Medicenna Announces EMA Approval of Its Clinical Trial Application to Expand Its Phase 1/2 ABILITY-1 Study to Europe
Medicenna Announces EMA Approval of Its Clinical Trial Application to Expand Its Phase 1/2 ABILITY-1 Study to Europe
- ABILITY-1 study is currently enrolling patients for the treatment of advanced solid tumors with MDNA11, a novel long-acting IL-2 super-agonist, as a monotherapy or in combination with KEYTRUDA, at clinical trial sites in U.S.A., Canada, Australia, and Korea
ABILITY-1研究目前正在招募病人接受MDNA11的治療，這是一種新型的長效IL-2超激動劑，作爲單藥或與KEYTRUDA聯合使用，以治療晚期實體瘤。在美國，加拿大，澳洲和韓國的臨床試點中。ABILITY-1研究的單藥擴展和聯合升級數據預計在2024年下半年公佈。
- Monotherapy expansion and combination escalation data of the ABILITY-1 study are expected in H2 2024
TORONTO和HOUSTON，2024年6月26日（全球資訊） - Medicenna Therapeutics Corp.（“Medicenna”或“公司”）（TSX：MDNA，OTCQB：MDNAF），一家專注於開發超級激素的臨床免疫治療公司，今天宣佈，歐洲藥品管理局（“EMA”）已批准MDNA11進行臨床試驗應用程序（“CTA”）進行相應的一期/二期ABILITY-1（僅βIL-2免疫治療）研究，用於單藥或與PEMBROLIZUMAB（KEYTRUDA）聯合使用，從而擴大了在歐洲聯盟的臨床試驗。MDNA11是該公司的長效“β增強非α”IL-2超激動劑，並且目前正在美國，加拿大，澳洲和韓國的臨床試點中招募晚期實體瘤病人進行ABILITY-1試驗。
TORONTO and HOUSTON, June 26, 2024 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQB: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines, today announced that the European Medicines Agency ("EMA") has approved the Clinical Trial Application ("CTA") for the conduct of the Phase 1/2 ABILITY-1 (A Beta-only IL-2 ImmunoTherapY) Study with MDNA11 either alone or in combination with pembrolizumab (KEYTRUDA) thereby expanding the clinical trial in the European Union ("EU"). MDNA11 is the Company's long-acting, "beta-enhanced not-alpha" IL-2 super-agonist and is currently enrolling patients with advanced solid tumors in the ABILITY-1 trial at clinical trial sites in U.S.A., Canada, Australia, and Korea.
“我們很高興能夠在我們正在進行的ABILITY-1研究中建立起早期成功和有前途的療效和安全性，正展示出MDNA11的最佳潛力，”Medicenna的總裁和首席執行官Fahar Merchant博士說道。 “將臨床試驗擴展到歐洲的各個中心是重要的里程碑，也爲我們MDNA11計劃的積極勢頭增添了動力。我們預計，歐洲的擴張將加速試驗的招募，並推進ABILITY-1研究的單藥擴展和聯合升級部分的關鍵更新，這些將在2024年下半年的醫學會議上展示。”ABILITY-1研究旨在評估靜脈注射MDNA11的不同劑量對晚期複發性或難治性實體瘤患者的安全性，藥代動力學，藥效學和抗腫瘤活性，幷包括MDNA11單藥療法和聯合療法，目的是評估MDNA11與pembrolizumab的聯合療效（KEYTRUDA）。
"We are excited to build on the early success and promising efficacy and safety of our ongoing ABILITY-1 study that is demonstrating MDNA11's best-in-class potential," said Fahar Merchant, PhD, President & CEO of Medicenna. "Expanding the clinical trial to various centers in the EU is an important milestone and adds to the positive momentum behind our MDNA11 program. We anticipate that the expansion to Europe will expedite enrolment in the trial and advance the study towards key updates in the monotherapy expansion and combination escalation portions of the ABILITY-1 study which will be presented at medical conferences during H2 2024."
關於MDNA11
The ABILITY-1 study is designed to assess the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of various doses of intravenously administered MDNA11 in patients with advanced, relapsed, or refractory solid tumors and includes an MDNA11 monotherapy arm, as well as a combination arm designed to evaluate MDNA11 in combination with pembrolizumab (KEYTRUDA).
MDNA11是一種長效的“β增強非α”白細胞介素-2（IL-2）超級素，通過選擇性激活免疫效應細胞（CD4，CD8 T細胞和NK細胞）來殺死癌細胞，減少或沒有對免疫抑制性Treg（調節性T細胞）的刺激，從而克服了aldesleukin和其他下一代IL-2變體的缺點。這些IL-2超級素獨特的專有特徵是通過融合七個特定突變體和遺傳改造人臍帶白蛋白結構體來實現的，以改善MDNA11的藥代動力學（PK）特性和藥理活性，由於白蛋白在高度血管化的部位，特別是腫瘤和引流淋巴結的自然趨向而積累。MDNA11目前正在進行第一/二期ABILITY-1研究，既是單藥療法，也是與pembrolizumab（KEYTRUDA）聯合療法。).
About MDNA11
關於ABILITY-1研究
MDNA11 is a long-acting 'beta-enhanced not-alpha' interleukin-2 (IL-2) Superkine specifically engineered to overcome the shortcomings of aldesleukin and other next generation IL-2 variants by preferentially activating immune effector cells (CD4+ T, 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 a monotherapy and in combination with pembrolizumab (KEYTRUDA).
