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Worldwide Clinical Trials - Oncology

Verismo Therapeutics Obtains FDA Clearance for SynKIR™-310 in Relapsed/Refractory B-cell NHL

Wednesday, May 15, 2024

Verismo Therapeutics has received approval from the US Food and Drug Administration (FDA) to proceed with the Phase 1 clinical trial of SynKIR™-310 for NHL. This trial, named CELESTIAL-301, will evaluate the safety, tolerability, and early efficacy of SynKIR™-310 in patients with relapsed/refractory B-cell Non-Hodgkin Lymphomas (B-cell NHL), including various subtypes. Patients who have previously undergone CAR T therapy but relapsed or became refractory to it, as well as those who haven't received CAR T therapy before, will be enrolled.

The CELESTIAL-301 trial aims to address significant unmet medical needs, especially in cases where patients relapse after commercial CAR T cell therapies. While these therapies initially demonstrate high response rates, a considerable number of patients experience relapse due to declining T cell function and persistence. Verismo's SynKIR™-310, based on its KIR-CAR platform and proprietary CD19 binder (DS191), targets a similar CD19 epitope as approved CAR T therapies but with the potential to enhance T cell function and persistence.

Verismo Therapeutics, emphasized the unique potential of SynKIR™-310 in improving anti-tumor activity and extending T cell efficacy. The therapy could be particularly beneficial for patients who relapse after previous CAR T cell infusions.

Verismo plans to commence the CELESTIAL-301 trial in the latter half of 2024, marking its second clinical study exploring the KIR-CAR platform technology. Their leading pipeline, SynKIR™-110, is already under investigation in a Phase 1 trial (STAR-101).

The KIR-CAR platform, demonstrated in preclinical models, exhibits the capability to maintain antitumor T cell activity even in challenging tumor microenvironments. By leveraging NK cell-derived KIR and DAP12 split signaling, it offers a novel approach to T cell activation and co-stimulation, leading to prolonged T cell functional persistence and promising results in preclinical models resistant to traditional CAR T cell therapies. This platform, when combined with emerging technologies, holds the potential to usher in a new era of multimodal targeted immunotherapy for patients with unmet needs.



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