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Jasper Therapeutics to Present Data on Briquilimab in Mast Cell Driven Diseases at the EAACI Congress 2024

Jasper Therapeutics to Present Data on Briquilimab in Mast Cell Driven Diseases at the EAACI Congress 2024

Jasper Therapeutics將在2024年的EAACI大會上發佈有關Briquilimab治療肥大細胞驅動疾病的數據
Jasper Therapeutics ·  05/30 12:00

REDWOOD CITY, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today announced presentations of data from its preclinical and healthy volunteer studies of briquilimab, as well as trial-in-progress presentations from its BEACON and SPOTLIGHT clinical studies, at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024, taking place May 31 – June 3 in Valencia, Spain.

加利福尼亞州雷德伍德城,2024年5月30日(GLOBE NEWSWIRE)——Jasper Therapeutics, Inc.(納斯達克股票代碼:JSPR)(賈斯珀),一家臨床階段的生物技術公司,專注於開發briquilimab,這是一種靶向C-kit(CD117)的新型抗體療法,用於治療慢性自發性蕁麻疹(CSU)、慢性誘發性蕁麻疹(CindU)等肥大細胞驅動的疾病還有哮喘,今天在會上宣佈了其對briquilimab的臨床前和健康志願者研究的數據,以及其BEACON和SPOTLIGHT臨床研究的正在進行中的試驗報告2024年歐洲過敏和臨床免疫學學會(EAACI)大會將於5月31日至6月3日在西班牙瓦倫西亞舉行。

The two preclinical studies being presented at EAACI showed the potential of briquilimab in asthma and atopic dermatitis (AD), respectively. The asthma study demonstrated that a single dose of briquilimab can deplete mast cells in both inflamed and non-inflamed tissue as well as improve lung function in an allergen-induced asthma model. In the AD study, treatment with briquilimab led to a reduction of dermal mast cells and inflammatory leukocytes, indicating that mast cells play a critical role in the pathogenesis of AD and that briquilimab has the potential to reverse AD pathology by depleting those cells. Both preclinical studies utilized Jasper's proprietary c-Kit Mouse, which overcomes the limitations of standard models that do not bind antibodies directed at the human c-Kit receptor.

EAACI上發表的兩項臨床前研究分別顯示了briquilimab在哮喘和特應性皮炎(AD)中的潛力。哮喘研究表明,單劑量的briquilimab可以消耗發炎和非發炎組織中的肥大細胞,並改善過敏原誘發的哮喘模型中的肺功能。在AD研究中,使用briquilimab進行治療可減少皮膚肥大細胞和炎性白細胞,這表明肥大細胞在AD的發病機制中起着至關重要的作用,而briquilimab有可能通過消耗這些細胞來逆轉AD病理。兩項臨床前研究都使用了賈斯珀專有的C-kit Mouse,它克服了不結合針對人體C-kit受體的抗體的標準模型的侷限性。

Jasper is also presenting data from the previously disclosed clinical study of briquilimab in healthy volunteers showing that it has a promising safety profile, appears to be well-tolerated, exhibits a favorable pharmacokinetic (PK) profile, and leads to sustained and dose-dependent depletion of mast cells in a cutaneous wound model. The PK and pharmacodynamic (PD) profiles demonstrated in the study support dose selection for Jasper's ongoing BEACON and SPOTLIGHT clinical trials in CSU and CIndU, the designs of which are being separately presented as well.

賈斯珀還提供了先前披露的briquilimab在健康志願者中的臨床研究的數據,這些數據表明,其安全性前景看好,耐受性良好,表現出良好的藥代動力學(PK)特徵,並導致皮膚傷口模型中肥大細胞的持續和劑量依賴性損耗。該研究中展示的藥效學和藥效學(PD)特徵支持賈斯珀正在科羅拉多州立大學和辛杜開展的BEACON和SPOTLIGHT臨床試驗的劑量選擇,這些試驗的設計也將單獨介紹。

"Following the announcement our development program in asthma, we are pleased to present promising preclinical results demonstrating that briquilimab depletes peribronchial mast cells in an allergen-induced asthma model," said Wendy Pang, M.D., Ph.D., Senior Vice President, Research and Translational Medicine of Jasper. "While we decided to first pursue development in asthma, we are also excited about briquilimab in AD based in part on the results being presented at EAACI, which provide early evidence of the ability of briquilimab to reverse the disease pathology by depleting mast cells in the skin and reducing inflammatory leukocytes."

