Jasper Therapeutics Reports Clinical Data Update from Briquilimab Studies in Chronic Spontaneous Urticaria
Jasper Therapeutics (NASDAQ:JSPR) reported mixed clinical data from its briquilimab studies in Chronic Spontaneous Urticaria (CSU). In the single-dose cohorts (240mg and 360mg), 8 of 9 participants (89%) achieved complete response, with 78% showing clinical response by week 2. The open-label extension study using 180mg Q8W showed 73% complete response rate at 12 weeks.
However, results from the 240mg Q8W and 240mg followed by 180mg Q8W cohorts were confounded by issues with one drug product lot. The company is investigating the affected lot and will enroll 10-12 additional patients across these cohorts. Due to the same lot issue, Jasper is halting the ETESIAN asthma study and SCID development, implementing cost-cutting measures. The Phase 2b CSU study is now delayed until mid-2026.
Jasper Therapeutics (NASDAQ:JSPR) ha riportato dati clinici contrastanti dai suoi studi su briquilimab nella Urticaria Spontanea Cronica (CSU). Nei gruppi a dose singola (240mg e 360mg), 8 su 9 partecipanti (89%) hanno ottenuto una risposta completa, con il 78% che ha mostrato una risposta clinica entro la seconda settimana. Lo studio in estensione open-label con 180mg ogni 8 settimane ha evidenziato un tasso di risposta completa del 73% a 12 settimane.
Tuttavia, i risultati dei gruppi con 240mg ogni 8 settimane e 240mg seguiti da 180mg ogni 8 settimane sono stati compromessi da problemi legati a un lotto di prodotto farmaceutico. L'azienda sta indagando sul lotto interessato e arruoler脿 10-12 pazienti aggiuntivi in questi gruppi. A causa dello stesso problema di lotto, Jasper ha sospeso lo studio ETESIAN sull'asma e lo sviluppo SCID, adottando misure di riduzione dei costi. Lo studio di fase 2b sulla CSU 猫 ora posticipato a met脿 2026.
Jasper Therapeutics (NASDAQ:JSPR) inform贸 datos cl铆nicos mixtos de sus estudios con briquilimab en Urticaria Cr贸nica Espont谩nea (CSU). En las cohortes de dosis 煤nica (240 mg y 360 mg), 8 de 9 participantes (89%) lograron una respuesta completa, con un 78% mostrando respuesta cl铆nica en la semana 2. El estudio de extensi贸n abierto con 180 mg cada 8 semanas mostr贸 una tasa de respuesta completa del 73% a las 12 semanas.
Sin embargo, los resultados de las cohortes de 240 mg cada 8 semanas y 240 mg seguidos de 180 mg cada 8 semanas se vieron afectados por problemas con un lote del producto farmac茅utico. La compa帽铆a est谩 investigando el lote afectado y reclutar谩 a 10-12 pacientes adicionales en estas cohortes. Debido al mismo problema con el lote, Jasper ha detenido el estudio ETESIAN para asma y el desarrollo de SCID, implementando medidas de reducci贸n de costos. El estudio de fase 2b para CSU se ha retrasado hasta mediados de 2026.
Jasper Therapeutics (NASDAQ:JSPR)電� 毵岇劚 鞛愲皽 霊愲摐霟赴(CSU)鞐愳劀 敫岆Μ韤茧Μ毵� 鞐瓣惮鞚� 鞛勳儊 雿办澊韯瓣皜 順检灛霅� 瓴瓣臣毳� 氤搓碃頄堨姷雼堧嫟. 雼澕 鞖╇焿 旖旐樃韸�(240mg 氚� 360mg)鞐愳劀 9氇� 欷� 8氇�(89%)鞚� 鞕勳爠 氚橃潙鞚� 氤挫榾鞙茧┌, 78%電� 2欤检皑鞐� 鞛勳儊 氚橃潙鞚� 雮橅儉雰堨姷雼堧嫟. 180mg鞚� 8欤茧雼� 韴棳頃橂姅 瓿店皽 霛茧波 鞐办灔 鞐瓣惮鞐愳劀電� 12欤检皑鞐� 73%鞚� 鞕勳爠 氚橃潙毳�鞚� 氤挫榾鞀惦媹雼�.
