Jasper Therapeutics presents briquilimab clinical data at AAAAI 2025, showing safety and efficacy for chronic mast cell diseases.
Quiver AI Summary
Jasper Therapeutics, Inc. announced that it is presenting updated clinical data from its Phase 1b/2a BEACON study on briquilimab, an antibody therapy targeting c-Kit to treat mast cell-driven diseases like chronic spontaneous urticaria (CSU) and asthma, at the AAAAI 2025 Annual Meeting in San Diego. The new data, from a January 31, 2025 data cut, indicates that briquilimab has maintained a favorable safety profile with no new adverse events related to c-Kit blockade. The company plans to initiate a Phase 2b study later in 2025 based on these encouraging outcomes, which suggest briquilimab could offer a rapid and effective treatment option for patients with moderate to severe CSU. Additional data from ongoing studies involving more patients treated with higher doses of briquilimab is expected to be reported mid-2025.
Potential Positives
- Jasper Therapeutics is presenting updated clinical data on briquilimab at the AAAAI 2025 Annual Meeting, showcasing ongoing research and engagement with the medical community.
- The latest BEACON study data indicates that briquilimab is well-tolerated and has a favorable safety profile with no new adverse events reported, strengthening confidence in the drug's safety.
- The study data supports advancing briquilimab into a registrational program, with a planned Phase 2b study expected to commence in the second half of 2025, indicating progress in development and potential future market entry.
- The positive feedback from clinical experts on briquilimab's efficacy, particularly its rapid and deep clinical responses in patients with moderate to severe CSU, highlights its potential as a differentiated treatment option in the market.
Potential Negatives
- The press release includes numerous forward-looking statements that highlight the potential risks and uncertainties associated with the continued development of briquilimab, which may lead to investor skepticism regarding the viability and future success of the product.
- The announcement of future clinical data expected mid-year 2025 suggests there may be significant waiting periods for stakeholders to receive crucial information about briquilimab's efficacy and safety, which can negatively impact investor confidence.
- While the safety profile is presented as favorable, the ongoing need for additional data to inform dose selection raises concerns about the stability and reliability of earlier trial results, creating uncertainty around the drug's commercial prospects.
FAQ
What is briquilimab?
Briquilimab is a novel antibody therapy targeting c-Kit, developed by Jasper Therapeutics for treating mast cell driven diseases.
What key results were presented at the AAAAI 2025 Annual Meeting?
Updated clinical data from the BEACON study showed briquilimab's favorable safety profile and efficacy in chronic spontaneous urticaria patients.
When will the Phase 2b study for briquilimab begin?
A Phase 2b operationally adaptive study for briquilimab is expected to commence in the second half of 2025.
How has briquilimab been received in clinical trials?
Briquilimab has demonstrated favorable safety and clinical response in patients with chronic spontaneous urticaria and other mast cell diseases.
What additional data is expected for briquilimab in 2025?
Additional clinical data from patients treated with briquilimab at doses of 180mg and higher will be reported mid-year 2025.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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 T max 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
[email protected]
Joyce Allaire (investors)
LifeSci Advisors
617-435-6602
[email protected]
Lauren Walker (media)
Real Chemistry
646-564-2156
[email protected]