Medicenna Presents Preclinical Information on MDNA11 and Bizaxofusp on the 2024 Annual Assembly of the Society for Neuro-Oncology (SNO)

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MDNA11 reveals important survival advantages in preclinical glioblastoma fashions, increasing CD8⁺ T and NK cells

Bizaxofusp selectively targets human tumor cells and immune-suppressive cells, enhancing anti-tumor immunity

Mixture remedy with MDNA11 and Bizaxofusp demonstrates synergistic tumor-killing in human GBM tumoroids

TORONTO and HOUSTON, Nov. 25, 2024 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or the “Firm”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy firm centered on the event of Superkines, immediately introduced the presentation of preclinical information on MDNA11, a long-acting “β-enhanced Not-α” IL-2 Superkine, and bizaxofusp (MDNA55), an IL-4 Empowered Superkine, on the 2024 Annual Assembly of the Society for Neuro-Oncology (SNO) held in Houston, Texas from November 21 – 24, 2024. These information present compelling proof of their mixed potential to concurrently improve immune activation with MDNA11 and weaken the tumor microenvironment (TME) with bizaxofusp, for the remedy of “chilly tumors” resembling glioblastoma (GBM).

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Scientific outcomes reported earlier this month have proven that MDNA11 can successfully assault aggressive cancers resembling pancreatic and colon cancers, by boosting the standard and amount of most cancers preventing immune cells, resembling CD8⁺ T cells and NK cells, in sufferers which have failed or don’t profit from blockbuster immunotherapies.

Bizaxofusp acts by focused supply of a potent toxin to a number of sorts of aggressive cancers that specific the interleukin-4 receptor (IL-4R), resembling GBM, with out harming wholesome cells. As well as, we now have now proven that bizaxofusp weakens the TME, by selectively killing immunosuppressive cells, resembling regulatory T cells (Tregs), which promote most cancers cells to develop, metastasize, evade the immune system, and resist remedy.

“The info offered at SNO 2024 this weekend and at SITC earlier this month, spotlight the transformative potential of our pipeline to deal with the challenges related to among the most aggressive and recalcitrant tumors resembling pancreatic, colon and mind most cancers,” stated Fahar Service provider, PhD, President and CEO of Medicenna. “These outcomes are notably thrilling as a result of they reveal, for the primary time, the synergistic potential of mixing MDNA11’s means to reinvigorate the most cancers preventing immune system with bizaxofusp’s capability to dismantle the protecting tumor microenvironment related to essentially the most formidable and devastating cancers resembling GBM. Our findings level to a possible breakthrough in addressing this important unmet medical want for 70% of cancers that don’t profit from the present class of immunotherapies. At Medicenna, we stay dedicated and sit up for pushing the boundaries of our superkine platforms to ship daring and synergistic approaches to considerably enhance affected person outcomes.”

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The presentation, titled “Invigorating Effector Immune Cells With Extremely Selective IL-2R Agonists and Potential Synergy With Tumor Focusing on Therapeutics for Therapy of Glioblastomas“, showcased the power of MDNA11 and bizaxofusp to focus on GBM’s immunosuppressive atmosphere and synergize to elicit strong anti-tumor responses.

MDNA11 is a next-generation IL-2 superkine designed to selectively stimulate effector immune cells (CD8⁺ T cells and NK cells) by enhancing affinity for IL-2Rβ (CD122) whereas avoiding IL-2Rα (CD25), which reduces Treg activation and related toxicities. Bizaxofusp is designed to focus on each the tumor and the TME, by selectively killing IL4R-expressing most cancers cells, immune suppressive myeloid-derived suppressor cells (MDSCs) and Tregs.

Key findings offered on the convention embrace:

MDNA11: A Lengthy-Performing IL-2 Superkine

• Demonstrated important survival profit (p = 0.031) in an aggressive orthotopic GBM mannequin, with preferential growth of CD8⁺ T cells and NK cells.

Bizaxofusp: An IL-4 Empowered Superkine Designed to Ship a Toxin Payload

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• Selectively kills IL4R-expressing tumor cells and immunosuppressive MDSCs, whereas invigorating anti-tumor immune responses.
• Potently (IC₅₀ = 0.011 nM) and selectively eradicated Tregs with out impacting CD8⁺ T cells and NK cells

Mixture Remedy

• MDNA11 and bizaxofusp synergistically enhanced tumor cell killing in patient-derived GBM tumoroids, providing a novel mixture strategy for treating immunologically “chilly” tumors.
• Findings counsel the mixture technique may redefine remedy paradigms for GBM and different difficult cancers.

A duplicate of the presentation will likely be accessible on the “Scientific Displays” web page of Medicenna’s web site.

