ABD-147 / Abdera Therap - LARVOL DELTA

First-In-Human Study of 225Ac-ABD147 for SCLC and LCNEC Post-Chemotherapy: Pharmacokinetics, Biodistribution and Safety Insights (IASLC-WCLC 2025) - P1 | "In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024; 84(6_Suppl): Abstract nr 6028."

Clinical • P1 data • PK/PD data • Endocrine Cancer • Immunology • Infectious Disease • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Small Cell Lung Cancer • Solid Tumor • DLL3

Abdera Therapeutics to Present Early Pharmacokinetics, Dosimetry and Safety Data from Ongoing Phase 1 Trial of ABD-147 at the IASLC 2025 World Conference on Lung Cancer and Participate in Upcoming Investor Conferences (Businesswire)

P1 data • PK/PD data • Large Cell Neuroendocrine Carcinoma • Small Cell Lung Cancer

Imaging of Solid Tumors Using DLL3 SPECT (clinicaltrials.gov) - P1 | N=45 | Not yet recruiting | Sponsor: Thomas Hope

New P1 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor

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 (AACR 2025) - P1 | "Phase 1a dose escalation is ongoing in the US. (NCT06736418)"

Clinical • Metastases • P1 data • Endocrine Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Abdera Therapeutics to Present Key Updates on its Radiopharmaceutical Development Pipeline at the 2025 American Association for Cancer Research (AACR) Annual Meeting (Businesswire) - "Abdera Therapeutics Inc...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."

P1 data • Preclinical • Neuroendocrine Carcinoma • Small Cell Lung Cancer

Abdera Therapeutics to Present at the 43rd Annual J.P. Morgan Healthcare Conference (Businesswire) - "Abdera Therapeutics Inc...announced that Lori Lyons-Williams, president and chief executive officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 10:30 a.m. PT in San Francisco, CA....Ms. Lyons will detail the company’s progress including the recently initiated first-in-human Phase 1 clinical trial evaluating ABD-147 for the treatment of small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). The company also plans to share, for the first time publicly, preclinical data for ABD-320, which is currently in IND-enabling studies, and provide an update on expanded radiotherapeutic capabilities."

Preclinical • Trial status • Neuroendocrine Tumor • Small Cell Lung Cancer

Study of 225Ac-ABD147 to Establish Optimal Dose in Patients with SCLC and LCNEC of the Lung That Previously Received Platinum-based Chemotherapy (clinicaltrials.gov) - P1 | N=65 | Recruiting | Sponsor: Abdera Therapeutics Inc.

New P1 trial • Endocrine Cancer • Large Cell Carcinoma • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Abdera Therapeutics Announces FDA Orphan Drug Designation for ABD-147 for the Treatment of Neuroendocrine Carcinoma (Businesswire) - "Abdera Therapeutics Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ABD-147 for the treatment of neuroendocrine carcinoma...In 2024, Abdera plans to initiate a first-in-human Phase 1 clinical trial with ABD-147 in patients with small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) who previously received platinum-based therapy."

New P1 trial • Orphan drug • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Abdera Therapeutics Announces FDA Fast Track Designation for ABD-147, a Next-Generation Precision Radiopharmaceutical Therapy, for the Treatment of Patients with Extensive-stage Small Cell Lung Cancer (Businesswire) - "Abdera Therapeutics Inc...today announced that 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. ABD-147 is a next-generation precision radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac) to solid tumors expressing DLL3, a protein found on the surface of neuroendocrine tumors, but rarely expressed on the surface of normal cells or tissues."

Fast track • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Abdera Therapeutics Announces FDA Clearance of IND Application for ABD-147 (Businesswire) - "Abdera Therapeutics Inc...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....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."

IND • New P1 trial • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Preferential tumor-to-normal tissue biodistribution and single-dose efficacy with ABD147, a DLL3-targeted engineered antibody-based radiotherapeutic, in preclinical small cell lung cancer models (AACR 2024) - "In summary, ABD147 can preferentially deliver radionuclides to DLL3-expressing tumor tissue while substantially reducing the systemic radioactive exposure typical of conventional IgG radioconjugates. Following promising results in preclinical models, including potent anti-tumor activity, 225Ac-ABD147 is now progressing into clinical development."

Preclinical • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Abdera Therapeutics Debuts With $142 Million in Financing to Engineer and Advance Best-in-Class Antibody-Based Radiopharmaceuticals for Cancer (Businesswire) - "Abdera Therapeutics Inc...today announced it has raised $142 million in combined Series A and B financing....Abdera’s lead program targets delta-like ligand 3 (DLL3), a protein in the Notch pathway that is upregulated and specifically expressed in small cell lung cancer (SCLC) and other solid tumors, with very rare expression on nonmalignant cells. The company’s DLL3 program is advancing through preclinical development, and Abdera expects to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) in 2024. In addition, Abdera is advancing a robust pipeline for other undisclosed cancer targets."

Financing • IND • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Thoracic Cancer