Syndax Pharmaceuticals : FDA Grants Orphan Drug Designation to SNDX-5613 for Adult and Pediatric Acute Myeloid Leukemia >SNDX
Syndax Pharmaceuticals : FDA Grants Orphan Drug Designation to SNDX-5613 for Adult and Pediatric Acute Myeloid Leukemia >SNDX
Press Release: Syndax Pharmaceuticals Announces Preclinical Profile and Initial Phase 1 Data Demonstrating Clinical Activity of Menin Inhibitor SNDX-5613 in Adults with Relapsed/Refractory Acute Leukemias
新聞稿：Syndax製藥公司宣佈臨牀前資料和初步的第一階段數據顯示，Menin抑制劑SNDX-5613在成人複發性/難治性急性白血病中具有臨牀活性
Syndax Pharmaceuticals Announces Preclinical Profile and Initial Phase 1 Data Demonstrating Clinical Activity of Menin Inhibitor SNDX-5613 in Adults with Relapsed/Refractory Acute Leukemias
Syndax製藥公司宣佈顯示Menin抑制劑SNDX-5613在成人復發/難治性急性白血病中的臨牀活性的臨牀前概況和第一階段初步數據
- Preliminary Phase 1 results represent first clinical evidence that inhibition of the menin-MLL1 interaction can induce response in patients with MLL-r acute leukemias -
-初步的第一階段結果是第一個臨牀證據，表明抑制腦膜素-MLL1相互作用可以誘導MLL-r急性白血病患者的反應-
- Data featured in New Drugs on the Horizon oral session at the 2020 AACR Virtual Annual Meeting I -
-2020年AACR虛擬年會上地平線上的新葯口頭會議上的數據-
- U.S. FDA grants orphan drug designation to SNDX-5613 for the treatment of adult and pediatric acute myeloid leukemia -
-美國FDA批准SNDX-5613為孤兒藥物，用於治療成人和兒童急性髓系白血病-
PR Newswire
美通社
WALTHAM, Mass., April 27, 2020
馬薩諸塞州沃爾瑟姆，2020年4月27日
WALTHAM, Mass., April 27, 2020 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today presents preclinical and initial clinical data for SNDX-5613, the Company's potent, highly selective oral menin inhibitor. The oral presentation will be featured during the New Drugs on the Horizon session at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I. The New Drugs on the Horizon session will take place today at 4:50 p.m. ET and features discussions of innovative small molecules and biologics that have recently entered Phase 1 clinical trials.
亞洲網馬薩諸塞州沃爾瑟姆2020年4月27日電臨牀階段生物製藥公司Syndax PharmPharmticals，Inc.(以下簡稱“Syndax”，“本公司”或“WE”)(納斯達克市場代碼：SNDX)今天公佈了該公司高效、高選擇性口服薄荷素抑制劑SNDX-5613的臨牀前和初步臨牀數據。口頭陳述將在2020年美國癌症研究協會(AACR)虛擬年會I的新葯地平線會議上進行。地平線新葯會議將於今天下午4點50分舉行。ET，並以最近進入第一階段臨牀試驗的創新小分子和生物製品的討論為特色。
"Within months of initiating the Phase 1/2 AUGMENT-101 trial, we are excited to present to the cancer research community the first clinical evidence that disrupting the interaction between menin and MLL1 with our potent and selective inhibitor, SNDX-5613, can induce response in patients with genetically-defined acute leukemias," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Notably, clinical activity was achieved rapidly after a single, 28-day cycle, a highly encouraging sign in this population of patients who face a particularly poor prognosis with few effective treatment options. We look forward to presenting additional findings from this trial in the fourth quarter."
Syndax公司首席執行官布里格斯·W·莫里森(Briggs W.Morrison)説：“在啟動1/2增強-101期試驗的幾個月內，我們很高興能向癌症研究界提交首個臨牀證據，證明用我們的有效和選擇性抑制劑SNDX-5613干擾薄荷素和MLL1之間的相互作用，可以在基因定義的急性白血病患者中引起反應。”值得注意的是，在一個28天的週期後，臨牀活動迅速實現，對於這羣面臨特別糟糕的預後、幾乎沒有有效治療選擇的患者來説，這是一個非常令人鼓舞的跡象。我們期待着在第四季度公佈這項試驗的更多發現。“
The Company also announced today that SNDX-5613 was recently granted Orphan Drug Designation for the treatment of adult and pediatric acute myeloid leukemia (AML) by the U.S. Food and Drug Administration (FDA).
