Abdera Therapeutics has reported initial data from its Phase Ia study of the radiopharmaceutical biologic therapy, ABD-147, in treating individuals with small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC).
The therapy, ABD-147, is designed to transport an alpha-emitting isotope, Actinium-225, to solid tumours that exhibit the delta-like ligand 3 (DLL3), a marker present in approximately 85% of SCLC cases, a cancer type known for its radiosensitivity.
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The Phase I trial assessed the therapy’s tolerability, safety, preliminary anti-tumour activity, and pharmacokinetics (PK) in subjects with locally advanced or metastatic SCLC and LCNEC who also underwent platinum-based chemotherapy.
A dosimetry analysis with Indium-111 has been used to track the distribution and calculate organ-specific radiation doses of ABD-147.
The company noted that data up to 15 August from the initial cohort of six subjects showed positive results.
The PK profile in human subjects was consistent with that anticipated from preclinical models, exhibiting minimal variability among patients.
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By GlobalDataThe therapy is said to have shown favourable tumour uptake and quick elimination from the bloodstream and critical organs, such as the kidneys.
The projected level of Actinium-225-ABD147 across all planned dosages remained within the safety limits for vital organs, including the liver, bone marrow, and kidneys.
Computed tomography (CT) scans confirmed the selective uptake of the therapy by targeted lesions, confirming the therapy’s specificity for DLL3.
From a safety standpoint, the treatment has been well-received, with no reports of infusion-related events, dose modifications, or dose-limiting toxicities.
Early indications of its anti-tumour activity have been noted, with disease stabilisation seen in patients, including one who has maintained stability after multiple treatment cycles over four months.
These initial results have led the independent safety review committee to support the continued dose escalation of the therapy in the trial.
The therapy secured fast track designation from the US Food and Drug Administration (FDA) for treating those with extensive-stage SCLC (ES-SCLC) post-progression on platinum-based chemotherapy, as well as orphan drug status for neuroendocrine carcinoma.
This announcement follows the FDA’s approval last year for Abdera Therapeutics’ investigational new drug application, which enabled the Phase I trial of ABD-147 for SCLC and LCNEC to commence.
