MDNA11 / Medicenna - LARVOL DELTA

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

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.Clinical trial identification NCT05086692.Legal entity responsible for the study Medicenna Therapeutics."

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

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

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 • 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

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

Updated MDNA11 Monotherapy and Combination Clinical Data from the Ongoing Phase 1/2 ABILITY-1 Study to be Presented at the 2024 Immunotherapy Bridge Conference (GlobeNewswire) - "The oral presentation will include updated clinical data from the monotherapy and combination arms of the ongoing Phase 1/2 ABILITY-1 Study evaluating MDNA11, a long-acting ‘beta-enhanced not-alpha’ interleukin-2 ('IL-2') super-agonist, in patients with advanced or metastatic solid tumors."

P1/2 data • Oncology • Solid Tumor

Medicenna Provides Clinical Update and Announces First Complete Responder in MDNA11 and KEYTRUDA (pembrolizumab) Combination Dose Escalation Arm of the ABILITY-1 Study (GlobeNewswire) - P1/2 | N=115 | ABILITY-1 (NCT05086692) | Sponsor: Medicenna Therapeutics, Inc.| "70-year-old patient with advanced chemo-refractory anal cancer achieves complete response (CR) in 8 weeks when treated with MDNA11 in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab); Complete regression of all tumors in two CPI-resistant patients in monotherapy arms continue to show durability with a patient with melanoma remaining tumor free at week 63 while a patient with pancreatic cancer remains off all anti-cancer therapy for 11 months after completing the study; The ABILITY-1 study is showing promising disease control rates (DCR = CR+PR+SD) of 55% (1 CR, 4 PRs, and 6 SDs) and 78% (1 CR, 1 PR and 5 SDs) in the monotherapy and combination arms, respectfully; Additional monotherapy and combination clinical data from the ABILITY-1 study will be presented at medical conferences in Q1 and Q2 of 2025."

P1/2 data • Anal Carcinoma • Colorectal Cancer • Oncology • Pancreatic Cancer

Medicenna Presents Preclinical Data on MDNA11 and Bizaxofusp at the 2024 Annual Meeting of the Society for Neuro-Oncology (SNO) (GlobeNewswire) - "MDNA11 shows significant survival benefits in preclinical glioblastoma models, expanding CD8+ T and NK cells; Bizaxofusp selectively targets human tumor cells and immune-suppressive cells, enhancing anti-tumor immunity; Combination therapy with MDNA11 and Bizaxofusp demonstrates synergistic tumor-killing in human GBM tumoroids."

Preclinical • Glioblastoma • Oncology

Stimulation of IL-2 signaling with highly selective IL-2R agonists enhances immune effector cell response in mouse and patient-derived glioblastomas (SITC 2024) - "Conclusions In vivo studies in mouse orthoptic GBM models and primary human GBM explants demonstrate the potential use of MDNA11 and MDNA223 for the treatment of this highly aggressive tumor indication with a high unmet need. Ongoing research focuses on further elucidating the mechanism of action of MDNA11 and MDNA223 in GBM as well as exploring potential synergy with other therapeutics and treatment modalities."

IO biomarker • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD8 • FASLG • GZMB • IL2RA • STAT5 • STAT5AWqe

Medicenna Reports Second Quarter Fiscal 2025 Financial Results and Corporate Update (GlobeNewswire) - "In Q1 and Q2 of calendar 2025, Medicenna anticipates achieving several milestones in the MDNA11 program. These include completing monotherapy expansion and combination dose-escalation enrollment, initiating the combination expansion phase of the Phase 1/2 ABILITY-1 study...As at September 30, 2024, the Company had a cash and cash equivalents balance of $30.4 million...The Company also received an additional $1.9 million subsequent to the end of the quarter from the exercise of 1.1 million warrants with a strike price of $1.75 per warrant. These funds are expected to provide the Company with sufficient capital to execute planned expenditures through the completion of the ABILITY-1 study and through mid-calendar year 2026...R&D expenses of $3.7 million were incurred during the three months ended September 30, 2024....The increase is primarily related to increased clinical costs from the expansion of the MDNA11 ABILITY-1 Study..."

Commercial • Trial status • Breast Cancer • Colon Cancer • Melanoma • Microsatellite Instability • Oncology • Ovarian Cancer • Pancreatic Ductal Adenocarcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Medicenna Announces Positive Single-Agent Activity of MDNA11 from Dose Expansion Cohort and Encouraging Safety Profile in Combination with KEYTRUDA (pembrolizumab) at the 39th Annual Meeting of SITC (GlobeNewswire) - P1/2 | N=115 | ABILITY-1 (NCT05086692) | Sponsor: Medicenna Therapeutics, Inc. | "'We look forward to sharing additional clinical updates from the monotherapy and combination arms at medical conferences in the first half of 2025'....An objective response rate (ORR) of 30% in the monotherapy dose expansion arm with 3 PRs among 10 patients who had all previously failed ICI therapy and had advanced and/or metastatic melanoma, non-melanoma skin cancer or MSI-H/dMMR tumors irrespective of tumor origin....Encouraging preliminary signs of anti-tumor activity were observed with MDNA11 in combination with KEYTRUDA (400 mg Q6W) in dose escalation cohorts 1 (60 µg/kg Q2W MDNA11) and 2 (90 µg/kg Q2W MDNA11). Among 5 heavily pre-treated efficacy-evaluable patients, tumor control (PR or SD) was observed in 4 patients including a PR in a microsatellite-stable (MSS) colon cancer patient."

P1/2 data • Colon Cancer • Cutaneous Melanoma • Non-melanoma Skin Cancer • Pancreatic Cancer

Invigorating effector immune cells with highly selective IL-2R agonists and potential synergy with tumor targeting therapeutics for treatment of glioblastomas (SNO 2024) - "There was also increased release of soluble Fas ligand and granulysin, consistent with an activated anti-tumor immune response within the TME. Ongoing studies include in depth immune profiling to further understand the mechanism of MDNA11 and MDNA223 in GBM as well as to test potential synergy with tumor targeting therapeutics and other treatment modalities capable of eliciting immunogenic cell death."

Immune cell • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD8 • FAS • FASLG • GZMB • IL2 • IL2RA

Medicenna Announces Upcoming Presentations at the 29th Annual Meeting of the Society for Neuro-Oncology (SNO) and the 2024 San Antonio Breast Cancer Symposium (SABCS) (GlobeNewswire) - "Medicenna Therapeutics Corp...announced today that it will present pre-clinical data on MDNA11 and IL-2 Superkines in glioblastoma models at the 29th Annual Meeting of the Society of Neuro-Oncology (SNO) taking place in Houston, Texas from November 21 – 24, 2024. The Company will also present pre-clinical data in aggressive metastatic models of breast cancer incorporating MDNA11 pre-treatment prior to surgery (“neoadjuvant”) at the 2024 San Antonio Breast Cancer Symposium (SABCS), the world’s largest breast cancer conference taking place in San Antonio, Texas from December 10 – 13, 2024."

Preclinical • Breast Cancer • Glioblastoma