ABILITY-1研究（NCT05086692）是一個全球性的多中心開放性研究，旨在評估MDNA11作爲單藥或與pembrolizumab（KEYTRUDA）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。在該研究中，約有12名患有各種可對免疫調節治療敏感的固體腫瘤的患者預計將參加聯合劑量遞增的第2期研究，每兩週靜脈注射升值劑量的MDNA11聯合pembrolizumab。在確定聯合劑量方案後，該研究將前往聯合劑量擴展隊。+T和CD8細胞+IL-2超級素（IL-2 Superkine）的獨特專利特點是：通過引入七種特定突變並將其基因融合到重組人白蛋白支架上，以提高MDNA11的藥代動力學（PK）和藥理學活性，因爲白蛋白具有在高度血管化的部位，特別是腫瘤和腫瘤引流淋巴結中積累的天然傾向。MDNA11目前正在進行1/2期ABILITY-1研究中的單藥和與Pembrolizumab（KEYTRUDA）的聯合用藥評估，致力於殺死癌細胞（包括腫瘤特異性CD8 T和NK細胞），同時最小化或不刺激免疫抑制的Treg細胞。).
About the ABILITY-1 Study
在單藥或與pembrolizumab（KEYTRUDA）聯合使用時的ABILITY-1研究(影響β- only IL-2免疫療法）。
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 (KEYTRUDA). In the combination dose escalation of the Phase 2 study, approximately 12 patients are expected to be enrolled and administered ascending doses of MDNA11 intravenously once every two weeks 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）是一個全球性的多中心開放性研究，旨在評估MDNA11作爲單藥或與pembrolizumab（KEYTRUDA）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。在第二期研究中，約有12名患有各種可對免疫調節治療敏感的固體腫瘤的患者預計將參加聯合劑量遞增的第2期研究，每兩週靜脈注射升值劑量的MDNA11聯合pembrolizumab。在確定聯合劑量方案後，該研究將前往聯合劑量擴展隊。
About Medicenna
關於Medicenna
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. 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 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，致力於開發新型、高選擇性的IL-2、IL-4和IL-13超干擾素和一類強化的超干擾素。Medicenna的長效IL-2超干擾素MDNA11是下一代具有優越CD122親和力（IL-2受體β）和無CD25（IL-2受體α）結合的IL-2，從而優先刺激癌殺效應T細胞和NK細胞。Medicenna的IL-4 Empowered Superkine，bizaxofusp（前身爲MDNA55），已經在5項招募了超過130名患者的臨床試驗中研究，並且在複發性GBM的2b期試驗中獲得了FDA的快速通道和孤兒藥物地位。Medicenna的早期BiSKITs（雙功能超干擾素免疫療法）和T-MASK（靶向金屬蛋白酶激活的超干擾）項目旨在增強超干擾素治療免疫學上“冷”腫瘤的能力。
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KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
KEYTRUDA是默沙東LLC的一個註冊商標，是默克和公司子公司，總部位於美國新澤西州拉哈威。
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 Company's clinical potential, of MDNA11 and the ABILITY-1 study and its, safety, enrollment and the reporting of data therefrom. 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 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. 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 Report on Form 20-F of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada.
本新聞發佈包含可適用證券法的前瞻性陳述。前瞻性陳述包括但不限於，明示或暗示的有關公司未來業務，估計，計劃，戰略雄心，合作伙伴活動和機會，目標，預期，意見，預測，投影，指導，展望或不是歷史事實的其他聲明，例如有關MDNA11和ABILITY-1研究，以及其的臨床潛力，安全性，招募和數據報道。藥物研發和商業化涉及高度風險，只有少數研究和開發項目會導致產品商業化。早期臨床研究的結果可能不足以預示完整結果或來自後期或大規模臨床研究的結果，並且不能確保獲得監管批准。您不應過度依賴這些聲明或所提出的科學數據。前瞻性陳述經常被識別爲“將”，“可能”，“應該”，“預計”，“期望”，“相信”，“尋求”，“潛在”及類似表達。前瞻性陳述基於公司在本新聞發佈日認爲合理的一些假設。儘管該公司認爲此類前瞻性陳述所反映的期望是合理的，但不能保證此類聲明將被證明準確。這些聲明受到某些風險和不確定性的影響，並且可能基於可能導致實際結果和未來事件與這些聲明所預計的結果或意義有所不同的假設。導致實際結果與公司預期不同的重要因素包括該公司最新20-F表格中詳述的風險以及該公司在加拿大適用的任何其他證券監管機構隨時提交的其他文件。
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.
讀者應該注意任何前瞻性信息的假設準備可能被證明是不正確的。事件或環境可能導致實際結果與預測結果有實質性差異，這是由於衆多已知和未知的風險、不確定性和其他因素造成的，其中許多因素超出了公司的控制範圍。讀者應該謹慎地對任何前瞻性信息進行評估，雖然公司管理層認爲該信息是合理的，但實際結果可能與預期或暗示的前瞻性陳述有所不同。本新聞發佈中包含的前瞻性陳述受到本警示聲明的明確限制。本新聞發佈中的前瞻性陳述是根據本日起的情況進行的，並且除非根據法律要求，否則我們不打算並不承擔更新或公開修訂任何已包含在其中的前瞻性陳述的任何義務。
This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this news release.
本新聞發佈包含指向不被認爲是本新聞發佈所包含的信息的超鏈接。
Investor and Media Contact:
投資者和媒體聯繫人：
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
譯文內容由第三人軟體翻譯。