A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.

Start Date27 Aug 2021

Sponsor / Collaborator

Medicenna Therapeutics, Inc.

[+1]

100 Clinical Results associated with MDNA-11

100 Translational Medicine associated with MDNA-11

100 Patents (Medical) associated with MDNA-11

Literatures (Medical) associated with MDNA-11

01 Jan 2022·Journal for immunotherapy of cancerQ2 · MEDICINE

Fine-tuned long-acting interleukin-2 superkine potentiates durable immune responses in mice and non-human primate

Q2 · MEDICINE

ArticleOA

Author: Smith, Paul ; Lloyd, Peter ; Merchant, Rosemina ; Munegowda, Manjunatha Ankathatti ; To, Minh D ; Merchant, Fahar ; Pearce, L Bruce ; Galligan, Carole

Background:

Recombinant human interleukin-2 (rhIL-2, aldesleukin) is Food and Drug Administration approved for the treatment of metastatic melanoma and renal cell carcinoma and has achieved durable response in a subset of patients. However, its utility as an immunotherapeutic drug is limited by undesirable activation of immune suppressive regulatory T cells (Tregs) and a short half-life requiring frequent high dose administration, leading to unacceptable toxicities. We have engineered MDNA11, a long-acting IL-2 superkine, to overcome these limitations by (1) modifying receptor selectivity in favor of anti-cancer immune cells to increase therapeutic efficacy and (2) fusion to human albumin to extend the pharmacokinetic (PK) profile, circumventing the need for frequent dosing.

Methods:

MDNA11 was evaluated using in vitro and in vivo studies including: binding analyses to measure receptor affinity, IL-2 pathway signaling, PK studies in mice, and efficacy studies in syngeneic tumor models as single agent and in combination with immune checkpoint inhibitors. Finally, the safety and pharmacodynamic profile of MDNA11 was assessed in non-human primate (NHP).

Results:

Binding studies with MDNA11 demonstrated increased affinity for IL-2Rβ (CD122) and no binding to IL-2Rα (CD25). As a result, MDNA11 exhibits reduced/limited Treg stimulation while triggering an enhanced activation of natural killer and naïve CD8 T cells compared with rhIL-2. When administered to animals with pre-established tumors, MDNA11 controlled tumor growth in a monotherapy setting and in combination with anti-PD1 or anti-CTLA4 to induce durable tumor clearance with a once weekly dosing regimen. In a NHP model, MDNA11 was well tolerated while triggering durable and potent immune responses including expansion of lymphocytes without significant effect on Tregs and eosinophils, the latter been linked to an increased risk of vascular leak syndrome.

Conclusion:

MDNA11 is a next generation long-acting IL-2 immunotherapeutic with a highly favorable pharmacodynamic profile that translates to a strong therapeutic efficacy in preclinical tumor models and a strong and durable immune response in NHP.

139

News (Medical) associated with MDNA-11

05 Oct 2026

·www.biospace.com

Medicenna Announces Oral Presentation of Topline Data from the Phase 1/2 ABILITY-1 Study of MDNA11 at SITC 2026

