An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma

This is a single-arm, open-label, multicenter study in approximately 52 adults with primary (de novo) GB that has recurred or progressed (first or second recurrence, including this recurrence) after treatment(s) including surgery and radiotherapy with or without chemotherapy and following discontinuation of any previous standard or investigational lines of therapy.

Start Date11 Apr 2017

Sponsor / Collaborator

Medicenna Therapeutics, Inc.

NCT00797940

/ WithdrawnPhase 2

Phase II, Multi-center, Open-Label, Single-Arm Study of Intratumoral Infusion of PRX321 in Subjects With Glioblastoma Multiforme at First Recurrence or Progression

A Phase II, multi-center, open-label, single-arm study in up to 42 subjects with first recurrence or progression of GBM at up to 12 sites in Australia, Europe, Israel, and the United States. Subjects will receive intratumoral infusion of PRX321 administered via convection-enhanced delivery (CED) at a concentration of 1.5 μg/mL and a total volume of 60 mL over 2 to 7 days.
Primary Objective:
To evaluate the efficacy (expressed as overall survival at 6 months [OS-6]) of intratumoral infusion of PRX321 in subjects with first recurrence or progression of glioblastoma multiforme (GBM).
Secondary Objectives:
To assess the safety of intratumoral infusion with PRX321 in subjects with recurrent or progressive GBM.
To evaluate objective response rate (ORR), duration of response (DR), overall survival (OS), and progression-free survival (PFS).
Tertiary Objective:
To evaluate the relationship of observed infusate distribution with clinical and radiological responses.

Start Date01 Jan 2009

Sponsor / Collaborator

Sophiris Bio, Inc.

NCT00039052

/ CompletedPhase 1

An Open Label, Multiple-Dose, Sequential Dose-Escalation Study of NBI-3001 in Patients With Recurrent or Unresponsive Solid Tumors Known to Over-Express IL-4 Receptors

RATIONALE: Interleukin-4 PE38KDEL cytotoxin may be able to deliver cancer-killing substances directly to solid tumor cells.
PURPOSE: Phase I trial to study the effectiveness of intravenous interleukin-4 PE38KDEL cytotoxin in treating patients who have recurrent or metastatic kidney cancer, non-small cell lung cancer, or breast cancer that has not responded to previous treatment.

Start Date01 Jan 2002

Sponsor / Collaborator

Neurocrine Biosciences, Inc.

100 Clinical Results associated with Bizaxofusp

100 Translational Medicine associated with Bizaxofusp

100 Patents (Medical) associated with Bizaxofusp

Literatures (Medical) associated with Bizaxofusp

02 Jun 2023·Neuro-oncology

Targeting the IL4 receptor with MDNA55 in patients with recurrent glioblastoma: Results of a phase IIb trial

Article

Author: Zabek, Miroslaw ; Merchant, Nina ; Aghi, Manish K ; Coello, Melissa ; Brem, Steven ; Sampson, John H ; Vrionis, Frank ; Han, Seunggu ; Bankiewicz, Krystof ; Butowski, Nicholas ; Chandhasin, Chandtip ; Mardor, Yael ; Vogelbaum, Michael ; Kesari, Santosh ; Singh Achrol, Achal ; Randazzo, Dina ; Ellingson, Benjamin M ; Merchant, Fahar ; Bexon, Martin ; Wembacher-Schroeder, Eva ; Chowdhary, Sajeel ; Floyd, John R ; Brenner, Andrew

Abstract:

Background:

MDNA55 is an interleukin 4 receptor (IL4R)-targeting toxin in development for recurrent GBM, a universally fatal disease. IL4R is overexpressed in GBM as well as cells of the tumor microenvironment. High expression of IL4R is associated with poor clinical outcomes.

Methods:

MDNA55-05 is an open-label, single-arm phase IIb study of MDNA55 in recurrent GBM (rGBM) patients with an aggressive form of GBM (de novo GBM, IDH wild-type, and nonresectable at recurrence) on their 1st or 2nd recurrence. MDNA55 was administered intratumorally as a single dose treatment (dose range of 18 to 240 ug) using convection-enhanced delivery (CED) with up to 4 stereo-tactically placed catheters. It was co-infused with a contrast agent (Gd-DTPA, Magnevist®) to assess distribution in and around the tumor margins. The flow rate of each catheter did not exceed 10μL/min to ensure that the infusion duration did not exceed 48 h. The primary endpoint was mOS, with secondary endpoints determining the effects of IL4R status on mOS and PFS.