賈斯珀研究與轉化醫學高級副總裁溫迪·龐博士說:“在宣佈我們的哮喘開發計劃之後,我們很高興公佈令人鼓舞的臨床前結果,表明briquilimab會耗盡過敏原誘發的哮喘模型中的支氣管周圍肥大細胞。”“雖然我們決定首先在哮喘領域進行開發,但我們也對briquilimab在AD 中的應用感到興奮,部分原因是EAACI公佈的研究結果,這些結果爲briquilimab能夠通過消耗皮膚中的肥大細胞和減少炎性白細胞來逆轉疾病病理提供了早期證據。”

"As we execute our Phase 1b/2a BEACON and SPOTLIGHT trials in CSU and CIndU, we continue to explore briquilimab's broader potential in several mast cell diseases," said Edwin Tucker, Chief Medical Officer of Jasper. "We look forward to continuing to advance briquilimab in additional indications beyond urticaria, beginning with the planned commencement of patient enrollment in a Phase 1b/2a challenge study in asthma in the fourth quarter of 2024."

賈斯珀首席醫學官埃德溫·塔克說:“當我們在科羅拉多州立大學和CindU進行1b/2a期BEACON和SPOTLIGHT試驗時,我們將繼續探索briquilimab在幾種肥大細胞疾病中的更廣泛潛力。”“我們期待繼續在蕁麻疹以外的其他適應症中推進briquilimab,首先是計劃於2024年第四季度開始一項針對哮喘的1b/2a期挑戰性研究的患者入組。”

The details of the presentations are below:

演講的細節如下:

Title: The BEACON Study: A Phase 1b/2a, Dose Escalation Study of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of the c-Kit Mab Briquilimab in Adults with symptomatic Chronic Spontaneous Urticaria (CSU)
Abstract Number: 000792
Session Type: Oral Abstract Session
Session Title: Advances in Chronic Urticaria treatment
Location: Granada
Date/Time: Saturday, June 1, 2024; 8:30am-10:00am CEST

標題:BEACON研究:一項針對C-kit 單抗Briquilimab在成人有症狀的慢性自發性蕁麻疹(CSU)中的安全性、藥代動力學/藥效學和初步臨床活性的1b/2a期劑量遞增研究
摘要編號:000792
會議類型:口頭摘要會議
會議標題:慢性蕁麻疹治療的進展
地點:格拉納達
日期/時間:2024 年 6 月 1 日,星期六;歐洲中部標準時間上午 8:30 至上午 10:00

Title: Briquilimab, an Anti-Human CD117 Antibody, Effectively Treats Cockroach Allergen-Induced Asthma Model Elicited in Mice Expressing Chimeric Human/Mouse CD117
Abstract Number: 100178
Session Type: Flash Talk
Session Title: Flash Talks on Allergic Response Management
Location: Palma
Date/Time: Saturday, June 1, 2024; 12:00pm-1:00pm CEST

標題:Briquilimab 是一種抗人 CD117 抗體,可有效治療表達嵌合人類/小鼠 CD117 的小鼠身上誘發的蟑螂過敏原誘發的哮喘模型
摘要編號:100178
會話類型:Flash Talk
會議標題:過敏反應管理快訊
地點:帕爾馬
日期/時間:2024 年 6 月 1 日,星期六;中歐標準時間下午 12:00 至下午 1:00

Title: Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Briquilimab after Single Subcutaneous (SC) Administration to Healthy Male and Female Participants
Abstract Number: 000789
Session Type: Poster Session
Session Title: Epithelial Cell Biology
Location: Poster Zone
Date/Time: Saturday, June 1, 2024; 12:00pm-1:00pm CEST

標題:Briquilimab對健康的男性和女性參與者進行單次皮下(SC)給藥後的安全性、藥代動力學(PK)和藥效學(PD)
摘要編號:000789
會議類型:海報會議
會議標題:上皮細胞生物學
地點:海報區
日期/時間:2024 年 6 月 1 日,星期六;中歐標準時間下午 12:00 至下午 1:00

Title: SPOTLIGHT: A Phase 1b/2a, Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients with Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment with H1-Antihistamines
Abstract Number: 000796
Session Type: Poster Session
Session Title: Mastocytosis and Mast Cells
Location: Poster Zone
Date/Time: Sunday, June 2, 2024; 12:00pm-1:00pm CEST

標題:聚焦:一項針對布里曲利單抗安全性、藥代動力學/藥效學和初步臨床活性的1b/2a期劑量遞增試驗,用於治療儘管使用H1抗組胺藥治療但仍有症狀的慢性誘發性蕁麻疹(cinDU)成年患者
摘要編號:000796
會議類型:海報會議
會議標題:肥大細胞增多症和肥大細胞
地點:海報區
日期/時間:2024 年 6 月 2 日星期日;中歐標準時間下午 12:00 至下午 1:00

