Medicenna Reports MDNA11’s Compelling Anti-Cancer Activity is Associated with Significant Expansion of ‘Stem-Like’ Cancer Fighting Immune Cells at the Inaugural AACR-Immuno-Oncology Conference and Provides ABILITY-1 Study Update
Medicenna Therapeutics (TSX: MDNA, OTCQX: MDNAF) presented new clinical data from the ABILITY-1 study of MDNA11 at the inaugural AACR Immuno-Oncology Conference. The study evaluates MDNA11 alone or combined with Merck's KEYTRUDA® in advanced solid tumors.
Key highlights include MDNA11's ability to significantly expand 'stem-like' CD8+ T cells, which are associated with more persistent anti-tumor activity. In the monotherapy dose expansion cohort, MDNA11 showed a 30% objective response rate in checkpoint-resistant patients. The combination with KEYTRUDA® demonstrated a 78% disease control rate, including one complete response, one partial response, and five stable disease cases.
The Safety Review Committee cleared the 120 µg/kg MDNA11 dose every two weeks in combination with KEYTRUDA®, with no dose-limiting toxicities observed. The company is also exploring dosing every three weeks for improved patient convenience. Additional tumor types will be evaluated, with combination dose expansion expected to begin mid-2025.
Medicenna Therapeutics (TSX: MDNA, OTCQX: MDNAF) ha presentato nuovi dati clinici dallo studio ABILITY-1 di MDNA11 durante la prima Conferenza AACR sull'Immuno-Oncologia. Lo studio valuta MDNA11 da solo o in combinazione con KEYTRUDA® di Merck in tumori solidi avanzati.
I punti salienti includono la capacità di MDNA11 di espandere significativamente le cellule T CD8+ 'simili a staminali', associate a un'attività anti-tumorale più persistente. Nel coorte di espansione della monoterapia, MDNA11 ha mostrato un tasso di risposta obiettivo del 30% nei pazienti resistenti ai checkpoint. La combinazione con KEYTRUDA® ha dimostrato un tasso di controllo della malattia del 78%, inclusa una risposta completa, una risposta parziale e cinque casi di malattia stabile.
Il Comitato di Revisione della Sicurezza ha approvato la dose di 120 µg/kg di MDNA11 ogni due settimane in combinazione con KEYTRUDA®, senza osservare tossicità limitanti alla dose. L'azienda sta anche esplorando la somministrazione ogni tre settimane per migliorare il comfort del paziente. Ulteriori tipi di tumori saranno valutati, con l'espansione della dose combinata prevista per iniziare a metà 2025.
Medicenna Therapeutics (TSX: MDNA, OTCQX: MDNAF) presentó nuevos datos clínicos del estudio ABILITY-1 de MDNA11 en la inaugural Conferencia AACR sobre Inmuno-Oncología. El estudio evalúa MDNA11 solo o combinado con KEYTRUDA® de Merck en tumores sólidos avanzados.
Los aspectos más destacados incluyen la capacidad de MDNA11 para expandir significativamente las células T CD8+ 'parecidas a células madre', que están asociadas con una actividad anti-tumoral más persistente. En la cohorte de expansión de monoterapia, MDNA11 mostró una tasa de respuesta objetiva del 30% en pacientes resistentes a los puntos de control. La combinación con KEYTRUDA® demostró una tasa de control de la enfermedad del 78%, incluyendo una respuesta completa, una respuesta parcial y cinco casos de enfermedad estable.
El Comité de Revisión de Seguridad aprobó la dosis de 120 µg/kg de MDNA11 cada dos semanas en combinación con KEYTRUDA®, sin observar toxicidades limitantes de dosis. La empresa también está explorando la dosificación cada tres semanas para mejorar la comodidad del paciente. Se evaluarán tipos adicionales de tumores, con la expansión de la dosis combinada prevista para comenzar a mediados de 2025.
메디센나 테라퓨틱스(MDNA, OTCQX: MDNAF)는 최초의 AACR 면역종양학 회의에서 MDNA11의 ABILITY-1 연구에서 새로운 임상 데이터를 발표했습니다. 이 연구는 고급 고형 종양에서 MDNA11 단독 또는 머크의 KEYTRUDA®와 결합하여 평가합니다.
주요 하이라이트는 MDNA11이 더 지속적인 항종양 활성이 연관된 '줄기세포 유사' CD8+ T 세포를 유의미하게 확장할 수 있다는 것입니다. 단독 요법 용량 확장 집단에서 MDNA11은 체크포인트 저항 환자에서 30%의 객관적 반응률을 보였습니다. KEYTRUDA®와의 조합은 한 건의 완전 반응, 한 건의 부분 반응, 다섯 건의 안정적인 질병 사례를 포함하여 78%의 질병 조절률을 나타냈습니다.