Results:

MDNA55 showed an acceptable safety profile at doses up to 240 μg. In all evaluable patients (n = 44) mOS was 11.64 months (80% one-sided CI 8.62, 15.02) and OS-12 was 46%. A subgroup (n = 32) consisting of IL4R High and IL4R Low patients treated with high-dose MDNA55 (>180 ug) showed the best benefit with mOS of 15 months, OS-12 of 55%. Based on mRANO criteria, tumor control was observed in 81% (26/32), including those patients who exhibited pseudo-progression (15/26).

Conclusions:

MDNA55 demonstrated tumor control and promising survival and may benefit rGBM patients when treated at high-dose irrespective of IL4R expression level.Trial Registration: Clinicaltrials.gov NCT02858895.

15 Jul 2021·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

Modified RANO, Immunotherapy RANO, and Standard RANO Response to Convection-Enhanced Delivery of IL4R-Targeted Immunotoxin MDNA55 in Recurrent Glioblastoma

Q1 · MEDICINE

Article

Author: Vrionis, Frank ; Achrol, Achal Singh ; Wang, Chencai ; Han, Seunggu ; Sampson, John ; Coello, Melissa ; Kesari, Santosh ; Vogelbaum, Michael A. ; Butowski, Nicholas ; Randazzo, Dina ; Aghi, Manish K. ; Bankiewicz, Krystof ; Floyd, John R. ; Ellingson, Benjamin M. ; Brem, Steven ; Merchant, Nina ; Bexon, Martin ; Zabek, Miroslaw ; Brenner, Andrew ; Merchant, Fahar ; Chowdhary, Sajeel

Abstract:

Purpose::

The current study compared the standard response assessment in neuro-oncology (RANO), immunotherapy RANO (iRANO), and modified RANO (mRANO) criteria as well as quantified the association between progression-free (PFS) and overall survival (OS) in an immunotherapy trial in recurrent glioblastoma (rGBM).

Patients and Methods::

A total of 47 patients with rGBM were enrolled in a prospective phase II convection-enhanced delivery of an IL4R-targeted immunotoxin (MDNA55-05, NCT02858895). Bidirectional tumor measurements were created by local sites and centrally by an independent radiologic faculty, then standard RANO, iRANO, and mRANO criteria were applied.

Results::

A total of 41 of 47 patients (mean age 56 ± 11.7) were evaluable for response. PFS was significantly shorter using standard RANO compared with iRANO (log-rank, P < 0.0001; HR = 0.3) and mRANO (P < 0.0001; HR = 0.3). In patients who died and had confirmed progression on standard RANO, no correlation was observed between PFS and OS (local, P = 0.47; central, P = 0.34). Using iRANO, a weak association was observed between confirmed PFS and OS via local site measurements (P = 0.017), but not central measurements (P = 0.18). A total of 24 of 41 patients (59%) were censored using iRANO and because they lacked confirmation of progression 3 months after initial progression. A strong correlation was observed between mRANO PFS and OS for both local (R2 = 0.66, P < 0.0001) and centrally determined reads (R2 = 0.57, P = 0.0007).

Conclusions::

No correlation between radiographic PFS and OS was observed for standard RANO or iRANO, but a correlation was observed between PFS and OS using the mRANO criteria. Also, the iRANO criteria was difficult to implement due to need to confirm progression 3 months after initial progression, censoring more than half the patients.

01 Apr 2019·ImmunotherapyQ4 · MEDICINE

Combination Immunotherapy with IL-4 Pseudomonas Exotoxin and IFN-α and IFN-γ Mediate Antitumor Effects in vitro and in a Mouse Model of Human Ovarian Cancer

Q4 · MEDICINE

Article

Author: Green, Daniel S ; Joshi, Bharat ; Sato, Yuki ; Zoon, Kathryn C ; Husain, Syed R ; Johnson, Chase L ; Hewitt, Stephen M ; Han, Jing ; Puri, Raj K

AIM:

We have shown that IL-4 fused to Pseudomonas exotoxin (IL-4-PE) is cytotoxic to ovarian cancer cell lines. The antineoplastic properties of IFN-α, IFN-γ and IL-4-PE have been studied and showed some promise in the clinical trials. Here, we investigated whether the combination of IL-4-PE, IFN-α and IFN-γ will result in increased ovarian cancer cell death in vitro and in vivo.

MATERIALS & METHODS:

Ovarian cancer cells were tested in vitro to analyze the cytotoxic effects of IL-4-PE, IFN-α and IFN-γ, and the combination of all three. Tumor-bearing xenograft mice were treated with the combination of IL-4-PE, IFN-α and IFN-γ to monitor their overall survival. The JAK/STAT phosphorylation signaling pathways were studied to delineate the mechanism of synergistic antitumor activity.

RESULTS:

The combination of IL-4-PE with IFN-α and IFN-γ resulted in increased ovarian cancer cell death in vitro and in vivo. Mechanistically, the synergistic antitumor effect was dependent on interferon signaling, but not IL-4-PE signaling as determined by signaling specific chemical inhibitors. The combination therapy induced the activation of critical mediators of apoptosis.

