转自：一度医药 BMO Capital Markets的分析师认为，在当前市场环境下，此次批次问题会让Jasper的股票更难吸引投资 者，"我们认为，在今天的更新之后，投资者不会愿意再关注这个公司了"。 Jasper目前正在调查药物批次问题的具体原因，同时将为这10名患者提供新的药物，让他们改用在早期 队列中已显示出疗效的新批次药物。此外，公司将在受影响的两个剂量组中再增加10至12名新患 者，"以确保数据集的稳健性"，预计将在第四季度公布这些新增参与者的数据。由于此次批次问题，公 司还将briquilimab用于慢性自发性荨麻疹的IIb期临床试验的启动时间推迟至2026年中期。 此次药物批次问题还影响了briquilimab的哮喘临床试验，Jasper公司表示将不再继续开发该抗体用于哮 喘适应症。 此次药物批次问题给Jasper Therapeutics的研发之路蒙上了一层阴影，其后续的战略调整和临床试验进展 值得行业持续关注。 药物批次问题干扰临床试验结果 Jasper公司周一发布公告称，其在研抗体药物briquilimab的一个批次出现问题，干扰了BEACON Ib/IIa期 临床试验的读数。该试验针对 ...

Summary of Jasper Therapeutics (JSPR) Update / Briefing July 07, 2025 Company Overview - **Company**: Jasper Therapeutics (JSPR) - **Focus**: Development of therapies for chronic spontaneous urticaria (CSU) using the drug vaprolimab Key Points Industry and Company Context - The conference call was focused on updated data from the BEACON trial and initial data from the open label extension study evaluating vaprolimab in patients with CSU [4][20] Core Findings from the BEACON Trial - **Efficacy**: - A greater than 25 drop in UAS7 (Urticaria Activity Score over 7 days) was observed in the 240 mg and 360 mg single dose cohorts, with 78% complete response and 89% well-controlled disease by week four [4][21] - In the open label extension study, 73% of patients achieved complete response and 82% well-controlled disease at the 12-week assessment with a mean reduction in UAS7 scores of greater than 25 points [17][22] - **Safety Profile**: - Vaprolimab demonstrated a favorable safety profile with no dose-limiting toxicities reported. Treatment emergent adverse events were similar in both active and placebo groups [13][22] - Mild transient adverse events were observed, including taste changes and neutrophil count reductions, but these were self-resolving and did not lead to discontinuations [14][15] Issues Identified - **Confounding Results**: - Two cohorts (240 mg Q8 weeks and 240 mg followed by 180 mg Q8 weeks) showed confounded results due to an issue with a specific drug product lot (lot A34954), which resulted in lower than expected drops in mean tryptase levels and no discernible effect on UAS7 in 10 out of 10 patients dosed with this lot [5][12] - An investigation into the affected lot is ongoing, with results expected in the coming weeks [6][20] - **Next Steps**: - Additional 10 to 12 patients will be enrolled in the affected cohorts to ensure a robust data set for the Phase IIb CSU study expected to commence mid-2026 [6][20] Financial and Operational Insights - **Cash Runway**: - Current guidance into the fourth quarter remains unchanged, but the company is evaluating its cost structure and may need to raise additional capital to extend its runway [54] - **Regulatory Communication**: - The company is in communication with the FDA regarding the lot issue, but there are no safety concerns associated with the affected lot [48][41] Additional Observations - **Durability of Responses**: - The data suggests that the depth of triptase reduction correlates with the depth of UAS7 reductions, indicating a potential for durable effects with the 180 mg dosing regimen [55] - **Patient Management**: - Patients who received the inactive dose from the compromised lot will be transitioned to a new drug product that has demonstrated efficacy in other cohorts [20][48] Conclusion - Jasper Therapeutics is optimistic about the potential of vaprolimab as a differentiated therapeutic option for CSU, despite the setback from the compromised drug lot. The company is taking proactive steps to address the issue and continue its clinical development program.

8 of 9 participants (89%) treated in the 240mg and 360mg single dose cohorts achieved a complete response 8 of 11 participants (73%) enrolled in the 180mg Q8W open label extension study achieved a complete response at 12 weeks 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 ...

Jasper Therapeutics SPOTLIGHT Data Update June 16, 2025 Safe Harbor Statements Forward-Looking Statements Certain statements in this Presentation include "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. All statements other than statements of historical fact contained in this Presentation, including statements regarding Jasper's future opportunities and prospects, including milestones, potential regulatory filings and the anticipated timing ...

REDWOOD CITY, Calif., May 14, 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 to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today announced that management will participate in the following investor conferences: RBC Capital Markets 2025 Global Healthcare Conference Conference Dates: ...

REDWOOD CITY, Calif., May 12, 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 to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today reported results for the fiscal quarter ended March 31, 2025 and provided a corporate update. “During the first quarter of 2025 we made great progress ad ...