Medicenna Provides Clinical Update and Announces First Complete Responder in MDNA11 and KEYTRUDA® (pembrolizumab) Combination Dose Escalation Arm of the ABILITY-1 Study
Medicenna Therapeutics announced updated clinical data from its Phase 1/2 ABILITY-1 study, highlighting significant progress in cancer treatment. A notable achievement includes the first complete response (CR) in a 70-year-old patient with advanced anal cancer within 8 weeks of treatment combining MDNA11 with KEYTRUDA®.
The study demonstrates promising disease control rates of 55% in monotherapy and 78% in combination arms. Key findings include durable complete regression in two CPI-resistant patients, with one melanoma patient remaining tumor-free at week 63 and a pancreatic cancer patient maintaining response for 11 months post-study.
Safety profile shows over 90% of treatment-related adverse events were Grade 1-2 and transient. Additional clinical data will be presented at medical conferences in Q1 and Q2 of 2025.
Medicenna Therapeutics ha annunciato dati clinici aggiornati dal suo studio di Fase 1/2 ABILITY-1, evidenziando progressi significativi nel trattamento del cancro. Un risultato notevole include la prima risposta completa (CR) in un paziente di 70 anni con cancro anale avanzato, ottenuta entro 8 settimane dal trattamento che combina MDNA11 con KEYTRUDA®.
Lo studio dimostra promettenti tassi di controllo della malattia, pari al 55% in monoterapia e al 78% nelle combinazioni. I risultati chiave includono una regressione completa durevole in due pazienti resistenti ai CPI, con un paziente affetto da melanoma rimasto senza tumore alla settimana 63 e un paziente con cancro pancreatico che ha mantenuto la risposta per 11 mesi dopo lo studio.
Il profilo di sicurezza mostra che oltre il 90% degli eventi avversi correlati al trattamento erano di Grado 1-2 e transitori. Ulteriori dati clinici verranno presentati in conferenze mediche nel primo e nel secondo trimestre del 2025.
Medicenna Therapeutics anunció datos clínicos actualizados de su estudio de Fase 1/2 ABILITY-1, destacando importantes avances en el tratamiento del cáncer. Un logro notable es la primera respuesta completa (CR) en un paciente de 70 años con cáncer anal avanzado, obtenida en 8 semanas de tratamiento combinando MDNA11 con KEYTRUDA®.
El estudio muestra tasas prometedoras de control de la enfermedad del 55% en monoterapia y del 78% en los brazos de combinación. Los hallazgos clave incluyen una regresión completa duradera en dos pacientes resistentes a CPI, con un paciente de melanoma que permanece libre de tumor en la semana 63 y un paciente con cáncer pancreático que mantiene la respuesta durante 11 meses después del estudio.
El perfil de seguridad muestra que más del 90% de los eventos adversos relacionados con el tratamiento fueron de Grado 1-2 y transitorios. Datos clínicos adicionales se presentarán en conferencias médicas en el primer y segundo trimestre de 2025.
Medicenna Therapeutics는 Fase 1/2 ABILITY-1 연구의 업데이트된 임상 데이터를 발표하며 암 치료에서 중요한 진전을 강조했습니다. 주목할 만한 성과는 MDNA11과 KEYTRUDA®의 조합 치료 8주 만에 진행성 항문암을 앓고 있는 70세 환자에서 처음으로 완전 반응(CR)을 기록한 것입니다.
연구 결과 단일요법에서 55%, 조합요법에서 78%의 유망한 질병 조절 비율을 보여줍니다. 주요 발견으로는 CPI에 저항하는 두 환자에게서 지속적인 완전 퇴행이 있었으며, 한 멜라노마 환자는 63주째 종양이 없는 상태를 유지하고, 췌장암 환자는 연구 후 11개월 동안 반응을 유지했습니다.
안전 프로필에서는 치료와 관련된 부작용의 90% 이상이 1-2도였으며 일시적이었습니다. 추가 임상 데이터는 2025년 1분기와 2분기 의학 회의에서 발표될 예정입니다.
Medicenna Therapeutics a annoncé des données cliniques mises à jour de son étude de Phase 1/2 ABILITY-1, mettant en évidence des progrès significatifs dans le traitement du cancer. Un accomplissement notoire comprend la première réponse complète (CR) chez un patient de 70 ans atteint d’un cancer anal avancé, obtenue dans les 8 semaines suivant un traitement combinant MDNA11 avec KEYTRUDA®.
