Tryptase

14 of 15 participants enrolled achieved a clinical response 10 of 12 participants in the 120mg cohort achieved a complete response No serious adverse events; no grade 3 or higher adverse events reported Initial data from BEACON study expected week of January 6th, 2025, including 180mg Q8W cohort Company to host conference call and webinar today at 8:00 a.m. EDT Oct. 14, 2024 -- 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 reported preliminary data from the Company’s ongoing SPOTLIGHT Phase 1b/2a study of subcutaneous briquilimab in adult participants with cold urticaria (ColdU) or symptomatic dermographism (SD), the two most prevalent sub types of CIndU. 14 of 15 participants (93%) enrolled in both dose cohorts of the study (n=15) achieved a clinical response within the 6-week preliminary analysis period following administration. In the 120mg dose cohort, 10 of 12 participants (83%) experienced a complete response (CR), and 1 participant experienced a partial response (PR). Briquilimab was well tolerated in the study, with no serious adverse events (SAEs) and no grade 3 or higher adverse events (AEs) reported. In alignment with the Company’s clinical development plan, Jasper has obtained regulatory clearance to enroll a 180mg dose cohort (n=12) in the SPOTLIGHT study. Jasper expects to present full data from the SPOTLIGHT study in the first half of 2025. Jasper also announced that it expects to report initial data from all cohorts of the BEACON study in CSU during the week of January 6th, 2025, including the recently added 180mg Q8W dose cohort. “We are very excited to report positive data from the SPOTLIGHT study, our first readout from a clinical trial evaluating briquilimab in chronic urticaria, with briquilimab driving rapid complete responses in over 80% of CIndU patients enrolled in the 120mg cohort,” said Ronald Martell, President and Chief Executive Officer of Jasper. “In addition to the responses observed, we are pleased that briquilimab was well tolerated in the study. These results demonstrate the ability of briquilimab to support optimal biologic dosing by rapidly delivering robust and durable clinical benefit along with a potentially differentiated safety profile. Additionally, we look forward to presenting initial data from all cohorts of the BEACON study in CSU in early January of next year. On behalf of the entire Jasper team, I’d like to thank both the investigators and the patients who participated in both studies, along with their families and caregivers.” SPOTLIGHT Study Design and Data Summary: The SPOTLIGHT study is a Phase 1b/2a open label clinical trial evaluating a single dose of subcutaneous briquilimab in adult patients with ColdU or SD who are refractory to antihistamines. The study will enroll 27 patients across three dose cohorts, 40mg (n=3), 120mg (n=12), and 180mg (n=12). 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. To assess clinical activity, participants' symptoms are induced via provocation testing prior to dosing with briquilimab and at defined time points through 12 weeks post-dosing. As of the data cut date of October 10th, 2024, 15 participants have been enrolled in the study and received a single dose of subcutaneous briquilimab (n=3 at 40mg, n=12 at 120mg), with all participants having at least 6 weeks of follow-up post-dosing. 12 participants (n=4 ColdU, n=8 SD) were enrolled in the 120mg dose cohort. Participants had high disease burden as assessed by provocation threshold testing. In the 120mg cohort, mean baseline TempTest® threshold was 20.8°C (range: 15-27°C) for ColdU patients, and mean baseline FricTest® threshold was 3.9 of 4 (range: 3-4) for SD patients. 14 of 15 participants (93%) enrolled in both dose cohorts of the study (n=15) achieved a clinical response to provocation testing within the 6-week preliminary analysis period following treatment. 10 of 12 participants (83%) treated in the 120mg cohort achieved a CR with either their critical temperature threshold improving to at least 4°C for ColdU patients or their FricTest® score improving to 0 for SD patients, and 1 of 12 participants enrolled in the 120mg cohort achieved a PR as their best response. 1 of 3 participants treated in the 40mg cohort achieved a CR and the other two participants achieved a PR as their best response. Complete responses in TempTest® or FricTest® were observed as early as 1 week following dosing. All patients will continue to be assessed for response through week 12, and Jasper expects to present full study results, including the 180mg cohort, in the first half of 2025. Mean baseline serum tryptase for participants in the 120mg cohort was 7.6 ng/ml (range: 3.6-25.7 ng/ml). Significant reductions in tryptase were observed as early as the week 1 assessment and were correlated with the onset of clinical responses. The greatest reduction in mean tryptase of 66% was observed at 2 weeks following treatment in the 120mg cohort. At the week 6 assessment, mean tryptase reduction observed was 31% below baseline and 7 of 12 participants (58%) enrolled in the 120mg cohort continued to maintain a clinical response (CR=6, PR=1). Briquilimab was well tolerated in the study. No SAEs or AEs grade 3 were reported. Furthermore, there were no reported AEs related to hair or skin color changes, hypersensitivity, or anemia. Mild decreases in neutrophil counts were observed, with no participants experiencing neutrophil counts below 1500. “It is very exciting to see initial clinical data showing that treatment with briquilimab can lead to deep clinical benefit shortly after administration, particularly given the difficult-to-treat patient population in antihistamine refractory CIndU,” said Martin Metz, M.D., Professor of Dermatology and Allergy Charité – Universitätsmedizin Berlin. “I am also encouraged by the safety and tolerability profile observed in the SPOTLIGHT study thus far, particularly the lack of hypopigmentation or hair color changes. Patients with CIndU currently have very few treatment options, and I look forward to continuing to support the development of briquilimab in chronic urticarias.” 