The US Food and Drug Administration (FDA) has granted clearance for Abdera Therapeutics’ investigational new drug (IND) application to commence a Phase I clinical trial of ABD-147 for small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC).

The upcoming, first-in-human, open-label study will assess the initial efficacy and safety of ²²⁵Ac-ABD-147 in SCLC or LCNEC patients.

These patients should have previously received platinum-based therapy to be part of the trial.

The trial’s primary goal is to establish the recommended dosage regimen for future research and development stages.

Abdera intends to launch the Phase I clinical trial in the second half of this year.

A delta-like ligand 3 (DLL3) targeting radiopharmaceutical biologic therapy, ABD-147 is engineered to deliver Actinium-225 (225Ac), an alpha-emitting radioisotope, to solid tumours that express DLL3 protein.

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DLL3 functions within the Notch signalling pathway, which is crucial for the differentiation of neuroendocrine and epithelial cells in the lungs.

In high-grade neuroendocrine carcinomas, including SCLC, DLL3 is overexpressed and found on the cell surface in more than 80% of cases, whereas it is absent or very rarely seen on non-malignant cells.

The high specificity of DLL3 expression on cancer cells combined with the unique action mechanism makes DLL3 an attractive target for treating SCLC and other DLL3-positive solid tumours with targeted radiotherapy.

Abdera Therapeutics chief medical officer Philippe Bishop said: “ABD-147 represents a potential best-in-class treatment for SCLC and other aggressive neuroendocrine tumours.

“Leveraging our ROVEr platform, we custom-engineered ABD-147 with optimised pharmacokinetic properties and tumour penetration to destroy tumour cells while limiting radiation toxicity to the body.

“We are hopeful this highly potent next generation radiotherapeutic will provide a potential breakthrough addressing a critical medical need for the treatment of SCLC and other high-grade neuroendocrine cancers.”