The use of radiopharmaceuticals in oncology is expected to attract more investment and become a more common treatment. Credit: Rido / Shutterstock.

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. 

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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. 

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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 Clinical Trials Arena. 

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.”