Jasper Therapeutics Announces Further Expansion of Clinical Program in Chronic Spontaneous Urticaria

Rhea-AI Summary

Jasper Therapeutics (JSPR) announced an expansion of its clinical program for chronic urticaria treatments. The company is initiating an open-label extension study that will include patients from both BEACON and SPOTLIGHT studies. Additionally, Jasper received regulatory approval in the US and EU to add a 360mg single-dose cohort to the BEACON study in chronic spontaneous urticaria (CSU), with enrollment already begun.

Initial data from all doses up to 240mg in the BEACON study will be reported during the week of January 6th, 2025, while data from the new 360mg cohort is expected in the first half of 2025. The company plans to commence registrational studies in the second half of 2025.

Positive

• Received US and EU regulatory clearance for 360mg dose expansion
• Successfully initiated enrollment in new 360mg cohort
• On track to report initial BEACON study data in January 2025
• Expanding clinical program with open-label extension study

Negative

• None.

Insights

Medical Research Analyst

The expansion of Jasper Therapeutics' clinical program for briquilimab represents an incremental development in their CSU pipeline. The addition of a 360mg single-dose cohort and an open-label extension study will provide valuable long-term safety and efficacy data. However, this is primarily a procedural update about ongoing trials rather than results-driven news.

The key milestone to watch remains the initial data readout from the BEACON study (up to 240mg doses) expected in January 2025, followed by 360mg cohort data in H1 2025. These future catalysts, along with planned registrational studies in H2 2025, will be more significant for assessing briquilimab's potential in the competitive CSU market.

REDWOOD CITY, Calif., Oct. 23, 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 it is commencing an open-label extension study in chronic urticarias that will roll over patients from the BEACON and SPOTLIGHT studies upon completion of their initial follow up period. Additionally, Jasper also announced it has obtained regulatory clearance in the US and in the EU to further expand the BEACON study in CSU by adding a 360mg single-dose cohort (n=4), and that enrollment in this cohort has commenced. Jasper continues to plan to report initial data from all doses of the BEACON study up through 240mg in CSU during the week of January 6^th, 2025. Data from the newly added 360mg single-dose cohort is expected to be reported in the first half of 2025.

“I am very pleased with the ability of our clinical and regulatory teams to efficiently advance our clinical development plan in support of generating a robust data set in chronic urticaria,” said Ronald Martell, President and Chief Executive Officer of Jasper. “The addition of the 360mg single-dose cohort in the BEACON study in CSU will allow us to evaluate another potential loading dose leveraging the ongoing clinical trial, and the rollover extension study will allow us to gather longer-term safety and efficacy data at therapeutic doses for patients in both BEACON and SPOTLIGHT. The expanded breadth of clinical data provided in CSU and CindU should further support optimal biologic dosing in our registrational studies, planned to commence in the second half of 2025.”

About Briquilimab

Briquilimab 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 initiating 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 160 dosed participants and healthy volunteers, with clinical outcomes in CIndU, and 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 160 dosed participants and healthy volunteers, with clinical outcomes in CIndU and as a conditioning agent in SCID, AML, MDS, FA, and SCD. 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; the expected number of participants in the 360mg single-dose cohort; Jasper’s expected timing for presenting initial data from all doses of the BEACON study up through the 240mg dose cohort in CSU and from the 360mg single-dose cohort; Jasper’s expectations regarding the commencement and timing of registrational studies; and Jasper’s expectation that the expanded clinical data should further support optimal biologic dosing in its registrational studies. 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@jaspertx.com

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

Lauren Walker (media)
Real Chemistry
646-564-2156
lbarbiero@realchemistry.com

FAQ

When will Jasper Therapeutics (JSPR) report initial data from the BEACON study?

Jasper Therapeutics will report initial data from all doses up through 240mg in the BEACON study during the week of January 6th, 2025.

What is the new dosage cohort added to JSPR's BEACON study?

Jasper Therapeutics has added a 360mg single-dose cohort to the BEACON study in chronic spontaneous urticaria (CSU).

When will JSPR begin its registrational studies for chronic urticaria treatments?

Jasper Therapeutics plans to commence registrational studies in the second half of 2025.

When will JSPR report data from the new 360mg cohort in the BEACON study?

Data from the 360mg single-dose cohort is expected to be reported in the first half of 2025.