Drugs / MDNA11
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05086692 | Aug 2021 → Jun 2026 overdue | acral lentiginous melanoma, cervical cancer, clear cell renal carcinoma, colorectal cancer +17 | Medicenna Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2026-02-13 | Medicenna Therapeutics, Inc. | Results Medicenna Therapeutics Reports Third Quarter Fiscal 2026 Financial Results and Provides a Corporate Update medicenna.com ↗
Updated ABILITY-1 clinical data for MDNA11 demonstrates compelling activity in earlier-line expansion cohorts |
| 2026-01-15 | Medicenna Therapeutics, Inc. | Results Medicenna Therapeutics Announces Key Program Updates and 2026 Outlook medicenna.com ↗
Among monotherapy expansion cohorts (n=21), ORR was 50% in patients treated with MDNA11 in 2L/3L setting and 42% when MDNA11 was the next treatment post-ICI failure, showing best-in-class potential for advanced cancer patients with no treatment options |
| 2025-12-10 | Medicenna Therapeutics, Inc. | Results Medicenna Updates MDNA11 Clinical Trial Results at the ESMO-IO Congress 2025, Further Bolstering its Anti-Tumor Activity in Advanced Solid Tumors medicenna.com ↗
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 |
| 2025-06-26 | Medicenna Therapeutics, Inc. | Results Medicenna Therapeutics Reports Fiscal Year 2025 Financial Results and Operational Highlights medicenna.com ↗
We are delighted to announce that the first MDNA11 monotherapy responder, a pancreatic cancer patient who had failed multiple lines of therapy including a checkpoint inhibitor, continues to be in remission for at least 18 months without any further treatment. |
| 2025-04-28 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Compelling Results from the ABILITY-1 Clinical Trial at the 2025 AACR Annual Meeting medicenna.com ↗
Highest ORR of 50% achieved amongst MSI-H patients receiving MDNA11 monotherapy (2 of 4) and endometrial cancer patients receiving a combination of MDNA11 and KEYTRUDA (2 of 4) |
| 2025-02-25 | Medicenna Therapeutics, Inc. | Results 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 medicenna.com ↗
MDNA11 has shown durable single agent activity, with a 30% (3 of 10) objective response rate (ORR) in the monotherapy dose expansion cohort in checkpoint-resistant patients (as of Dec. 5, 2024 ) |
| 2024-12-13 | Medicenna Therapeutics, Inc. | Results 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) medicenna.com ↗
Single-agent MDNA11 was more effective than a combination of immune checkpoint inhibitors (anti-mPD1 and anti-mCTLA4) in preventing metastasis and achieving long-term survival in an aggressive mouse model of triple negative breast cancer |
| 2024-12-05 | Medicenna Therapeutics, Inc. | Results Medicenna Provides Clinical Update and Announces First Complete Responder in MDNA11 in Combination with KEYTRUDA® (pembrolizumab) Combination Dose Escalation Arm of the ABILITY-1 Study medicenna.com ↗
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) |
| 2024-11-25 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Preclinical Data on MDNA11 and Bizaxofusp at the 2024 Annual Meeting of the Society for Neuro-Oncology (SNO) medicenna.com ↗
Demonstrated significant survival benefit (p = 0.031) in an aggressive orthotopic GBM model, with preferential expansion of CD8 + T cells and NK cells. |
| 2024-11-11 | Medicenna Therapeutics, Inc. | Results 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 medicenna.com ↗
Single-agent MDNA11 shows a 30% objective response rate (3 of 10) in the monotherapy dose expansion cohort among patients with advanced and/or metastatic solid tumors who had disease progression with immune checkpoint inhibitor (ICI) therapy |
| 2024-11-08 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Preclinical Data from its Anti-PD1-IL-2 BiSKIT and IL-2 Super Agonist Programs at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) medicenna.com ↗
