Abdera Therapeutics Announces FDA Clearance of IND Application for ABD-147

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Abdera Therapeutics Inc., a biopharmaceutical company leveraging its advanced antibody engineering ROVEr™ platform to design and develop tunable, precision radiopharmaceuticals for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for ABD-147, the first delta-like ligand 3 (DLL3) targeting radiopharmaceutical for the treatment of small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). Abdera plans to initiate a Phase 1 clinical trial in the second half of 2024.

ABD-147 is a next-generation precision radiopharmaceutical biologic therapy designed to deliver Actinium-225 (²²⁵Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing DLL3. DLL3 is a protein found on the surface of neuroendocrine tumors, but rarely expressed on the surface of normal cells or tissues.

“ABD-147 represents a potential best-in-class treatment for SCLC and other aggressive neuroendocrine tumors,” said Philippe Bishop, M.D., chief medical officer. “Leveraging our ROVEr platform, we custom-engineered ABD-147 with optimized pharmacokinetic properties and tumor penetration to destroy tumor cells while limiting radiation toxicity to the body. We are hopeful this highly potent next generation radiotherapeutic will provide a potential breakthrough addressing a critical medical need for the treatment of SCLC and other high-grade neuroendocrine cancers. We look forward to initiating a Phase 1 clinical trial of ABD-147 later this year.”

The Phase 1, first-in-human, open-label clinical study aims to evaluate the safety and preliminary efficacy of ²²⁵Ac-ABD-147 in patients with SCLC or LCNEC who previously received platinum-based therapy. The study will determine the recommended dose regimen for future development.

“FDA clearance of our first IND marks a major milestone for Abdera as we transition into a clinical-stage radiopharmaceutical company,” said Lori Lyons-Williams, president and chief executive officer. “We believe our ROVEr™ platform uniquely enables a new wave of innovation in targeted radiotherapeutics, with ABD-147 representing the first in a robust pipeline of custom-engineered programs we are advancing to the clinic.”

About Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

The global incidence for SCLC and LCNEC has been reported to represent approximately 325,000 patients and is expected to increase 4% annually through 2029. In the U.S., the incidence has been reported to be approximately 35,000 new cases annually. Fifteen percent of all lung cancer cases are high-grade neuroendocrine cancers. These cancers have the most aggressive clinical course of any type of pulmonary tumor and often metastasize to other parts of the body, including the brain, liver and bone. Without treatment, the median survival from diagnosis has been reported to be only two to four months. With treatment, the overall survival at five years is 5% to 10% for SCLC, and 15% to 25% for LCNEC. SCLC and LCNEC generally carry a poor prognosis and new treatment options are urgently needed.

About ABD-147

ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (²²⁵Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch pathway that is critical for the development and regulation of neuroendocrine versus epithelial cell differentiation in the lungs. In certain high grade neuroendocrine carcinomas including small cell lung cancer (SCLC), DLL3 is upregulated and specifically expressed on the cell surface in more than 80% of cases. In contrast, DLL3 is absent or very rarely expressed on the surface of nonmalignant cells. Given the high specificity of DLL3 expression on cancer cells and the distinct mechanism of action, DLL3 represents a compelling target for treating SCLC and other DLL3+ solid tumors with targeted radiotherapy.

About the ROVEr™ Platform

Abdera’s Radio Optimized Vector Engineering (ROVEr™) platform enables the company to custom-engineer targeted radiopharmaceuticals with tunable pharmacokinetic (PK) properties to achieve high tumor uptake while minimizing renal exposure and mitigating other systemic radiotoxicities such as myelosuppression. Abdera can optimize the delivery and therapeutic index of potent radioisotopes capable of emitting powerful alpha or beta particles to selectively destroy tumor cells while sparing healthy cells, providing patients with potentially transformative new cancer treatments.

Abdera’s approach offers the ability to design radiotherapeutics against virtually any cancer target expressed on the cell surface. Coupled with a highly potent mechanism of cell killing, the ROVEr platform is uniquely poised to exploit both high- and low-expressing targets to selectively deliver therapeutic levels of radioisotope to cancer cells.

About Abdera

Abdera Therapeutics is a biopharmaceutical company leveraging antibody engineering to design and develop new precision radiopharmaceuticals for cancer. Abdera’s Radio Optimized Vector Engineering (ROVEr™) platform enables the company to engineer potential best-in-class therapies for both clinically validated and novel targets that deliver potent radioisotopes capable of emitting alpha or beta particles to selectively destroy cancer cells. Abdera’s lead program, ABD-147, is a next-generation precision radiopharmaceutical biologic therapy designed to deliver Actinium-225 (²²⁵Ac) to solid tumors expressing delta-like ligand 3 (DLL3) for the treatment of small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). Headquartered in South San Francisco, CA, Abdera also has offices in Vancouver, British Columbia, Canada. To learn more, please visit www.abderatx.com and follow us on LinkedIn and X.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240522691994/en/