Briquilimab

Novartis is spending $55 million on global rights to Kyorin Pharmaceutical’s preclinical drug for inflammatory diseases in a deal that comes almost two decades after Novartis’ first pact with the Japanese drugmaker. The Swiss company will get an exclusive license to develop, manufacture and sell Kyorin’s MRGPRX2 antagonist, dubbed KRP-M223. The Japanese biotech could receive up to $777.5 million in milestones as well as tiered royalties on sales, according to a company release Monday. The release did not say when the program could be ready to enter the clinic. Novartis will be responsible for global development of KRP-M223 but Kyorin still has the option to manufacture and commercialize the drug in Japan. KRP-M223 has the potential to treat several mast cell-driven conditions, including chronic spontaneous urticaria (CSU). CSU leads to spontaneous hives and swelling that can last for more than six weeks. The disease affects around 40 million people worldwide. Kyorin’s drug works by blocking MRGPRX2, which is involved in activating mast cells that release histamine and tryptase, leading to itching and swelling. Incyte’s INCB000262, which shares the same target, hit a snag in November when preclinical safety concerns forced the company to pause enrollment in a Phase 2 CSU trial. Other candidates in more advanced development for CSU target the c-Kit protein. These include Celldex’s barzolvolimab and Jasper Therapeutics’ briquilimab , both of which are in mid-stage studies. Novartis previously teamed up with Kyorin in 2006, when it licensed the rights to the Japanese biotech’s immunosuppressant drug KRP-203, although that program was later shelved. In 2020, two former Novartis executives launched a company called Priothera Limited to continue advancing KRP-203 with a focus on acute myeloid leukemia patients getting a hematopoietic stem cell transplant.

REDWOOD CITY, Calif., March 01, 2025 (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 to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, is presenting updated clinical data from the Phase 1b/2a BEACON study, as well as data from four preclinical studies evaluating briquilimab, at the AAAAI 2025 Annual Meeting, being held February 28 - March 3, 2025, in San Diego, CA. The BEACON update, based on a data-cut date of January 31, 2025, features approximately one month of additional dosing and follow-up from the 49 participants covered in Jasper’s preliminary data disclosure on January 8, 2025. Briquilimab continues to be well tolerated in the study and has continued to demonstrate a favorable safety profile, with no additional adverse events (AEs) potentially related to c-Kit blockade observed. The data collected in the study to-date support advancing briquilimab into a registrational program in CSU, beginning with a planned Phase 2b operationally adaptive study expected to commence in the second half of 2025. Final dose selection for the Phase 2b study will be further informed by additional clinical data from patients treated at doses of 180mg and higher, expected to be reported mid-year 2025. “I am pleased to present updated data from the BEACON study at AAAAI, which continue to demonstrate that treatment with briquilimab leads to rapid and deep clinical responses in omalizumab-experienced patients with moderate to severe CSU,” said Thomas B. Casale, M.D., Professor of Medicine and Pediatrics, University of South Florida Morsani College of Medicine. “The safety profile observed is also highly encouraging, with a low frequency of c-Kit related adverse events, which were transient, low-grade, and did not result in any dose delays or discontinuations. The favorable safety data reported in the study are supported by the predictable drug clearance observed, which may allow for restoration of signaling on c-Kit-expressing cells between doses. In addition, the early Tmax observed was consistent with rapid onset of clinical response. Taken together, I believe this data set underscores the potential of briquilimab to serve as a differentiated treatment option for patients with CSU.” “We remain very excited by the efficacy and safety data generated in the BEACON study,” said Ronald Martell, President and Chief Executive Officer of Jasper. “We believe that these data demonstrate the potential of briquilimab to differentiate from other therapies, approved and in-development, with regard to onset of action, depth of response, and safety/tolerability. With a substantial number of additional patients being enrolled in the BEACON and SPOTLIGHT studies, as well as patients rolling over from those studies to the Open-Label Extension study, we look forward to reporting data from approximately 70 additional patients treated with briquilimab doses of 180mg or higher around mid-year 2025. These data will inform final dose selection for our planned Phase 2b operationally adaptive study expected to commence later this year.” Details of the presentations are as follows: Abstract Title: Initial Results from BEACON, a Phase 1b/2a Dose Escalation Study of the anti-c-Kit Briquilimab Antibody in Adults with Chronic Spontaneous Urticaria (CSU)Publication Number: L24Session Title: Late Breaking Oral Abstract SessionSession Type: Oral Abstract SessionPresentation Date / Time: Saturday, March 1, 2025; 2:55 p.m. PST Abstract Title: Initial Results from BEACON, a Phase 1b/2a Dose Escalation Study of the anti-c-Kit Briquilimab Antibody in Adults with Chronic Spontaneous Urticaria (CSU)Poster Number: L24Session Title: Late Breaking Poster Session ISession Type: Poster SessionSession Date / Time: Saturday, March 1, 2025; 9:45 - 10:45 a.m. PST Abstract Title: Briquilimab, an Anti-c-Kit Antibody, Induces Durable Depletion of Mast Cells (MCs) Across Multiple Tissues in Mice Expressing Chimeric Human/Mouse CD117 (c-Kit)Poster Number: 540Session Title: Novel Mechanisms of Mast Cells, Basophils and IgESession Type: Poster SessionSession Date / Time: Saturday, March 1, 2025; 9:45 - 10:45 a.m. PST Abstract Title: Briquilimab Potently Inhibits Stem Cell Factor (SCF)/c-Kit Signaling and Induces Mast Cell ApoptosisPoster Number: 541Session Title: Novel Mechanisms of Mast Cells, Basophils and IgESession Type: Poster SessionSession Date / Time: Saturday, March 1, 2025; 9:45 - 10:45 a.m. PST Abstract Title: Briquilimab, an Anti-Human CD117 Antibody, Prevents Epicutaneous Oxazolone-Induced Features of Dermatitis in Mouse Model Expressing Chimeric Human/Mouse CD117Poster Number: 662Session Title: Atopic Dermatitis, Contact Dermatitis, Urticaria, AngioedemaSession Type: Poster SessionSession Date / Time: Sunday, March 2, 2025; 9:45 - 10:45 a.m. PST Abstract Title: Briquilimab, an Anti-Human CD117 Antibody, Treats Low-Calcemic Vitamin D3 Analog MC903-Induced Dermatitis in Mouse Model Expressing Chimeric Human/Mouse CD117Poster Number: 690Session Title: Atopic Dermatitis, Contact Dermatitis, Urticaria, AngioedemaSession Type: Poster SessionSession Date / Time: Sunday, March 2, 2025; 9:45 - 10:45 a.m. PST 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 c-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, CIndU or asthma. 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 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, its potential to serve as a differentiated treatment option for patients with CSU, its potential to differentiate from other therapies, approved and in-development, with regard to onset of action, depth of response, and safety/tolerability and its potential allow for restoration of signaling on c-Kit-expressing cells between doses; Jasper’s expectations regarding advancing briquilimab into a registrational program in CSU, including the potential commencement of a Phase 2b operationally adaptive study and the expected timing for commencing such trial; the expected timing for reporting additional clinical data from the Phase 1b/2a BEACON study for patients treated at doses of 180mg and higher; and Jasper’s poster presentations and oral presentation of briquilimab data at the AAAAI 2025 Annual Meeting. 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 Therapeutics650-549-1454 agray@jaspertherapeutics.com Joyce Allaire (investors)LifeSci Advisors617-435-6602jallaire@lifesciadvisors.com Lauren Walker (media)Real Chemistry646-564-2156lbarbiero@realchemistry.com