Jasper Therapeutics Presents Clinical and Preclinical Briquilimab Data at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting
Jasper Therapeutics (Nasdaq: JSPR) presented updated clinical data from its Phase 1b/2a BEACON study and four preclinical studies for briquilimab at the AAAAI 2025 Annual Meeting. The latest data, with a cut-off date of January 31, 2025, includes one month of additional dosing and follow-up from 49 participants.
The study shows that briquilimab continues to demonstrate favorable safety profile in treating chronic spontaneous urticaria (CSU), with no additional adverse events related to c-Kit blockade. The treatment resulted in rapid and deep clinical responses in omalizumab-experienced patients with moderate to severe CSU.
Based on these positive results, Jasper plans to advance briquilimab into a Phase 2b operationally adaptive study in the second half of 2025. The company expects to report additional clinical data from approximately 70 patients treated with briquilimab doses of 180mg or higher by mid-year 2025, which will inform the final dose selection for the Phase 2b study.
Jasper Therapeutics (Nasdaq: JSPR) ha presentato dati clinici aggiornati dal suo studio BEACON di fase 1b/2a e quattro studi preclinici per briquilimab durante il Meeting Annuale AAAAI 2025. I dati più recenti, con una data di cut-off del 31 gennaio 2025, includono un mese di somministrazione aggiuntiva e follow-up di 49 partecipanti.
Lo studio mostra che briquilimab continua a dimostrare un profilo di sicurezza favorevole nel trattamento dell'orticaria spontanea cronica (CSU), senza eventi avversi aggiuntivi legati al blocco di c-Kit. Il trattamento ha portato a risposte cliniche rapide e profonde in pazienti con CSU moderata a grave già trattati con omalizumab.
In base a questi risultati positivi, Jasper prevede di avanzare briquilimab in uno studio adattivo operativo di fase 2b nella seconda metà del 2025. L'azienda si aspetta di riportare ulteriori dati clinici da circa 70 pazienti trattati con dosi di briquilimab di 180mg o superiori entro metà del 2025, il che informerà la selezione finale della dose per lo studio di fase 2b.
Jasper Therapeutics (Nasdaq: JSPR) presentó datos clínicos actualizados de su estudio BEACON de fase 1b/2a y cuatro estudios preclínicos para briquilimab en la Reunión Anual AAAAI 2025. Los últimos datos, con una fecha de corte del 31 de enero de 2025, incluyen un mes de dosificación adicional y seguimiento de 49 participantes.
El estudio muestra que briquilimab continúa demostrando un perfil de seguridad favorable en el tratamiento de la urticaria espontánea crónica (CSU), sin eventos adversos adicionales relacionados con el bloqueo de c-Kit. El tratamiento resultó en respuestas clínicas rápidas y profundas en pacientes con CSU moderada a grave que habían sido tratados previamente con omalizumab.
Con base en estos resultados positivos, Jasper planea avanzar briquilimab a un estudio adaptativo operativo de fase 2b en la segunda mitad de 2025. La compañía espera reportar datos clínicos adicionales de aproximadamente 70 pacientes tratados con dosis de briquilimab de 180mg o más para mediados de 2025, lo que informará la selección final de dosis para el estudio de fase 2b.
재스퍼 테라퓨틱스 (Nasdaq: JSPR)는 AAAAI 2025 연례 회의에서 브리퀼리맙에 대한 1b/2a BEACON 연구의 업데이트된 임상 데이터와 네 가지 전임상 연구 결과를 발표했습니다. 최신 데이터는 2025년 1월 31일 기준으로, 49명의 참가자로부터 한 달간의 추가 투여 및 추적 조사를 포함합니다.
이 연구는 브리퀼리맙이 만성 자발성 두드러기(CSU) 치료에 있어 유리한 안전성 프로필을 지속적으로 보여주며, c-Kit 차단과 관련된 추가적인 부작용이 없음을 나타냅니다. 이 치료는 오말리주맙을 경험한 중등도에서 중증 CSU 환자에서 빠르고 깊은 임상 반응을 가져왔습니다.
이러한 긍정적인 결과를 바탕으로, 재스퍼는 2025년 하반기에 2b 단계의 운영 적응형 연구로 브리퀼리맙을 진행할 계획입니다. 회사는 2025년 중반까지 180mg 이상의 브리퀼리맙 용량으로 치료받은 약 70명의 환자로부터 추가 임상 데이터를 보고할 것으로 예상하고 있으며, 이는 2b 단계 연구의 최종 용량 선택에 도움이 될 것입니다.
Jasper Therapeutics (Nasdaq: JSPR) a présenté des données cliniques mises à jour de son étude BEACON de phase 1b/2a ainsi que quatre études précliniques sur briquilimab lors de la réunion annuelle AAAAI 2025. Les dernières données, avec une date de coupure au 31 janvier 2025, incluent un mois de traitement supplémentaire et de suivi de 49 participants.