L'étude démontre des taux de contrôle prometteurs de la maladie de 55% en monothérapie et de 78% dans les bras de combinaison. Les principales découvertes incluent une régression complète durable chez deux patients résistants aux CPI, un patient atteint de mélanome restant sans tumeur à la semaine 63 et un patient atteint de cancer du pancréas maintenant sa réponse pendant 11 mois après l'étude.
Le profil de sécurité montre qu'au-delà de 90% des événements indésirables liés au traitement étaient de Grade 1-2 et transitoires. Des données cliniques supplémentaires seront présentées lors de conférences médicales au premier et au deuxième trimestre de 2025.
Medicenna Therapeutics hat aktualisierte klinische Daten aus ihrer Phase 1/2 ABILITY-1-Studie bekannt gegeben, die bedeutende Fortschritte in der Krebsbehandlung hervorheben. Ein bemerkenswerter Erfolg ist die erste vollständige Reaktion (CR) bei einem 70-jährigen Patienten mit fortgeschrittenem Analkrebs, die innerhalb von 8 Wochen der Behandlung mit MDNA11 in Kombination mit KEYTRUDA® erreicht wurde.
Die Studie zeigt vielversprechende Krankheitskontrollraten von 55% in der Monotherapie und 78% in den Kombinationsarmen. Wichtige Ergebnisse umfassen eine dauerhafte vollständige Regression bei zwei CPI-resistenten Patienten, wobei ein Melanom-Patient in der Woche 63 tumorfrei bleibt und ein Bauchspeicheldrüsenkrebs-Patient 11 Monate nach der Studie die Reaktion aufrechterhält.
Das Sicherheitsprofil zeigt, dass über 90% der behandlungsbedingten Nebenwirkungen Grad 1-2 und vorübergehend waren. Weitere klinische Daten werden in medizinischen Konferenzen im ersten und zweiten Quartal 2025 präsentiert.
- First complete response achieved in combination therapy for advanced anal cancer within 8 weeks
- High disease control rates: 55% in monotherapy and 78% in combination arms
- Durable responses in CPI-resistant patients, including one patient tumor-free at week 63
- Favorable safety profile with 90% of adverse events being Grade 1-2
- 30% objective response rate in monotherapy dose expansion arm
- patient sample size (N=9) in combination dose escalation arm
- Study still in early phases with ongoing dose escalation
70-year-old patient with advanced chemo-refractory anal cancer achieves complete response (CR) in 8 weeks when treated with MDNA11 in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab)
Complete regression of all tumors in two CPI-resistant patients in monotherapy arms continue to show durability with a patient with melanoma remaining tumor free at week 63 while a patient with pancreatic cancer remains off all anti-cancer therapy for 11 months after completing the study
A patient with advanced MSS colorectal cancer with a previously announced partial response (PR) continues treatment in the combination escalation arm as of week 32 with a confirmed PR
Both objective responses (1 CR and 1PR) among evaluable patients in the combination dose escalation arm (N=9) are in tumor types with high unmet need and where checkpoint inhibitors (CPI) have not been approved
The ABILITY-1 study is showing promising disease control rates (DCR = CR+PR+SD) of
Additional monotherapy and combination clinical data from the ABILITY-1 study will be presented at medical conferences in Q1 and Q2 of 2025
TORONTO and HOUSTON, Dec. 05, 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 updated clinical data from the ongoing Phase 1/2 ABILITY-1 study were presented today at the 2024 Immunotherapy Bridge held in Naples, Italy.
The oral presentation by Dr Arash Yavari, MB BS, DPhil, included new data highlighting the first complete response (CR) in the combination dose escalation phase of the study in a 70-year-old patient with advanced anal squamous cell carcinoma (anal SCC), in addition to follow up safety and efficacy results from the monotherapy and combination arms of the ABILITY-1 study. The anal SCC patient previously progressed on two prior lines of treatment comprising of chemotherapy combination and chemo-radiation treatments. The patient achieved a
“These remarkable results from our monotherapy and early data from the combination dose escalation highlights the transformative potential of MDNA11 as a combination therapy with checkpoint inhibitors like KEYTRUDA®, while demonstrating an acceptable safety profile as dose escalation continues,” said Fahar Merchant, PhD, President and CEO of Medicenna. “Achieving a complete response in a patient with anal squamous cell carcinoma, a cancer with historically low immunotherapy response rates, demonstrates MDNA11’s ability to reinvigorate the immune system and tackle difficult-to-treat tumors. We look forward to sharing additional clinical data at medical conferences in Q1 and Q2 of 2025 as we advance MDNA11 as a potent and safe immunotherapy to dramatically improve current immunotherapies and deliver life-changing outcomes for patients.”
