Pharma Focus America

Abdera Therapeutics Receives FDA Fast Track Status for ABD-147, a Next-Generation Precision Radiopharmaceutical Therapy, Aimed at Treating Extensive-Stage Small Cell Lung Cancer

Friday, June 28, 2024

Abdera Therapeutics Inc. has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its drug candidate ABD-147, aimed at treating patients with extensive stage small cell lung cancer (ES-SCLC) who have relapsed after platinum-based chemotherapy. ABD-147 is a next-generation precision radiopharmaceutical designed to target tumors expressing DLL3, a protein found on neuroendocrine tumors but rarely on normal cells.

Fast Track designation from the FDA facilitates the expedited review of drugs for serious conditions with unmet medical needs. This status allows for enhanced communication with the FDA during the review process and potential eligibility for Accelerated Approval and Priority Review based on certain criteria.

Abdera, emphasized the urgent need for new treatments for aggressive neuroendocrine cancers like SCLC, which often metastasize quickly and have poor prognoses. Abdera plans to initiate a Phase 1 clinical trial for ABD-147 in the latter half of 2024 in patients with SCLC or large cell neuroendocrine carcinoma (LCNEC) who have previously received platinum-based therapy.

Globally, small cell lung cancer and large cell neuroendocrine carcinoma collectively affect approximately 325,000 patients, with an annual increase expected through 2029. In the U.S. alone, there are about 35,000 new cases annually. These cancers are highly aggressive, often metastasizing to critical organs such as the brain, liver, and bone. Survival rates without treatment are typically very low, underscoring the critical need for innovative therapies.

ABD-147 employs Actinium-225 (225Ac), an alpha-emitting radioisotope, to specifically target DLL3-expressing tumors, utilizing Abdera's ROVEr™ platform. This platform allows for tailored engineering of radiopharmaceuticals to maximize tumor uptake while minimizing systemic exposure, potentially transforming cancer treatment by sparing healthy tissues from harmful effects.

Abdera's dedication to advancing targeted radiopharmaceuticals through the ROVEr™ platform represents a promising approach in oncology, offering new hope to patients facing difficult-to-treat cancers.



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