Dosing underway in Phase 1 clinical trial for ABD-147 (DLL3-targeting radiopharmaceutical) in patients with extensive stage small cell lung cancer and large cell neuroendocrine carcinoma of the lung; Abdera to present trial-in-progress poster
Poster presentation of preclinical data for Abdera’s second development program, ABD-320, representing the first radiopharmaceutical therapy in development targeting 5T4
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Abdera Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging its advanced antibody engineering ROVEr™ platform to design and develop tunable precision radiopharmaceuticals for cancer, today announced two upcoming presentations at the American Association for Cancer Research (AACR) Annual Meeting, being held from April 25 – 30, 2025 in Chicago, IL. These include: (1) a poster presentation of Abdera’s ongoing Phase 1 clinical trial for ABD-147, a DLL3-targeting radiopharmaceutical, and (2) preclinical data on ABD-320, a 5T4-targeting radiopharmaceutical and Abdera’s second development program.
“We are pleased with the progress we’re making at Abdera and are excited to share our developments at AACR this year,” said Lori Lyons-Williams, president and chief executive officer. “Our first-in-human Phase 1 study for ABD-147 is enrolling and dosing patients. We are also unveiling compelling preclinical data for ABD-320, the first radiopharmaceutical therapy in development targeting 5T4. This widely prevalent target is associated with poor outcomes across multiple cancer types and we look forward to advancing ABD-320 into clinical development in the first half of 2026.”
Details of the presentations are as follows:
Title: A phase 1a/b, open-label, dose-escalation study of 225Ac-ABD147 for locally advanced or metastatic small cell lung cancer and large cell neuroendocrine carcinoma of the lung following platinum-based chemotherapy
Abstract Number: CT107 / 2
Session: PO.CTP01.01 - Phase I Clinical Trials in Progress 1
Date/Time: April 28, 2025 / 2:00 PM - 5:00 PM
Location: Section 51
Title: 111In/225Ac-ABD320, a novel 5T4-targeted radiopharmaceutical with favorable tumor-to-normal tissue biodistribution and single-dose efficacy in preclinical cancer models
Abstract Number: 580 / 15
Session: PO.ET08.01 - Theranostics and Radiotheranostics
Date/Time: April 27, 2025 / 2:00 PM - 5:00 PM
Location: Section 25
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.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy and Orphan Drug Designation to ABD-147 for the treatment of neuroendocrine carcinoma. ABD-147 is currently being evaluated in a first-in-human Phase 1 clinical trial in patients with SCLC or large cell neuroendocrine carcinoma of the lung who have previously received platinum-based therapy.
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-320
ABD-320 is a targeted radiopharmaceutical biologic therapy engineered to deliver Actinium-225 (225Ac) to solid tumors expressing 5T4. This oncofetal protein is rarely expressed in normal adult tissues but has been shown to be up-regulated in multiple cancer types, including colorectal, head and neck, non-small cell lung, pancreatic, gastric, mesothelioma, bladder, renal, cervical, ovarian, and breast cancers. By driving tumor cell migration and survival, 5T4 plays a key role in cancer progression and is associated with advanced disease, increased invasiveness, and poor clinical outcomes in solid tumors. ABD-320 was developed leveraging Abdera’s ROVEr™ platform and is custom-engineered to achieve an ideal balance of tumor uptake and retention while avoiding systemic radiotoxicities. Preclinical data with ABD-320 demonstrates potent anticancer activity. ABD-320 represents the first radiopharmaceutical therapy in development to address 5T4.
About Abdera
Abdera Therapeutics is a clinical-stage biopharmaceutical company leveraging antibody engineering to design and develop new precision radiopharmaceuticals for cancer. Abdera’s Radio Optimized Vector Engineering (ROVEr™) proprietary 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.
Contacts
Media:
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Katie Engleman
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Investors:
1AB
Steve Klass
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