頃橃毵� 240mg 8欤� 臧勱博 氚� 240mg 頉� 180mg 8欤� 臧勱博 旖旐樃韸胳潣 瓴瓣臣電� 頃� 鞎巾拡 搿滍姼 氍胳牅搿� 鞚疙暣 順茧瀫鞚� 鞛堨棃鞀惦媹雼�. 須岇偓電� 頃措嫻 搿滍姼毳� 臁办偓 欷戩澊氅� 鞚� 旖旐樃韸胳棎 10-12氇呾潣 於旉皜 頇橃瀽毳� 霌彪頃� 鞓堨爼鞛呺媹雼�. 臧欖潃 搿滍姼 氍胳牅搿� 鞚疙暣 Jasper電� ETESIAN 觳滌嫕 鞐瓣惮鞕� SCID 臧滊皽鞚� 欷戨嫧頃橁碃 牍勳毄 鞝堦皭 臁办箻毳� 鞁滍枆頃橁碃 鞛堨姷雼堧嫟. 2b靸� CSU 鞐瓣惮電� 2026雲� 欷戨皹鞙茧 歆�鞐半悩鞐堨姷雼堧嫟.
Jasper Therapeutics (NASDAQ:JSPR) a rapport茅 des donn茅es cliniques mitig茅es issues de ses 茅tudes sur le briquilimab dans l'urticaire chronique spontan茅e (CSU). Dans les cohortes 脿 dose unique (240 mg et 360 mg), 8 participants sur 9 (89%) ont obtenu une r茅ponse compl猫te, avec 78% montrant une r茅ponse clinique d猫s la semaine 2. L'茅tude en extension en ouvert avec 180 mg toutes les 8 semaines a montr茅 un taux de r茅ponse compl猫te de 73% 脿 12 semaines.
Cependant, les r茅sultats des cohortes 脿 240 mg toutes les 8 semaines et 240 mg suivis de 180 mg toutes les 8 semaines ont 茅t茅 perturb茅s par des probl猫mes li茅s 脿 un lot de m茅dicament. La soci茅t茅 enqu锚te sur le lot concern茅 et recrutera 10 脿 12 patients suppl茅mentaires dans ces cohortes. En raison du m锚me probl猫me de lot, Jasper suspend l'茅tude ETESIAN sur l'asthme et le d茅veloppement SCID, en mettant en place des mesures de r茅duction des co没ts. L'茅tude de phase 2b sur la CSU est d茅sormais retard茅e jusqu'脿 mi-2026.
Jasper Therapeutics (NASDAQ:JSPR) berichtete gemischte klinische Daten aus seinen briquilimab-Studien bei chronischer spontaner Urtikaria (CSU). In den Einzeldosis-Kohorten (240 mg und 360 mg) erreichten 8 von 9 Teilnehmern (89%) eine vollst盲ndige Reaktion, wobei 78% bereits in Woche 2 eine klinische Wirkung zeigten. Die Open-Label-Verl盲ngerungsstudie mit 180 mg alle 8 Wochen zeigte nach 12 Wochen eine vollst盲ndige Ansprechrate von 73%.
Die Ergebnisse der Kohorten mit 240 mg alle 8 Wochen und 240 mg gefolgt von 180 mg alle 8 Wochen wurden jedoch durch Probleme mit einer Charge des Arzneimittels beeintr盲chtigt. Das Unternehmen untersucht die betroffene Charge und wird 10-12 zus盲tzliche Patienten in diese Kohorten aufnehmen. Aufgrund desselben Charge-Problems stoppt Jasper die ETESIAN-Asthmastudie und die SCID-Entwicklung und f眉hrt Kostensenkungsma脽nahmen durch. Die Phase-2b-CSU-Studie verz枚gert sich nun bis Mitte 2026.