The Phase 1/2 ABILITY-1 Clinical Trial is evaluating MDNA11 in expansion cohorts comprised of patients with advanced and metastatic gastrointestinal, endometrial, and melanoma cancers Selected as one of the Top 150 Abstracts at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting TORONTO and HOUSTON, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company developing Superkines for targeting cancer and autoimmune disease, today announced that an abstract reporting topline data from the Phase 1/2 study of MDNA11 has been selected for oral presentation at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting. Details of the oral presentation are as follows: Abstract Number: 517 Presentation Type: Oral Presentation Presentation Date: Saturday, November 7, 2026 Presentation Time: 4:30-4:45 p.m. MST Session: Oral Session 3, 3:30-4:50 p.m. MST Location: Phoenix Convention Center, Room 301D, Phoenix, Arizona Title: “MDNA11 Demonstrates Clinical Activity as Monotherapy and in Combination with Pembrolizumab in Biomarker-Enriched Gastrointestinal Malignancies, Including ICI-Refractory Disease.” About Medicenna Therapeutics Medicenna is a clinical-stage immunotherapy company developing engineered cytokine therapies designed to selectively engage the immune system to treat cancer. The Company’s most advanced program, bizaxofusp (formerly MDNA55), is a targeted IL-4 Empowered Superkine that has been evaluated in more than 130 patients across five clinical trials, including a Phase 2b study in recurrent glioblastoma. Bizaxofusp has received Fast Track designation from the FDA and Orphan Drug designation in the United States and Europe. Medicenna is also advancing MDNA11, a long-acting IL-2 Superkine designed to selectively activate cancer-fighting immune cells, which is currently being evaluated in the Phase 1/2 ABILITY-1 study and the Phase 1b NEO-CYT study. The Company is also developing MDNA113, a targeted PD-1 x IL-2 bifunctional immunotherapy for solid tumors, and MDNA209, an antagonist of CD122 blocking IL-2/IL-15 signaling, using its proprietary BiSKIT and T-MASK platforms. For more information, please visit , and follow us on X and LinkedIn . Forward-Looking Statements This news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, express or implied statements regarding the future operations of the Company, estimates, plans, strategic ambitions, partnership activities and opportunities, objectives, expectations, opinions, forecasts, projections, guidance, outlook or other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions. and are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the latest annual information form of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements. This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this new release. Investor and Company Contact Daniel Scarr Director, Corporate Development Medicenna Therapeutics ir@medicenna.com

Fast TrackImmunotherapyOrphan DrugPhase 2Phase 1

02 Oct 2026

·www.biospace.com

Medicenna Announces Results of Annual General and Special Meeting of Shareholders

TORONTO and HOUSTON, Oct. 01, 2026 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQB: MDNAF), a clinical-stage immunotherapy company developing Superkines for targeting cancer and autoimmune diseases, today announced the voting results from the Company’s annual general and special meeting of shareholders held today, October 1, 2026 (the “Meeting”). Medicenna is pleased to announce that all of the nominees listed in its management information circular dated August 19, 2026 (the “Circular”), were elected as directors. Each director was elected with greater than 97% of the votes cast for by shareholders present at the Meeting or represented by proxy. The results of the vote are detailed below: Nominee Votes For % of Votes For Votes Against % of Votes Against Mr. Albert Beraldo 27,751,517 97.42% 736,191 2.58% Mr. Richard Sutin 27,779,927 97.52% 707,781 2.48% Mr. Angelos Georgakis 27,779,495 97.51% 708,213 2.49% Dr. Fahar Merchant 27,715,844 97.29% 771,864 