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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

已更新的MDNA11单药治疗和联合治疗的临床数据将于2024年免疫治疗桥会议上呈现
GlobeNewswire ·  11/27 20:00

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.

多伦多和休斯敦,2024年11月27日(全球新闻社) - Medicenna Therapeutics Corp.("Medicenna"或"公司")(TSX:MDNA,OTCQX:MDNAF),一家专注于超级素线研发的处于临床阶段的免疫疗法公司,今天宣布,来自正在进行的1/2期ABILITY-1研究的最新临床数据将在2024年免疫疗法桥梁会议上作为口头台上报告的一部分进行展示,该会议将于2024年12月4-5日在意大利那不勒斯举行。

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.

口头报告将包括正在进行的1/2期ABILITY-1研究的单药和联合治疗阵线的最新临床数据,评估MDNA11,一种长效的'β增强非α'干扰素-2("IL-2")超激动剂,用于晚期或转移性实体肿瘤患者。

Presentation Details:

演示说明:

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

标题:MDNA11第一人体试验的安全性和有效性结果更新(ABILITY-1),一种下一代'β增强非α' IL-2 超素,展示单药物在晚期实体瘤患者中的活性
演示日期:2024年12月5日 星期四 8:45上午欧洲中部时间(美国东部时间2:30上午)
主讲者:Dr. Arash Yavari, MBBS, DPhil; 临床策略董事

Following the presentation, a copy of the presentation will be available on the "Scientific Presentations" page of Medicenna's website.

演示结束后,演示内容的副本将会在Medicenna网站的“科学演示”页面上提供。

About MDNA11

关于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是一种静脉给药、长效的“β增强不是α” IL-2 Superkine,经过特别设计以克服aldesleukin和其他下一代IL-2变体的缺点,通过优先激活对杀死癌细胞负责的免疫效应细胞(CD8+ t和Nk细胞),最小或不刺激免疫抑制性Tregs。这种IL-2 Superkine的独特专有特性得到了通过合并七个特定突变并基因融合到重组人血清白蛋白支架上来改善MDNA11的药代动力学(PK)和药理活性,因为人血清白蛋白在高血管化部位,特别是肿瘤和肿瘤引流淋巴结中很容易积累。MDNA11目前正在进行第1/2期ABILITY-1研究的评估,作为单药治疗和与pembrolizumab联合使用。

About the ABILITY-1 Study

关于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)是一项全球范围内的多中心、开放标签研究,旨在评估MDNA11作为单药或与pembrolizumab联合使用时的安全性、耐受性、药代动力学、药效动力学及抗肿瘤活性。在第2期研究的联合剂量递增部分中,预计将招募并给予大约20名患者MDNA11的静脉递增剂量,同时与pembrolizumab联合使用。这部分研究包括对一系列固体肿瘤患者的研究,这些患者可能对免疫调节治疗具有敏感性。在确定了适当的联合剂量方案后,研究将继续进行到联合剂量扩展队列。

About Medicenna Therapeutics

关于医药技术公司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是一家临床阶段的免疫疗法公司,专注于开发新颖、高度选择性的IL-2、IL-4和IL-13超型蛋白以及首创的Empowered Superkines。Medicenna的长效IL-2 Superkine,MDNA11,是一种下一代IL-2,对CD122(IL-2受体β)具有更强的亲和力,不结合CD25(IL-2受体α),从而优先刺激杀灭癌细胞效应T细胞和Nk细胞。MDNA11正在作为单药和与帕博利珠单抗联合使用在第1/2阶段ABILITY-1研究(NCT05086692)中进行评估。Medicenna的IL-4 Empowered Superkine,bizaxofusp(前身为MDNA55),已在5项招募超过130名患者的临床试验中研究,其中包括用于复发性GBm的第20亿期试验,这是大脑癌最常见且普遍致命的形式。Bizaxofusp已获得FDA的FastTrack和孤儿药品地位,分别获得了FDA/EMA的认可。Medicenna早期的高亲和力IL-2β偏向性IL-2/IL-15超拮抗剂,来源于其MDNA209平台,正在评估作为自身免疫和移植物抗宿主病的潜在治疗方案。Medicenna早期的BiSKITs(Bifunctional SuperKine免疫疗法)和t-MASk(靶向金属酶活化的超型蛋白)项目旨在增强Superkines治疗免疫"冷"肿瘤的能力。

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Forward-Looking Statements

前瞻性声明

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.

本新闻发布包含根据适用证券法的前瞻性声明。前瞻性声明包括但不限于有关公司未来运营、估计、计划、战略抱负、合作伙伴活动和机会、目标、期望、意见、预测、投影、指引、展望或其他非历史事实的明示或暗示声明,例如关于MDNA11(作为单药物治疗和与Pembrolizumab联合使用的治疗潜力和安全性,以及任何额外临床更新的时间和/或发布的声明。药物开发和商业化涉及高风险,并且只有少数研发项目最终导致产品商业化。早期前临床或临床研究的结果可能并不预示完整结果或后期或大规模临床研究的结果,并不能保证获得监管批准。您不应过分依赖这些声明或所呈现的科学数据。

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.

前瞻性声明通常可根据"将"、"可能"、"应"、"预计"、"预期"、"相信"、"寻求"、"潜在"等表达方式进行识别,并受风险和不确定性的影响。不能保证此类声明会被证明准确,实际结果和未来事件可能与该类声明中预期的有重大差异。可能导致实际结果与公司预期有重大差异的重要因素包括公司最新年度信息表格中详细列出的风险,以及公司不时向加拿大适用证券监管机构提交的其他备案文件中的风险。

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.

读者应当注意,在准备任何前瞻性信息时所做的假设有可能被证明是不正确的。由于无数已知和未知的风险、不确定性和其他因素,大量已知和未知的风险、不确定性和其他因素可能导致事件或情况导致实际结果与预测结果不同,这是由于公司无法控制。读者被警告不要过度依赖任何前瞻性信息。尽管管理层认为这些信息是合理的,但这些信息有可能被证明是不正确的,实际结果可能与预期的结果有很大不同。本新闻发布所包含的前瞻性声明在此谨此声明。本新闻发布所包含的前瞻性声明是根据此处的日期进行的,除非法律要求,否则我们没有意图并不会承担更新或修订所包含的前瞻性声明的任何义务。

This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this new release.

本新闻稿含有超链接到未被视为本新闻稿参考的信息。

Investor and Company Contact:

投资者和公司联系方式:

Christina Cameron
Investor Relations, Medicenna Therapeutics
ir@medicenna.com
(647) 953-0673

Christina Cameron
投资者关系,Medicenna Therapeutics
ir@medicenna.com
(647) 953-0673

Daniel Scarr
Investor Relations & Business Development, Medicenna Therapeutics
dscarr@medicenna.com
(647) 220-4509

丹尼尔·斯卡尔
投资者关系与业务发展,Medicenna Therapeutics
dscarr@medicenna.com
(647) 220-4509


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