FDA Grants Fast Track Status to Abdera Therapeutics' ABD-147 for Extensive-stage Small Cell Lung Cancer

Abdera Therapeutics Inc., based in South San Francisco, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its drug candidate ABD-147. This designation aims to expedite the development and review process of ABD-147 for the treatment of extensive stage small cell lung cancer (ES-SCLC) in patients who have not responded to or have progressed following platinum-based chemotherapy. ABD-147 is a pioneering radiopharmaceutical designed to target solid tumors that express the protein delta-like ligand 3 (DLL3), delivering the alpha-emitting isotope Actinium-225 (225Ac) for precise cancer treatment.

The FDA's Fast Track program accelerates the development and review process for drugs that address serious medical conditions with unmet needs. Fast Track status enables more frequent communication with the FDA and eligibility for Accelerated Approval and Priority Review, potentially speeding up the time it takes for a drug to reach patients.

According to Lori Lyons-Williams, President and CEO of Abdera Therapeutics, aggressive neuroendocrine cancers like SCLC have the poorest prognosis among all pulmonary tumors and often metastasize quickly. She expressed excitement about the FDA’s recognition of ABD-147's potential and highlighted the urgency of developing new treatment options for SCLC patients.

Abdera plans to commence a first-in-human Phase 1 clinical trial for ABD-147 in the latter half of 2024. This trial will focus on patients with SCLC or large cell neuroendocrine carcinoma (LCNEC) who have previously undergone platinum-based therapy.

Small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC) are highly aggressive forms of cancer. Globally, approximately 325,000 new cases are reported annually, with an expected increase of 4% per year through 2029. In the U.S., around 35,000 new cases are diagnosed each year. These cancers, which account for about 15% of all lung cancer cases, often spread to other parts of the body, including the brain, liver, and bones. Without treatment, median survival from diagnosis is only two to four months, and even with treatment, the five-year survival rate is only 5% to 10% for SCLC and 15% to 25% for LCNEC. This underscores the critical need for new treatment options.

ABD-147 stands out as a targeted radiopharmaceutical therapy that delivers Actinium-225 (225Ac) to tumors expressing DLL3 with high specificity. DLL3 is a protein found in over 80% of high-grade neuroendocrine carcinomas like SCLC but is rarely expressed on normal cells. This makes DLL3 a compelling target for radiotherapy, allowing for the selective killing of cancer cells while sparing healthy tissues.

Abdera's ROVEr™ platform underpins the development of ABD-147. This platform enables the company to design radiopharmaceuticals with optimized pharmacokinetic properties, ensuring high tumor uptake and minimizing exposure to non-targeted tissues. By doing so, Abdera aims to deliver potent radioisotopes capable of destroying cancer cells with minimal side effects.

Abdera Therapeutics, leveraging its ROVEr™ platform, focuses on creating precision radiopharmaceuticals for cancer treatment. By engineering therapies that deliver potent radioisotopes to targeted cancer cells, the company aims to provide transformative treatment options. ABD-147, their lead program, targets DLL3-expressing tumors, offering new hope for patients with small cell lung cancer and large cell neuroendocrine carcinoma. Abdera is headquartered in South San Francisco, CA, with additional offices in Vancouver, British Columbia, Canada.