Internationally recognized academic teams in the UK showed promising pre-clinical results with a long-acting IL-2 SK (MDNA11) and anti-PD1-IL-2 SK BiSKIT, in mouse models of glioblastoma (GBM) and patient-derived GBM explants |
| 2024-08-01 | Medicenna Therapeutics, Inc. | Results Medicenna Reports First Quarter Fiscal 2025 Financial Results and Announces First Complete Responder with MDNA11 Monotherapy medicenna.com ↗ |
| 2024-06-26 | Medicenna Therapeutics, Inc. | Regulatory Medicenna Announces EMA Approval of its Clinical Trial Application to Expand its Phase 1/2 ABILITY-1 Study to Europe medicenna.com ↗ |
| 2024-05-31 | Medicenna Therapeutics, Inc. | Results Medicenna To Present Evidence of Durable Single Agent Activity and Potent Immune Effector Response with MDNA11 in the Dose Escalation Portion of Phase 1/2 ABILITY-1 Study at the 10th Annual Oncology Innovation Forum medicenna.com ↗
MDNA11 demonstrates durable response in pancreatic cancer patient with 100% regression of target and non-target lesions for over 104 weeks and continues to show remission 4 months after stopping treatment |
| 2024-05-13 | Medicenna Therapeutics, Inc. | Results Medicenna Provides Update on its Presentations at the 2024 ASCO Annual Meeting medicenna.com ↗
As of the March 22, 2024 , data cut-off date, MDNA11 has demonstrated a response rate of 29% (4 partial responses) and a clinical benefit rate of 50% (4 partial responses, and 3 stable diseases > 24 weeks). |
| 2024-04-09 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Updated Results of Single Agent MDNA11 Anti-tumor Activity from Dose Escalation and Ongoing Dose Expansion of the Phase 1/2 ABILITY-1 Study at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) medicenna.com ↗
With response rate and clinical benefit rate increasing to 29% and 50% (4 PR, 3 SD), respectively, MDNA11 continues to demonstrate compelling single-agent activity in the ABILITY-1 study amongst high-dose phase-2 eligible patients (N=14) who have failed checkpoint inhibitor therapies |
| 2023-11-06 | Medicenna Therapeutics, Inc. | Results Medicenna Announces Promising Single-Agent Response and Durability of MDNA11 in the Phase 1/2 ABILITY Study During Dose Escalation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) medicenna.com ↗
MDNA11 also showed durable stable disease in 3 melanoma patients for at least 5 months to 18 months with concomitant shrinkage of tumor size following failure with check-point inhibitor therapies |
| 2023-08-09 | Medicenna Therapeutics, Inc. | Results Medicenna Completes MDNA11 Dose Escalation and Commences Monotherapy Dose Expansion in the Phase 1/2 ABILITY Study medicenna.com ↗ |
| 2023-03-30 | Medicenna Therapeutics, Inc. | Results Medicenna Provides Clinical Update from Monotherapy Dose Escalation Portion of Phase 1/2 ABILITY Study medicenna.com ↗
Initial PD data from ABILITY’s fifth dose escalation cohort, reported today, were consistent with the encouraging findings from the first four cohorts. |
| 2022-11-10 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Updated Clinical Data from Dose Escalation Portion of Phase 1/2 ABILITY Study of MDNA11 at the SITC Annual Meeting medicenna.com ↗ |
| 2022-11-04 | Medicenna Therapeutics, Inc. | Results Medicenna Reports Second Quarter Fiscal 2023 Financial Results and Operational Highlights medicenna.com ↗
Results from low and mid-dose escalation cohorts in Phase 1/2 ABILITY study show tumor control in 5 of 14 evaluable patients, including a confirmed partial response in pancreatic cancer |
| 2022-09-28 | Medicenna Therapeutics, Inc. | Results Medicenna Reports Confirmed Partial Response in Pancreatic Cancer and Clinical Update on MDNA11’s Monotherapy Dose Escalation Portion of the Ongoing Phase 1/2 ABILITY Study medicenna.com ↗
These data include a confirmed partial response (PR) in a fourth-line metastatic pancreatic ductal adenocarcinoma (PDAC) patient that had previously failed chemo and checkpoint inhibitor therapies. |
