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
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
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.
多倫多和休斯敦，2024年11月27日（全球新聞社） - Medicenna Therapeutics Corp.（"Medicenna"或"公司"）（TSX：MDNA，OTCQX：MDNAF），一家專注於超級素線研發的處於臨床階段的免疫療法公司，今天宣佈，來自正在進行的1/2期ABILITY-1研究的最新臨床數據將在2024年免疫療法橋樑會議上作爲口頭臺上報告的一部分進行展示，該會議將於2024年12月4-5日在意大利那不勒斯舉行。
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.
口頭報告將包括正在進行的1/2期ABILITY-1研究的單藥和聯合治療陣線的最新臨床數據，評估MDNA11，一種長效的'β增強非α'干擾素-2（"IL-2"）超激動劑，用於晚期或轉移性實體腫瘤患者。
Presentation Details:
演示說明：
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
標題：MDNA11第一人體試驗的安全性和有效性結果更新（ABILITY-1），一種下一代'β增強非α' IL-2 超素，展示單藥物在晚期實體瘤患者中的活性
演示日期：2024年12月5日 星期四 8:45上午歐洲中部時間（美國東部時間2:30上午）
主講者：Dr. Arash Yavari, MBBS, DPhil; 臨床策略董事
Following the presentation, a copy of the presentation will be available on the "Scientific Presentations" page of Medicenna's website.
演示結束後，演示內容的副本將會在Medicenna網站的「科學演示」頁面上提供。
About MDNA11
關於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.
MDNA11是一種靜脈給藥、長效的「β增強不是α」 IL-2 Superkine，經過特別設計以克服aldesleukin和其他下一代IL-2變體的缺點，通過優先激活對殺死癌細胞負責的免疫效應細胞（CD8+ t和Nk細胞），最小或不刺激免疫抑制性Tregs。這種IL-2 Superkine的獨特專有特性得到了通過合併七個特定突變並基因融合到重組人血清白蛋白支架上來改善MDNA11的藥代動力學（PK）和藥理活性，因爲人血清白蛋白在高血管化部位，特別是腫瘤和腫瘤引流淋巴結中很容易積累。MDNA11目前正在進行第1/2期ABILITY-1研究的評估，作爲單藥治療和與pembrolizumab聯合使用。
About the ABILITY-1 Study
關於ABILITY-1研究
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.
ABILITY-1研究（NCT05086692）是一項全球範圍內的多中心、開放標籤研究，旨在評估MDNA11作爲單藥或與pembrolizumab聯合使用時的安全性、耐受性、藥代動力學、藥效動力學及抗腫瘤活性。在第2期研究的聯合劑量遞增部分中，預計將招募並給予大約20名患者MDNA11的靜脈遞增劑量，同時與pembrolizumab聯合使用。這部分研究包括對一系列固體腫瘤患者的研究，這些患者可能對免疫調節治療具有敏感性。在確定了適當的聯合劑量方案後，研究將繼續進行到聯合劑量擴展隊列。
About Medicenna Therapeutics
關於醫藥技術公司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.
Medicenna是一家臨床階段的免疫療法公司，專注於開發新穎、高度選擇性的IL-2、IL-4和IL-13超型蛋白以及首創的Empowered Superkines。Medicenna的長效IL-2 Superkine，MDNA11，是一種下一代IL-2，對CD122(IL-2受體β)具有更強的親和力，不結合CD25(IL-2受體α)，從而優先刺激殺滅癌細胞效應T細胞和Nk細胞。MDNA11正在作爲單藥和與帕博利珠單抗聯合使用在第1/2階段ABILITY-1研究(NCT05086692)中進行評估。Medicenna的IL-4 Empowered Superkine，bizaxofusp(前身爲MDNA55)，已在5項招募超過130名患者的臨床試驗中研究，其中包括用於複發性GBm的第20億期試驗，這是大腦癌最常見且普遍致命的形式。Bizaxofusp已獲得FDA的FastTrack和孤兒藥品地位，分別獲得了FDA/EMA的認可。Medicenna早期的高親和力IL-2β偏向性IL-2/IL-15超拮抗劑，來源於其MDNA209平台，正在評估作爲自身免疫和移植物抗宿主病的潛在治療方案。Medicenna早期的BiSKITs(Bifunctional SuperKine免疫療法)和t-MASk(靶向金屬酶活化的超型蛋白)項目旨在增強Superkines治療免疫"冷"腫瘤的能力。
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Forward-Looking Statements
前瞻性聲明
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.
本新聞發佈包含根據適用證券法的前瞻性聲明。前瞻性聲明包括但不限於有關公司未來運營、估計、計劃、戰略抱負、合作伙伴活動和機會、目標、期望、意見、預測、投影、指引、展望或其他非歷史事實的明示或暗示聲明，例如關於MDNA11（作爲單藥物治療和與Pembrolizumab聯合使用的治療潛力和安全性，以及任何額外臨床更新的時間和/或發佈的聲明。藥物開發和商業化涉及高風險，並且只有少數研發項目最終導致產品商業化。早期前臨床或臨床研究的結果可能並不預示完整結果或後期或大規模臨床研究的結果，並不能保證獲得監管批准。您不應過分依賴這些聲明或所呈現的科學數據。
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. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated 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.
前瞻性聲明通常可根據"將"、"可能"、"應"、"預計"、"預期"、"相信"、"尋求"、"潛在"等表達方式進行識別，並受風險和不確定性的影響。不能保證此類聲明會被證明準確，實際結果和未來事件可能與該類聲明中預期的有重大差異。可能導致實際結果與公司預期有重大差異的重要因素包括公司最新年度信息表格中詳細列出的風險，以及公司不時向加拿大適用證券監管機構提交的其他備案文件中的風險。
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.
讀者應當注意，在準備任何前瞻性信息時所做的假設有可能被證明是不正確的。由於無數已知和未知的風險、不確定性和其他因素，大量已知和未知的風險、不確定性和其他因素可能導致事件或情況導致實際結果與預測結果不同，這是由於公司無法控制。讀者被警告不要過度依賴任何前瞻性信息。儘管管理層認爲這些信息是合理的，但這些信息有可能被證明是不正確的，實際結果可能與預期的結果有很大不同。本新聞發佈所包含的前瞻性聲明在此謹此聲明。本新聞發佈所包含的前瞻性聲明是根據此處的日期進行的，除非法律要求，否則我們沒有意圖並不會承擔更新或修訂所包含的前瞻性聲明的任何義務。
This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this new release.
本新聞稿含有超鏈接到未被視爲本新聞稿參考的信息。
Investor and Company Contact:
投資者和公司聯繫方式：
Christina Cameron
Investor Relations, Medicenna Therapeutics
ir@medicenna.com
(647) 953-0673
Christina Cameron
投資者關係，Medicenna Therapeutics
ir@medicenna.com
(647) 953-0673
Daniel Scarr
Investor Relations & Business Development, Medicenna Therapeutics
dscarr@medicenna.com
(647) 220-4509
丹尼爾·斯卡爾
投資者關係與業務發展，Medicenna Therapeutics
dscarr@medicenna.com
(647) 220-4509
譯文內容由第三人軟體翻譯。
