Jasper Therapeutics(JSPR)
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Jasper Therapeutics Reports Clinical Data Update from Briquilimab Studies in Chronic Spontaneous Urticaria
Globenewswire· 2025-07-07 11:30
Core Insights - Jasper Therapeutics, Inc. reported updated data from the BEACON Phase 1b/2a study of briquilimab, showing high efficacy in treating chronic spontaneous urticaria (CSU) with 89% of participants in the 240mg and 360mg cohorts achieving a complete response [1][5] - The study faced confounding results due to issues with a specific drug product lot, prompting an investigation and a halt in the ETESIAN asthma study [2][4] - The company plans to transition affected patients to a new drug product and enroll additional participants to strengthen the data set for the upcoming Phase 2b study [3][5] Study Results - In the BEACON study, 8 of 9 participants (89%) in the 240mg and 360mg single-dose cohorts achieved a complete response, while 73% of participants in the 180mg Q8W open-label extension study achieved a complete response at 12 weeks [1][11] - The 240mg Q8W and 240mg followed by 180mg Q8W cohorts showed confounding results due to the drug product lot issue, with 10 of 13 patients affected [2][5] - Substantial reductions in UAS7 scores were observed, with a mean change of 28.3 points in the 240mg single-dose cohort and 22.9 points in the 360mg single-dose cohort [10] Safety and Tolerability - No grade 3 or higher treatment-related adverse events were reported, indicating a favorable safety profile for briquilimab [1][13] - Mild and predictable decreases in neutrophil counts were observed, but these resolved during the study without leading to discontinuations [13] Future Plans - The company is investigating the drug product lot issue and expects results in the coming weeks, while also planning to enroll an additional 10-12 patients in the affected cohorts [2][3] - The commencement of the Phase 2b study is now expected in mid-2026, with data from additional BEACON patients anticipated in Q4 2025 [3][5] Company Overview - Jasper Therapeutics focuses on developing briquilimab, a monoclonal antibody targeting mast cell-driven diseases such as CSU and chronic inducible urticaria (CIndU) [16][17] - The company aims to address the underlying inflammatory responses in these conditions through its innovative therapeutic approach [16]
Jasper Therapeutics (JSPR) Update / Briefing Transcript
2025-06-16 13:00
Summary of Jasper Therapeutics Spotlight Data Update Conference Call Company Overview - **Company**: Jasper Therapeutics - **Focus**: Development of briquilimab for chronic inducible urticaria (Sindu) and other mast cell diseases Key Industry Insights - **Industry**: Biopharmaceuticals, specifically targeting mast cell-driven diseases - **Condition**: Chronic inducible urticaria (Sindu) is a debilitating skin condition with significant quality of life impacts and no approved treatments globally beyond antihistamines [6][8] Core Findings and Data - **Clinical Trial**: Phase Ib/IIa Spotlight clinical trial evaluating briquilimab in chronic inducible urticaria - **Cohort Data**: - 180 mg cohort: 100% clinical response rate, with 92% achieving complete response [11][12] - 120 mg cohort: 92% clinical response rate, with 83% achieving complete response [11][15] - Overall, 96% of patients across all doses achieved a clinical response, and 81% achieved a complete response [5] - **Safety Profile**: - Briquilimab was well tolerated with no serious adverse events reported at the 180 mg dose level [18][21] - Adverse events included nasopharyngitis, fatigue, and headache, all mild and transient [19][20] - **Efficacy Timeline**: - 67% of participants in the 180 mg cohort achieved a clinical response by week two [12] - 58% maintained clinical response at week eight [12][21] Additional Important Insights - **Unmet Medical Need**: Chronic inducible urticaria has a high unmet medical need, with significant impacts on patients' quality of life [6][8] - **Mechanism of Action**: Briquilimab targets KIT on mast cells, potentially offering a new treatment paradigm for mast cell diseases [21] - **Future Studies**: Plans for registrational studies in Sindu and chronic spontaneous urticaria (CSU) are underway, with a focus on advancing briquilimab into further clinical trials [22][23] - **Upcoming Milestones**: Full results from the Spotlight study are expected to be presented at a medical conference in the second half of 2025 [23] Conclusion - Jasper Therapeutics is making significant progress in developing briquilimab for chronic inducible urticaria, demonstrating robust efficacy and a favorable safety profile. The company is poised to advance its clinical programs, addressing a critical gap in treatment options for patients suffering from mast cell-driven diseases.