L'étude montre que briquilimab continue de démontrer un profil de sécurité favorable dans le traitement de l'urticaire spontanée chronique (CSU), sans événements indésirables supplémentaires liés au blocage de c-Kit. Le traitement a entraîné des réponses cliniques rapides et profondes chez des patients atteints de CSU modérée à sévère ayant déjà été traités par omalizumab.
Sur la base de ces résultats positifs, Jasper prévoit d'avancer briquilimab dans une étude adaptative opérationnelle de phase 2b dans la seconde moitié de 2025. L'entreprise s'attend à rapporter des données cliniques supplémentaires d'environ 70 patients traités avec des doses de briquilimab de 180 mg ou plus d'ici le milieu de l'année 2025, ce qui informera la sélection finale de la dose pour l'étude de phase 2b.
Jasper Therapeutics (Nasdaq: JSPR) hat aktualisierte klinische Daten aus seiner Phase 1b/2a BEACON-Studie und vier präklinischen Studien zu briquilimab auf dem AAAAI-Jahrestreffen 2025 vorgestellt. Die neuesten Daten, mit einem Cut-off-Datum vom 31. Januar 2025, umfassen einen Monat zusätzlicher Dosierung und Nachverfolgung von 49 Teilnehmern.
Die Studie zeigt, dass briquilimab weiterhin ein günstiges Sicherheitsprofil bei der Behandlung der chronischen spontanen Urtikaria (CSU) aufweist, ohne zusätzliche unerwünschte Ereignisse im Zusammenhang mit der c-Kit-Blockade. Die Behandlung führte zu schnellen und tiefen klinischen Reaktionen bei Patienten mit moderater bis schwerer CSU, die zuvor mit Omalizumab behandelt wurden.
Basierend auf diesen positiven Ergebnissen plant Jasper, briquilimab in eine operativ adaptive Phase-2b-Studie in der zweiten Hälfte des Jahres 2025 voranzutreiben. Das Unternehmen erwartet, bis zur Mitte des Jahres 2025 zusätzliche klinische Daten von etwa 70 Patienten zu berichten, die mit Dosen von 180 mg oder mehr behandelt wurden, was die endgültige Dosisauswahl für die Phase-2b-Studie informieren wird.
- Favorable safety profile with no additional adverse events
- Rapid and deep clinical responses in CSU patients
- Advancing to Phase 2b trial in H2 2025
- Predictable drug clearance with early Tmax
- Final dose selection still pending additional clinical data
- Phase 2b trial timeline pushed to second half of 2025
Insights
Jasper Therapeutics' updated Phase 1b/2a BEACON study data represents a meaningful clinical milestone for briquilimab in chronic spontaneous urticaria (CSU). The continued favorable safety profile and efficacy signals in omalizumab-experienced patients are particularly noteworthy, as this positions the candidate as a potential option for patients who've failed first-line biologic therapy.
The reported rapid onset of action and deep clinical responses, coupled with transient, low-grade c-Kit related adverse events that didn't require dose modifications, suggest a potentially differentiated clinical profile. The pharmacokinetic data showing early Tmax aligns with the rapid clinical response, while the predictable drug clearance may explain the favorable safety observations.
This data package supports Jasper's advancement toward a registrational pathway, with a Phase 2b study planned for H2 2025. The upcoming mid-year 2025 data from approximately 70 additional patients at higher doses (≥180mg) represents a critical near-term catalyst that will inform final dose selection.
The multiple preclinical presentations demonstrate mechanistic validation across various models and strengthen the scientific rationale for briquilimab's development in mast cell-driven diseases. While these results are encouraging, investors should recognize that substantial development hurdles remain before potential commercialization.
REDWOOD CITY, Calif., March 01, 2025 (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 to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, is presenting updated clinical data from the Phase 1b/2a BEACON study, as well as data from four preclinical studies evaluating briquilimab, at the AAAAI 2025 Annual Meeting, being held February 28 - March 3, 2025, in San Diego, CA.
The BEACON update, based on a data-cut date of January 31, 2025, features approximately one month of additional dosing and follow-up from the 49 participants covered in Jasper’s preliminary data disclosure on January 8, 2025. Briquilimab continues to be well tolerated in the study and has continued to demonstrate a favorable safety profile, with no additional adverse events (AEs) potentially related to c-Kit blockade observed. The data collected in the study to-date support advancing briquilimab into a registrational program in CSU, beginning with a planned Phase 2b operationally adaptive study expected to commence in the second half of 2025. Final dose selection for the Phase 2b study will be further informed by additional clinical data from patients treated at doses of 180mg and higher, expected to be reported mid-year 2025.
“I am pleased to present updated data from the BEACON study at AAAAI, which continue to demonstrate that treatment with briquilimab leads to rapid and deep clinical responses in omalizumab-experienced patients with moderate to severe CSU,” said Thomas B. Casale, M.D., Professor of Medicine and Pediatrics, University of South Florida Morsani College of Medicine. “The safety profile observed is also highly encouraging, with a low frequency of c-Kit related adverse events, which were transient, low-grade, and did not result in any dose delays or discontinuations. The favorable safety data reported in the study are supported by the predictable drug clearance observed, which may allow for restoration of signaling on c-Kit-expressing cells between doses. In addition, the early Tmax observed was consistent with rapid onset of clinical response. Taken together, I believe this data set underscores the potential of briquilimab to serve as a differentiated treatment option for patients with CSU.”
