients with tumor types currently enrolling in the Phase 2 monotherapy expansion cohort. All patients had previously failed ICI therapy and had advanced and/or metastatic cutaneous melanoma with secondary resistance to ICI or MSI-H/dMMR tumors...2 PRs among 4 MSI-H patients (ORR of 50%) with both responders having metastatic pancreatic ductal adenocarcinoma (PDAC); 1 CR and 1 PR among 6 patients with ICI secondary resistant melanoma (ORR of 33.3%); 1 PR among patients with ICI primary resistant melanoma...SD in 6 patients for a disease control rate (DCR = CR+PR+SD) of 65% including 2 with duration > 6 months....Additional monotherapy and combination data from the ABILITY-1 study expected at future medical conferences..."

dMMR • MSI-H • P1/2 data • Cutaneous Melanoma • Melanoma • Microsatellite Instability • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Medicenna to Provide Clinical Update on the MDNA11 ABILITY-1 Trial at the Upcoming American Association for Cancer Research Annual Meeting (GlobeNewswire) - "The Company will present an update from its Phase 1/2 ABILITY-1 Study evaluating MDNA11, the only long-acting, ‘beta-enhanced not-alpha’ interleukin-2 (IL-2) super-agonist in clinical development. In addition, pre-clinical data for MDNA113, a novel first-in-class tumor-targeted and tumor-activated bi-functional anti-PD1-IL2 Superkine, will also be presented at the conference."

P1/2 data • Preclinical • Oncology • Solid Tumor

Other ABILITY-1 Study Updates: (GlobeNewswire) - "Additional tumor types to be evaluated as part of MDNA11 monotherapy and KEYTRUDA combination dose expansion cohorts: MSI-H/dMMR, TMB-H, cutaneous melanoma, virally associated tumors (monotherapy portion only), and gynecological tumors (combination portion only). Completion of monotherapy expansion and combination dose escalation enrollment anticipated mid calendar 2025. Combination dose expansion expected to initiate mid calendar 2025."

Trial status • Gynecologic Cancers • Melanoma • Microsatellite Instability

Medicenna Reports MDNA11’s Compelling Anti-Cancer Activity is Associated with Significant Expansion of ‘Stem-Like’ Cancer Fighting Immune Cells at the Inaugural AACR-Immuno-Oncology Conference and Provides ABILITY-1 Study Update (GlobeNewswire) - P1/2 | N=115 | ABILITY-1 (NCT05086692) | Sponsor: Medicenna Therapeutics, Inc. | "Safety Review Committee cleared the 120 µg/kg MDNA11 every two weeks in combination with KEYTRUDA as no dose-limiting toxicities (DLTs) have been observed to date...Pharmacokinetics: MDNA11 exhibits consistent PK profiles with repeat administration as both single agent and when combined with KEYTRUDA. Pharmacodynamics: MDNA11 associated with dose-dependent expansion of CD8+ T and NK cells which is sustained over repeat dose cycles as both single agent and when combined with KEYTRUDA. Significant expansion of activated effector CD8+ T cells, effector memory T cells and central memory T cells with MDNA11, key immune cell subsets associated with durable anti-tumor response."

P1/2 data • Solid Tumor

Medicenna Reports Third Quarter Fiscal 2025 Financial and Operational Results and Provides Anticipated Milestones (GlobeNewswire) - "ANTICIPATED MILESTONES FOR 2025:...MDNA11:...(i) Present PK/PD data from ongoing ABILITY-1 trial at AACR-Immuno-Oncology Conference with additional efficacy and safety data to be presented in calendar Q2 and remainder of 2025: Feb. 2025; (ii) Complete enrollment for the MDNA11 monotherapy dose expansion arm of ABILITY-1 trial: mid 2025; (iii) Present results from combination dose escalation arm of the ABILITY-1 trial at a major medical conference (with further updates anticipated in H2/25): Q2 2025; (iv) Complete enrollment for combination dose escalation arm of the ABILITY-1 trial (MDNA11 + KEYTRUDA): mid 2025; (v) Initiate combination dose expansion arm of the ABILITY-1 trial to assess efficacy of MDNA11 with KEYTRUDA in specific tumor types: Q2 2025."

P1/2 data • Trial status • Solid Tumor

Medicenna Presents Preclinical Data on MDNA11 as First Step to Shrink Tumors Before Surgery and Prevent Metastasis at the 2024 San Antonio Breast Cancer Symposium (SABCS) (GlobeNewswire) - "The presentation at 2024 SABCS highlighted the potential of MDNA11, a long-acting ‘β-enhanced not-α’ IL-2 Superkine, to improve treatment outcomes when administered prior to surgery. New findings demonstrated that a single low dose of MDNA11 as a neoadjuvant therapy significantly prevented metastasis, extended survival, and enabled a memory immune response that protects against tumor rechallenges in a TNBC model...Key findings from presentation of MDNA11 pre-treatment prior to surgery in the aggressive TNBC model included: Metastasis Prevention: A single dose of neoadjuvant MDNA11 prevented the spread of tumors, with vast majority of treated mice (7/8 at high-dose of 5 mg MDNA11/kg and 6/7 at low-dose of 2 mg MDNA11/kg) surviving to study end (>4 months) without signs of metastasis despite tumor rechallenges. By contrast, all mice in the control group developed multiple metastasis and died within ~2 months even after tumor resection surgery."

Preclinical • Triple Negative Breast Cancer

Results from ABILITY-1 monotherapy dose escalation and ongoing monotherapy expansion with MDNA11, a long-acting 'beta-enhanced not-alpha' IL-2 superkine, in patients with advanced solid tumors (SITC 2024) - P1/2 | "Conclusions MDNA11 demonstrated a favorable safety profile and compelling single-agent activity in dose escalation and ongoing dose expansion in heavily pretreated patients with advanced solid tumors. Monotherapy expansion and combination dose escalation with pembrolizumab are enrolling."

Clinical • Metastases • Monotherapy • Colorectal Cancer • Cutaneous Melanoma • Melanoma • Microsatellite Instability • Oncology • Small Intestinal Carcinoma • Solid Tumor • CD8 • IL2 • MSI

Neo-adjuvant administration of MDNA11, a long-acting IL-2 Superkine, prevents metastasis, protects against tumor rechallenges and provides long-term survival in an orthotopic model of breast cancer (SABCS 2024) - "A single dose of MDNA11 in a neo-adjuvant setting confers immediate and long-term protection from metastatic disease in the 4T1.2 orthotopic breast cancer model."

Clinical • Breast Cancer • Oncology • Solid Tumor • CD8 • IL2