Title: Briquilimab, an Anti-Human CD117 Antibody, Effectively Treats Epicutaneous Allergen-Induced Atopic Dermatitis in Mouse Model Expressing Chimeric Human/Mouse CD117
Abstract Number: 001032
Session Type: Oral Abstract Session
Session Title: Cutting Edge Mastocytosis: Genetics, Burden, and Therapeutic
Location: Bilbao
Date/Time: Sunday, June 2, 2024; 4:45pm-6:15pm CEST

標題:Briquilimab 是一種抗人 CD117 抗體,可有效治療表達嵌合人類/小鼠 CD117 的小鼠模型中表皮過敏原誘發的特應性皮炎
摘要編號:001032
會議類型:口頭摘要會議
會議標題:尖端肥大細胞增多症:遺傳學、負擔和治療
地點:畢爾巴鄂
日期/時間:2024 年 6 月 2 日星期日;歐洲中部標準時間下午 4:45 至下午 6:15

The presentations will be available on the EAACI website as well as the event page on the Jasper Therapeutics IR website.

演示文稿將在EAACI網站上公佈,也將在 活動頁面 在 Jasper Therapeutics 投資者關係網站上。

About Briquilimab

關於 briquilimab

Briquilimab (formerly JSP191) is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor c-Kit, also known as CD117, thereby inhibiting signaling through the receptor. This inhibition disrupts the critical survival signal, leading to the depletion of the mast cells via apoptosis which removes the underlying source of the inflammatory response in mast cell driven diseases such as chronic urticaria. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU or with CIndU, and is planning to initiate a clinical study in patients with asthma. Briquilimab is also currently in clinical studies as a treatment for patients with LR-MDS and as a conditioning agent for cell therapies for rare diseases. To date, briquilimab has a demonstrated efficacy and safety profile in more than 145 dosed participants and healthy volunteers, with clinical outcomes as a conditioning agent in severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD).

Briquilimab(前身爲 JSP191)是一種靶向的糖基化單克隆抗體,可阻止幹細胞因子與細胞表面受體 C-kit(也稱爲 CD117)結合,從而抑制通過受體的信號傳導。這種抑制會干擾關鍵的存活信號,通過細胞凋亡導致肥大細胞枯竭,從而消除肥大細胞驅動的疾病(例如慢性蕁麻疹)炎症反應的潛在來源。賈斯珀目前正在進行布里曲利單抗作爲科羅拉多州立大學或CinDU患者的治療藥物的臨床研究,並計劃啓動一項針對哮喘患者的臨床研究。Briquilimab目前也在臨床研究中,它既是LR-MDS患者的治療方法,也是罕見疾病細胞療法的調理劑。迄今爲止,briquilimab在超過145名給藥參與者和健康志願者中具有顯著的療效和安全性,作爲重度聯合免疫缺陷(SCID)、急性髓系白血病(AML)、骨髓增生異常綜合徵(MDS)、範可尼貧血(FA)和鐮狀細胞病(SCD)的臨床療效。

About Jasper

關於賈斯珀

Jasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic urticaria and lower to intermediate risk MDS and as a conditioning agent for stem cell transplants for rare diseases such as SCD, FA and SCID. To date, briquilimab has a demonstrated efficacy and safety profile in more than 145 dosed participants and healthy volunteers, with clinical outcomes as a conditioning agent in SCID, AML, MDS, FA, and SCD. For more information, please visit us at www.jaspertherapeutics.com.

Jasper是一家處於臨床階段的生物技術公司,正在開發briquilimab,這是一種靶向 c-kit (CD117) 的單克隆抗體,用於治療慢性蕁麻疹和低至中等風險 MDS 等慢性肥大和幹細胞疾病,並作爲 SCD、FA 和 SCID 等罕見疾病幹細胞移植的調節劑。迄今爲止,briquilimab在超過145名給藥參與者和健康志願者中已得到證實的療效和安全性,作爲SCID、AML、MDS、FA和SCD的調理劑,其臨床結果爲調理劑。欲了解更多信息,請訪問我們的網站 www.jaspertherapeut

Forward-Looking Statements

前瞻性陳述

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the Company's proposed presentations at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024, briquilimab's potential, including with respect to its potential in mast cell driven diseases such as CSU, CIndU, asthma and AD, a single dose's ability to deplete mast cells in both inflamed and non-inflamed tissue as well as improve lung function in an allergen-induced asthma model, its potential to lead to a reduction of dermal mast cells and inflammatory leukocytes in AD and its potential to reverse AD pathology by depleting those cells, its potential to lead to sustained and dose-dependent depletion of mast cells in a cutaneous wound model, its ability to deplete peribronchial mast cells in an allergen-induced asthma model, dose selection for Jasper's ongoing BEACON and SPOTLIGHT clinical trials in CSU and CIndU and the expected timing of patient enrollment in a Phase 1b/2a challenge study in asthma. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that Jasper's product candidates may not be beneficial to patients or successfully commercialized; patients' willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper's business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper's business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper's filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper's assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper's assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

