FDA awards ODD to Abdera's neuroendocrine carcinoma therapy

The US Food and Drug Administration (FDA) recently awarded orphan drug designation (ODD) to Abdera Therapeutics’ innovative treatment, ABD-147, specifically designed for neuroendocrine carcinoma. This biologic therapy is engineered to transport the radioisotope Actinium-225 (225Ac) to tumors that express the DLL3 protein. DLL3 is generally found on the surface of neuroendocrine tumors but is rarely present on normal cells or tissues.

Receiving ODD status confers several benefits to Abdera, including tax credits, waiver of certain user fees, and the possibility of seven years of market exclusivity following regulatory approval. Abdera Therapeutics is preparing to initiate a first-in-human Phase I clinical trial of ABD-147 in 2024.

This upcoming trial will focus on patients suffering from small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) who have already undergone platinum-based therapy. ABD-147 employs Actinium-225, a potent alpha-emitting radioisotope, to selectively target and attack solid tumors that express the DLL3 protein with high affinity.

Philippe Bishop, the chief medical officer of Abdera Therapeutics, highlighted that neuroendocrine carcinomas, including SCLC and LCNEC, are particularly aggressive and difficult to treat effectively using current systemic therapies. Bishop expressed optimism, stating, "By delivering a potent radioisotope to neuroendocrine tumors expressing DLL3 with custom-engineered pharmacokinetic properties, we believe ABD-147 has the potential to become a best-in-class DLL3-targeting treatment for aggressive neuroendocrine tumors."

In addition to the orphan drug designation, the FDA has also granted fast track designation to ABD-147 for treating patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed after undergoing platinum-based chemotherapy. Bishop added, "This orphan drug designation for neuroendocrine carcinoma further underscores the potential of ABD-147 development to offer a significant advantage beyond currently approved drugs."

ABD-147’s development represents a significant step forward in the treatment of aggressive neuroendocrine tumors, providing new hope for patients who have limited options after traditional therapies fail. As Abdera Therapeutics advances toward clinical trials, the medical community will closely watch the progress of ABD-147.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!