FDA Grants Fast Track Designation to ABD-147 for Small Cell Lung Cancer

The FDA granted fast track designation to Abdera Therapeutics’ ABD-147 as treatment for extensive stage small cell lung cancer (SCLC) who have progressed on or after platinum-based chemotherapy. The drug is a next-generation precision radiopharmaceutical that delivers Actinium-225 to solid tumors that express the DLL3 protein.¹

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“Aggressive neuroendocrine cancers such as SCLC carry a poor prognosis and new treatment options are urgently needed,” Lori Lyons-Williams, president and CEO of Abdera, said in a news release. “These cancers have the most aggressive clinical course of any type of pulmonary tumor and often rapidly metastasize to other parts of the body. We are thrilled the FDA has recognized the potential of ABD-147 to become a transformative treatment option for SCLC and we are excited to begin clinical development and provide ABD-147 to patients in need.”¹

Lung cancer is the second most diagnosed cancer in the United States and is the leading cause of cancer-related death for men and women. SCLC consists of approximately 15% of lung cancer cases but has been declining due to the decline of smoking. Smoking accounts for approximately 85% of lung cancer cases. The 5-year survival for SCLC increased from 4.9% (from 1983 through 1993) to 6.4% (from 2002 through 2012), according to the National Library of Medicine. Median survival has remained stable at 7 months, with greater survival improvements for patients who are younger.²

SCLC is genetically instable, with nearly universal inactivation of TP53 and RB1, according to authors of a review in CA: A Cancer Journal for Clinicians. The authors stated that “Because of early metastasis, only a small fraction of patients is amenable to curative-intent lung resection, and these individuals require adjuvant platinum-etoposide chemotherapy.” Initially, SCLC is responsive to platinum-based chemotherapy, but it does develop drug resistance over time. The authors concluded that better treatment options for SCLC are needed.³

The company plans to initiate the first-in-human phase 1 clinical trial for the drug in patients with SCLC or large cell neuroendocrine carcinoma who previously received platinum-based therapy. In May 2024, the FDA cleared the company’s investigational new drug (IND) application for the drug, which will be evaluated in the second half of 2024. The phase 1, first-in-human, open-label clinical study will evaluate the safety and preliminary efficacy of ABD-147 and will serve as the basis of future developments and determine recommended dose regimen.⁴

“FDA clearance of our first IND marks a major milestone for Abdera as we transition into a clinical-stage radiopharmaceutical company,” Lyons-Williams said in a news release. “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.”⁴

References

1. 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. News release. Abdera Therapeutics. June 27, 2024. Accessed June 28, 2024. https://www.businesswire.com/news/home/20240626199382/en

2. Basumallik N, Agarwal M. Small Cell Lung Cancer. [Updated 2023 Jul 10]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. https://www.ncbi.nlm.nih.gov/books/NBK482458/

3. Megyesfalvi Z, Gay CM, Popper H, et al. Clinical insights into small cell lung cancer: Tumor heterogeneity, diagnosis, therapy, and future directions. CA Cancer J Clin. 2023;73(6):620-652. doi:10.3322/caac.21785

4. Abdera Therapeutics Announces FDA Clearance of IND Application for ABD-147. News release. Abdera Therapeutics. May 23, 2024. Accessed June 28, 2024. https://abderatx.com/press-releases/abdera-therapeutics-announces-fda-clearance-of-ind-application-for-abd-147/