Jasper Therapeutics Announces Health Canada Clearance of Clinical Trial Application for Phase 1b/2a Study of Briquilimab in Asthma
Jasper Therapeutics (Nasdaq: JSPR) announced Health Canada's clearance of its Clinical Trial Application for a Phase 1b/2a asthma challenge study evaluating briquilimab. The study, set to enroll 30 patients across Canada and the EU, aims to demonstrate proof-of-concept for mast cell depletion as an effective mechanism in asthma treatment. Key assessments include early and late asthmatic response, airway hyperresponsiveness changes, and mast cell depletion.
The company plans to begin dosing patients in Q4 2024 and report initial data in H2 2025. Additionally, Jasper received trademark approval for its proprietary Jasper c-Kit Mouse™ model, which enables direct testing of c-Kit inhibitors across various diseases, overcoming limitations of standard models.
Jasper Therapeutics (Nasdaq: JSPR) ha annunciato l'autorizzazione da parte di Health Canada per la sua Richiesta di Sperimentazione Clinica per uno studio di sfida asmatica di Fase 1b/2a che valuta briquilimab. Lo studio, che prevede di arruolare 30 pazienti in Canada e nell'UE, punta a dimostrare la prova di concetto per l'esaurimento dei mastociti come meccanismo efficace nel trattamento dell'asma. Le valutazioni chiave includono la risposta asmatica precoce e tardiva, le variazioni nella iperresponsività delle vie aeree e l'esaurimento dei mastociti.
L'azienda prevede di iniziare la somministrazione ai pazienti nel quarto trimestre del 2024 e di riportare i dati iniziali nel secondo semestre del 2025. Inoltre, Jasper ha ricevuto l'approvazione del marchio per il suo modello proprietario Jasper c-Kit Mouse™, che consente il test diretto degli inibitori di c-Kit in diverse malattie, superando le limitazioni dei modelli standard.
Jasper Therapeutics (Nasdaq: JSPR) anunció la aprobación de Health Canada para su Solicitud de Ensayo Clínico para un estudio de desafío asmático de Fase 1b/2a que evalúa briquilimab. El estudio, que planea inscribir a 30 pacientes en Canadá y la UE, tiene como objetivo demostrar la prueba de concepto para la depleción de mastocitos como un mecanismo efectivo en el tratamiento del asma. Las evaluaciones clave incluyen la respuesta asmática temprana y tardía, los cambios en la hiperreactividad de las vías respiratorias y la depleción de mastocitos.
La empresa planea comenzar a dosificar pacientes en el cuarto trimestre de 2024 y reportar datos iniciales en la segunda mitad de 2025. Además, Jasper recibió la aprobación de la marca para su modelo propietario Jasper c-Kit Mouse™, que permite probar directamente los inhibidores de c-Kit en diversas enfermedades, superando las limitaciones de los modelos estándar.
자스퍼 테라퓨틱스(Jasper Therapeutics, Nasdaq: JSPR)는 브리퀼리맙(briquilimab)을 평가하는 1b/2a 단계의 천식 유발 연구에 대한 임상 시험 신청서가 캐나다 보건부(Health Canada)의 승인을 받았다고 발표했습니다. 이 연구는 캐나다와 유럽연합(EU)에서 30명의 환자를 모집할 예정이며, mast cell의 고갈을 천식 치료의 효과적인 메커니즘으로 증명하기 위한 개념 증명을 목표로 하고 있습니다. 주요 평가 항목으로는 조기 및 후기 천식 반응, 기도의 과민성 변화 및 mast cell 고갈이 포함됩니다.
회사는 2024년 4분기에 환자 투약을 시작하고 2025년 하반기에 초기 데이터를 보고할 계획입니다. 또한, 자스퍼는 다양한 질병에서 c-Kit 억제제를 직접 테스트할 수 있는 독점 모델인 Jasper c-Kit Mouse™의 상표 승인을 받았습니다. 이 모델은 표준 모델의 한계를 극복합니다.
