Abdera Therapeutics Receives FDA Clearance for ABD-147 IND Application

Abdera Therapeutics Inc., a company specializing in biopharmaceutical innovations through its advanced antibody engineering ROVEr™ platform, has announced a significant development in cancer treatment. The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for ABD-147, marking the first delta-like ligand 3 (DLL3) targeting radiopharmaceutical for addressing small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). The company has plans to commence a Phase 1 clinical trial in the latter half of 2024.

ABD-147 is a state-of-the-art radiopharmaceutical biologic designed to deliver Actinium-225 (225Ac), a potent alpha-emitting radioisotope, specifically to solid tumors that express DLL3. DLL3 is predominantly found on neuroendocrine tumors and is scarcely present on normal cells, making it a selective target for treatment.

Philippe Bishop, M.D., Chief Medical Officer of Abdera, highlighted the potential of ABD-147 as a leading treatment option for aggressive neuroendocrine tumors such as SCLC. He emphasized that using the ROVEr platform, ABD-147 is custom-engineered with optimized pharmacokinetic properties and enhanced tumor penetration capabilities. This is intended to maximize the destruction of tumor cells while minimizing radiation exposure to healthy tissues. Bishop expressed optimism that this next-generation radiotherapeutic could be a breakthrough in addressing the critical medical needs for treating SCLC and other high-grade neuroendocrine cancers. The first Phase 1 trial is anticipated to begin later in the year.

The upcoming Phase 1 clinical study, which is open-label and first-in-human, aims to assess the safety and preliminary effectiveness of 225Ac-ABD-147 in patients with SCLC or LCNEC who have previously undergone platinum-based therapy. The study will also aim to establish the recommended dosage for subsequent clinical development.

Lori Lyons-Williams, President and CEO of Abdera Therapeutics, described the FDA's clearance of the IND as a pivotal achievement for the company, indicating their transition into a clinical-stage radiopharmaceutical entity. She noted that the ROVEr™ platform is instrumental in ushering in a new era of targeted radiotherapeutics, with ABD-147 being the first among many custom-engineered programs slated for clinical advancement.

SCLC and LCNEC are both high-grade neuroendocrine cancers with a reported global incidence of approximately 325,000 patients, projected to increase by 4% annually through 2029. In the United States, around 35,000 new cases are reported each year. These cancers are notably aggressive with a propensity to metastasize to the brain, liver, and bone. Without treatment, median survival is reported to be only two to four months, while treatment can extend overall survival to five years for 5% to 10% of SCLC patients and 15% to 25% of LCNEC patients. Therefore, there is an urgent need for new treatment options.

ABD-147 is designed to target DLL3, a protein involved in the Notch signaling pathway critical for neuroendocrine cell development in the lungs. DLL3 is highly expressed in over 80% of high-grade neuroendocrine carcinomas, including SCLC, but is absent in nonmalignant cells. This makes DLL3 a compelling target for radiotherapy in SCLC and other DLL3-positive tumors.

The ROVEr™ platform by Abdera allows for the custom-engineering of radiopharmaceuticals with adjustable pharmacokinetic properties to ensure high tumor uptake while reducing renal exposure and other systemic radiotoxicities. The platform is capable of delivering potent radioisotopes that selectively destroy tumor cells, offering the potential for transformative cancer treatments.

Abdera Therapeutics, headquartered in South San Francisco, CA, also has offices in Vancouver, British Columbia, Canada. The company's ROVEr™ platform aims to engineer pioneering radiopharmaceutical therapies for cancer, with ABD-147 being its lead program targeting DLL3-expressing tumors.