Jasper Therapeutics (JSPR) Earnings Call Presentation
2025-06-16 11:10
Efficacy of Briquilimab 180mg - A single 180mg dose of briquilimab demonstrated a 100% clinical response in participants with Chronic Inducible Urticaria (CIndU) [31] - 92% (11 out of 12) of participants in the 180mg cohort achieved a Complete Response (CR) by week 8 [21] - 83% (10 out of 12) of participants at 180mg had tryptase measurements below the Lower Limit of Quantification (LLOQ) [16] - 67% (8 out of 12) of patients in the 180mg group achieved a clinical response by week 2 [24] - Durability was shown with 58% (7 out of 12) clinical response maintained at 8 weeks (5 CRs and 2 PRs) in the 180mg dose [31] Safety and Tolerability - Briquilimab was well-tolerated in participants with CIndU [31] - Possibly KIT-related adverse events observed were low-grade and transient [31] - A reduction to below Lower Limit of Quantification (LLOQ) (1 µg/L) was seen in 833% (10/12) participants at 180mg [18] Study Design and Demographics - The SPOTLIGHT study is a Phase 1b/2a open-label, single ascending dose study in Chronic Inducible Urticaria [12] - The study included approximately 27 participants across ~5 sites in the EU [12] - The study evaluated briquilimab at 40mg (n=3), 120mg (n=12), and 180mg (n=12) single doses [12]
Jasper Therapeutics Reports Positive Data from 180mg Cohort in SPOTLIGHT Study of Briquilimab in Chronic Inducible Urticaria
Globenewswire· 2025-06-14 14:00
Core Insights - Jasper Therapeutics, Inc. presented promising data from the 180mg cohort of its SPOTLIGHT Phase 1b/2a study, showing that 100% of participants achieved a clinical response and 92% achieved a complete response [1][2][5] - The study demonstrated rapid and durable efficacy, with significant improvements observed as early as week 1, and 66% of participants achieving clinical response by week 2 [1][5][10] - Briquilimab was well tolerated, with no serious adverse events reported in the 180mg cohort, indicating a potentially differentiated safety profile [1][9][10] Study Design and Results - The SPOTLIGHT study is an open-label clinical trial evaluating briquilimab in adult participants with cold urticaria or symptomatic dermographism who are refractory to antihistamines, enrolling 27 participants across three dose cohorts: 40mg, 120mg, and 180mg [3][4] - Among the 12 participants in the 180mg cohort, 25% were diagnosed with cold urticaria and 75% with symptomatic dermographism, with a high disease burden indicated by provocation threshold testing [4][5] - Overall, 81% of participants in the study achieved a complete response, and 96% achieved either a complete or partial response [6][7] Safety and Tolerability - The mean baseline serum tryptase for the 180mg cohort was 5.1 ng/ml, with significant reductions observed, correlating with clinical responses [8] - No serious adverse events or grade 3 or higher adverse events were reported, with mild, transient drops in neutrophil counts observed in some participants [9][10] - The safety profile of briquilimab appears favorable, with low frequency and low-grade adverse events that resolved quickly [10] Company Information - Jasper Therapeutics is focused on developing briquilimab as a therapeutic for chronic mast cell diseases, including chronic spontaneous urticaria and asthma [13] - The company is conducting clinical studies to further evaluate briquilimab's efficacy and safety profile in patients with chronic urticaria and asthma [13]
Jasper Therapeutics (JSPR) 2025 Conference Transcript
2025-06-05 16:42
Summary of Jasper Therapeutics Conference Call Company Overview - **Company**: Jasper Therapeutics - **Lead Program**: Briquilimab, targeting mast cell-mediated diseases [2][4] Industry Context - **Focus Area**: Mast cell-driven diseases, including chronic spontaneous urticaria, chronic inducible urticaria, and asthma [2][6] - **Market Opportunity**: Significant potential in treating over 3.5 million patients with urticaria and a large asthma market [39] Core Insights and Arguments 1. **Mechanism of Action**: Briquilimab targets the KIT receptor on mast cells, leading to apoptosis and depletion of these cells, which are implicated in various diseases [4][5] 2. **Clinical Trials**: Currently conducting trials for chronic spontaneous urticaria, chronic inducible urticaria, and asthma [6][35] 3. **Efficacy in Urticaria**: Briquilimab demonstrated rapid onset of clinical activity, with significant responses observed within the first week [9][18] 4. **Dosing Strategy**: The company is exploring optimal dosing intervals to maximize efficacy while minimizing adverse effects [7][8] 5. **Safety Profile**: Favorable safety profile with transient adverse events, including hair color changes and taste alterations, which resolved before the next dose [20][25][30] 6. **Comparative Efficacy**: Briquilimab shows competitive efficacy compared to other drugs in development for urticaria [19][28] Additional Important Points 1. **Upcoming Data Releases**: Mid-year data expected from ongoing studies, including the BEACON study and the asthma challenge study [32][38] 2. **Phase 2b Clinical Trial**: Planned initiation in the second half of the year, leading to phase 3 registrational trials [40] 3. **Market Differentiation**: Briquilimab and barzolimab are the only drugs aimed at depleting mast cells, while others only inhibit them [39] Conclusion - **Transformative Year Ahead**: 2025 is projected to be pivotal for Jasper Therapeutics with significant data readouts and trial initiations [40]