Jasper Therapeutics (Nasdaq: JSPR) a annoncé l'approbation de Health Canada pour sa Demande d'Essai Clinique pour une étude de défi asthmatique de Phase 1b/2a évaluant briquilimab. L'étude, qui prévoit d'inscrire 30 patients au Canada et dans l'UE, vise à démontrer la preuve de concept de la déplétion des mastocytes comme un mécanisme efficace dans le traitement de l'asthme. Les évaluations clés comprennent la réponse asthmatique précoce et tardive, les changements dans l'hyperréactivité des voies respiratoires et la déplétion des mastocytes.
L'entreprise prévoit de commencer à administrer des traitements aux patients au quatrième trimestre de 2024 et de rapporter des données initiales au second semestre de 2025. De plus, Jasper a reçu l'approbation de marque pour son modèle propriétaire Jasper c-Kit Mouse™, qui permet de tester directement les inhibiteurs de c-Kit dans diverses maladies, surmontant ainsi les limites des modèles standard.
Jasper Therapeutics (Nasdaq: JSPR) gab bekannt, dass Health Canada seine Antragsstellung für eine klinische Studie der Phase 1b/2a genehmigt hat, in der briquilimab zur Behandlung von Asthma bewertet wird. Die Studie plant die Rekrutierung von 30 Patienten in Kanada und der EU und zielt darauf ab, den Nachweis zu erbringen, dass die Depletion von Mastzellen ein effektiver Mechanismus zur Behandlung von Asthma ist. Bedeutende Bewertungen umfassen die frühe und späte asthmatische Reaktion, Veränderungen der Atemwegs-Hyperreaktivität sowie die Depletion von Mastzellen.
Das Unternehmen plant, im vierten Quartal 2024 mit der Dosierung der Patienten zu beginnen und die ersten Daten im zweiten Halbjahr 2025 zu berichten. Darüber hinaus erhielt Jasper die Markenbewilligung für sein proprietäres Modell Jasper c-Kit Mouse™, das die direkte Prüfung von c-Kit-Inhibitoren bei verschiedenen Krankheiten ermöglicht und damit die Einschränkungen herkömmlicher Modelle überwindet.
- Health Canada cleared Clinical Trial Application for Phase 1b/2a asthma study
- Study to enroll 30 patients across Canada and EU
- Dosing expected to commence in Q4 2024
- Initial data anticipated in H2 2025
- Trademark allowed for proprietary Jasper c-Kit Mouse™ model
- None.
Health Canada's clearance of Jasper Therapeutics' Clinical Trial Application (CTA) for briquilimab in asthma is a significant step forward. This Phase 1b/2a study aims to demonstrate proof-of-concept for mast cell depletion as an effective mechanism in asthma treatment. The single-dose, double-blind, placebo-controlled study will enroll 30 patients across Canada and the EU, using a 180mg subcutaneous dose of briquilimab.
Key points to consider:
- The study design allows for rapid advancement and efficient pathway to clinical development.
- Assessments will include early and late asthmatic response, airway hyperresponsiveness and mast cell depletion/recovery.
- Initial data is expected in the second half of 2025, which could provide valuable insights into briquilimab's potential in asthma treatment.
The allowed trademark for the Jasper c-Kit Mouse™ model is also noteworthy, as it enables more clinically translatable preclinical studies for c-Kit inhibitors across various diseases.
This development positions Jasper Therapeutics favorably in the competitive landscape of asthma therapeutics. Key considerations for investors:
- Expansion into asthma broadens Jasper's potential market, adding to their existing focus on urticaria.
- The 180mg dose being used directly in this study, based on the BEACON study results, could accelerate the development timeline.
- The proprietary Jasper c-Kit Mouse™ model provides a strategic advantage in preclinical testing, potentially leading to more efficient and targeted drug development.
However, it's important to note that this is still an early-stage trial and success is not guaranteed. The timeline for initial data in H2 2025 means investors should be prepared for a wait before seeing concrete results. The company's ability to execute this trial efficiently and produce positive data will be important for its future prospects in the asthma market.