About MDNA11

MDNA11 is an intravenously administered, long-acting ‘beta-enhanced not-alpha’ IL-2 Superkine particularly engineered to beat the shortcomings of aldesleukin and different subsequent era IL-2 variants by preferentially activating immune effector cells (CD8⁺ T and NK cells) chargeable for killing most cancers cells, with minimal or no stimulation of immunosuppressive Tregs. These distinctive proprietary options of the IL-2 Superkine have been achieved by incorporating seven particular mutations and genetically fusing it to a recombinant human albumin scaffold to enhance the pharmacokinetic (PK) profile and pharmacological exercise of MDNA11 because of albumin’s pure propensity to build up in extremely vascularized websites, particularly tumor and tumor draining lymph nodes. MDNA11 is presently being evaluated within the Section 1/2 ABILITY-1 research (NCT05086692) as each monotherapy and together with pembrolizumab.

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About Bizaxofusp

Bizaxofusp (previously often called MDNA55) is Medicenna’s IL-4 Empowered Superkine that has been studied in 5 medical trials in over 130 sufferers, together with a Section 2b trial in sufferers with recurrent glioblastoma (rGBM), the most typical and uniformly deadly type of mind most cancers. Outcomes from the Section 2b research, which have been revealed within the journal Neuro-Oncology^® (Sampson, et al. June 2023), demonstrated that bizaxofusp greater than doubled the median survival in end-stage rGBM sufferers when in comparison with a well-matched exterior management arm. Medicenna has obtained settlement from the U.S. FDA on the research design for the registrational Section 3 LIGHT™ (Localized Infusion for the remedy of recurrent Glioblastoma with High-dose bizaxofusp Therapy) trial and the Firm is actively pursuing potential partnerships to conduct the LIGHT trial, and if authorised, bizaxofusp’s commercialization in key world markets. Bizaxofusp has been granted FastTrack and Orphan Drug standing from the FDA and FDA/EMA, respectively.

About Medicenna

Medicenna is a clinical-stage immunotherapy firm centered on growing novel, extremely selective variations 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 towards 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 (previously MDNA55), has been studied in 5 medical trials enrolling over 130 sufferers, together with a Section 2b trial for recurrent GBM, the most typical and uniformly deadly type of mind most cancers. Bizaxofusp has obtained FastTrack and Orphan Drug standing from the FDA and FDA/EMA, respectively. Medicenna’s early-stage BiSKITs™ (Bipurposeful SuperOkayine ImmunoTherapies) and the T-MASK™ (Targeted Metallo/Protease Activated SuperOkayine) packages are designed to reinforce the power of Superkines to deal with immunologically “chilly” tumors.

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For extra info, please go to www.medicenna.com, and observe us on X and LinkedIn.

Ahead-Wanting Statements

This information launch comprises forward-looking statements inside the which means of relevant securities legal guidelines. Ahead-looking statements embrace, however will not be restricted to, specific or implied statements concerning the long run operations of the Firm, estimates, plans, strategic ambitions, partnership actions and alternatives, targets, expectations, opinions, forecasts, projections, steerage, outlook or different statements that aren’t historic details, resembling statements on the Firm’s money runway and deliberate expenditures, the medical efficiency and potential, security profile of MDNA11 and bizaxofusp, in addition to MDNA11’s and bizaxofusp’s remedy potential, the reporting of extra outcomes, and anticipated company milestones. Drug growth and commercialization contain a excessive diploma of danger, and solely a small variety of analysis and growth packages end in commercialization of a product. Ends in early-stage medical research will not be indicative of full outcomes or outcomes from later stage or bigger scale medical research and don’t guarantee regulatory approval. You shouldn’t place undue reliance on these statements or the scientific information offered. Ahead-looking statements are sometimes recognized by phrases resembling “will”, “could”, “ought to”, “anticipate”, “count on”, “consider”, “search”, “doubtlessly” and related expressions and are topic to dangers and uncertainties. Ahead-looking statements are based mostly on a lot of assumptions believed by the Firm to be affordable on the date of this information launch. Though the Firm believes that the expectations mirrored in such forward-looking statements are affordable, there could be no assurance that such statements will show to be correct. These statements are topic to sure dangers and uncertainties and could also be based mostly on assumptions that would trigger precise outcomes and future occasions to vary materially from these anticipated or implied in such statements. Necessary components that would trigger precise outcomes to vary materially from the Firm’s expectations embrace the dangers detailed within the newest annual info type of the Firm and in different filings made by the Firm with the relevant securities regulators infrequently in Canada.

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The reader is cautioned that assumptions used within the preparation of any forward-looking info could show to be incorrect. Occasions or circumstances could trigger precise outcomes to vary materially from these predicted, on account of quite a few identified and unknown dangers, uncertainties, and different components, lots of that are past the management of the Firm. The reader is cautioned to not place undue reliance on any forward-looking info. Such info, though thought-about affordable by administration, could show to be incorrect and precise outcomes could differ materially from these anticipated or implied in forward-looking statements. Ahead-looking statements contained on this information launch are expressly certified by this cautionary assertion. The forward-looking statements contained on this information launch are made as of the date hereof and besides as required by regulation, we don’t intend and don’t assume any obligation to replace or revise publicly any of the included forward-looking statements.

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Investor and Firm Contact:

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

Daniel Scarr
Investor Relations & Enterprise Improvement, Medicenna Therapeutics
dscarr@medicenna.com
(647) 220-4509

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