Jasper Therapeutics Announces Briquilimab Presentations at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress
GlobeNewswire News Room· 2025-06-03 12:00
Core Insights - Jasper Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing briquilimab, an antibody therapy targeting c-Kit (CD117) for mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma [1][3] - The company announced that four abstracts have been accepted for presentation at the EAACI Congress 2025, highlighting initial clinical data from the SPOTLIGHT Phase 1b/2a study [1][2] Presentation Details - The first abstract discusses initial results from the SPOTLIGHT study on briquilimab in adults with CIndU who remain symptomatic despite H-1 antihistamine treatment, scheduled for presentation on June 14 [2] - The second abstract presents findings on briquilimab's efficacy in protecting against relapse of dermatitis in a mouse model, also scheduled for June 14 [2] - The third abstract reports updated results showing briquilimab's rapid and clinically meaningful disease control in adults with CSU, to be presented on June 15 [2] - The fourth abstract focuses on briquilimab's effects on mitigating COPD-like features in an asthma model, scheduled for presentation on June 15 [2] Company Overview - Jasper is developing briquilimab as a targeted aglycosylated monoclonal antibody that inhibits signaling through the c-Kit receptor, leading to mast cell depletion and addressing inflammatory responses in mast cell driven diseases [3] - The company has demonstrated efficacy and safety of briquilimab in clinical studies involving patients and healthy volunteers, with positive outcomes reported in CSU and CIndU [3]
Jasper Therapeutics (JSPR) 2025 Conference Transcript
2025-05-21 16:00
Summary of Jasper Therapeutics (JSPR) Conference Call Company Overview - Jasper Therapeutics focuses on mast cell-mediated diseases, with its lead asset being briquelimab, a monoclonal antibody targeting c-KIT on mast cells [2][3] Core Points and Arguments Mechanism of Action - Briquelimab targets c-KIT, which is crucial for mast cell survival. Inhibition leads to mast cell apoptosis, making it a clean mechanism for treating related diseases [3][4][5] Clinical Trials and Data - The BEACON study is a Phase 1/2 trial exploring optimal dosing of briquelimab in chronic spontaneous urticaria (CSU) [6] - Initial data showed a rapid onset of clinical relief, with complete responses ranging from 50% to 100% at the 240 mg dose level, durable for eight weeks [10][12] - The study tested doses from 10 mg to 240 mg, with a half-life of approximately nine days for briquelimab [7][9] Safety Profile - The safety profile of briquelimab appears favorable, with no unexpected adverse events reported. Most c-KIT related adverse events were mild and transient [21][24] - Neutropenia concerns were addressed, indicating that stem cells remain viable despite c-KIT inhibition [22][24] Future Data and Expectations - Upcoming data from the BEACON study is expected in mid-2025, which will help differentiate briquelimab from competitors like Barzolumab [25][26] - The company plans to initiate a Phase 2b adaptive clinical trial by the end of 2025 [27] Competitive Landscape - The approval of Dupixent is seen as beneficial for educating dermatologists about biologics in CSU, but briquelimab and Barzolumab are the only therapies that deplete mast cells [39][40] - Briquelimab is positioned as a potential therapy of choice in the CSU setting due to its unique mechanism [41] Broader Pipeline - Jasper Therapeutics is also exploring briquelimab for mild to moderate asthma, with data expected in the second half of 2025 [42][43] - The company is considering additional indications, targeting diseases that are mast cell-mediated [42] Important but Overlooked Content - The BEACON study's small sample size may affect the interpretation of data, particularly regarding the complete response rates [12][18] - The potential for misdiagnosis in patients with CSU was highlighted, indicating the need for careful patient selection [19] This summary encapsulates the key points discussed during the conference call, providing insights into Jasper Therapeutics' current status, future plans, and competitive positioning in the market.