CONCLUSION:

The combination of IL-4-PE with interferons increased overall survival of mice with human ovarian cancer xenograft. These data suggest that this novel combination could provide a unique approach to treating ovarian cancer.

126

News (Medical) associated with Bizaxofusp

26 Jun 2026

·www.biospace.com

Medicenna Therapeutics Reports Fiscal Year 2026 Financial Results and Operational Highlights

MDNA11, as a single agent or in combination with pembrolizumab, continues to demonstrate compelling anti-tumor activity in patients with advanced or metastatic cutaneous melanoma, endometrial cancer and gastrointestinal cancers unresponsive to checkpoint inhibitors Enrolment in ABILITY-1 to be completed in Q3 2026 with key data readouts expected in Q4 2026 which will guide development strategy for a potential registrational pathway and partnerships Enrolment in the NEO-CYT Phase 1b trial, funded by Fondazion Melanoma, is well underway. In this study, which was highlighted at ASCO 2026, MDNA11 is being evaluated in combination with checkpoint inhibitors for the treatment of advanced melanoma prior to surgery Data presented at AACR 2026 showed that MDNA113, Medicenna’s anti-PD1-IL-2 bifunctional immunotherapy, was safer even at doses 30-fold higher than a competing anti-PD1-IL-2 a-biase d agent Strengthened management team by appointment of Dr. Nageatte Ibrahim, MD, as fractional Chief Medical Officer, who brings considerable clinical expertise in cancer immunotherapy from her long tenure at Merck and more recently as the CMO at Innovent Biologics USA Cash runway expected to extend through Q1 calendar 2027, assuming completion of the contemplated structured financing as planned TORONTO and HOUSTON, June 26, 2026 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines targeting cancer, autoimmune, and inflammatory diseases, today reported financial results and corporate highlights for the fiscal year ended March 31, 2026, as well as anticipated corporate milestones. “Fiscal 2026 was a year of important execution across our Superkine pipeline, highlighted by compelling efficacy of MDNA11 in at least three different advanced cancer indications complemented by the impressive pre-clinical pro MDNA113 in the breakthrough era of bi-functional immunotherapies,” said Fahar Merchant, Ph.D., President and CEO of Medicenna. “As we look ahead, we believe that the upcoming MDNA11 clinical data readouts from both the ABILITY-1 and NEO-CYT studies will form the foundation of a broad development strategy and expedite collaboration, partnering, registrational, and commercial opportunities in select cancers. In parallel, MDNA113 continues to demonstrate a highly differentiated profile, with preclinical data showing its potential to dramatically widen the therapeutic window without sacrificing efficacy. With patent cliffs for key checkpoint inhibitors on the horizon, we aspire to provide better and safer options to patients where mega-blockbuster therapies have failed. With our recent financing activities, advances in partnering efforts, and continued focus on disciplined execution, we are well positioned to achieve multiple value-driving milestones across our pipeline this fiscal year.” Program highlights for the fiscal year ended March 31, 2026, along with recent developments, include: MDNA11: IL-2 Superkine Program MDNA11 continues to exhibit compelling deep and durable anti-tumor activity in difficult-to-treat solid tumors with best-in-class potential relative to competing IL-2 programs Updated results from the Phase 1/2 ABILITY-1 study presented at ESMO-IO Congress 2025 and earlier this calendar year demonstrate response rates in the 30-40% range in the 2L/3L Tx setting or as next-line following resistance to checkpoint inhibitor therapy During the second half of 2026, Medicenna plans to present updated clinical results from both the monotherapy and combination arms of the Phase 1/2 ABILITY-1 study and Phase 1b NEO-CYT study in earlier line settings Medicenna plans to solidify its Phase 2b development strategy for MDNA11 by the end of this calendar year, including strategies for evaluation of MDNA11 in tumor types with accelerated approval potential MDNA113: First-in-Class Anti-PD-1-IL-2 Bifunctional Superkine Anti-PD-1-IL-2 bispecifics have emerged as a promising class of immuno-oncology therapies due to cis-binding synergies At the 2026 AACR Annual Meeting, the Company presented new preclinical data highlighting the differentiated and first-in-class potential of MDNA113, its IL-13Rα2 targeted anti-PD-1-IL-2 bifunctional superkine, which is designed to widen the therapeutic window through its tumor-targeting and activation within the tumor micro-environment The AACR presentation highlighted MDNA113’s capability to be dosed at a level consistent with or exceeding that of standard-of-care commercial anti-PD-1 therapies with data demonstrating dosing up to 50 mg/kg in non-human primates Superior safety and dosing capabilities were also demonstrated compared to a competing anti-PD-1-IL-2 a-bias ed design Medicenna is advancing its novel first-in-class anti-PD-1 x IL-2 bifunctional superkine through IND-enabling studies with a planned IND submission in Q4 2026 followed by the initiation of a first-in-human trial soon thereafter Bizaxofusp (formerly MDNA55): Empowered IL-4 Superkine Program The Company is currently pursuing partnership opportunities for its phase-3 ready IL-4 Superkine for recurrent glioblastoma (rGBM). Bizaxofusp, which holds both FastTrack and Orphan drug status from the FDA and FDA/EMA, respectively, is Medicenna’s Phase 3-ready asset for rGBM which has been tested in 118 patients with high grade gliomas (including 112 patients with rGBM). Anticipated Milestones for Fiscal 2027 Complete patient enrollment in