Abdera Therapeutics Receives FDA Clearance for ABD-147 IND Application

Friday, May 24, 2024

Abdera Therapeutics Inc., a biopharmaceutical company specializing in precision radiopharmaceuticals for cancer treatment, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application regarding ABD-147. This marks a significant step forward as ABD-147 is the first radiopharmaceutical targeting delta-like ligand 3 (DLL3) for small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). Abdera is set to launch a Phase 1 clinical trial in the latter part of 2024.

ABD-147 is an advanced precision radiopharmaceutical therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing DLL3. DLL3 is a protein typically found on neuroendocrine tumor surfaces but rarely on normal cells.

Dr. Philippe Bishop, Chief Medical Officer, expressed optimism about ABD-147's potential, stating, "ABD-147 represents a promising treatment option for SCLC and other aggressive neuroendocrine tumors. Leveraging our ROVEr platform, we have customized ABD-147 with optimized pharmacokinetic properties to target tumor cells while minimizing radiation toxicity to healthy tissues. We believe this next-generation radiotherapeutic could address a critical medical need."

The Phase 1 clinical trial aims to evaluate the safety and efficacy of 225Ac-ABD-147 in patients who have previously received platinum-based therapy for SCLC or LCNEC. The study will establish the recommended dosage regimen for further development.

Lori Lyons-Williams, President, and CEO, emphasized the significance of FDA clearance, stating, "This marks a major milestone for Abdera as we move into the clinical stage. We believe our ROVEr platform enables innovation in targeted radiotherapeutics, with ABD-147 leading our pipeline of custom-engineered programs."

Globally, SCLC and LCNEC affect approximately 325,000 patients, with an expected annual increase of 4% through 2029. In the U.S., there are around 35,000 new cases annually. These cancers are aggressive, often metastasizing to other organs, and have poor prognoses without treatment.

ABD-147 is a targeted radiopharmaceutical therapy designed to deliver Actinium-225 (225Ac) to tumors expressing DLL3. DLL3 is upregulated in certain neuroendocrine carcinomas, making it a compelling target for radiotherapy.

Abdera’s ROVEr platform allows the custom-engineering of radiopharmaceuticals with optimized pharmacokinetic properties, maximizing tumor uptake while minimizing toxicity to healthy tissues. This platform enables the development of potent radiotherapeutics against various cancer targets.

Source: businesswire.com