| 2022-08-15 | Medicenna Therapeutics, Inc. | Results Medicenna Reports First Quarter Fiscal 2023 Financial Results and Operational Highlights medicenna.com ↗ |
| 2022-07-27 | Medicenna Therapeutics, Inc. | Results Medicenna Announces New Clinical Data Providing Preliminary Evidence of MDNA11’s Single Agent Anti-Cancer Activity in the Phase 1/2 ABILITY Study medicenna.com ↗ |
| 2022-05-11 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Phase 1/2 ABILITY Study Data Highlighting MDNA11’s Favorable Clinical Profile at the 2022 Frontiers in Cancer Immunotherapy Meeting medicenna.com ↗ |
| 2022-05-02 | Medicenna Therapeutics, Inc. | Results Medicenna Announces New Clinical Data Showing Dose-Dependent Stimulation of Anti-Cancer Immune Cells with MDNA11 in the Phase 1/2 ABILITY Study medicenna.com ↗ |
| 2022-01-26 | Medicenna Therapeutics, Inc. | Results Medicenna Announces Peer-Reviewed Publication of Preclinical Data on MDNA11 in the Journal for ImmunoTherapy of Cancer medicenna.com ↗ |
| 2021-12-22 | Medicenna Therapeutics, Inc. | Results Medicenna Announces Preliminary Clinical Data Showing Preferential Stimulation of Anti-Cancer Immune Cells with MDNA11 Treatment in the Phase 1/2 ABILITY Study medicenna.com ↗
CD8 + T and NK cell levels increased by ~2 fold over baseline with MDNA11 treatment at doses where competing “not-alpha” IL-2 variants have not demonstrated any activity. |
| 2021-12-17 | Medicenna Therapeutics, Inc. | Regulatory Medicenna Receives Regulatory Clearance to Expand the Phase 1/2 ABILITY Study of MDNA11 to Canada medicenna.com ↗ |
| 2021-10-27 | Medicenna Therapeutics, Inc. | Regulatory Medicenna Announces FDA Clearance of IND to Expand the Phase 1/2 ABILITY Study of MDNA11 to the United States medicenna.com ↗ |
| 2021-10-07 | Medicenna Therapeutics, Inc. | Results Medicenna Presents MDNA11 Data from IND-Enabling Studies at the AACR-NCI-EORTC Conference medicenna.com ↗
MDNA11 preferentially induced durable proliferation and expansion of anti-cancer immune cells with limited stimulation of pro-tumor Treg cells in non-human primates (NHP) |
| 2021-06-23 | Medicenna Therapeutics, Inc. | Regulatory Medicenna Announces Submission of Clinical Trial Application in Australia for a Phase 1/2 Study of MDNA11 medicenna.com ↗ |
| 2021-03-25 | Medicenna Therapeutics, Inc. | Results Medicenna Announces Preclinical Data on MDNA11 with Anti-PD-1 Therapy and Unveils Novel Bifunctional Superkines at the Cytokine-Based Cancer Immunotherapies Summit medicenna.com ↗
New data show that MDNA11 monotherapy or when combined with anti-PD-1 therapy stimulated potent immune responses in preclinical tumor models highlighting the potential of our Superkine platform to address this need. |
| 2020-10-26 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Promising Preclinical Data on IL-2 and IL-13 Superkines at the EORTC-NCI-AACR Annual Meeting medicenna.com ↗
Taken together with data from the poster demonstrating MDNA11’s ability to induce the expansion of a multitude of anti-cancer immune cells without increasing toxicity, these results highlight the versatility of our Superkine platform as a tool for the development of novel cytokine-based immunotherapies. |
| 2020-05-29 | Medicenna Therapeutics, Inc. | Results Medicenna Presents Data on MDNA11, an IL-2 Superkine at ASCO 2020 medicenna.com ↗
When administered to NHP, MDNA11 demonstrated a dose dependent increase in absolute number of circulating CD8 T-cells, non-Treg CD4 T-cells and NK cells with minimal effect on Treg). |
All press releases naming this drug 53 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MDNA11 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05086692 ↗ |
| Modality | Protein / enzyme biologic | “long-acting "beta-only" recombinant interleukin-2 (rIL-2)” NCT05086692 ↗ |
| Route | Intravenous | “MDNA11 will be administered, IV on a once every 2 weeks (Q2W) dosing schedule.” NCT05086692 ↗ |