ABILITY-1 study in MDNA11 monotherapy and combination arms across prioritized indications (cutaneous melanoma, endometrial cancer, MSI-H/dMMR and MSS/TMB-H cancers) including any new expansion cohorts (for e.g., CRC and NSCLC) with a focus on 2L/3L in post–anti-PD1 settings Report updated clinical data from MDNA11 monotherapy and combination expansion cohorts including 2L/3L and last-line anti-PD1–treated patients enrolled within the ABILITY-1 study Share interim clinical data from the Phase 1b NEO-CYT study of MDNA11 in neoadjuvant melanoma trial Secure FDA guidance on first potential registrational trial of MDNA11 in at least one advancer cancer indication in 2L/3L setting post-ICI therapy, including dose selection for Project Optimus File an investigational new drug (IND) application for MDNA113 in Q4 2026 and initiate a Phase 1 trial soon thereafter Strengthen the balance sheet through partnership and/or financing in preparation for registrational trial for MDNA11 and commence FIH trial for MDNA113 Present new clinical data on bizaxofusp in recurrent GBM in Q4 2026 Advance and close a strategic collaboration or partnership for bizaxofusp Annual Financial Results Medicenna exited the fiscal year ended March 31, 2026 with cash and cash equivalents of $6.3 million. Subsequent to year end, the Company announced the closing of its previously announced $4.4 million public offering of units and the execution of a term sheet related to a structured financing arrangement with Sorbie Bornholm LP and Sorbie Investments LLP (“Sorbie”) pursuant to which the Company may ultimately receive more or materially less than $8.0 million (the “Sorbie Transaction”). The completion of the Sorbie Transaction and the execution of the required documentation are each subject to the satisfaction of customary closing conditions, including the receipt of all necessary regulatory and stock exchange approvals. The proceeds from these financings, in conjunction with cash on hand, are expected, if completed as contemplated, to provide the Company with sufficient capital to execute its current planned expenditures through the first quarter of calendar 2027. For the year ended March 31, 2026, the Company reported total operating costs of $22.4 million compared to total operating costs of $20.4 million for the year ended March 31, 2025. The increase is related to an increase in research and development expenses of $2.4 million which was partially offset by a reduction in general and administrative expenses of $0.4 million as discussed further below. Net loss for the year ended March 31, 2026, was $18.4 million ($0.22 loss per share), compared to a net loss of $11.8 million ($0.15 loss per share) for the year ended March 31, 2025. The increase in net loss during the current period relative to the year ended March 31, 2025 is primarily due to an increase in R&D expenses of $2.4 million, a decrease in the gain recognized on the change in fair value of the warrant derivative of $2.1 million, a decrease in finance income of $0.8 million and a decrease in foreign exchange gain of $1.7 million. Research and development expenses of $16.9 million were incurred during the year ended March 31, 2026, compared with $14.4 million incurred in the year ended March 31, 2025. The increase in research and development expenses in the current fiscal year is primarily attributed to increased clinical costs during the current year due to the expansion of the MDNA11 ABILITY-1 Study to new clinical sites, the inclusion of more patients in the study relative to the prior year, and the commencement of the NEO-CYT study during the current year. General and administrative expenses of $5.5 million were incurred during the year ended March 31, 2026, compared with $6.0 million during the year ended March 31, 2025. The decrease in G&A expenses in the current year primarily relates to lower stock-based compensation expense associated with option grants made during the current year. Medicenna’s financial statements for the year ended March 31, 2026 and the related management’s discussion and analysis (MD&A) will be available on SEDAR+ at . About Medicenna Therapeutics Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first-in-class Empowered Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior affinity toward CD122 (IL-2 receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby preferentially stimulating cancer-killing effector T cells and NK cells. Medicenna’s first-in-class targeted PD-1 x IL-2 bifunctional, MDNA113, is in development for solid tumors and was designed using the Company’s proprietary BiSKITs (Bifunctional SuperKine ImmunoTherapies) and T-MASK (Targeted Metalloprotease Activated SuperKine) platforms. Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), has been studied in 5 clinical trials enrolling over 130 patients, including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained Fast Track and Orphan Drug status from the FDA and FDA/EMA, respectively. 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, such as statements on the therapeutic potential and safety pro MDNA11, MDNA113 and MDNA55 (bizaxofusp), anticipated milestones for Fiscal 2027, the Company's expected cash runway and financing plans, statements regarding the Sorbie Transaction, its completion and any potential additional proceeds that may be received by the Company from such potential investment (including the timing thereof), the receipt of any required approvals in connection with the Sorbie Transaction and upcoming expected developments, timelines, regulatory and other milestones and presentation of data. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage pre-clinical or clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. 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