- Strong efficacy in single-dose cohorts with 89% complete response rate
- 73% complete response rate in open-label extension study at 180mg Q8W
- Briquilimab demonstrated favorable safety profile with no grade 3 or higher treatment-related adverse events
- Rapid onset of action with 78% achieving clinical response by week 2
- Drug product lot issues affecting multiple cohorts requiring additional patient enrollment
- Phase 2b CSU study delayed until mid-2026
- Company halting ETESIAN asthma study and SCID development programs
- Implementation of cost-cutting measures and potential restructuring needed
Insights
Briquilimab shows promising efficacy in urticaria but faces setback with drug lot issue, delaying Phase 2b trial to mid-2026.
The latest data from Jasper Therapeutics' BEACON study demonstrates impressive efficacy for briquilimab in chronic spontaneous urticaria (CSU), with
However, a critical issue has emerged with one drug product lot affecting two multi-dose cohorts (240mg Q8W and 240mg followed by 180mg Q8W). The affected patients showed minimal tryptase reduction and no meaningful improvement in UAS7 scores 鈥� both key biomarker and symptom measures that should correlate with treatment success. This is clearly a manufacturing/quality control issue rather than a drug efficacy problem, as confirmed by the consistent performance of properly manufactured drug across other cohorts.
The open-label extension data at 180mg Q8W shows
The company's decision to halt the ETESIAN asthma trial, stop SCID development, and implement cost-cutting measures are prudent responses to extend runway while addressing the manufacturing issue. The delay of Phase 2b to mid-2026 is significant but necessary to ensure robust dose selection data. This setback, while disappointing, doesn't undermine the strong efficacy signals seen with properly manufactured briquilimab in CSU.
Strong efficacy in urticaria marred by manufacturing issue; program delays and pipeline cuts signal significant operational challenges ahead.
Jasper's clinical update presents a mixed picture with significant operational implications. The efficacy data from properly manufactured briquilimab is compelling 鈥�
However, the manufacturing issue affecting a specific drug product lot creates substantial near-term uncertainty. This forces the company to: 1) enroll 10-12 additional patients across two cohorts, 2) delay the Phase 2b study to mid-2026 (likely a 6-12 month setback), and 3) implement cost-cutting measures including potential restructuring. These actions will significantly extend the timeline to market and create additional cash burn when the company likely hoped to be advancing toward pivotal studies.
The decision to terminate the asthma program (ETESIAN trial) and halt SCID development represents a strategic narrowing to focus on urticaria indications. While this preserves capital, it reduces pipeline diversification and places more pressure on success in the CSU program. The mention of "potential restructuring" suggests potential headcount reductions to extend runway.
From a development perspective, the most concerning element is determining the root cause of the drug product lot issue. Manufacturing consistency is critical for biologics, and regulatory agencies will scrutinize this closely. If systemic manufacturing problems exist, this could create additional delays beyond those already announced. Investors should closely monitor the outcome of the company's investigation expected "in the coming weeks."
听8 of 9 participants (
8 of 11 participants (
Results from the 240mg Q8W and the 240mg followed by 180mg Q8W cohorts appear to be confounded by issues with one drug product lot
ETESIAN study in asthma to be stopped due to same drug product lot issue
No grade 3 or higher treatment related adverse events reported
Company to host conference call and webinar today, Monday, July 7, at 8:30 a.m. EDT
REDWOOD CITY, Calif., July 07, 2025 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting KIT (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), is reporting updated data from Company鈥檚 BEACON Phase 1b/2a study of subcutaneous briquilimab in adult participants with CSU and providing an update on the program. Briquilimab administration resulted in deep and rapid disease control in the 240mg and 360mg single-dose cohorts, with 8 of 9 (
Results from the 240mg Q8W and the 240mg followed by 180mg Q8W dose cohorts appear to be confounded by an issue with one drug product lot used in those cohorts, with 10 of the 13 patients dosed with drug from the lot in question. The Company is investigating the drug product lot in question and expects to have the results of that investigation in the coming weeks. Key observations noted in those 10 patients were lower than expected drops in mean tryptase levels and no discernable impact on UAS7 scores. The 2 participants enrolled in the cohorts that have been confirmed as being dosed with drug product from a different lot both achieved complete response.
