Medicenna Presents Preclinical Data from its Anti-PD1-IL-2 BiSKIT and IL-2 Super Agonist Programs at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)
Medicenna Therapeutics presented new preclinical data from its BiSKIT (MDNA113) and IL-2 super agonist (MDNA11) programs at the 39th Annual SITC Meeting. MDNA113, a novel tumor-targeted BiSKIT, achieved complete tumor regression in IL-13Rα2 expressing tumors and showed 100% survival in breast cancer models. The treatment demonstrated reduced peripheral lymphocyte expansion and better tolerability compared to unmasked alternatives. Additionally, independent UK research showed promising results with MDNA11 and anti-PD1-IL-2SK BiSKIT in glioblastoma models, significantly extending overall survival and enhancing immune cell response in patient-derived samples.
Medicenna Therapeutics ha presentato nuovi dati preclinici dai suoi programmi BiSKIT (MDNA113) e super agonista dell'IL-2 (MDNA11) durante il 39° Congresso Annuale SITC. MDNA113, un nuovo BiSKIT mirato ai tumori, ha ottenuto una regressione completa del tumore nei tumori esprimenti IL-13Rα2 e ha mostrato un tasso di sopravvivenza del 100% nei modelli di cancro al seno. Il trattamento ha dimostrato una riduzione dell'espansione dei linfociti periferici e una migliore tollerabilità rispetto alle alternative non mascherate. Inoltre, ricerche indipendenti nel Regno Unito hanno mostrato risultati promettenti con MDNA11 e BiSKIT anti-PD1-IL-2SK nei modelli di glioblastoma, estendendo significativamente la sopravvivenza complessiva e migliorando la risposta delle cellule immunitarie nei campioni derivati dai pazienti.
Medicenna Therapeutics presentó nuevos datos preclínicos de sus programas BiSKIT (MDNA113) y agonista super IL-2 (MDNA11) en la 39ª Reunión Anual de SITC. MDNA113, un nuevo BiSKIT dirigido a tumores, logró una regresión completa del tumor en tumores que expresan IL-13Rα2 y mostró un 100% de supervivencia en modelos de cáncer de mama. El tratamiento demostró una expansión reducida de linfocitos periféricos y una mejor tolerabilidad en comparación con alternativas no enmascaradas. Además, investigaciones independientes en el Reino Unido mostraron resultados prometedores con MDNA11 y BiSKIT anti-PD1-IL-2SK en modelos de glioblastoma, extendiendo significativamente la supervivencia general y mejorando la respuesta de las células inmunitarias en muestras derivadas de pacientes.
Medicenna Therapeutics는 39회 SITC 연례 회의에서 BiSKIT (MDNA113) 및 IL-2 슈퍼 아고니스트 (MDNA11) 프로그램의 새로운 전임상 데이터를 발표했습니다. MDNA113은 새로운 종양 표적 BiSKIT으로 IL-13Rα2가 발현되는 종양에서 완전한 종양 퇴축을 달성했으며 유방암 모델에서 100% 생존률을 보였습니다. 이 치료는 비암호화 대안에 비해 말초 림프구 확장이 감소하고 더 나은 내약성을 입증했습니다. 또한, 독립적인 영국 연구에서는 MDNA11과 항-PD1-IL-2SK BiSKIT이 신경 교모세포종 모델에서 유망한 결과를 보여 생존 기간을 유의미하게 연장하고 환자 유래 샘플에서 면역 세포 반응을 향상시켰습니다.
Medicenna Therapeutics a présenté de nouvelles données précliniques lors de son programme BiSKIT (MDNA113) et de l'agoniste super IL-2 (MDNA11) à la 39ème Réunion Annuelle de la SITC. MDNA113, un nouveau BiSKIT ciblé sur les tumeurs, a obtenu une régression complète de la tumeur dans les tumeurs exprimant l'IL-13Rα2 et a montré un taux de survie de 100 % dans les modèles de cancer du sein. Le traitement a montré une réduction de l'expansion des lymphocytes périphériques et une meilleure tolérance par rapport aux alternatives non masquées. De plus, des recherches indépendantes au Royaume-Uni ont montré des résultats prometteurs avec MDNA11 et le BiSKIT anti-PD1-IL-2SK dans des modèles de glioblastome, prolongeant de manière significative la survie globale et améliorant la réponse des cellules immunitaires dans les échantillons dérivés de patients.
Medicenna Therapeutics stellte neue präklinische Daten aus seinen Programmen BiSKIT (MDNA113) und IL-2 Super Agonist (MDNA11) auf dem 39. jährlichen SITC-Meeting vor. MDNA113, ein neuartiges tumortargetiertes BiSKIT, erreichte eine vollständige Tumorrückbildung in IL-13Rα2-expressierenden Tumoren und zeigte eine Überlebensrate von 100% in Brustkrebsmodellen. Die Behandlung demonstrierte eine reduzierte periphere Lymphozytenexpansion und eine bessere Verträglichkeit im Vergleich zu nicht maskierten Alternativen. Darüber hinaus zeigten unabhängige Forschungen aus dem Vereinigten Königreich vielversprechende Ergebnisse mit MDNA11 und dem anti-PD1-IL-2SK BiSKIT in Modellen von Glioblastomen, wodurch die Gesamtüberlebenszeit signifikant verlängert und die Immunzellreaktion in patientenabgeleiteten Proben verbessert wurde.