Phase 2Phase 1Orphan DrugExecutive ChangeImmunotherapy

11 Jun 2026

·www.biospace.com

Medicenna Strengthens U.S. Patent Estate with Newly Issued and Allowed Patents Across its IL-2, IL-4 and IL-13 Superkine Platforms

New U.S. patents extend protection for cellular immunotherapy applications, immune cell targeting constructs and bizaxofusp combination therapy with anti-VEGF agents for CNS tumors; global portfolio now exceeds 100 active granted patents and applications TORONTO, June 11, 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 the issuance of two new U.S. patents and the allowance of an additional U.S. patent application covering its proprietary IL-4 and IL-13 Superkine platforms, including bizaxofusp (formerly MDNA55), the Company’s IL-4 Empowered Superkine in clinical development for recurrent glioblastoma (rGBM). The newly issued U.S. patents, together with parallel patents recently granted in Australia and Canada within the same patent families, further reinforce Medicenna’s intellectual property position across the cytokine biology underlying its lead clinical programs: bizaxofusp, MDNA11 (IL-2 Superkine) and MDNA113 (anti–PD-1 × IL-2 bifunctional Superkine). “These newly issued and allowed U.S. patents underscore the depth and breadth of the Superkine science Medicenna has built and the strength of the IP estate now protecting the platforms behind bizaxofusp, MDNA11 and MDNA113,” said Dr. Fahar Merchant, President and Chief Executive Officer of Medicenna. “Our cytokine engineering work spans three distinct receptor systems, including IL-2, IL-4 and IL-13 and these grants extend protection into important new applications, including cellular immunotherapy and combination treatment of CNS tumors. With more than 100 active granted patents and applications worldwide, Medicenna has assembled what we believe is one of the most comprehensive patent estates in Superkine-based immunotherapy.” U.S. Patents Recently Issued U.S. Patent No. 12,503,496 : “Interleukin-4 Receptor-Binding Fusion Proteins and Uses Thereof” (Medicenna and the U.S. National Institutes of Health, co-owners). The issued patent covers the application of Medicenna’s proprietary IL-4 Superkine fusion proteins to enhancing cellular immunotherapy. With this grant, the family now includes three issued U.S. patents, and additional granted patents in Europe and India. U.S. Patent No. 12,590,133 : “IL-13/IL-4 Superkines: Immune Cell Targeting Constructs and Methods of Use Thereof” (in-licensed by Medicenna from Stanford University). The issued patent is directed to IL-13 Superkine immune cell targeting constructs, vectors, and engineered cells. The family is now granted in the United States and China, with pending applications in Canada and Europe. U.S. Patent Recently Allowed U.S. Patent Application No. 18/248,601 : “Combination Therapy of MDNA55 and a Vascular Endothelial Growth Factor a (VEGF-A)” (Medicenna-owned). Once issued, the patent will cover combinatorial treatment of CNS tumors with bizaxofusp, including with VEGF-A-directed agents. The family also has pending applications in Canada, China, Europe, India, Japan and Korea. Additional Recent Patent Grants Outside the United States In parallel with these U.S. milestones, Medicenna recently received patent grants in two additional jurisdictions that extend the geographic reach of its core Superkine families: Australian Patent No. 2018347796 , “IL-4 Fusion Formulations for Treatment of Central Nervous System (CNS) Tumors,” directed to Medicenna’s proprietary bizaxofusp formulation and its application to the treatment of CNS tumors. This family is now granted in Australia, Europe and the United States, with pending applications in Canada, China and India. Canadian Patent No. 3,067,909 , “Uses and Methods for IL-2 Superagonists, Agonists, and Fusions Thereof,” directed to the combination of Medicenna’s IL-2 Super Agonist and checkpoint inhibitors for the treatment of cancer. This family is now granted in Australia, Canada, Japan and the United States, with additional pending applications in China, Europe and India, as well as further applications in Australia, Japan and the United States. Medicenna continues to develop a robust global patent portfolio across its R&D platforms and clinical programs, with over 100 active granted patents and applications. About Medicenna Therapeutics Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first-in-class Empowered Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior affinity toward CD122 (IL-2 receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby preferentially stimulating cancer-killing effector T cells and NK cells. Medicenna’s first-in-class targeted PD-1 x IL-2 bispecific, MDNA113, is in development for solid tumors and was designed using the Company’s proprietary BiSKITs™ (Bifunctional SuperKine ImmunoTherapies) and T-MASK™ (Targeted Metalloprotease Activated SuperKine) platforms. Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), has been studied in 5 clinical trials enrolling over 130 patients, including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained Fast Track and Orphan Drug status from the FDA and FDA/EMA, respectively. 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, such as statements on or in respect of: the therapeutic potential, safety pro other potential biological responses to administration (or lack thereof) of bizaxofusp, MDNA11 and/or MDNA113; any IND submission and/or first-in-human trial for MDNA113 (including any expected timing thereof); the issuance of any patents applied for by the Company, now or in the future (inclidng any expected timing thereof); and any potential sales or revenue generation from the sale or other commercialization of bizaxofusp, MDNA11, MDNA113 or any other PD-1 inhibitors or other products of the Company (including any expected timing thereof). Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage pre-clinical or clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. 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. 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, the Company does not intend and does not assume any obligation to update or revise publicly any of the included forward-looking statements. Investor Contact Daniel Scarr Medicenna Therapeutics ir@medicenna.com