該公司今天還宣佈，SNDX-5613最近被美國食品和藥物管理局(FDA)授予治療成人和兒童急性髓系白血病(AML)的孤兒藥物稱號。
Preliminary AUGMENT-101 Data
初步增強-101數據
As of the April 17th data cutoff date, a total of six patients have been treated in the Phase 1 portion of the ongoing open-label AUGMENT-101 trial at increasing dose levels of SNDX-5613. Responses were observed in two of three patients harboring an MLL rearrangement. This included one patient, whose drug exposure was consistent with that needed for activity in preclinical models, who had a complete response with incomplete blood count recovery (CRi) after 28 days of therapy and subsequently improved to a complete response (CR). The second patient achieved a partial response with incomplete blood count recovery (PRi) after 28 days of therapy. Both patients continue to receive SNDX-5613. A third patient harboring an MLL rearrangement did not achieve drug exposure levels consistent with that needed for activity in preclinical models and was removed from the trial due to progressive disease. Treatment with SNDX-5613 has been tolerated well, with no dose limiting toxicities reported. One patient experienced a Grade 2 QTc prolongation but remains on treatment. Additional details regarding all six patients are available in the AACR presentation.
截至4月17日數據截止日期，在正在進行的開放標籤增強-101試驗的第一階段部分，共有6名患者在增加SNDX-5613的劑量水平下接受治療。在3例MLL重排患者中有2例觀察到反應。這包括一名患者，他的藥物暴露與臨牀前模型中活動所需的藥物相一致，在治療28天后，他的血細胞計數不完全恢復(CRI)，隨後改善為完全反應(CR)。第二例患者在治療28天后部分緩解，血細胞計數不完全恢復(PRI)。兩名患者繼續接受SNDX-5613治療。第三名攜帶MLL重排的患者沒有達到與臨牀前模型中活性所需的藥物暴露水平一致的水平，並因疾病進展而被從試驗中移除。SNDX-5613治療耐受性良好，沒有劑量限制毒性報告。1例患者出現2級QTc延長，但仍在接受治療。有關所有6名患者的更多細節可在AACR報告中獲得。
"Three decades of scientific research exploring the menin-MLL-r interaction and its importance in this subset of leukemias have helped establish our confidence in the therapeutic potential of SNDX-5613 for leukemia patients harboring MLL-r and NPM1 mutations," said Jerry McGeehan, Ph.D., Vice President, Menin Program at Syndax Pharmaceuticals. "Following the recently published preclinical studies in Cancer Cell and Science magazine highlighting the activity of menin inhibition in genetically-defined leukemias, we are thrilled to demonstrate in the clinical setting that SNDX-5613 could serve as a targeted agent with the potential to deliver durable benefit to a severely underserved patient population."
Syndax製藥公司梅寧項目副總裁Jerry McGeehan博士説：“三十年來探索薄荷素-MLL-r相互作用及其在這一亞型白血病中的重要性的科學研究幫助我們建立了對SNDX-5613對攜帶MLL-r和NPM1突變的白血病患者的治療潛力的信心。在最近發表在《癌症細胞與科學》雜誌上的臨牀前研究強調了薄荷素抑制在基因定義的白血病中的活性之後，我們很高興能在臨牀環境中證明SNDX-5613可以作為一種目標製劑，有可能為嚴重缺乏服務的患者羣體帶來持久的好處。“
The Company's presentation also highlighted preclinical data supporting the potential of single-agent menin-MLL inhibition to serve as an effective intervention for both NPM1 mutant AML and MLL-r acute leukemias.
該公司的報告還強調了臨牀前數據支持單劑腦膜素-MLL抑制作為對NPM1突變AML和MLL-r急性白血病的有效干預的潛力。
The AUGMENT-101 trial is a Phase 1/2 open-label trial designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of orally administered SNDX-5613. The Phase 1 dose escalation portion of AUGMENT-101 was recently separated into two cohorts based on concomitant treatment with a strong CYP3A4 inhibitor. Arm A will enroll patients not receiving a strong CYP3A4 inhibitor, while Arm B will enroll patients receiving a strong CYP3A4 inhibitor. The Phase 1 dose escalation portion of AUGMENT-101 is currently enrolling adults with R/R acute leukemias including MLL-r and nucleophosmin (NPM1) mutant acute leukemias and is expected to establish a recommended Phase 2 dose for both cohorts by the fourth quarter of 2020. The Phase 2 portion will evaluate efficacy, as defined by CR rate (per International Working Group response criteria), across three expansion cohorts: MLL-r acute lymphoblastic leukemia (ALL), MLL-r AML and NPM1 mutant AML. MLL rearrangements are seen in 5-10% of AML and ALL, while NPM1 mutations are seen in 30% of adult AML cases. The Company expects to present additional results from AUGMENT-101 at a medical conference in the fourth quarter of 2020.
