The US Food and Drug Administration (FDA) has cleared Verismo Therapeutics’ investigational new drug (IND) application to advance its CAR-T therapy SynKIR-310 into a Phase I clinical trial.
The Phase I CELESTIAL-301 trial will enrol patients with relapsed or refractory B-cell non-Hodgkin lymphomas (B-cell NHL), whether they have had prior CAR-T therapy or not. Verismo plans to initiate the CELESTIAL-301 clinical trial in the second half of 2024.
CAR-T therapies have proven to be successful in the management of select haematologic malignancies. However, many patients relapse due to a lack of long-term T cell effector function.
The therapeutic avenues available post-relapse after CAR-T therapy are limited, underscoring the need for new therapies that can augment current survival outcomes.
Verismo’s KIR-CAR platform uses natural killer (NK) cell-derived KIR and DAP12 split signalling to activate and stimulate the immune system, helping CAR-T cells stay active for longer and fight against both solid tumours and blood cancers. SynKIR-19 targets and destroys cells with CD19, a protein found in B lymphocytes. It binds to overexpressed tumour antigens, activating T cells and triggering targeted killing of tumour cells.
The cell therapy startup spun out of the University of Pennsylvania in 2020. It has since raised $50m, generating $17m in a second pre-Series A round co-led by DongKoo Bio, HLB Innovation and HLB in July 2023. Verismo established a research and development centre at CIC Philadelphia in 2022 to advance its KIR-CAR platform.
Verismo’s lead candidate SynKIR-110 is under investigation in the Phase I STAR-101 clinical trial (NCT05568680) for mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma. The study plans to enrol 42 subjects receiving single-dose intravenous (IV) administration, with dosing escalated using a 3 + 3 design. Additional subjects will be enrolled at the maximum tolerated dose to further evaluate safety and potential activity.
According to a report on GlobalData’s Pharma Intelligence Center, the number of diagnosed prevalent cases of B-cell NHL will exceed 1.8 billion in 2027 globally.
GlobalData is the parent company of Pharmaceutical Technology.
In the announcement accompanying the IND, Verismo’s chief scientific officer Laura Johnson said: “The SynKIR-310 technology is designed to enhance the anti-tumour activity and extend the efficacy of T cells. This could potentially improve persistence and prevent early disease relapse in patients with aggressive lymphomas. SynKIR-310 could be especially beneficial for patients that relapsed after previous infusions of CAR T cell therapies.”
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