ImmunotherapyOrphan DrugPhase 2Fast TrackClinical Result

03 Jun 2026

·www.biospace.com

Medicenna’s MDNA11 Potential in Earlier Line Melanoma Setting Highlighted in Presentation of the NEO-CYT trial at ASCO 2026

NEO-CYT positions MDNA11 in a frontline neoadjuvant melanoma setting, where immunotherapy before surgery may help generate deeper and more durable anti-tumor immune responses Up to 80 patients with locally advanced melanoma will be randomized in this Investigator-sponsored, multicenter Phase 1b NEO-CYT trial led by Professor Paolo A. Ascierto of the Istituto Nazionale Tumori Fondazione “G. Pascale” and sponsored by Fondazione Melanoma Onlus Together with the ongoing Phase 1/2 ABILITY-1 expansion cohorts in the 2L/3L Tx setting, NEO-CYT supports a broader clinical strategy to evaluate MDNA11 across select tumor types and multiple stages of disease, expanding future commercial opportunities MDNA11 clinical data updates from the ABILITY-1 and NEO-CYT trials are anticipated in H2 2026 TORONTO and HOUSTON, June 03, 2026 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company developing Superkines targeting cancer and autoimmune disease, today announced that its long-acting, “beta-enhanced not-alpha” IL-2 Superkine, MDNA11, was featured in a poster presentation describing the investigator-sponsored NEO-CYT trial at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO), held in Chicago from 28 th May to 2 nd June. Surgery has long been the first course of action in treating locally advanced melanoma. Recently, the landmark NADINA clinical trial (comprised of 2 pre-operative cycles of ipilimumab plus nivolumab) completely flipped the conventional treatment paradigm on its head by proving that giving combination immunotherapy before surgery is significantly more effective than the previous post-surgery standard, setting a new gold standard of care. However even with this regimen, 41% of patients did not achieve a Major Pathologic Response (< 10% of viable tumor). In view of the promising single agent activity of MDNA11 in patients with metastatic melanoma, the hypothesis of the NEO-CYT trial is to demonstrate if patient outcomes can be further enhanced over the gold-standard of care by introducing MDNA11 in combination with nivolumab +/- ipilimumab. “NEO-CYT provides an important opportunity to evaluate MDNA11, a potentially best-in-class IL-2 superagonist, in a frontline neoadjuvant setting where immune activation may be especially impactful,” said Fahar Merchant, Ph.D., President and Chief Executive Officer of Medicenna. “ If the tumor is still present at the time of the treatment, the immune cells ‘see’ more of the cancer cells. This allows the most potent anti-tumor immune cells to expand and attack the tumor and can remain active in the body for many years, preventing the tumors from recurring. Importantly, this trial complements our ongoing ABILITY-1 study, which has already demonstrated durable disease control in more advanced stages of melanoma. The ABILITY-1 trial is also advancing MDNA11 into earlier lines of therapy through expansion cohorts in 2L/3L melanoma, endometrial cancer, colorectal cancer, lung cancer and tumor agnostic biomarker driven cancers. We look forward to sharing updates on the ABILITY-1 trial and the NEO-CYT study during the second half of 2026.” NEO-CYT is a randomized, multicenter Phase 1b trial evaluating MDNA11 in combination with nivolumab, with or without ipilimumab, as neoadjuvant therapy in patients with high-risk, surgically resectable Stage IIIB/C/D cutaneous melanoma. The study is sponsored by Fondazione Melanoma Onlus and led by Professor Paolo A. Ascierto of the Istituto Nazionale Tumori Fondazione “G. Pascale” in Naples, Italy. The trial represents an important expansion of MDNA11’s clinical development into an earlier-line, curative-intent melanoma setting. Neoadjuvant immunotherapy, administered before surgery while the tumor and its immune microenvironment remain intact, has emerged as a promising strategy to generate deeper anti-tumor immune responses and improve long-term outcomes for patients with high-risk resectable melanoma. However, a meaningful proportion of patients still do not achieve a major pathologic response with checkpoint-based neoadjuvant therapy, underscoring the need for novel immune-activating approaches that may improve depth and durability of response. The NEO-CYT poster at ASCO highlighted the scientific rationale for combining MDNA11 with checkpoint inhibitors in the neoadjuvant setting. Prior clinical and translational research has shown that lack of response to neoadjuvant checkpoint therapy may be associated with an immunologically “cold” tumor microenvironment, including IL-2–related immune features. MDNA11 was designed to selectively engage the IL-2 receptor beta pathway, promoting expansion and activation of CD8 + T cells and NK cells that are central to anti-tumor immunity, while minimizing stimulation of immunosuppressive regulatory T cells. The study is expected to enroll up to 80 patients across four treatment arms. The control arm will comprise of patients treated with the current gold-standard, ipilimumab plus nivolumab, while investigational arms will evaluate MDNA11 in combination with nivolumab alone, MDNA11 in combination