Jasper Therapeutics announces key upcoming milestones

“2023 was a strategically important year for Jasper,” said Ronald Martell, President and CEO. “We secured IND clearance and CTA authorization for the Phase 1b/2a BEACON study of briquilimab in CSU and successfully dosed the first patient. Additionally, we reported positive data from the Phase 1/2 trial of briquilimab in patients with Fanconi Anemia along with the final Phase 1 results in patients with acute myeloid leukemia or myelodysplastic syndromes undergoing hematopoietic cell transplant, initiated the LR-MDS Phase 1b trial, and strengthened our leadership team. Our achievements in 2023 set the stage for a transformational year ahead with multiple key clinical milestones on the horizon across multiple indications. Specifically, we expect to present initial data from the Phase 1b/2a BEACON study in mid-2024, which will provide valuable insight into the therapeutic potential of briquilimab. We also anticipate initiating our Phase 1b/2a SPOTLIGHT study in CIndU following our recently obtained CTA authorization from the EMA, with initial data expected in the second half of the year. Finally, we expect to present data from our Phase 1b LR-MDS study in the first half of 2024.” Key Recent and Upcoming Milestones: Obtained IND clearance and CTA authorization for initiation of its Phase 1b/2a BEACON study of subcutaneous briquilimab in CSU. The BEACON study is a dose escalation trial evaluating repeat doses of subcutaneous briquilimab in adult CSU patients who remain symptomatic after treatment with, or who cannot tolerate, omalizumab, and is currently enrolling approximately 40 patients at sites in the US and EU. Jasper expects to report initial data on multiple cohorts from the study of briquilimab in CSU in mid-2024. Obtained CTA authorization for initiation of its Phase 1b/2a SPOTLIGHT study of subcutaneous briquilimab in CIndU. The SPOTLIGHT study is evaluating single doses of subcutaneous briquilimab in adult CIndU patients and is expected to enroll approximately 15 patients at sites in the EU. Patient enrollment is expected to commence in early 2024 and initial data is expected in the second half of 2024. Hosted a key opinion leader webinar on the potential of briquilimab as a therapeutic in chronic urticaria, as well as the current treatment landscape and unmet medical needs for patients with CSU. Initiated a Phase 1 trial of briquilimab as second-line therapy in subjects with LR-MDS. Data readout from the Phase 1 trial evaluating the safety and tolerability of briquilimab as a second-line therapy in subjects with LR-MDS is anticipated in the first half of 2024. Presented positive final results from the Phase 1 study of briquilimab in combination with fludarabine and low-dose irradiation conditioning in older adults with AML in complete remission or MDS undergoing allogeneic hematopoietic cell transplant at the America Society of Hematology 2023 Annual Meeting. Announced European Union Orphan Drug Designation for briquilimab as a conditioning treatment for patients prior to receiving a stem cell transplant.