Pharma Focus Europe

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.



Thermo Fisher Scientific - mRNA ServicesWorld Orphan Drug Congress 2024World Vaccine Congress Europe 2024Advanced Therapies USA 2024