Jasper pulls out of pivotal blood cancer trial at the last minute to prioritize other indications

Jasper pulls out of pivotal blood cancer trial at the last minute to prioritize other indications

Jasper Therapeutics spent the past 11 months working to kick off a phase 3 blood cancer trial. Now, with the first-quarter start date in sight, the biotech has pulled a volte-face, dropping plans to start the pivotal study and switching its focus to other indications.

The now-canned phase 3 clinical trial has loomed on the horizon since Jasper posted phase 1b data on its anti-CD117 monoclonal antibody briquilimab in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) in February. Jasper outlined plans to talk to the FDA about a pivotal study at the time of the data drop and quickly nailed down the first quarter of 2023 as its target start date.

California-based Jasper reaffirmed its plans in November after discussing the trial with the FDA but has now had a change of heart. Jasper CEO Ronald Martell explained the U-turn in a statement to disclose the new clinical development strategy.

“We believe focusing on the most well-characterized opportunities with the clearest and potentially fastest pathway to market is in the best interest of patients and our shareholders. As such, our near-term development program will consist of moving rapidly into a clinical trial in chronic severe urticaria and initiating our chronic lower-risk MDS study, while continuing recruitment in the [severe combined immunodeficiency] (SCID), Fanconi anemia and sickle cell disease transplant studies,” Martell said.

The active clinical trials of briquilimab, which are sponsored by Jasper and its collaborators, are all phase 1 or phase 1/2. While Jasper plans to work with “potential partners to explore development pathways and ensure briquilimab remains ready for a pivotal phase 3 study,” abandoning near-term plans to start the trial deprives it of an advanced application of its asset. Jasper is targeting a 2024 BLA filing in SCID.

Dropping plans for a pivotal AML/MDS clinical trial also removes the question of where funding for the study would come from. Jasper ended September with $51 million, down from $84.7 million at the start of 2022. The biotech forecast the money would keep it going “through early 2023.”

Jasper’s remaining funds will now go into a set of indications that it thinks are a good fit for briquilimab, an antibody that is designed to block c-Kit signaling and thereby deplete mast cells and diseased stem cells. The identification of chronic urticaria as an attractive indication moves Jasper onto turf targeted by Celldex’s barzolvolimab.

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