MDNA113 / Medicenna - LARVOL DELTA

Medicenna Presents Promising Preclinical Data from its First-in-Class Tumor Targeted and Conditionally Activated Anti-PD-1-IL-2 Bifunctional Superkine at the Annual 2025 AACR Meeting (GlobeNewswire) - "Key highlights from the presentation are:...MDNA113 retains PD-1/PDL-1 blockade while exhibiting attenuated IL-2R signaling that is restored upon cleavage by tumor-specific proteases in the tumor microenvironment (TME)....MDNA113 inhibits MC38/IL-13Rα2 tumor growth in mice and promotes memory response against tumor rechallenge with 100% protection observed with complete responders. MDNA113 enhances infiltration of functionally active CD8+ T cells over NK cells & Tregs in different tumor models. The combination of MDNA113’s tumor targeting and conditional activation represents a uniquely differentiated and potentially superior alternative to other anti-PD-1-IL-2 bispecifics currently in development."

Preclinical • Oncology

MDNA113: A tumor targeting and conditionally activated anti-PD1-IL2SK to enhance the therapeutic index (AACR 2025) - "MDNA113 is conditionally active anti-PD1-IL2SK designed by leveraging IL13SK as a dual tumor targeting and masking domain for enhanced tolerability and robust efficacy in both therapeutic and neoadjuvant settings."

Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • IL13 • IL2RA • STAT5 • STAT5AWqe

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

Medicenna Reports Third Quarter Fiscal 2025 Financial and Operational Results and Provides Anticipated Milestones (GlobeNewswire) - "ANTICIPATED MILESTONES FOR 2025:...Preclinical programs: Advance MDNA113 toward IND-enabling studies as an immunotherapy (MDNA113 is the only ‘β-enhanced’ anti-PD1-IL2 bi-specific molecule in development) - H2/2025."

Preclinical • Oncology

MDNA113 is a conditionally activatable anti-PD1-IL-2SK with a removable IL-13 dual masking/tumor-targeting domain to limit systemic immune stimulation while maximizing anti-tumor response (SITC 2024) - "MDNA113 also demonstrated superior efficacy than vehicle control and single agent anti-PD1 in a neoadjuvant setting in an aggressive orthotopic 4T1.2 breast tumor model. Conclusions MDNA113 is an IL-13SK tumor targeting and conditionally activatable anti-PD1-IL-2SK with enhanced tolerability and potent efficacy in both therapeutic and neo-adjuvant settings."

Breast Cancer • Oncology • Solid Tumor • CD8 • IL13 • IL2RA • STAT5 • STAT5AWqe

Medicenna Presents Preclinical Data from its Anti-PD1-IL-2 BiSKIT…Programs at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "MDNA113 is a novel IL-13Rα2 tumor-targeted and 'masked' BiSKIT (Bifunctional SuperKine for ImmunoTherapy), engineered to deliver an anti-PD1-IL-2 Superkine (anti-PD1-IL-2SK) to the tumor microenvironment (TME), where it is conditionally activated by tumor-associated proteases; MDNA113 treatment achieved complete tumor regression of IL-13Rα2 expressing tumors, highlighting its potential to treat a vast range of malignancies, including immunologically 'cold tumors' that annually affect over two million cancer patients worldwide."

Preclinical • Oncology

Medicenna to Present Clinical and Preclinical Data at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "Medicenna Therapeutics...announced today that it will present three posters at the 39th Annual Meeting of the Society for Immunotherapy of Cancer ('SITC')....The Company will present updated clinical data from the ongoing Phase 1/2 ABILITY-1 Study evaluating MDNA11, a long-acting ‘beta-enhanced not-alpha’ interleukin-2 ('IL-2') super-agonist, as both a monotherapy and in combination with pembrolizumab (KEYTRUDA) in patients with advanced or metastatic solid tumors. In addition, new pre-clinical data on the Company’s MDNA113, a novel first-in-class, masked, tumor-targeted bifunctional anti-PD1-IL-2 Superkine, and on Medicenna’s IL-2 agonists in glioblastoma, will also be presented at the conference."

P1/2 data • Preclinical • Glioblastoma • Solid Tumor

Medicenna Presents Preclinical Results from...Anti-PD1-IL-2 BiSKIT Programs at The Promise of Interleukin-2 Therapy Conference (GlobeNewswire) - "MDNA113 (masked version) showed reduced capacity to induce IL-2R mediated pSTAT5 signaling compared to anti-PD1-IL-2SK (non-mask version) in cell-based assay and human CD8+ T cells without impacting PD1/PDL1 blockade....Mice treated with MDNA113 showed reduced peripheral lymphocyte expansion compared to anti-PD1-IL-2SK due to masking by the IL-13 Superkine. MDNA113 showed greater tolerability than anti-PD1-IL-2SK following repeat dose administration in mice. MDNA113, but not a non-cleavable version, demonstrated similar efficacy as anti-PD1-IL-2SK in MC38 colon tumor model despite these tumors lacking IL-13Rα2 expression."