Jasper Therapeutics to Present at Upcoming Investor Conferences
Globenewswire· 2025-05-14 20:30
Company Overview - Jasper Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing briquilimab, a novel antibody therapy targeting KIT to treat mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma [2] Product Development - Briquilimab is a targeted aglycosylated monoclonal antibody that inhibits the binding of stem cell factor to the cell-surface receptor KIT, leading to the depletion of mast cells through apoptosis, which addresses the inflammatory response in mast cell driven diseases [2] - The company is currently conducting clinical studies of briquilimab for patients with CSU, CIndU, or asthma, demonstrating efficacy and safety in previous trials [2] Investor Engagement - Jasper Therapeutics will participate in the RBC Capital Markets 2025 Global Healthcare Conference on May 21, 2025, and the Jefferies 2025 Global Healthcare Conference on June 5, 2025, with live webcasts available on their Investor Relations website [1]
Jasper Therapeutics(JSPR) - 2025 Q1 - Quarterly Results
2025-05-12 20:05
Financial Performance - Jasper reported a net loss of $21.2 million for Q1 2025, with a net loss per share of $1.41, compared to a net loss of $13.7 million in Q1 2024[6][10]. - Total operating expenses for Q1 2025 were $21.8 million, compared to $15.1 million in Q1 2024[6][10]. - Cash and cash equivalents as of March 31, 2025, totaled $48.8 million, a decrease from $71.6 million at the end of 2024[6][12]. - Total current assets decreased to $53.2 million as of March 31, 2025, from $75.8 million at the end of 2024[6][12]. - Total liabilities decreased to $15.4 million as of March 31, 2025, compared to $18.2 million at the end of 2024[6][12]. Research and Development - Research and development expenses for the three months ended March 31, 2025, were $16.2 million, up from $10.3 million in the same period last year[6][10]. - The BEACON study in chronic spontaneous urticaria (CSU) is expected to provide mid-year data updates in Q3 2025, which will inform the final dose selection for the planned Phase 2b study[2][3]. - Enrollment in the SPOTLIGHT Phase 1b/2a study for cold urticaria and symptomatic dermographism has been completed, with data expected to be reported in June 2025[3]. - The ETESIAN Phase 1b/2a study for allergic asthma continues to enroll patients, with initial data anticipated in the second half of 2025[6][3]. - The company plans to commence the Phase 2b operationally-adaptive study in the second half of 2025, pending data from ongoing studies[3][2].
Jasper Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-05-12 20:05
Core Insights - Jasper Therapeutics is advancing briquilimab, a novel antibody therapy targeting mast cell-driven diseases, with significant progress reported in clinical trials [2][5][7] - The company reported a net loss of $21.2 million for the first quarter of 2025, with a basic and diluted net loss per share of $1.41 [6][10] Clinical Development - Jasper is focused on three clinical programs: chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), and asthma, with important data readouts expected later in 2025 [2][5] - The BEACON study in CSU continues to show promising results, with updated data presented at major allergy meetings [2][5] - Enrollment in the BEACON Phase 1b/2a study is ongoing, with additional data expected in Q3 2025 [5] - The SPOTLIGHT study for CIndU has completed enrollment in its final cohort, with data presentation planned for June 2025 [5] - The ETESIAN study for asthma is also enrolling patients, with initial data anticipated in the second half of 2025 [5] Financial Performance - As of March 31, 2025, Jasper had cash and cash equivalents totaling $48.8 million, down from $71.6 million at the end of 2024 [5][12] - Research and development expenses for Q1 2025 were $16.2 million, while general and administrative expenses were $5.6 million [5][10] - Total operating expenses for the first quarter were $21.8 million, compared to $15.1 million in the same period of 2024 [10]