Interim Results From the ARTACUS Clinical Trial of RP1 Monotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients With Skin Cancers Presented During Oral Presentation at the American Association of Cancer Research (AACR) 2024 Annual Meeting
Interim Results From the ARTACUS Clinical Trial of RP1 Monotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients With Skin Cancers Presented During Oral Presentation at the American Association of Cancer Research (AACR) 2024 Annual Meeting
RP1 monotherapy showed clear anti-tumor activity with an overall response rate of nearly 35 percent and complete response rate of nearly 22 percent in evaluable patients
SAN DIEGO, April 07, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today announced the presentation of interim results from ARTACUS, a Phase 1/2 clinical trial evaluating RP1 monotherapy for the treatment of skin cancers in patients who have had solid organ or hematopoietic cell transplants, by Michael R. Midgen, M.D., of the University of Texas MD Anderson Cancer Center during an oral session at the AACR 2024 Annual Meeting in San Diego. The results were initially presented late last year at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC).
In the study, treatment with RP1 as monotherapy, for up to 25 doses, resulted in an overall response rate (ORR) of 34.8 percent (8 of 23 evaluable patients, including 5 complete responses and 3 partial responses) with most responses ongoing as of the data cutoff date of September 18, 2023. In the evaluable patient population (n=23), 20 had cutaneous squamous cell carcinoma (CSCC) and three had merkel cell carcinoma. Of note, a patient treated with RP1 for CSCC also had a complete response of a new primary basal cell carcinoma which appeared post baseline. There was no evidence of allograft rejection including of hepatic and lung allografts. RP1 monotherapy was well tolerated, and the safety profile was similar to the profile in non-immunocompromised patients with advanced skin cancers. Additional biomarker data collected showed an increase in CD+8 T, a type of immune cell, and an increase in the expression of PD-L1, after treatment suggesting immune activation. The slides are available on the Replimune website under presentations.
"Organ transplant recipients are at a higher risk for skin cancer when compared to the broader population and have access to a limited number of treatment options given that systemic immunotherapy is typically contra-indicated," said Sushil Patel, Ph.D., CEO of Replimune. "These data show RP1 as monotherapy has clear anti-tumor activity and may be a safe and effective treatment option for these patients with an overall response rate of nearly 35 percent with good durability of benefit to date."
About ARTACUS