- Complete tumor regression achieved in IL-13Rα2 expressing tumors with MDNA113
- 100% survival rate in breast cancer prevention model with single MDNA113 treatment
- Significant extension of survival in glioblastoma models with MDNA11 and anti-PD1-IL-2SK BiSKIT
- Better tolerability profile compared to unmasked alternatives
- None.
MDNA113 is a novel IL-13Rα2 tumor-targeted and “masked” BiSKIT (Bifunctional SuperKine for ImmunoTherapy), engineered to deliver an anti-PD1-IL-2 Superkine (anti-PD1-IL-2SK) to the tumor microenvironment (TME), where it is conditionally activated by tumor-associated proteases
MDNA113 treatment achieved complete tumor regression of IL-13Rα2 expressing tumors, highlighting its potential to treat a vast range of malignancies, including immunologically “cold tumors” that annually affect over two million cancer patients worldwide
Internationally recognized academic teams in the UK showed promising pre-clinical results with a long-acting IL-2SK (MDNA11) and anti-PD1-IL-2SK BiSKIT, in mouse models of glioblastoma (GBM) and patient-derived GBM explants
Updated MDNA11 clinical results from the ABILITY-1 study will be presented tomorrow at SITC
TORONTO and HOUSTON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines, announced that new preclinical data from its BiSKIT (MDNA113) and IL-2 super agonist (MDNA11) programs will be presented today at the 39th Annual Meeting of SITC being held in Houston, Texas. In addition, as announced previously, updated clinical results from the MDNA11 Phase 1/2 ABILITY-1 study will be presented tomorrow, Saturday November 9, 2024 at SITC.
“We are excited to demonstrate our ability to generate novel therapeutics such as MDNA113, to address unmet needs in oncology, by smartly leveraging both our IL-2 and IL-13 Superkine platforms in one molecule,” said Fahar Merchant, Ph.D., President and CEO of Medicenna. “Today’s data demonstrates the effectiveness of MDNA113 to inhibit tumor growth, particularly in IL-13Rα2 positive tumors, and showcase its potential to completely protect and prevent metastasis in an aggressive breast cancer model when administered just once prior to surgery. In a separate presentation, independent work from our academic collaborator in the UK demonstrated the capacity of MDNA11 and anti-PD1-IL-2SK BiSKIT to significantly extend overall survival in an aggressive GBM mouse model and stimulate activity of resident effector immune cells in fresh human GBM explants.”
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, currently being evaluated in the Phase 1/2 ABILITY-1 study for the treatment of advanced and/or metastatic solid tumors.
Key highlights from the presentations are:
MDNA113 is a conditionally activatable anti-PD1-IL-2SK with a cleavable IL-13SK dual masking/tumor-targeting domain to limit systemic immune stimulation while maximizing anti-tumor response
- Mice treated with MDNA113 showed reduced peripheral lymphocyte expansion without impacting anti-PD1/PDL1 blockade, and better tolerability when compared to unmasked anti-PD1-IL-2SK.
- Cleavage by tumor-specific proteases removes the IL-13SK targeting and masking domain of MDNA113, restoring the synergy between IL-2R agonism and anti-PD1 blockade
- Efficacy of MDNA113 is substantially enhanced in mice harboring MC38 tumors that have been engineered to overexpress IL-13Rα2, resulting in complete tumor regression in a vast majority of animals
- Single neoadjuvant treatment (pre-surgery) with MDNA113 in a highly invasive orthotopic 4T1.2 model of triple negative breast cancer resulted in
100% survival by preventing metastasis and enrichment of cytotoxic GrzB-positive CD8+T cells within the tumor microenvironment.
Stimulation of IL-2 signaling with highly selective IL-2R super-agonists enhances immune effector cell response in mouse and patient-derived glioblastomas
- Long-acting IL-2SK (i.e., MDNA11) and anti-PD1-IL-2SK (i.e., therapeutic core of MDNA113) significantly extended the survival of mice bearing aggressive orthotopic GBMs when compared to control mice or mice treated with native IL-2 or anti-PD1.
- GBMs from anti-PD1-IL-2SK treated mice showed higher frequency of infiltrating CD8+T and NK cells with no change in immune suppressive Tregs.
- Ex-vivo primary patient-derived fresh GBM explants treated with IL-2SK or anti-PD1-IL-2SK showed increased CD8+ T and NK cell populations concomitant with reduced tumor cell burden.
Copies of the two presentations will be available on the “Scientific Presentations” page of Medicenna’s website after the conference.
About MDNA113
MDNA113 is a novel, first-in-class tumor-targeted and tumor-activated bi-functional anti-PD1-IL2 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 MDNA11
MDNA11 is an intravenously administered, 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) profile and 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 (NCT05086692) as both monotherapy and in combination with pembrolizumab.
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 MDNA11 and 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.
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Investor/Media Contact:
Christina Cameron
Investor Relations, Medicenna Therapeutics
(647) 953-0673
ir@medicenna.com
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