On April 23, 2025 Abdera Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable precision radiopharmaceuticals for cancer, reported two upcoming presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held from April 25 – 30, 2025 in Chicago, IL (Press release, Abdera Therapeutics, APR 23, 2025, View Source [SID1234652084]). 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.

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"We are pleased with the progress we’re making at Abdera and are excited to share our developments at AACR (Free AACR Whitepaper) 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.