Key findings from the on-going ABILITY-1 study (data cut-off as of November 18th, 2024) include:
Safety Profile
- MDNA11 has a favorable safety profile both as a monotherapy and in combination with KEYTRUDA®. Over
90% of treatment-related adverse events (TRAEs) were Grade 1-2 and transient, with no DLTs or new safety signals observed in combination dose escalation cohorts. MDNA11 at doses of 120 µg /kg (Q3W monotherapy; Q2W and Q3W in combination with Keytruda (400 mg Q6W) are currently being evaluated.
Immunodynamics
- MDNA11 preferentially expands immune effector cells, including activated (CD25+) and “stemness-like” (TCF-1+) CD8+ T cells, which are critical for sustained anti-tumor responses.
- Robust, dose-dependent lymphocyte expansion in combination with KEYTRUDA®, sustained with repeat MDNA11 dosing.
Monotherapy Tumor Response in Immune Checkpoint Inhibitor-Resistant Patients
MDNA11 continues to demonstrate encouraging deep and durable single-agent anti-tumor activity among patients who progressed on prior ICI therapy:
- An objective response rate (ORR) of
30% in the monotherapy dose expansion arm with 3 PRs among 10 patients who had all previously failed ICI therapy and had advanced and/or metastatic melanoma, non-melanoma skin cancer or MSI-H/dMMR tumors. The ORR is25% from a total of 20 patients when including 10 phase 2 eligible patients from the MDNA11 monotherapy dose escalation arm who received at least 60 µg/kg MDNA11 and were ICI-resistant. - Overall, objective responses in ICI-resistant patients include 1 CR and 4 PRs
- 2 PRs among 3 MSI-H patients (ORR of
66.7% ) with both responders having metastatic pancreatic ductal adenocarcinoma (PDAC). - 1 CR and 2 PRs among 11 patients with cutaneous melanoma (ORR of
27.3% ).
- 2 PRs among 3 MSI-H patients (ORR of
- Complete resolution of all target and non-target lesions in two patients:
- 1 confirmed CR in a melanoma patient continues on treatment as of week 63.
- Pancreatic cancer patient (MSI-H) achieved complete resolution of target and non-target metastatic lesions in the liver including a new lesion treated with MDNA11 following a single cycle of radiation, achieved durable response for 20 months during the study and continues to remain off anti-cancer therapy for 11 months.
- SD in 6 patients for a disease control rate (DCR = CR+PR+SD) of
55% including 3 with duration > 6 months, yielding a clinical benefit rate of40% (8/20).
MDNA11 Combination with KEYTRUDA® Tumor Response
The objective of the combination dose escalation/evaluation portion of the ABILITY-1 study is to assess the safety, pharmacokinetics and immunodynamics of MDNA11 at various doses and dosing regimens when combined with KEYTRUDA® (400mg, Q6W), and to determine the recommended dose and schedule for the combination dose expansion portion of the study.
Encouraging preliminary signs of anti-tumor activity have been observed with MDNA11 in combination with KEYTRUDA® to date in dose escalation cohorts 1 (60 µg/kg Q2W MDNA11) and 2 (90 µg/kg Q2W MDNA11). Among 9 heavily pre-treated, efficacy-evaluable patients, tumor control was observed in 7 patients for a DCR of
- CR in a 70-year-old male with anal squamous cell carcinoma
- Patient progressed on 2 prior lines of chemotherapy (1L capecitabine/mitomycin plus radiation therapy; 2L carboplatin/paclitaxel)
- CR achieved on first study evaluable imaging scan at Week 8; patient continues on combination treatment
- Confirmed PR in 52-year-old female with MSS colorectal cancer
- Patient progressed on 2 prior lines of chemotherapy (1L folinate/fluorouracil/oxaliplatin; 2L capecitabine)
- Continues on combination treatment as of week 32
A copy of the presentation has been posted 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 KEYTRUDA®.
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 KEYTRUDA®. 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 KEYTRUDA®. 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 combination dose expansion.
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 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 www.medicenna.com, and follow us on Twitter and LinkedIn.
Forward-Looking Statements
This news release may contain 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 treatment potential and safety profile of MDNA11 (both as monotherapy and in combination with KEYTRUDA®) 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.
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.
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 or implied in forward-looking statements. 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
ir@medicenna.com
(647) 953-0673
Daniel Scarr
Investor Relations & Business Development
dscarr@medicenna.com
(647) 220-4509
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