New drug product is being provided to clinical sites to transition the 10 patients who were initially dosed with drug from the lot in question to drug product for their next administration that has demonstrated efficacy in earlier and ongoing cohorts. The Company also plans to enroll an additional 10-12 patients in total across the 240mg Q8W and the 240mg followed by 180mg Q8W cohorts to ensure a robust data set to inform the Phase 2b CSU study. Data from the additional BEACON patients is expected in 4Q 2025 and commencement of the Phase 2b study is now expected in mid-2026.
The Company has also determined that the drug product lot in question was used to treat participants enrolled in the ETESIAN trial evaluating briquilimab in asthma. As a result, and in order to focus resources on advancing briquilimab in CSU, the Company is halting the study and pausing development in asthma. In addition, the Company is halting development in SCID and will be implementing a number of other cost cutting measures, including a potential restructuring, to extend runway and reduce expenses.
鈥淲e were pleased that results from the 240mg and 360mg single dose cohorts continue to indicate that briquilimab treatment can lead to deep and durable disease control in patients with CSU,鈥� said Ronald Martell, President and Chief Executive Officer of Jasper. 鈥淲e are also very excited by the performance of the 180mg Q8W dose in the open label extension study with the strong efficacy observed, in combination with the encouraging safety data, supporting a differentiated profile. While we are very disappointed by the confounded results seen in the two multi-dose cohorts of the BEACON study, we are currently investigating the cause and are taking steps to ensure that drug product from the lot in question is returned to the Company and that sites have drug product from other lots to continue dosing. We plan to enroll an additional 10-12 patients across the two impacted cohorts to inform final dose selection for the Phase 2b study, and will be implementing a number of cost cutting measures to reduce burn and extend our cash runway in light of this delay.鈥�
BEACON and Open-Label Extension Study Design and Data Summary:
The BEACON study is a randomized, double-blind, and placebo-controlled Phase 1b/2a trial evaluating multiple ascending doses of subcutaneous briquilimab as a therapy for adult patients with moderate to severe CSU despite treatment with high dose antihistamines. The primary endpoints are safety and tolerability of briquilimab and secondary endpoints are focused on clinical activity and PK/PD, including measurement of serum tryptase and mast cells in skin. Primary measurements used to assess clinical activity were the sum of the Hives Severity Score and the daily Itch Severity Score (ISS), as measured via the Urticaria Activity Score over 7 days (UAS7) on a 0 to 42-point scale.
The open-label extension study in chronic urticarias is enrolling participants from the BEACON study as well as the SPOTLIGHT study in CIndU upon completion of their initial follow up period. Participants in the open-label extension are treated with 180mg of briquilimab on a Q8W dosing schedule.
The updated data, as of July 3, 2025, includes the results from 20 additional patients treated with briquilimab in the BEACON study, including 2 additional participants at 240mg single dose (in addition to 3 previously enrolled participants), 6 at 240mg Q8W, 7 at 240mg followed by 180mg Q8W, and 5 at 360mg single dose (N=4 evaluable for efficacy), as well as from 11 participants enrolled in the open label extension study at 180mg Q8W, all of whom completed at least 12 weeks of follow-up following initial dosing with investigational product.