안전성 검토 위원회는 KEYTRUDA®와의 조합에서 120 µg/kg MDNA11 용량을 2주마다 투여하는 것을 승인했으며, 용량 제한 독성은 관찰되지 않았습니다. 회사는 또한 환자 편의를 위해 3주마다 투여하는 방안을 탐색하고 있습니다. 추가 종양 유형이 평가될 예정이며, 조합 용량 확장은 2025년 중반에 시작될 것으로 예상됩니다.
Medicenna Therapeutics (TSX: MDNA, OTCQX: MDNAF) a présenté de nouvelles données cliniques de l'étude ABILITY-1 sur MDNA11 lors de la première Conférence AACR sur l'Immuno-Oncologie. L'étude évalue MDNA11 seul ou en combinaison avec KEYTRUDA® de Merck dans des tumeurs solides avancées.
Les points clés incluent la capacité de MDNA11 à élargir significativement les cellules T CD8+ 'semblables à des cellules souches', qui sont associées à une activité anti-tumorale plus persistante. Dans la cohorte d'expansion de monothérapie, MDNA11 a montré un taux de réponse objective de 30% chez les patients résistants aux points de contrôle. La combinaison avec KEYTRUDA® a démontré un taux de contrôle de la maladie de 78%, incluant une réponse complète, une réponse partielle et cinq cas de maladie stable.
Le Comité d'examen de la sécurité a approuvé la dose de 120 µg/kg de MDNA11 toutes les deux semaines en combinaison avec KEYTRUDA®, sans observer de toxicités limitantes de la dose. L'entreprise explore également une posologie toutes les trois semaines pour améliorer le confort des patients. D'autres types de tumeurs seront évalués, avec une expansion de la dose combinée prévue pour débuter à la mi-2025.
Medicenna Therapeutics (TSX: MDNA, OTCQX: MDNAF) hat auf der ersten AACR-Konferenz für Immunonkologie neue klinische Daten aus der ABILITY-1-Studie zu MDNA11 präsentiert. Die Studie bewertet MDNA11 allein oder in Kombination mit Mercks KEYTRUDA® bei fortgeschrittenen soliden Tumoren.
Wichtige Höhepunkte sind die Fähigkeit von MDNA11, 'stammzellähnliche' CD8+ T-Zellen signifikant zu erweitern, die mit einer nachhaltigeren anti-tumoralen Aktivität verbunden sind. In der Monotherapie-Dosis-Erweiterungsgruppe zeigte MDNA11 eine objektive Ansprechrate von 30% bei checkpoint-resistenten Patienten. Die Kombination mit KEYTRUDA® zeigte eine Krankheitskontrollrate von 78%, einschließlich einer kompletten Antwort, einer partiellen Antwort und fünf stabilen Krankheitsfällen.
Das Sicherheitsprüfungskomitee genehmigte die Dosis von 120 µg/kg MDNA11 alle zwei Wochen in Kombination mit KEYTRUDA®, ohne dass dosislimitierende Toxizitäten festgestellt wurden. Das Unternehmen untersucht auch eine Dosierung alle drei Wochen zur Verbesserung des Patientenkomforts. Weitere Tumorarten werden bewertet, und eine Erweiterung der Kombinationsdosis wird voraussichtlich Mitte 2025 beginnen.
- 30% objective response rate in monotherapy cohort for checkpoint-resistant patients
- 78% disease control rate in combination with KEYTRUDA®
- One complete response and one partial response in combination therapy
- No dose-limiting toxicities observed in combination therapy
- Significant expansion of stem-like CD8+ T cells associated with clinical responses
- Consistent pharmacokinetic profiles with repeated dosing
- Combination dose expansion not expected until mid-2025
- Complete monotherapy expansion and combination dose escalation enrollment still pending (expected mid-2025)
MDNA11 significantly expands a unique population of ‘stem-like’ CD8+ T cells that leads to more persistent and effective anti-tumor activity
MDNA11 has shown durable single agent activity, with a
Disease control rate (DCR) of
Safety Review Committee cleared the 120 µg/kg MDNA11 every two weeks in combination with KEYTRUDA® as no dose-limiting toxicities (DLTs) have been observed to date
To improve patient convenience, dosing of 120 µg/kg MDNA11 every three weeks as a monotherapy or in combination with KEYTRUDA® is currently in progress
Additional tumor types to be evaluated as part of ABILITY-1 Study in monotherapy and combination dose expansion cohorts with combination dose expansion expected to initiate mid 2025
Updated safety and efficacy results of MDNA11 as a monotherapy and in combination with KEYTRUDA® are to be presented at medical conferences in H1 2025
TORONTO and HOUSTON, Feb. 25, 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, today announced the presentation of new clinical data from its ongoing ABILITY-1 study evaluating MDNA11 alone or in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors. The data was presented in a late-breaking abstract at the inaugural American Association for Cancer Research Immuno-Oncology Conference (AACR-IO), taking place in Los Angeles, California, from February 23-26, 2025.