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). 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.jaspertherapeutics.com. 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iStock, wisely With positive results for patients with the chronic skin condition, Jasper Therapeutics’ briquilimab is looking to take on Novartis and Genentech’s Xolair as well as Sanofi and Regeneron’s Dupixent. Jasper Therapeutics on Monday announced that its investigational antibody briquilimab showed strong initial signs of efficacy in patients with chronic inducible urticaria, according to a topline readout of the Phase Ib/II SPOTLIGHT study. During the first six weeks following treatment, 14 of 15 patients showed clinical response to briquilimab in a provocation test. Of the 12 patients given the 120-mg dose of briquilimab, 83% showed complete response, with the critical temperature threshold improving to at least 4°C for those with cold urticaria, or with FricTest dermographometer scores improving to zero for symptomatic dermographism patients. One of 12 patients in the 120-mg dose group hit partial response as their best response. Meanwhile, of the three patients treated with 40-mg briquilimab, one reached complete response while the other two achieved partial response. SPOTLIGHT also demonstrated “significant reductions” in serum tryptase levels as early as week one after 120-mg briquilimab treatment, according to Jasper. At six weeks, mean tryptase levels dropped by 31% from baseline, with one patient showing a 66% reduction at week two. In terms of safety, briquilimab was well-tolerated overall, with no severe or grade 3 adverse events documented. There were also no cases of hypersensitivity, anemia or hair or skin color changes. Jasper CEO Ronald Martell in a statement said that the company is “very excited” about these data, which “demonstrate the ability of briquilimab to support optimal biologic dosing by rapidly delivering robust and durable clinical benefit along with a potentially differentiated safety profile.” William Blair analyst Matt Phipps in a note to investors said that SPOTLIGHT’s readout points to the “strong initial efficacy” of one 120-mg subcutaneous dose of briquilimab, though there are still “outstanding questions on how durable the activity is.” Still, the results show “that at worst, briquilimab could be successfully dosed every four weeks, and there is reason to believe a 180 mg or 240 mg dose could achieve greater durability and less frequent dosing,” Phipps wrote. “We believe this alone is an important de-risking event for Jasper.” Briquilimab is an investigational aglycosylated monoclonal antibody that targets the stem cell factor and disrupts its binding to the CD117 receptor found on the surface of several healthy cells, including mast cells. This mechanism of action allows briquilimab to block crucial cell survival signals, leading to the overall depletion of mast cells and the suppression of the inflammatory response in related diseases. With Monday’s readout, Jasper is poised to challenge several major players in the inflammatory space, including Novartis and Genentech’s Xolair and Sanofi and Regeneron’s Dupixent. First approved in 2003, Xolair is an anti-IgE antibody indicated for asthma, nasal polyps and chronic idiopathic urticaria. Last year, the drug generated sales of $1.46 billion , growing 9% year-over-year at constant currencies. Meanwhile, Dupixent was first approved in 2017 and can be used to treat atopic dermatitis, asthma, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps. Last month, Dupixent secured a label expansion for chronic obstructive pulmonary disease, which is expected to boost its sales even further. The therapy brought in around $11.6 billion .

Jasper Therapeutics’ anti-c-KIT antibody has shown promise in a Phase 1b/2a test in people with certain irritable skin conditions, sending its shares rising on Monday. Fourteen out of fifteen participants in the SPOTLIGHT study with cold urticaria or symptomatic dermographism who are refractory to antihistamines had a clinical response to briquilimab within the six-week preliminary analysis period, according to a Monday release . Cold urticaria and symptomatic dermographism both lead to hives and swelling but are caused by different triggers. Cold urticaria is due to cold temperatures, while symptomatic dermographism is provoked by rubbing or scratching of the skin. Jasper’s shares $JSPR rose by as much as 20% at market open Monday. Out of 12 participants given a higher 120 mg dose of briquilimab, 10 had a complete response and the eleventh patient had a partial response. “Overall, the data shows clear activity for briquilimab, with a rapid onset of action across both response rate and serum tryptase reductions,” the William Blair analysts said. But the complete responses only lasted around four weeks, with the number of responders dropping from 10 to six afterwards, the analysts added. In contrast, Celldex Therapeutics’ anti-KIT antibody, barzolvolimab, given at the 1.5 mg/kg dose produced responses that lasted through six weeks in a Phase 1b test in people with the same skin conditions. However, almost half of those treated in Celldex’s study also had hair color changes. In SPOTLIGHT, Jasper said briquilimab was well-tolerated with no serious or grade 3 or higher adverse events observed. The company added that there were no skin color or hair color side effects. The California biotech now has “regulatory clearance” to add a 180 mg dose cohort to the SPOTLIGHT study, with full results expected in the first half of next year. Elsewhere, Jasper’s briquilimab is also being tested in the Phase 1b/2a BEACON trial in chronic spontaneous urticaria patients who still have symptoms despite treatment with Novartis and Genentech’s Xolair or can’t tolerate that treatment. Jasper said initial results from that study are expected in January.