Engment-101試驗是一項1/2期開放標籤試驗，旨在評估口服SNDX-5613的安全性、耐受性、藥代動力學和療效。基於同時使用一種強大的CYP3A4抑制劑治療的基礎上，增強-101的第一階段劑量遞增部分最近被分成兩個隊列。A組將招募沒有接受強CYP3A4抑制劑的患者，而B組將招募接受強CYP3A4抑制劑的患者。Augment-101的第一階段劑量遞增部分目前正在招募患有R/R急性白血病的成年人，包括MLL-r和核磷脂(NPM1)突變急性白血病，預計到2020年第四季度將為這兩個隊列確定推薦的第二階段劑量。第二階段部分將根據CR率(根據國際工作組的反應標準)對三個擴大隊列進行療效評估：MLL-r急性淋巴細胞白血病(ALL)、MLL-r AML和NPM1突變AML。MLL重排見於5-10%的AML和ALL，而NPM1突變見於30%的成人AML病例。該公司預計將在2020年第四季度的一次醫學會議上公佈Augment-101的更多結果。
Additional AACR Presentations
其他AACR演示文稿
In addition to the SNDX-5613 presentation, data from the Phase 1 trials of the Company's anti-CSF-1R monoclonal antibody, axatilimab, both as a monotherapy and in combination with IMFINZI(R) (durvalumab) in patients with locally-advanced or metastatic solid tumors, were summarized in two oral presentations. These data indicate that axatilimab is tolerated well in solid tumor patients, generated a recommended Phase 2 dose for axatilimab for the treatment of patients with solid tumors, and provided evidence of its ability to deplete circulating pro-inflammatory monocytes.
除了SNDX-5613報告外，該公司的抗CSF-1R單克隆抗體axatilimab作為單一療法以及與IMFINZI(R)(Durvalumab)聯合用於局部晚期或轉移性實體腫瘤患者的第一階段試驗的數據在兩次口頭報告中進行了總結。這些數據表明，Aaxatilimab在實體腫瘤患者中耐受性良好，產生了治療實體腫瘤患者的Aaxatilimab推薦的2期劑量，併為其清除循環促炎單核細胞的能力提供了證據。
A copy of all AACR presentations will be available via Syndax's website at http://www.syndax.com/science/publications/.
所有AACR演示文稿的副本將通過Syndax公司的網站http://www.syndax.com/science/publications/.獲得。
About SNDX-5613
關於SNDX-5613
SNDX-5613 is a potent, selective, small molecule inhibitor of the menin-MLL binding interaction that is being developed for the treatment of MLL-rearranged (MLL-r) acute leukemias, including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) and NPM1 mutant AML. In preclinical models of MLL-r acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit. Menin-MLL interaction inhibitors have also demonstrated robust treatment benefit in multiple preclinical models of NPM1 mutant AML, which represents the most frequent genetic abnormality in adult AML. SNDX-5613 is currently being evaluated in the Company's AUGMENT-101 Phase 1/2 open-label clinical trial for the treatment of relapsed/refractory (R/R) acute leukemias.
SNDX-5613是用於治療MLL重排(MLL-r)急性白血病(包括急性淋巴細胞白血病(ALL)、急性髓系白血病(AML)和NPM1突變型AML)的一種有效的、選擇性的、小分子的腦膜素-MLL結合作用抑制劑。在MLL-r急性白血病的臨牀前模型中，SNDX-5613表現出強有力的、劑量依賴性的抑制腫瘤生長，導致顯著的生存益處。Menin-MLL相互作用抑制劑在NPM1突變型AML的多種臨牀前模型中也顯示出強大的治療效益，這種突變型AML代表了成人AML中最常見的遺傳異常。SNDX-5613目前正在該公司治療復發/難治性(R/R)急性白血病的Augment-101階段1/2開放標籤臨牀試驗中進行評估。
About Mixed Lineage Leukemia Rearranged (MLL-r)
關於混合血統白血病重排(MLL-r)
Rearrangements of the MLL gene give rise to MLL-r acute leukemias, known to have a poor prognosis, with less than 55% of patients surviving past 5 years. MLL rearrangements produce fusion proteins that require interaction with the protein called menin to drive leukemic cancer growth. Disruption of the menin-MLL-r interaction has been shown to halt the growth of MLL-r leukemic cells. MLL-r leukemias, which are routinely diagnosed through currently available cytogenetic or molecular diagnostic techniques, occur in approximately 80% of infant acute leukemias and up to 10% of all acute leukemias. There are currently no approved therapies indicated for MLL-r leukemias.
