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.
多倫多和休斯頓,2024年11月27日(環球資訊網)-- Medicenna Therapeutics Corp.("Medicenna"或"公司")(TSX: MDNA,OTCQX: MDNAF),一家專注於Superkines開發的臨床階段免疫治療公司,今天宣佈將於2024年12月4日至5日在意大利那不勒斯舉行的2024年免疫治療橋樑大會上進行關於正在進行的1/2期ABILITY-1研究更新臨床數據的口頭報告。
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.
口頭報告將包括來自正在進行的1/2期ABILITY-1研究的單藥和聯合用藥組的更新臨床數據,該研究評估了針對晚期或轉移性實體瘤患者的MDNA11,一種長效的「β增強型非α」白介素-2("IL-2")超級激動劑。
Presentation Details:
展示詳情:
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
報告日期:2024年12月5日(星期四)上午8:45(中歐時間) (美國東部時間凌晨2:30)
演講者:阿拉什·雅瓦里博士,醫學學士,博士;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.
演講結束後,演示文稿的副本將可在Medicenna網站的「科學演示」頁面上獲取。
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是一種靜脈注射的、開多的「β增強非α」IL-2超級細胞因子,經過特別設計以克服阿德西尤單抗(aldesleukin)和其他下一代IL-2變體的不足,優先激活負責殺死癌細胞的免疫效應細胞(CD8+ T細胞和NK細胞),對免疫抑制性Tregs的刺激最小或沒有。這些IL-2超級細胞因子的獨特專有特性是通過整合七種特定突變並將其基因融合到重組人白蛋白支架上實現的,以改善MDNA11的藥代動力學(PK)特徵和藥理學活性,因爲白蛋白自然傾向於在高度血管化的部位積累,特別是腫瘤及其引流淋巴結。目前MDNA11正在進行1/2期ABILITY-1研究的評估,作爲單藥治療和與帕博利珠單抗聯合使用。
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)是一項全球多中心開放標籤研究,評估MDNA11作爲單藥治療或與pembrolizumab聯合使用的安全性、耐受性、藥代動力學、藥效學和抗腫瘤活性。在2期研究的聯合劑量遞增部分,預計將招募約20名患者,並在靜脈注射中與pembrolizumab聯合使用MDNA11的遞增劑量。該研究部分包括具有廣泛類型實體腫瘤的患者,這些患者可能對免疫調節治療有易感性。在確定適當的聯合劑量方案後,研究將進入聯合劑量擴展隊列。
About Medicenna Therapeutics
關於Medicenna治療公司
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,專注於開發新型高選擇性的IL-2、IL-4和IL-13超級細胞因子及首創的增強型超級細胞因子。Medicenna的長效IL-2超級細胞因子MDNA11是一種具有超強親和力的下一代IL-2,具有對CD122(IL-2受體β)優越的親和力,而不與CD25(IL-2受體α)結合,從而優先刺激癌細胞殺傷效應T細胞和NK細胞。MDNA11作爲單藥和與pembrolizumab聯合使用正在進行1/2期ABILIT-1研究(NCT05086692)。Medicenna的IL-4增強型超級細胞因子bizaxofusp(原名MDNA55)已在5項臨床試驗中進行研究,共招募超過130名患者,包括針對復發GBm的20億期試驗,這是最常見且均致死的腦癌類型。Bizaxofusp已獲得FDA及FDA/EMA的快速通道和孤兒藥地位。Medicenna的早期高親和力IL-2β偏向型IL-2/IL-15超級拮抗劑,來自其MDNA209平台,正在評估作爲自免疫和移植物抗宿主疾病的潛在治療方法。Medicenna的早期雙功能超級細胞因子免疫療法(BiSKITs)和t-MASk(靶向金屬蛋白酶激活的超級細胞因子)項目旨在增強超級細胞因子治療免疫學「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.
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.
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.
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.
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.
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.
This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this new release.
本新聞稿包含不被視爲引用於本新聞稿的信息的超鏈接。
Investor and Company Contact:
投資者和公司聯繫:
Christina Cameron
Investor Relations, Medicenna Therapeutics
ir@medicenna.com
(647) 953-0673
克里斯蒂娜·卡梅隆
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