with ipilimumab plus nivolumab, and an optional arm adding tocilizumab to MDNA11 plus ipilimumab and nivolumab following Steering Committee safety review. The primary efficacy endpoint is Major Pathologic Response at surgery, defined as 10% or less viable tumor in the treated tumor bed. Co-primary safety endpoints include the incidence, severity and duration of treatment-related adverse events, with particular focus on immune-related adverse events. MDNA11 is also being evaluated in Medicenna’s ongoing Phase 1/2 ABILITY-1 study, where it has demonstrated immune activation, including expansion of CD8 + T cells and NK cells, as well as single-agent clinical activity and a manageable safety pro patients with advanced solid tumors. Together, NEO-CYT and ABILITY-1 are intended to inform Medicenna’s broader development strategy for MDNA11 across multiple treatment settings, including earlier-line melanoma populations where patients may have more intact immune systems and greater potential to benefit from immunotherapy. Clinical updates from MDNA11 studies are anticipated in the second half of 2026. About High-Risk Stage III Surgically Resectable Melanoma Melanoma is the fifth most common cancer in the United States and the most lethal form of skin cancer. Stage III melanoma refers to disease that has spread beyond the primary tumor to regional lymph nodes or nearby tissue, but not to distant organs. In high-risk Stage III melanoma, patients face a significant risk of recurrence even after complete surgical removal, underscoring the need for effective systemic treatment strategies. Neoadjuvant immunotherapy, administered before surgery while the tumor and its immune microenvironment remain intact, has emerged as a promising approach to improve pathologic responses and long-term outcomes in this setting. About MDNA11 MDNA11 is a long-acting, ‘beta-enhanced not-alpha’ IL-2 Superkine specifically engineered to overcome the shortcomings of aldesleukin and other next generation IL-2 variants by preferentially activating immune effector cells (CD8 + T and NK cells) responsible for killing cancer cells, with minimal or no stimulation of immunosuppressive Tregs. These unique proprietary features of the IL-2 Superkine have been achieved by incorporating seven specific mutations and genetically fusing it to a recombinant human albumin scaffold to improve the pharmacokinetic (PK) pro pharmacological activity of MDNA11 due to albumin’s natural propensity to accumulate in highly vascularized sites, in particular tumor and tumor draining lymph nodes. MDNA11 is currently being evaluated in the Phase 1/2 ABILITY-1 study as both monotherapy and in combination with pembrolizumab. About Fondazione Melanoma Onlus Fondazione Melanoma Onlus is a non-profit organization based in Naples, Italy, that supports and promotes melanoma research, education, and clinical trials. It is known for organizing international conferences like the Melanoma Bridge, which bring together clinicians and researchers to discuss advancements in melanoma treatment and its related fields. The foundation also sponsors scientific awards for outstanding achievements in melanoma research. About Medicenna Therapeutics Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first-in-class Empowered Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior affinity toward CD122 (IL-2 receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby preferentially stimulating cancer-killing effector T cells and NK cells. Medicenna’s first-in-class targeted PD-1 x IL-2 bispecific, MDNA113, is in development for solid tumors and was designed using the Company’s proprietary BiSKITs™ (Bifunctional SuperKine ImmunoTherapies) and T-MASK™ (Targeted Metalloprotease Activated SuperKine) platforms. Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), has been studied in 5 clinical trials enrolling over 130 patients, including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained Fast Track and Orphan Drug status from the FDA and FDA/EMA, respectively. For more information, please visit , and follow us on X and LinkedIn . Forward-Looking Statements This news release may contain 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, such as statements on the potential for the NEO-CYT trial, the ABILITY-1 study, the therapeutic treatment potential and safety pro MDNA11 , cash runway, and the timing and/or release of any additional clinical updates. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage pre-clinical or clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. 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. Forward-looking statements are based on a number of assumptions believed by the Company to be reasonable at the date of this news release. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such statements will prove to be accurate. These statements are subject to certain risks and uncertainties and may be based on assumptions that could cause actual results and future events to differ materially from those anticipated or implied 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 or implied in forward-looking statements. 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. Investors Shushu Feng Investor Relations, Medicenna Therapeutics (416) 964-5442 ir@medicenna.com