2.71% Medicenna shareholders also approved the re-appointment of MNP LLP as auditor of the Company. Finally, the shareholders approved the special resolution authorizing the consolidation of the Company’s issued and outstanding common shares (the “Share Consolidation”) at a ratio to be determined by the Company’s board of directors (the “Board”), within the range of one post-consolidation share for every 2 to 20 pre-consolidation shares and subject to the Board’s authority to decide not to proceed with the Share Consolidation. The Share Consolidation may be undertaken as part of Medicenna’s evaluation of available strategic opportunities, including, if appropriate, to support compliance with the listing requirements of a major U.S. stock exchange. If implemented, the Share Consolidation could, among other things, increase the trading price per common share and support compliance with a major U.S. stock exchange’s minimum bid price requirements, if determined to be desired, and potentially enhance the Company’s ability to attract U.S. institutional investors and other investors subject to minimum share-price requirements. If and when the Board determines to proceed with the Share Consolidation, the Company will announce the applicable consolidation ratio and effective date, subject to receipt of all required regulatory approvals. To the extent Medicenna pursues a U.S. stock exchange listing for its common shares, the Share Consolidation is not a guarantee that Medicenna will satisfy all major U.S. stock exchange listing requirements or that its common shares will be accepted for listing. Any major U.S. stock exchange listing remains subject to the Company satisfying all applicable listing requirements and receiving approval from the major U.S. stock exchange. A total of 31.82% of the issued and outstanding common shares of the Company were represented in person and by proxy at the Meeting. Please refer to the Circular available on SEDAR+ at for more information on the business transacted at the Meeting. A report on voting results will also be filed on SEDAR+. About Medicenna Therapeutics Medicenna is a clinical-stage immunotherapy company developing engineered cytokine therapies designed to selectively engage the immune system to treat cancer. The Company’s most advanced program, bizaxofusp (formerly MDNA55), is a targeted IL-4 Empowered Superkine that has been evaluated in more than 130 patients across five clinical trials, including a Phase 2b study in recurrent glioblastoma. Bizaxofusp has received Fast Track designation from the FDA and Orphan Drug designation in the United States and Europe. Medicenna is also advancing MDNA11, a long-acting IL-2 Superkine designed to selectively activate cancer-fighting immune cells, which is currently being evaluated in the Phase 1/2 ABILITY-1 study and the Phase 1b NEO-CYT study. The Company is also developing MDNA113, a targeted PD-1 x IL-2 bifunctional immunotherapy for solid tumors, and MDNA209, an antagonist of CD122 blocking IL-2/IL-15 signaling, using its proprietary BiSKIT and T-MASK platforms. For more information, please visit , and follow us on X and LinkedIn . Forward Looking Statements This news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, express or implied statements regarding the Share Consolidation, the possibility of the Company pursuing a U.S. stock exchange listing for its common shares, the future operations of the Company, estimates, plans, strategic ambitions, partnership activities and opportunities, objectives, expectations, opinions, forecasts, projections, guidance, outlook or other statements that are not historical facts . Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions. and are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the latest annual information form of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements. This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this new release. Investor/Company Contact Daniel Scarr Director, Corporate Development Medicenna Therapeutics ir@medicenna.com