“We remain very excited by the efficacy and safety data generated in the BEACON study,” said Ronald Martell, President and Chief Executive Officer of Jasper. “We believe that these data demonstrate the potential of briquilimab to differentiate from other therapies, approved and in-development, with regard to onset of action, depth of response, and safety/tolerability. With a substantial number of additional patients being enrolled in the BEACON and SPOTLIGHT studies, as well as patients rolling over from those studies to the Open-Label Extension study, we look forward to reporting data from approximately 70 additional patients treated with briquilimab doses of 180mg or higher around mid-year 2025. These data will inform final dose selection for our planned Phase 2b operationally adaptive study expected to commence later this year.”
Details of the presentations are as follows:
Abstract Title: Initial Results from BEACON, a Phase 1b/2a Dose Escalation Study of the anti-c-Kit Briquilimab Antibody in Adults with Chronic Spontaneous Urticaria (CSU)
Publication Number: L24
Session Title: Late Breaking Oral Abstract Session
Session Type: Oral Abstract Session
Presentation Date / Time: Saturday, March 1, 2025; 2:55 p.m. PST
Abstract Title: Initial Results from BEACON, a Phase 1b/2a Dose Escalation Study of the anti-c-Kit Briquilimab Antibody in Adults with Chronic Spontaneous Urticaria (CSU)
Poster Number: L24
Session Title: Late Breaking Poster Session I
Session Type: Poster Session
Session Date / Time: Saturday, March 1, 2025; 9:45 - 10:45 a.m. PST
Abstract Title: Briquilimab, an Anti-c-Kit Antibody, Induces Durable Depletion of Mast Cells (MCs) Across Multiple Tissues in Mice Expressing Chimeric Human/Mouse CD117 (c-Kit)
Poster Number: 540
Session Title: Novel Mechanisms of Mast Cells, Basophils and IgE
Session Type: Poster Session
Session Date / Time: Saturday, March 1, 2025; 9:45 - 10:45 a.m. PST
Abstract Title: Briquilimab Potently Inhibits Stem Cell Factor (SCF)/c-Kit Signaling and Induces Mast Cell Apoptosis
Poster Number: 541
Session Title: Novel Mechanisms of Mast Cells, Basophils and IgE
Session Type: Poster Session
Session Date / Time: Saturday, March 1, 2025; 9:45 - 10:45 a.m. PST
Abstract Title: Briquilimab, an Anti-Human CD117 Antibody, Prevents Epicutaneous Oxazolone-Induced Features of Dermatitis in Mouse Model Expressing Chimeric Human/Mouse CD117
Poster Number: 662
Session Title: Atopic Dermatitis, Contact Dermatitis, Urticaria, Angioedema
Session Type: Poster Session
Session Date / Time: Sunday, March 2, 2025; 9:45 - 10:45 a.m. PST
Abstract Title: Briquilimab, an Anti-Human CD117 Antibody, Treats Low-Calcemic Vitamin D3 Analog MC903-Induced Dermatitis in Mouse Model Expressing Chimeric Human/Mouse CD117
Poster Number: 690
Session Title: Atopic Dermatitis, Contact Dermatitis, Urticaria, Angioedema
Session Type: Poster Session
Session Date / Time: Sunday, March 2, 2025; 9:45 - 10:45 a.m. PST
About Jasper
Jasper is a clinical-stage biotechnology company focused on developing briquilimab as a therapeutic for chronic mast cell diseases. Briquilimab is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor c-Kit, 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 and asthma. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU, CIndU or asthma. Briquilimab has a demonstrated efficacy and safety profile in patients and healthy volunteers, with positive clinical outcomes in CSU and CIndU. For more information, please visit us at www.jaspertx.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, its potential to serve as a differentiated treatment option for patients with CSU, its potential to differentiate from other therapies, approved and in-development, with regard to onset of action, depth of response, and safety/tolerability and its potential allow for restoration of signaling on c-Kit-expressing cells between doses; Jasper’s expectations regarding advancing briquilimab into a registrational program in CSU, including the potential commencement of a Phase 2b operationally adaptive study and the expected timing for commencing such trial; the expected timing for reporting additional clinical data from the Phase 1b/2a BEACON study for patients treated at doses of 180mg and higher; and Jasper’s poster presentations and oral presentation of briquilimab data at the AAAAI 2025 Annual Meeting. 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 prior test, study and trial results may not be replicated in continuing or future studies and trials; 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:
Alex Gray (investors)
Jasper Therapeutics
650-549-1454
agray@jaspertherapeutics.com
Joyce Allaire (investors)
LifeSci Advisors
617-435-6602
jallaire@lifesciadvisors.com
Lauren Walker (media)
Real Chemistry
646-564-2156
lbarbiero@realchemistry.com
FAQ
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