Substantial reductions in UAS7 scores were reported with a mean change from baseline at 4 weeks of 28.3 points in the 240mg single-dose cohort and 22.9 points in the 360mg single-dose cohort. Complete responses (UAS7 = 0) were achieved by 5 of 5 (
Briquilimab treatment also resulted in deep and durable disease control in the open label extension study evaluating briquilimab at 180mg Q8W, with 8 of 11 participants (
Substantial reductions in tryptase were observed as early as the week 1 assessment and were correlated with the onset of clinical responses. Tryptase levels below the lower limit of quantification were reported for 8 of 10 (
Briquilimab continued to be well tolerated in the BEACON study, as well as the open label extension, with no dose limiting toxicities observed. Safety observations potentially related to KIT blockade were infrequent and generally limited to听low grade events, none of which resulted in discontinuations or听dose delays and the majority of which resolved during repeat dosing. Mild and predictable decreases in neutrophil counts were observed upon dosing, with counts generally recovering prior to subsequent dose and no association to fever or infection. All cases of neutrophil count reduction observed in the 240mg and 360mg single dose cohorts resolved while on study with a median time to resolution of 42 days.
Conference Call / Webinar
Jasper will host a conference call and webinar on Monday, July 7, 2025, at 8:30 a.m. EDT. A live question and answer session with management will follow the formal presentations. A link to the webinar, including presentation slides, can be found听. To access the live conference call via phone, dial 844-826-3033 from the US or 412-317-5185 from outside the US, or click . The conference ID is 10201355, and the conference call passcode is 6702622.
The presentation slides and a link to the live and archived webinar will also be available on the page of Jasper鈥檚 Investor Relations website.
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 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 and CIndU. 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 .
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 鈥渂elieve,鈥� 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渆stimate,鈥� 鈥渃ontinue,鈥� 鈥渁nticipate,鈥� 鈥渋ntend,鈥� 鈥渆xpect,鈥� 鈥渟hould,鈥� 鈥渨ould,鈥� 鈥減lan,鈥� 鈥減redict,鈥� 鈥減otential,鈥� 鈥渟eem,鈥� 鈥渟eek,鈥� 鈥渇uture,鈥� 鈥渙utlook鈥� 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鈥檚 potential, including with respect to its potential in mast cell driven diseases such as CSU, CIndU, and asthma and that briquilimab treatment can lead to deep and durable disease control in patients with CSU; Jasper鈥檚 planned investigation of drug product lot and expected timing for the results of such investigation; the expected provision of new drug product to transition patients who were initially dosed with drug from the lot in question and the expected results of any such transition; Jasper鈥檚 plans to enroll additional patients in the 240mg Q8W and the 240mg followed by 180mg Q8W cohorts and the expected number of patients to be enrolled in such cohorts; the expected timing of announcing data from additional BEACON study patients and the expected timing for commencing any Phase 2b study; potential cost cutting measures that may be implemented, including a potential restructuring, and the potential effects thereof, including on Jasper鈥檚 cash runway and expenses; and briquilimab鈥檚 safety profile. 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鈥檚 investigation into the drug product lot may be inconclusive or may not lead to the anticipated conclusion; the risk that Jasper may be unable to raise capital to continue its operations and continue the BEACON study; 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鈥檚 product candidates may not be beneficial to patients or successfully commercialized; patients鈥� willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper鈥檚 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鈥檚 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鈥檚 filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper鈥檚 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鈥檚 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听
Joyce Allaire (investors)
LifeSci Advisors
617-435-6602
Lauren Walker (media)
AG真人官方 Chemistry
646-564-2156
FAQ
What were the key results from Jasper Therapeutics' (JSPR) briquilimab trials in CSU?
What issues did Jasper Therapeutics encounter with briquilimab's clinical trials?
How is JSPR addressing the drug lot issues in their clinical trials?
What is the safety profile of briquilimab in CSU treatment?
How will the drug lot issues impact Jasper Therapeutics' development timeline?