ARTACUS is a multicenter, open-label, two-part Phase 1b/2 study evaluating RP1 as monotherapy for the treatment of locally advanced or metastatic cutaneous malignancies in patients who underwent a kidney, liver, heart, lung, or other solid organ transplant, or hematopoietic cell transplantation, who are on chronic immunosuppressive treatment, in whom systemic immunotherapy is typically contra-indicated. Researchers will assess the safety of RP1 and also evaluate its ability to shrink tumors. ARTACUS is currently recruiting patients. To learn more, contact clinicaltrials@replimune.com or +1-781-222-9570.
About RP1
RP1 is Replimune's lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune's proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit .
Forward-Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as "could," "expects," "intends," "may," "plans," "potential," "should," "will," "would," or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Investor Inquiries
Chris Brinzey
ICR Westwicke
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
RP1單一療法顯示出明顯的抗腫瘤活性,可評估患者的總體反應率接近35%,完全緩解率接近22%
聖地亞哥,2024年4月7日(GLOBE NEWSWIRE)——率先開發新型溶瘤免疫療法組合的臨床階段生物技術公司Replimune Group, Inc.(納斯達克股票代碼:REPL)今天宣佈了ARTACUS的中期結果。ARTACUS是一項1/2期臨床試驗,評估了用於治療實體器官或造血細胞移植患者的皮膚癌的RP1單一療法,由德克薩斯大學醫學博士安德森癌症中心醫學博士邁克爾·米根在聖彼得堡舉行的AACR 2024年年會口頭會議上撰寫迭戈。結果最初於去年年底在第38次會議上公佈第四 癌症免疫療法學會(SITC)年會。
在這項研究中,使用RP1作爲單一療法進行治療,最多25劑,總緩解率(ORR)爲34.8%(23名可評估患者中有8名,包括5例完全反應和3例部分反應),截至2023年9月18日數據截止日期,大多數反應仍在繼續。在可評估的患者群體(n=23)中,有20人患有皮膚鱗狀細胞癌(CSCC),3人患有默克爾細胞癌。值得注意的是,接受RP1治療的CSCC患者對基線後出現的新原發性基底細胞癌也有完全的反應。沒有證據顯示同種異體移植排斥反應,包括肝臟和肺部同種異體移植。RP1 單一療法耐受性良好,其安全性與非免疫功能低下晚期皮膚癌患者的特徵相似。收集的其他生物標誌物數據顯示,在治療提示免疫激活後,CD+8 T(一種免疫細胞)增加,PD-L1 的表達增加。這些幻燈片可在Replimune網站上的 “演示文稿” 下找到。
Replimune首席執行官蘇希爾·帕特爾博士說:“與更廣泛的人群相比,器官移植接受者患皮膚癌的風險更高,而且鑑於全身免疫療法通常是禁忌的,因此獲得的治療選擇有限。”“這些數據顯示,RP1作爲單一療法具有明顯的抗腫瘤活性,對於這些患者的總體反應率接近35%,迄今爲止,其療效持久性良好,可能是一種安全有效的治療選擇。”
關於 ARTACUS
ARTACUS是一項多中心、開放標籤、由兩部分組成的1b/2期研究,評估RP1作爲單一療法,用於治療接受腎臟、肝臟、心臟、肺或其他實體器官移植或造血細胞移植的患者的局部晚期或轉移性皮膚惡性腫瘤,這些患者接受慢性免疫抑制治療,通常禁用全身免疫療法。研究人員將評估RP1的安全性,並評估其縮小腫瘤的能力。ARTACUS目前正在招募患者。要了解更多信息,請聯繫 clinicaltrials@replimune.com 或 +1-781-222-9570。
關於 RP1
RP1是Replimune的主要候選產品,它基於一種專有的新型單純皰疹病毒菌株,該菌株經過精心設計和基因武裝,其中含有共生蛋白(GALV-GP R-)和轉基因CSF,可最大限度地提高腫瘤殺傷力、腫瘤細胞死亡的免疫原性以及全身抗腫瘤免疫反應的激活。
關於 Replimune
總部位於馬薩諸塞州沃本的Replimune Group, Inc. 成立於2015年,其使命是通過率先開發新的溶瘤免疫療法產品組合來改變癌症治療。Replimune 專有的 RpX 平台基於強大的 HSV-1 骨幹,旨在最大限度地提高免疫原性細胞死亡和誘導全身抗腫瘤免疫反應。RpX 平台旨在具有獨特的局部和全身雙重活性,包括直接選擇性病毒介導的腫瘤殺死,從而釋放腫瘤衍生抗原,改變腫瘤微環境以激發強烈而持久的全身反應。預計RpX候選產品將與大多數成熟的和實驗性的癌症治療方式產生協同作用,從而具有多功能性,可以單獨開發或與各種其他治療方案結合使用。欲了解更多信息,請訪問。
前瞻性陳述
本新聞稿包含經修訂的1933年《證券法》第27A條和經修訂的1934年《證券交易法》第21E條所指的前瞻性聲明,包括有關我們臨床試驗的設計和進展、臨床試驗結果的時機和充分性以支持任何候選產品的潛在批准、我們開發和商業化候選產品的目標、現有和計劃中的臨床試驗患者註冊情況的聲明及其時間,以及其他由 “可以”、“期望”、“打算”、“可能”、“計劃”、“潛在”、“應該”、“將”、“將” 等詞語識別的陳述以及這些術語的否定詞。前瞻性陳述不是對未來業績的承諾或保證,受各種風險和不確定性的影響,其中許多風險和不確定性是我們無法控制的,可能導致實際業績與此類前瞻性陳述中設想的結果存在重大差異。這些因素包括與我們有限的運營歷史相關的風險、我們爲候選產品產生積極臨床試驗結果的能力、運營內部製造設施的成本和時間、監管部門批准的時間和範圍、我們所受法律和法規的變化、競爭壓力、我們確定其他候選產品的能力、政治和全球宏觀因素,包括冠狀病毒作爲全球疫情的影響和相關的公共衛生問題,以及可能詳述的其他風險不時在我們的10-K表年度報告和10-Q表季度報告以及我們向證券交易委員會提交的其他報告中。我們的實際業績可能與此類前瞻性陳述中描述或暗示的結果存在重大差異。前瞻性陳述僅代表截至本文發佈之日,除非法律要求,否則我們沒有義務更新或修改這些前瞻性陳述。
投資者查詢
克里斯·布林茲
ICR Westwicke
339.970.2843
chris.brinzey@westwicke.com
媒體查詢
艾琳·戈登伯格
Replimune
917.548.1582
media@replimune.com
譯文內容由第三人軟體翻譯。
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