FDA has granted Orphan Drug Designation (ODD) to Abdera Therapeutics ABD-147 for treating neuroendocrine carcinoma.
Abdera planned to start a Phase 1 clinical trial of ABD-147 in 2024, focusing on patients with small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) who have already been treated with platinum-based therapy.
Philippe Bishop, CMO, emphasized that neuroendocrine carcinomas, including SCLC and LCNEC, are aggressive and challenging to treat effectively with current systemic therapies.
He believed that ABD-147 has the potential to become a best-in-class DLL3-targeting treatment for aggressive neuroendocrine tumors because it delivered a potent radioisotope to neuroendocrine tumors expressing DLL3 with custom-engineered PK properties.
He also highlighted the FDA’s recent granting of FTD to ABD-147 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy.
The ODD for neuroendocrine carcinoma further underscored the potential of ABD 147 development to offer a significant advantage beyond approved drugs.
Source: Abdera Therapeutics Announces FDA Orphan Drug Designation for ABD-147 for the Treatment of Neuroendocrine Carcinoma
https://abderatx.com/press-releases/abdera-therapeutics-announces-fda-orphan-drug-designation-for-abd-147-for-the-treatment-of-neuroendocrine-carcinoma/