Cancer often leaves the immune system in a state of exhaustion, where its frontline defenders – CD8+ T cells – lose their ability to function effectively. Checkpoint inhibitors, such as anti-PD-1, have been shown to reinvigorate exhausted T cells and improve the outcome in patients with cancer. Unfortunately, only a fraction of the patients with cancer respond to PD-1 blockade, thus prompting a vigorous search for other pathways that can improve the efficacy of immunotherapies. A rare type of immune cells, called stem-like CD8+ T cells, holds the key to maintaining powerful, long-term immune responses. Stem-like T cells have the remarkable ability to resist burnout, have the ability to renew themselves, to proliferate, and remain in battle mode until all tumor cells are eliminated.
“To the best of our knowledge these are the first reported human clinical data to demonstrate the ability of any type of IL-2 to dramatically boost the population of stem-like T cells that subsequently result in durable tumor control,” said Dr Fahar Merchant, President and CEO of Medicenna. “Stem-like T cells are like the ‘superheroes’ of the immune system. They can renew themselves, multiply, and keep fighting cancer over time. What’s exciting about these pharmacodynamic data is that they provide us with a potential roadmap for how we might further reinvigorate the immune system with MDNA11 to leverage stem-like T cells, the immune system’s secret power, to improve health outcomes for people living with cancer, further demonstrating MDNA11’s best-in-class potential.”
Dr. Arash Yavari, Director of Clinical Strategy at Medicenna, added, “The combination of MDNA11 with KEYTRUDA® in ABILITY-1 has shown consistent pharmacokinetic and pharmacodynamic profiles with repeated dosing. Combined with preliminary evidence of clinical activity in less immunologically responsive tumor types observed to date during combination dose escalation, these findings highlight the potential of MDNA11 to enhance both the efficacy and scope of immune checkpoint inhibition. We have also announced the addition of several new tumor types in the ABILITY-1 trial. We are confident about the potential of the combination of MDNA11 with KEYTRUDA® to improve outcomes for patients with a range of difficult-to-treat cancers.”
Key Highlights from the Presentation:
Pharmacokinetics
- MDNA11 exhibits consistent PK profiles with repeat administration as both single agent and when combined with KEYTRUDA®.
Pharmacodynamics
- MDNA11 associated with dose-dependent expansion of CD8+ T and NK cells which is sustained over repeat dose cycles as both single agent and when combined with KEYTRUDA®.
- Significant expansion of activated effector CD8+ T cells, effector memory T cells and central memory T cells with MDNA11, key immune cell subsets associated with durable anti-tumor response.
- MDNA11 promotes the expansion of a unique subset of cancer fighting CD8+ T Cells with stem-like properties: MDNA11 significantly expands a unique progenitor population of stem-like TCF1+ CD8+ T cells, which possess remarkable self-renewal capabilities and have the ability to differentiate into potent effector cells upon encountering tumor antigen to promote sustained anti-tumor immune responses. These cells are regarded as critical for maintaining long-lasting anti-tumor immunity and have been positively linked to immunotherapy responses such as immune checkpoint blockade.
- Greater expansion of stem-like CD8+ T cells was significantly associated with clinical responses to MDNA11 (pooled monotherapy and combination therapy data).
Other ABILITY-1 Study Updates:
- Additional tumor types to be evaluated as part of MDNA11 monotherapy and KEYTRUDA® combination dose expansion cohorts: MSI-H/dMMR, TMB-H, cutaneous melanoma, virally associated tumors (monotherapy portion only), and gynecological tumors (combination portion only).
- Completion of monotherapy expansion and combination dose escalation enrollment anticipated mid calendar 2025.
- Combination dose expansion expected to initiate mid calendar 2025.
A copy of the presentation has been posted on the “Scientific Presentations” page of Medicenna’s website.
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. MDNA11 is being evaluated in the Phase 1/2 ABILITY-1 Study (NCT05086692) as monotherapy and in combination with KEYTRUDA®. 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 medicenna.com, and follow us on Twitter and LinkedIn.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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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.
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