24 Sep 2026

·www.biospace.com

Medicenna Announces Oral Presentation of New Bizaxofusp Results in Recurrent Glioblastoma at the 2026 Society for Neuro-Oncology Annual Meeting

TORONTO and HOUSTON, Sept. 24, 2026 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company developing Superkines for targeting cancer and autoimmune disease, today announced that an abstract evaluating survival outcomes with bizaxofusp (formerly MDNA55) in unresectable, IDH-wildtype recurrent glioblastoma (rGBM) has been selected for an oral presentation at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO 2026), taking place November 12-15, 2026, in Philadelphia. The oral presentation will be delivered by Dr. Nicholas A. Butowski, MD, Professor of Neurological Surgery and Director of Translational Research, Neuro-Oncology at the University of California, San Francisco. "Selection for an oral presentation at SNO highlights the interest of the neuro-oncology community in the continued clinical development of bizaxofusp for patients with recurrent glioblastoma," said Fahar Merchant, PhD, President and Chief Executive Officer of Medicenna. "We look forward to presenting this survival analysis in the intended Phase 3 population and continue engaging with leading clinicians, researchers and potential pharma partners during SNO 2026." Details of the oral presentation are as follows: Presentation Type: Oral Presentation Title: Survival outcomes with bizaxofusp (MDNA55) in unresectable IDH-wildtype recurrent glioblastoma (rGBM) using a propensity score-weighted external control arm (ECA) in the intended Phase 3 population Session: Clinical Trials Oral Abstracts Session I Presenter: Nicholas A. Butowski, MD, University of California, San Francisco Date and Time: Friday, November 13, 2026, 10:36 a.m. ET Group Q&A: Friday, November 13, 2026, 10:43 a.m. ET Location: Room 118 ABC, First Floor, Pennsylvania Convention Center, Philadelphia About Bizaxofusp Bizaxofusp (formerly MDNA55) is Medicenna's IL-4 Empowered Superkine that has been evaluated in more than 130 patients across five clinical trials, including a Phase 2b study in recurrent glioblastoma. Bizaxofusp is designed to selectively target the interleukin-4 receptor (IL-4R), which is overexpressed by glioblastoma cells and cells in the tumor microenvironment, and is administered directly into the tumor using convection-enhanced delivery. Bizaxofusp has received Fast Track designation from the U.S. Food and Drug Administration and Orphan Drug designation in the United States and Europe. About Medicenna Therapeutics Medicenna is a clinical-stage immunotherapy company developing engineered cytokine therapies designed to selectively engage the immune system to treat cancer. The Company’s most advanced program, bizaxofusp (formerly MDNA55), is a targeted IL-4 Empowered Superkine that has been evaluated in more than 130 patients across five clinical trials, including a Phase 2b study in recurrent glioblastoma. Bizaxofusp has received Fast Track designation from the FDA and Orphan Drug designation in the United States and Europe. Medicenna is also advancing MDNA11, a long-acting IL-2 Superkine designed to selectively activate cancer-fighting immune cells, which is currently being evaluated in the Phase 1/2 ABILITY-1 study and the Phase 1b NEO-CYT study. The Company is also developing MDNA113, a targeted PD-1 x IL-2 bifunctional immunotherapy for solid tumors, and MDNA209, an antagonist of CD122 blocking IL-2/IL-15 signaling, using its proprietary BiSKIT and T-MASK platforms. For more information, please visit , and follow us on X and LinkedIn . Forward-Looking Statements This news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, express or implied statements regarding the future operations of the Company, estimates, plans, strategic ambitions, partnership activities and opportunities, objectives, expectations, opinions, forecasts, projections, guidance, outlook or other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions. and are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the latest annual information form of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements. This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this new release. Investor/Company Contact Daniel Scarr Director, Corporate Development Medicenna Therapeutics ir@medicenna.com