ImmunotherapyOrphan DrugASCOPhase 1Phase 2

100 Deals associated with Bizaxofusp

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glioblastoma Multiforme	Phase 2	-	Sophiris Bio, Inc.	01 Jan 2009
Recurrent Glioblastoma	Phase 2	United States	Neurocrine Biosciences, Inc.	01 Mar 2001
Glioblastoma	Phase 2	United States	Medicenna Therapeutics, Inc.	-
Breast Cancer	Phase 1	United States	Neurocrine Biosciences, Inc.	01 Jan 2002
Kidney Neoplasms	Phase 1	United States	Neurocrine Biosciences, Inc.	01 Jan 2002
Non-Small Cell Lung Cancer	Phase 1	United States	Neurocrine Biosciences, Inc.	01 Jan 2002
Relapsed Solid Neoplasm	Phase 1	United States	Neurocrine Biosciences, Inc.	01 Jan 2002

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02858895 (MDNA55-05, ASCO2024)	Phase 2	Glioblastoma Multiforme IL-4R expression	-	Bizaxofusp	wgzsngvdzw(wneenjzudq) = wrbdmdqlrn oznhguyjdd (ocmcejdncb ) View more	Positive	24 May 2024
				bizaxofusp (Standard of care)	wgzsngvdzw(wneenjzudq) = gmttxcyiva oznhguyjdd (ocmcejdncb )
SNO2023 Manual	Phase 2	Recurrent Glioblastoma	125	BIZAXOFUSP	zpzjixkhtj(gviocboosg) = zkeafgzdbq iqkntzqwor (zlxjyaquux )	Positive	10 Nov 2023
				external control arm	zpzjixkhtj(gviocboosg) = vxrjurilos iqkntzqwor (zlxjyaquux )
NCT02858895 (MDNA55-05, Pubmed)	Phase 2	Recurrent Glioblastoma	44	MDNA55	ziylcuezdd(bkoxvylall) = ocmgwxvkdc iolfnsrekb (teqyngdliy ) View more	Positive	14 Jan 2023
MDNA55-05 (SNO2021)	Phase 3	Recurrent Glioblastoma IL4R \| IDH wild type	-	MDNA55	hxgvveugej(jlbufykvyj) = tqfwmosatb gmavniugbm (ahotxudvgv ) View more	Positive	12 Nov 2021
				Avastin	hxgvveugej(jlbufykvyj) = vkyakxqosb gmavniugbm (ahotxudvgv ) View more
MDNA55-05 (SNO2020)	Phase 1	Glioblastoma Multiforme IL4R	44	MDNA55	gnxinecurx(ocpcfnkdmn) = vrquwxbvid vndyhhzbiy (cnojqqcbtm ) View more	Positive	09 Nov 2020
				MDNA55 (Synthetic Control Arm (SCA))	gnxinecurx(ocpcfnkdmn) = uywtrhzvxl vndyhhzbiy (cnojqqcbtm )
ATIM-30 (SNO2019)	Phase 2	Recurrent Glioblastoma IL4R expression	46	MDNA55 low dose (63µg)	fuqglddteh(gvyawarzfc) = ticbftfntb ulmdnlatkb (xjiksbfngp )	Positive	11 Nov 2019
				MDNA55 (IL4R+ve subjects)	fuqglddteh(gvyawarzfc) = whkxmxxwsb ulmdnlatkb (xjiksbfngp )
ATIM-05 (SNO2018)	Phase 2	Recurrent Glioblastoma	52	MDNA55	gqbkdyumhv(tzryhwmjen) = ojqrwdvfgw zdcvloilsv (mgxagdyvuc )	Positive	05 Nov 2018

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