MLL基因的重排導致MLL-r急性白血病，已知預後很差，只有不到55%的患者存活超過5年。MLL重排產生的融合蛋白需要與稱為腦膜素的蛋白質相互作用才能驅動白血病癌症的生長。研究表明，破壞腦膜素-MLL-γ相互作用可以阻止MLL-γ白血病細胞的生長。MLL-r白血病是通過目前可用的細胞遺傳學或分子診斷技術常規診斷的，大約80%的嬰兒急性白血病和高達10%的急性白血病都會發生。目前還沒有批准的治療MLL-r白血病的方法。
About NPM1 Mutant Acute Myeloid Leukemia
關於NPM1突變型急性髓系白血病
NPM1 mutant AML, which is distinguished by point mutations in the NPM1 gene that drive the leukemic phenotype, is the most common type of cytogenetically normal adult AML and represents approximately 30% of all adult AML cases. This subtype of AML has a 5-year overall survival rate of approximately 50%. Similar to MLL-r leukemias, NPM1 mutant AML is highly dependent on the expression of specific developmental genes, shown to be negatively impacted by inhibitors of the menin-MLL interaction. NPM1 mutant AML is routinely diagnosed through currently available screening techniques. There are currently no approved therapies indicated for NPM1 mutant AML.
NPM1突變型AML以驅動白血病表型的NPM1基因點突變為特徵，是細胞遺傳學正常的成人AML中最常見的類型，約佔所有成人AML病例的30%。這一亞型AML的5年總存活率約為50%。與MLL-r白血病相似，NPM1突變型AML高度依賴於特定發育基因的表達，顯示出受到腦膜素-MLL相互作用抑制劑的負面影響。NPM1突變型AML通過目前可用的篩查技術進行常規診斷。目前還沒有批准的治療NPM1突變型急性髓系白血病的方法。
About Orphan Drug Designation
關於孤兒藥物名稱
The Orphan Drug Designation program provides orphan status to drugs and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Among the benefits of orphan designation in the U.S. are seven years of market exclusivity following FDA approval, waiver or partial payment of application fees, and tax credits for clinical testing expenses conducted after orphan designation is received.
孤兒藥物指定計劃為用於安全有效地治療、診斷或預防在美國影響不到20萬人的罕見疾病的藥物和生物製品提供孤兒身份。在美國，孤兒指定的好處包括FDA批准後的七年市場排他性、免除或部分支付申請費，以及在收到孤兒指定後進行的臨牀測試費用的税收抵免。
About Syndax Pharmaceuticals, Inc.
Syndax製藥公司簡介
Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company's lead product candidate, entinostat, a once-weekly, oral, small molecule, class I HDAC inhibitor, is being tested in a Phase 3 combination trial with exemestane for treatment of advanced HR+, HER2- breast cancer and has been evaluated in combination with several approved PD-1/PD-(L)1 antagonists. The Company's pipeline also includes axatilimab, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, and SNDX-5613, a highly selective inhibitor of the menin--MLL binding interaction. For more information, please visit www.syndax.com or follow the Company on Twitter and LinkedIn.