100 Deals associated with MDNA-11

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acral Lentiginous Malignant Melanoma	Phase 2	United States	Medicenna Therapeutics, Inc.	27 Aug 2021
Acral Lentiginous Malignant Melanoma	Phase 2	Australia	Medicenna Therapeutics, Inc.	27 Aug 2021
Acral Lentiginous Malignant Melanoma	Phase 2	Canada	Medicenna Therapeutics, Inc.	27 Aug 2021
Acral Lentiginous Malignant Melanoma	Phase 2	Ireland	Medicenna Therapeutics, Inc.	27 Aug 2021
Acral Lentiginous Malignant Melanoma	Phase 2	Portugal	Medicenna Therapeutics, Inc.	27 Aug 2021
Acral Lentiginous Malignant Melanoma	Phase 2	South Korea	Medicenna Therapeutics, Inc.	27 Aug 2021
Acral Lentiginous Malignant Melanoma	Phase 2	Spain	Medicenna Therapeutics, Inc.	27 Aug 2021
Acral Lentiginous Malignant Melanoma	Phase 2	Switzerland	Medicenna Therapeutics, Inc.	27 Aug 2021
Advanced Malignant Solid Neoplasm	Phase 2	United States	Medicenna Therapeutics, Inc.	27 Aug 2021
Advanced Malignant Solid Neoplasm	Phase 2	Australia	Medicenna Therapeutics, Inc.	27 Aug 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05086692 (ABILITY, Company_Website) Manual	Phase 1/2	Advanced cancer	102	MDNA11 (expansion cohorts + as a 2L/3L treatment)	zdaqhecuiv(fxjoqsplsl) = ayglsjzdma gegqdcsuea (urffgkunyt ) View more	Positive	15 Jan 2026
NCT05086692 (ABILITY, Company_Website) Manual	Phase 1/2	Advanced cancer	102	MDNA11 (expansion cohorts + as next treatment line post-ICI failure)	zdaqhecuiv(fxjoqsplsl) = dihwfpqqdr gegqdcsuea (urffgkunyt ) View more	Positive	15 Jan 2026
NCT05086692 (ABILITY-1, GlobeNewswire) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm Microsatellite Stable (MSS) \| MSI-High \| TMB-High	-	MDNA11	wuuwxupjki(elpcugtylm) = Over 90% were Grade 1-2 and transient, typically resolving within 48 hours. Grade 3-4 events were mainly laboratory abnormalities without clinical sequelae. fbpeemswmj (oszenlzakx ) View more	Positive	10 Dec 2025
NCT05086692 (ABILITY-1, GlobeNewswire) Manual	Phase 1/2		-	MDNA11+ KEYTRUDA		Positive	10 Dec 2025
NCT05086692 (ABILITY-1, AACR2025 \| GlobeNewswire) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	-	MDNA11	bjfwrzemzl(ifpbzfosbr) = grade 1-2 and transient, resolving within 72 hours zuoxtisdkn (texyyzgeac ) View more	Positive	28 Apr 2025
NCT05086692 (ABILITY-1, GlobeNewswire) Manual	Phase 1/2	Solid tumor	-	MDNA11 (Immune Checkpoint Inhibitor-Resistant)	uszxnkmdng(jzmpqbzbxf) = Over 90% of treatment-related adverse events (TRAEs) were Grade 1-2 and transient, with no DLTs or new safety signals observed in combination dose escalation cohorts. epkvzvohxy (lsehneiwcu ) View more	Positive	05 Dec 2024
NCT05086692 (ABILITY-1, GlobeNewswire) Manual	Phase 1/2	Solid tumor	-	MDNA11+KEYTRUDA		Positive	05 Dec 2024
NCT05086692 (ABILITY-1, SITC2024 \| GlobeNewswire) Manual	Phase 1/2	Melanoma, Cutaneous Malignant \| Advanced Malignant Solid Neoplasm \| Pancreatic Cancer	30	MDNA11 (patients with advanced and/or metastatic solid tumors who had disease progression with immune checkpoint inhibitor (ICI) therapy)	ghfukngcus(lrhqmjnduf) = predominantly grade 1–2 (94.1%) and included infusion-related reactions, pyrexia, nausea, chills and fatigue, all of which resolved within 72 hours dtpnnaglhc (tkmifwaduc )	Positive	05 Nov 2024
NCT05086692 (ABILITY-1, SITC2024 \| GlobeNewswire) Manual	Phase 1/2		30	MDNA11 (Among ICI-resistant, high-dose MDNA11, phase 2-eligible patients in the monotherapy escalation and expansion cohorts)		Positive	05 Nov 2024
NCT05086692 (ABILITY-1, GlobeNewswire) Manual	Phase 1/2	Metastatic Solid Tumor	14	MDNA11	idufbziqfs(uxxcybxyad) = qwkwnwwisr mbafktraqh (oyozrzsmlv ) View more	Positive	13 May 2024
NCT05086692 (ABILITY-1, AACR2024) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	30	MDNA11	osuyctelxg(occeikizay) = none xqgxotbvgs (svvaqccubt ) View more	-	05 Apr 2024
NCT05086692 (ABILITY-1, SITC 12023 \| SITC 22023) Manual	Phase 1/2	Solid tumor	20	MDNA11	wcwisffhwh(aujakxximn) = voxmkwbuty iiyaarhlyw (illkfwqaug ) View more	Positive	31 Oct 2023
NCT05086692 (Biospace) Manual	Phase 1/2	Advanced Malignant Solid Neoplasm	20	MDNA11	fsaghsxxjs(uhexbxszvp) = MDNA11 was generally well tolerated across cohorts, with the majority of adverse events (AEs) being grade 1 or 2, with no grade 4 or 5 AEs. xflmtoplzd (vxfdrhshii )	Positive	09 Aug 2023
NCT05086692 (ABILITY, SITC2022) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors	-	MDNA11	hzdhmstnan(ijeaofuspn) = dose dependent activation of various biomarkers on effector cells without concomitant stimulation of immune suppression iqagmzuvtv (rpprtlkcwi )	Positive	01 Nov 2022

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