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

Rhea-AI Summary

Medicenna Therapeutics has presented promising preclinical data for MDNA113, their novel tumor-targeted immunotherapy candidate, at the 2025 AACR Meeting. MDNA113 is a first-in-class anti-PD-1-IL-2 bifunctional Superkine designed to target IL-13Rα2, which is overexpressed in "immunologically cold" tumors.

The therapy shows potential in treating multiple cancer types, including pancreatic, liver, brain, breast, colon, and prostate cancer, affecting over 2 million patients worldwide. Key findings demonstrate:

• Preferential tumor localization lasting 72+ hours
• Enhanced tolerability through IL-13SK masking
• 100% protection in complete responders against tumor rechallenge
• Improved CD8+ T cell infiltration in tumor models

According to CEO Fahar Merchant, MDNA113's unique approach combines targeted delivery with conditional activation, potentially offering superior results compared to current anti-PD-1-IL-2 bispecifics in development.

Positive

• MDNA113 shows promising preclinical data with anti-tumor activity in IL-13Rα2 positive tumors
• Technology targets over 2 million patients annually across multiple cancer types (pancreatic, liver, brain, breast, colon, prostate)
• MDNA11 (company's other product) has shown durable single agent anti-tumor activity in ongoing Phase 1/2 ABILITY-1 study
• 100% protection observed in complete responders against tumor rechallenge, indicating strong efficacy
• Growing commercial interest in bi-specific anti-PD-1 therapies validates market potential
• Unique differentiation from competitors through tumor targeting and conditional activation approach

Negative

• Still in preclinical stage, indicating long path to market
• No human trial data available yet
• No financial metrics or funding details provided
• Competing products in development by other companies in the anti-PD-1-IL-2 bispecifics space

MDNA113 is a novel IL-13Rα2 tumor-targeted and “masked” anti-PD-1-IL-2 Superkine (anti-PD1-IL-2^SK), engineered to precisely deliver clinically validated anti-PD1 and IL-2^SK to the tumor microenvironment (TME)

IL-13Rα2 is overexpressed by some of the most “immunologically cold” tumors with high unmet needs in pancreatic, liver, brain, breast, colon and prostate cancer that annually affect over 2 million patients worldwide

MDNA113’s tumor targeting together with conditional activation provides a highly differentiated and potentially superior approach to current anti-PD-1-IL-2 bispecifics in development

TORONTO and HOUSTON, April 30, 2025 (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 and autoimmune diseases, today presents new pre-clinical data from MDNA113, its first candidate from the BiSKIT (Bifunctional SuperKine ImmunoTherapies) platform, at the 2025 Annual Meeting of the American Association for Cancer Research (AACR) in Chicago, Illinois.

“Our MDNA113 program continues to generate encouraging pre-clinical data that underscores its potential as a first-in-class immunotherapy for immunologically cold tumors,” said Fahar Merchant, Ph.D., President and CEO of Medicenna. “MDNA113 is uniquely differentiated against competing anti-PD-1-IL-2 therapies, with an optimized safety and efficacy profile that leverages its clinically validated pharmacology and novel IL-13 targeting approach. Not only are we observing compelling anti-tumor activity in IL-13Rα2 positive tumors but also signs of enhanced memory that may support durable responses. Commercial interest for bi-specific anti-PD-1 therapies is gaining momentum, with several recent transactions validating this emerging class of immunotherapies with the potential to offer new hope to millions of cancer patients worldwide.”

MDNA113 is based on the Company’s IL-2 and IL-13 Superkine Platforms, the former being used to develop MDNA11, a long-acting IL-2 super agonist, which has demonstrated durable single agent anti-tumor activity in the ongoing Phase 1/2 ABILITY-1 study of patients with advanced solid tumors.

Key highlights from the presentation are:

• Cis-binding maximizes synergy between immune checkpoint blockade and IL-2R activation on the same CD8⁺ T effector cells for optimal tumor cytotoxicity.​
• 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).
  
• Preferential tumor localization and retention of MDNA113 in the TME for at least 72 hours in mice implanted with tumors expressing IL-13R⍺2.
• IL-13^SK masking of IL-2^SK in MDNA113 enhances tolerability and attenuates IL-2^SK induced peripheral lymphocyte expansion in mice.
• 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.
  
  

A copy of the poster and related slide deck are available on the “Scientific Presentations” page of Medicenna’s website.

About MDNA113

MDNA113 is a novel, first-in-class tumor-targeted and tumor-activated bi-functional anti-PD1-IL-2 Superkine with exceptionally high affinity for IL-13Rα2 without binding to the functional IL-13R⍺1. IL-13Rα2 is overexpressed in a wide range of solid tumors, including cold tumors with minimal to no expression in normal tissues. IL-13Rα2 expressing tumors also have abundant matrix metalloprotease in the tumor microenvironment that may efficiently activate MDNA113. IL-13Rα2 expression is associated with poor clinical outcome in multiple tumor types including prostate cancer, pancreatic cancer, ovarian cancer, liver cancer, breast cancer and brain cancer, with an annual world-wide incidence of over 2 million.

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 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 FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively. Medicenna’s early-stage high-affinity IL-2β biased IL-2/IL-15 Super-antagonists, from its MDNA209 platform, are being evaluated as potential therapies for autoimmune and graft-versus host diseases. Medicenna’s early-stage BiSKITs™ (Bifunctional SuperKine ImmunoTherapies) and the T-MASK™ (Targeted Metalloprotease Activated SuperKine) programs are designed to enhance the ability of Superkines to treat immunologically “cold” tumors.

For more information, please visit www.medicenna.com, and follow us on Twitter 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 profile of MDNA113. 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/Media Contact:

Christina Cameron
Investor Relations, Medicenna Therapeutics
(647) 953-0673
ir@medicenna.com

FAQ

What is MDNA113 and how does it target cancer in Medicenna's (MDNAF) 2025 AACR presentation?

MDNA113 is a novel IL-13Rα2 tumor-targeted and masked anti-PD-1-IL-2 Superkine that delivers anti-PD1 and IL-2SK to tumor sites. It specifically targets immunologically cold tumors in pancreatic, liver, brain, breast, colon and prostate cancers, potentially benefiting over 2 million patients worldwide.

What are the key benefits of Medicenna's (MDNAF) MDNA113 compared to other cancer treatments?

MDNA113's main benefits include tumor-specific targeting, conditional activation in the tumor environment, enhanced CD8+ T cell infiltration, and improved safety through IL-13SK masking. It shows promising anti-tumor activity in IL-13Rα2 positive tumors and supports durable responses through enhanced memory.

What preclinical results did Medicenna (MDNAF) report for MDNA113 at AACR 2025?

Medicenna reported that MDNA113 showed tumor localization lasting 72 hours, improved tolerability, 100% protection in complete responders against tumor rechallenge, and enhanced infiltration of active CD8+ T cells over NK cells and Tregs in various tumor models.

Which types of cancer does Medicenna's (MDNAF) MDNA113 target?

MDNA113 targets immunologically cold tumors in pancreatic, liver, brain, breast, colon and prostate cancers that affect over 2 million patients annually worldwide, specifically focusing on tumors that overexpress IL-13Rα2.

How does MDNA113's mechanism of action work in cancer treatment for Medicenna (MDNAF)?

MDNA113 works through cis-binding that maximizes synergy between immune checkpoint blockade and IL-2R activation on CD8⁺ T cells. It maintains PD-1/PDL-1 blockade while featuring attenuated IL-2R signaling that activates specifically in the tumor microenvironment.