Updated MDNA11 Monotherapy and Combination Clinical Data from the Ongoing Phase 1/2 ABILITY-1 Study to be Presented at the 2024 Immunotherapy Bridge Conference
Medicenna Therapeutics announced it will present updated clinical data from its ongoing Phase 1/2 ABILITY-1 study at the 2024 Immunotherapy Bridge Conference in Naples, Italy. The presentation will showcase results from both monotherapy and combination arms evaluating MDNA11, a long-acting 'beta-enhanced not-alpha' interleukin-2 super-agonist, in patients with advanced or metastatic solid tumors. Dr. Arash Yavari will deliver the presentation on December 5, 2024, focusing on safety and efficacy results from this first-in-human study.
Medicenna Therapeutics ha annunciato che presenterà dati clinici aggiornati del suo studio in corso di Fase 1/2 ABILITY-1 alla Conferenza sul Ponte dell'Immunoterapia del 2024 a Napoli, in Italia. La presentazione mostrerà i risultati sia dal braccio della monoterapia sia da quello della combinazione che valutano MDNA11, un super-agonista dell'interleuchina-2 «beta-enhanced not-alpha» a lunga durata d'azione, in pazienti con tumori solidi avanzati o metastatici. Il Dr. Arash Yavari effettuerà la presentazione il 5 dicembre 2024, concentrandosi sui risultati di sicurezza ed efficacia di questo studio pionieristico.
Medicenna Therapeutics anunció que presentará datos clínicos actualizados de su estudio en curso de Fase 1/2 ABILITY-1 en la Conferencia de Inmunoterapia del Puente 2024 en Nápoles, Italia. La presentación mostrará los resultados de los brazos de monoterapia y combinación que evalúan MDNA11, un superagonista de interleucina-2 'beta-enhanced not-alpha' de acción prolongada, en pacientes con tumores sólidos avanzados o metastásicos. El Dr. Arash Yavari realizará la presentación el 5 de diciembre de 2024, centrándose en los resultados de seguridad y eficacia de este estudio pionero en humanos.
메디센나 치료제는 그들의 진행 중인 1/2상 ABILITY-1 연구의 업데이트된 임상 데이터를 2024년 나폴리, 이탈리아에서 열리는 면역요법 브리지 컨퍼런스에서 발표할 것임을 발표했습니다. 발표에서는 고급 또는 전이성 고형 종양 환자에서 MDNA11의 단독 요법과 병용 요법의 결과를 보여줄 예정입니다. 아라시 야바리 박사가 2024년 12월 5일 발표를 진행하며, 이 인체 최초 연구의 안전성과 효능 결과에 중점을 둘 것입니다.
Medicenna Therapeutics a annoncé qu'elle présentera des données cliniques mises à jour de son étude en cours de Phase 1/2 ABILITY-1 lors de la Conférence sur le Pont d'Immunothérapie 2024 à Naples, en Italie. La présentation mettra en avant les résultats des bras de monothérapie et de combinaison évaluant MDNA11, un super-agoniste de l'interleukine-2 « beta-enhanced not-alpha » à longue durée d'action, chez des patients atteints de tumeurs solides avancées ou métastatiques. Le Dr Arash Yavari fera la présentation le 5 décembre 2024, en se concentrant sur les résultats de sécurité et d'efficacité de cette étude pionnière chez l'homme.
Medicenna Therapeutics gab bekannt, dass es aktualisierte klinische Daten aus seiner laufenden Phase-1/2-Studie ABILITY-1 auf der Immuntherapie Bridge Conference 2024 in Neapel, Italien, präsentieren wird. Die Präsentation wird Ergebnisse aus den Monotherapie- und Kombinationsteilen zeigen, die MDNA11, einen langwirksamen 'beta-enhanced not-alpha' Interleukin-2-Superagonisten, bei Patienten mit fortgeschrittenen oder metastatischen soliden Tumoren bewerten. Dr. Arash Yavari wird die Präsentation am 5. Dezember 2024 halten und dabei die Sicherheits- und Wirksamkeitsresultate dieser ersten menschlichen Studie hervorheben.
- Study shows single-agent activity in patients with advanced solid tumors
- None.
TORONTO and HOUSTON, Nov. 27, 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 today that updated clinical data from the ongoing Phase 1/2 ABILITY-1 study will be presented as part of an oral podium presentation at the 2024 Immunotherapy Bridge Conference, taking place from December 4-5, 2024 in Naples, Italy.
The oral presentation will include updated clinical data from the monotherapy and combination arms of the ongoing Phase 1/2 ABILITY-1 Study evaluating MDNA11, a long-acting ‘beta-enhanced not-alpha’ interleukin-2 (“IL-2”) super-agonist, in patients with advanced or metastatic solid tumors.
Presentation Details:
Title: Updated Safety and Efficacy Results from the First-in-Human Study of MDNA11 (ABILITY-1), a Next Generation ‘Beta-Enhanced Not-Alpha’ IL-2 Superkine, Show Single-Agent Activity in Patients with Advanced Solid Tumors
Presentation Date: Thursday, December 5, 2024 8:45 AM CET (2:30 AM EST)
Presenter: Dr. Arash Yavari, MBBS, DPhil; Director of Clinical Strategy
Following the presentation, a copy of the presentation will be available on the “Scientific Presentations” page of Medicenna’s website.
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 as both monotherapy and in combination with pembrolizumab.
About the ABILITY-1 Study
The ABILITY-1 study (NCT05086692) is a global, multi-center, open-label study that assesses the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MDNA11 as monotherapy or in combination with pembrolizumab. In the combination dose escalation portion of the Phase 2 study, approximately 20 patients are expected to be enrolled and administered ascending doses of MDNA11 intravenously in combination with pembrolizumab. This portion of the study includes patients with a wide range of solid tumors with the potential for susceptibility to immune modulating therapeutics. Upon identification of an appropriate dose regimen for combination, the study will proceed to a combination dose expansion cohort.
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 a monotherapy and in combination with pembrolizumab. 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 (both as monotherapy and in combination with pembrolizumab), 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.
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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.
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Investor and Company Contact:
Christina Cameron
Investor Relations, Medicenna Therapeutics
ir@medicenna.com
(647) 953-0673
Daniel Scarr
Investor Relations & Business Development, Medicenna Therapeutics
dscarr@medicenna.com
(647) 220-4509
FAQ
What will be presented at the 2024 Immunotherapy Bridge Conference regarding MDNAF's ABILITY-1 study?
When and where will MDNAF present the ABILITY-1 study results?
What is MDNA11 being evaluated for in the ABILITY-1 study?