REDWOOD CITY, Calif., Sept. 10, 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 that Health Canada has cleared the Company’s Clinical Trial Application (CTA) for a Phase 1b/2a asthma challenge study evaluating briquilimab in asthma.
“We are excited to announce that Health Canada has issued a no objection letter allowing us to move forward with our first clinical trial evaluating briquilimab in asthma, and we look forward to commencing patient enrollment shortly,” said Edwin Tucker, M.D., Chief Medical Officer. “Our clinical development plan follows an established and efficient pathway beginning with a challenge study in patients with allergic asthma to enable rapid advancement of the program. We aim to demonstrate proof of concept for the depletion of mast cells with briquilimab as an effective mechanism of action in asthma and to inform potential future studies in the broader asthma population.”
The Phase 1b/2a study in asthma is a single dose double-blind, placebo-controlled study that is expected to enroll 30 patients across as many as 10 sites in Canada and the EU with a key objective of demonstrating proof-of-concept in asthma utilizing a therapeutic dose to inform future trials in the broader asthma population. The study will be conducted utilizing a single 180mg dose of subcutaneous briquilimab and key assessments will be both early and late asthmatic response, changes in airway hyperresponsiveness, mast cell depletion and recovery and safety. Jasper expects to commence dosing patients in the fourth quarter of 2024 and to report initial data in the second half of 2025.
“Clearance of the CTA for the asthma study is an important milestone for Jasper as we continue to build out our pipeline of programs evaluating briquilimab in mast cell driven diseases,” said Ronald Martell, President and Chief Executive Officer of Jasper. “Being able to move directly to a 180mg dose in this study as a result of the dose escalation in the BEACON study is an excellent outcome as we believe that driving deep depletion of mast cells in the airways with a higher dose of briquilimab will be key to demonstrating durable clinical benefit in asthma patients.”
Trademark Allowed for Jasper c-Kit Mouse™ Model
Jasper also announced that a registered trademark has been allowed by the U.S. Patent and Trademark Office for the proprietary Jasper c-Kit Mouse™ model. The Jasper c-Kit Mouse™ model was developed to enable direct testing of c-Kit inhibitors across numerous diseases, overcoming the limitations of standard models which do not bind antibodies directed at the human c-Kit receptor.
“We are pleased that the U.S. Patent and Trademark Office has allowed registration of a trademark for the Jasper c-Kit Mouse™ model,” said Wendy Pang, M.D., Ph.D., Senior Vice President, Research and Translational Medicine. “Briquilimab was shown to reduce asthmatic response to allergen in the Jasper c-Kit Mouse™ model, supporting the launch of our clinical program in asthma. We believe that our ability to conduct preclinical studies with superior clinical translatability via the Jasper c-Kit Mouse™ model provides a strategic advantage as we continue to expand development into additional indications.”
About 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).
About Jasper
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, asthma 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.
Forward-Looking Statements
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 briquilimab’s potential, including with respect to its potential in mast cell driven diseases such as CSU, CIndU, and asthma, the potential for the depletion of mast cells with briquilimab to be an effective mechanism of action in asthma and its potential durable clinical benefits; Jasper’s expectations regarding the Phase 1b/2a asthma challenge study evaluating briquilimab in asthma, including protocols and expected patient enrollment and timing thereof, expected site locations, expected key objectives, expected timing to commence dosing and expected timing to report initial data; and Jasper’s expectations regarding building out its pipeline of programs evaluating briquilimab in mast cell driven diseases. 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.
Contacts:
Joyce Allaire (investors)
LifeSci Advisors
617-435-6602
jallaire@lifesciadvisors.com
Alex Gray (investors)
Jasper Therapeutics
650-549-1454
agray@jaspertherapeutics.com
Lauren Walker (media)
Real Chemistry
646-564-2156
lbarbiero@realchemistry.com
FAQ
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