就1995年《美國私人證券訴訟改革法》的安全港條款而言,本新聞稿中包含的某些非歷史事實的陳述是前瞻性陳述。前瞻性陳述有時伴隨着諸如 “相信”、“可能”、“將”、“估計”、“繼續”、“預測”、“打算”、“預期”、“應該”、“將”、“計劃”、“潛在”、“看來”、“尋找”、“未來”、“展望” 等詞語以及預測或表明未來事件或趨勢或不是歷史問題陳述的類似表達。這些前瞻性陳述包括但不限於有關公司在2024年歐洲過敏與臨床免疫學會(EAACI)大會上的擬議演講、briquilimab的潛力,包括其在肥大細胞驅動的疾病(例如科羅拉多州立大學、cinDU、哮喘和AD)中的潛力、單劑量消耗發炎和非發炎組織中的肥大細胞以及改善肺功能的能力的聲明過敏原誘發的哮喘模型,它有可能導致皮膚肥大細胞減少和發炎AD 中的白細胞及其通過消耗這些細胞來逆轉 AD 病理的潛力、它可能導致皮膚傷口模型中肥大細胞持續和劑量依賴性枯竭、過敏原誘發的哮喘模型中消耗支氣管周圍肥大細胞的能力、Jasper 正在科羅拉多州立大學和 CinDU 進行的 BEACON 和 SPOTLIGHT 臨床試驗的劑量選擇,以及1b/2a期挑戰研究的患者入組預期時機在哮喘中。這些陳述基於各種假設,無論是否在本新聞稿中提出,也基於賈斯珀當前的預期,不是對實際業績的預測。這些前瞻性陳述僅用於說明目的,無意用作擔保、保證、預測或明確的事實或概率陳述,投資者也不得依賴這些陳述作爲擔保、保證、預測或明確的事實或概率陳述。許多實際事件和情況都超出了賈斯珀的控制範圍。這些前瞻性陳述受許多風險和不確定性的影響,包括總體經濟、政治和商業狀況;賈斯珀開發的潛在候選產品可能無法在預期的時間表內或根本無法通過臨床開發取得進展或獲得所需的監管部門批准的風險;臨床試驗可能無法證實本新聞稿中描述或假設的任何安全性、效力或其他產品特徵的風險;賈斯珀無法成功上市或獲得市場認可的風險其候選產品;先前研究結果無法複製的風險;賈斯珀的候選產品可能無法使患者受益或無法成功商業化的風險;患者嘗試新療法的意願和醫生開這些療法的意願;競爭對賈斯珀業務的影響;賈斯珀賴以提供實驗室、臨床開發、製造和其他關鍵服務的第三方無法令人滿意地表現的風險;賈斯珀的風險 Per 的業務、運營、臨床發展計劃和時間表以及供應鏈可能會受到以下因素的不利影響:健康流行病的影響;賈斯珀無法爲其研究產品獲得和維持足夠的知識產權保護或侵犯他人知識產權保護的風險;以及賈斯珀向美國證券交易委員會提交的文件中不時指出的其他風險和不確定性,包括其截至2023年12月31日止年度的10-K表年度報告和隨後的表格季度報告 10-Q。如果其中任何風險得以實現或賈斯珀的假設被證明不正確,則實際結果可能與這些前瞻性陳述所暗示的結果存在重大差異。儘管賈斯珀可能會選擇在未來的某個時候更新這些前瞻性陳述,但賈斯珀明確表示不承擔任何更新這些前瞻性陳述的義務。不應將這些前瞻性陳述視爲賈斯珀對本新聞稿發佈之日後任何日期的評估。因此,不應過分依賴前瞻性陳述。

Contacts:

聯繫人:

Joyce Allaire (investors)
LifeSci Advisors
617-435-6602
jallaire@lifesciadvisors.com

喬伊斯·阿萊爾(投資者)
生命科學顧問
617-435-6602
jallaire@lifesciadvisors.com

Alex Gray (investors)
Jasper Therapeutics
650-549-1454
agray@jaspertherapeutics.com

亞歷克斯·格雷(投資者)
賈斯珀療法
650-549-1454
agray@jaspertherapeutics.com

Lauren Walker (media)
Real Chemistry
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勞倫·沃克(媒體)
真正的化學
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lbarbiero@realchemistry.com

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