Syndax製藥公司是一家臨牀階段的生物製藥公司，正在開發癌症治療的創新流水線。該公司的主要候選產品Eninostat是一種每週一次的口服小分子I類HDAC抑制劑，目前正在與西西美坦進行3期聯合試驗，用於治療HR+、HER2-晚期乳腺癌，並已與幾種已獲批准的PD-1/PD-(L)1拮抗劑一起進行評估。該公司正在研發的產品還包括Aaxatilimab和SNDX-5613。Aaxatilimab是一種阻斷集落刺激因子1(CSF-1)受體的單克隆抗體，SNDX-5613是一種高選擇性的薄荷素-MLL結合相互作用的抑制劑。欲瞭解更多信息，請訪問www.syndax.com或在Twitter和LinkedIn上關注該公司。
Syndax's Cautionary Note on Forward-Looking Statements
Syndax關於前瞻性陳述的告誡
(MORE TO FOLLOW) Dow Jones Newswires
(更多後續報道)道瓊斯通訊社
April 27, 2020 16:05 ET (20:05 GMT)
2020年4月27日東部時間16：05(格林尼治標準時間20：05)
Press Release: Syndax Pharmaceuticals Announces -2-
新聞稿：Syndax製藥宣佈-2-
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of our product candidates to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
本新聞稿包含符合1995年“私人證券訴訟改革法案”的前瞻性陳述。諸如“可能”、“將”、“預期”、“計劃”、“預期”、“估計”、“打算”、“相信”等詞語以及類似的表述(以及涉及未來事件、條件或情況的其他詞語或表述)旨在識別前瞻性陳述。這些前瞻性陳述是基於截至本新聞稿發佈之日Syndax公司的預期和假設。這些前瞻性陳述中的每一項都涉及風險和不確定因素。實際結果可能與這些前瞻性陳述大不相同。本新聞稿中包含的前瞻性陳述包括但不限於有關臨牀試驗的進展、時間、臨牀開發和範圍、Syndax候選產品的臨牀數據的報告，以及我們候選產品用於治療各種癌症適應症的潛在用途的陳述。許多因素可能會導致當前預期與實際結果之間存在差異，包括在臨牀前或臨牀試驗期間觀察到的意外安全性或有效性數據、臨牀試驗現場激活或入院率低於預期、預期或現有競爭的變化、監管環境的變化、Syndax的合作者未能支持或推進合作或候選產品以及意外的訴訟或其他糾紛。其他可能導致Syndax公司的實際結果與本新聞稿中的前瞻性陳述所表達或暗示的結果不同的因素在Syndax公司提交給美國證券交易委員會的文件中進行了討論，包括其中包含的“風險因素”部分。除非法律另有規定, Syndax公司沒有義務更新本文中包含的任何前瞻性陳述，以反映預期的任何變化，即使有新的信息可用。
Syndax Contacts
Syndax聯繫人
Investor Contact
投資者聯繫方式
Melissa Forst
梅麗莎·福斯特
Argot Partners
隱語合夥人
melissa@argotpartners.com
郵箱：melissa@argopartners.com
Tel 212.600.1902
電話212.600.1902
Media Contact
媒體聯繫人
Ted Held
泰德·霍爾德
ted.held@gcihealth.com
郵箱：ted.hold@gciHealth.com
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View original content:http://www.prnewswire.com/news-releases/syndax-pharmaceuticals-announces-preclinical-profile-and-initial-phase-1-data-demonstrating-clinical-activity-of-menin-inhibitor-sndx-5613-in-adults-with-relapsedrefractory-acute-leukemias-301047764.html
查看原始content:http://www.prnewswire.com/news-releases/syndax-pharmaceuticals-announces-preclinical-profile-and-initial-phase-1-data-demonstrating-clinical-activity-of-menin-inhibitor-sndx-5613-in-adults-with-relapsedrefractory-acute-leukemias-301047764.html
SOURCE Syndax Pharmaceuticals, Inc.
來源：Syndax製藥公司
/Web site: http://www.syndax.com
網址：http://www.syndax.com
(END) Dow Jones Newswires
(完)道瓊通訊社
April 27, 2020 16:05 ET (20:05 GMT)
2020年4月27日東部時間16：05(格林尼治標準時間20：05)
*DJ Syndax Pharmaceuticals Announces Preclinical Profile and Initial Phase 1 Data Demonstrating Clinical Activity of Menin Inhibitor SNDX-5613 in Adults With Relapsed/Refractory Acute Leukemias
*DJ Syndax製藥公司宣佈臨牀前概況和第一階段數據顯示，Menin抑制劑SNDX-5613在成人復發/難治性急性白血病中具有臨牀活性
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April 27, 2020 16:05 ET (20:05 GMT)
2020年4月27日東部時間16：05(格林尼治標準時間20：05)
*DJ Syndax: Preliminary Phase 1 Results Represent First Clinical Evidence Inhibition of Menin-MLL1 Interaction Can Induce Response With MLL-r Acute Leukemias >SNDX
*DJ Syndax：初步的第一階段結果是第一個臨牀證據，抑制Menin-MLL1相互作用可以誘導對MLL-r急性白血病的應答>SNDX
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April 27, 2020 16:12 ET (20:12 GMT)
2020年4月27日美國東部時間16：12(格林尼治標準時間20：12)
*DJ Syndax Pharmaceuticals : FDA Grants Orphan Drug Designation to SNDX-5613 for Adult and Pediatric Acute Myeloid Leukemia >SNDX
*DJ Syndax製藥公司：FDA授予SNDX-5613孤兒藥物名稱，用於成人和兒童急性髓系白血病>SNDX
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April 27, 2020 16:13 ET (20:13 GMT)
2020年4月27日美國東部時間16：13(格林尼治標準時間20：13)
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