Preclinical • Oncology

Medicenna Announces Upcoming Presentations at The Promise of Interleukin-2 Therapy Conference (GlobeNewswire) - "Medicenna Therapeutics...announced today that the Company will present two abstracts, both as oral presentations, at the Promise of Interleukin-2 Therapy Conference, taking place at the Centre International de Conférences Sorbonne Université in Paris, France, from September 4-7, 2024. The Company will present preclinical data for the first time on its MDNA209 platform, featuring long-acting, high-affinity IL-2β biased IL-2/IL-15 Super-antagonists with therapeutic potential for autoimmune and graft-versus-host diseases. Additionally, further preclinical data will be presented on MDNA113, the Company’s novel first-in-class IL-13Rα2 tumor-targeted and tumor-activated bifunctional anti-PD1-IL-2 Superkine."

Preclinical • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology • Oncology

Characterization of MDNA113, a tumor-targeting anti-PD1-IL-2SK immunocytokine with conditional activation to increase tolerability and maximize efficacy (AACR 2024) - "Background-MDNA113 consists of an IL-13 decoy receptor-binding domain (MDNA213) fused to anti-PD1-IL-2SK (MDNA223) immunocytokine using a matrix metalloprotease (MMP) sensitive linker (PSL). Conclusion-MDNA113 is a tumor-targeting and conditional-activatable anti-PD1/IL-2SK fusion characterized with potent PD1/PDL1 blockade and 'not-alpha, beta enhanced' IL-2R agonism. MDNA113 is better tolerated than the non-mask version while achieving similar effect on tumor control, therefore offering a much broader therapeutic index."

Clinical • IO biomarker • Oncology • Solid Tumor • CD8 • IL13 • STAT5 • STAT5AWqe

Medicenna Presents Updated Preclinical Data on MDNA113, a First-in-Class, Targeted and Masked Bi-functional anti-PD1-IL2 Superkine, at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) (GlobeNewswire) - "Medicenna Therapeutics...announced new preclinical data on MDNA113, the Company’s novel T-MASK (Targeted Metallo/protease Activated SuperKine) candidate, an IL-13R⍺2 (Interleukin-13 receptor alpha2) specific superkine featuring unique masking and tumor targeting characteristics, were presented at the 2024 Annual Meeting of the American Association for Cancer Research (AACR)....MDNA113 shows attenuated systemic lymphocyte expansion compared to non-masked version (MDNA223), consistent with design of MDNA113. MDNA113 is better tolerated than non-masked counterpart (MDNA223), supporting higher and more efficacious dosing schedule. MDNA113 selectively binds IL-13R⍺2 positive tumor cells in vitro, and durably accumulates (>7 days) in IL-13R⍺2 positive tumors in mice."

Preclinical • Breast Cancer • Oncology

Medicenna to Provide Clinical Update on the MDNA11 ABILITY-1 Trial at the Upcoming American Association for Cancer Research Annual Meeting (GlobeNewswire) - "Medicenna Therapeutics Corp...announced today that two posters will be presented at the American Association for Cancer Research Annual Meeting 2024 (AACR 2024), taking place in San Diego, CA from April 5-10, 2024. The Company will present an update from its Phase 1/2 ABILITY-1 Study including anti-tumor activity, safety, pharmacokinetic and pharmacodynamic data following treatment with 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-IL-2 Superkine, will also be presented at the conference."

P1/2 data • PK/PD data • Preclinical • Oncology • Solid Tumor

Characterization of a tumor-targeting and activatable T-MASK platform to enhance tumor accumulation and tolerability of potent immune modulators (SITC 2023) - "MDNA213 is fused via a PSL to MDNA11 and MDNA223, both containing a not-alpha, beta-enhanced IL-2 fused with albumin or anti-PD1 antibody respectively. Conclusions MDNA113 is a novel T-MASK construct designed to increase tolerability while leveraging the synergy between PD1/PDL-1 blockade and IL-2R agonism for immunotherapy. Ongoing studies investigate alternative tumor-targeting/masking domains and immune modulators, including other cytokines and potent therapeutic agents, to potentially broaden the utility of the T-MASK platform."

Oncology • Solid Tumor • IL13 • IL2RA • STAT5 • STAT5AWqe

Medicenna Presents Preclinical Data on MDNA113, its Targeted Metalloprotease Activated SuperKine (T-MASK) at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "Key findings include:T-MASK platform integrates tumor targeting and prolonged tumor retention with conditional activation to maximize anti-tumor efficacy and minimize systemic toxicity; MDNA113 shows reduced IL-2R agonism with no change to PD1/PDL-1 blockade; MDNA113 reduces systemic lymphocyte expansion showing dampening of systemic activity; Cleavage of MDNA113 by tumor associated metalloproteases restores IL-2R signaling; MDNA113 is as effective as non-masked MDNA223 (a bispecific antiPD1-IL-2 superkine) in tumor models."

Preclinical • Oncology • Solid Tumor

Medicenna Announces Presentations at the 38th Annual Meeting of the Society for Immunotherapy of Cancer’s (SITC) (GlobeNewswire) - "Medicenna Therapeutics...announced poster presentations at the 38th Annual Meeting of the Society for Immunotherapy of Cancer ('SITC') to be held in San Diego, CA, from November 1-5th, 2023. The company will present an update from its Phase 1/2 ABILITY Study including anti-tumor activity, safety, pharmacokinetic and pharmacodynamic data following treatment with MDNA11, a long-acting, beta-enhanced IL-2 Superkine. In addition, pre-clinical data for MDNA113, a novel first-in-class tumor-targeted and tumor-activated bi-functional anti-PD1-IL-2 superkine, will also be presented at the conference."

P1/2 data • Preclinical • Solid Tumor