Lantern Pharma Receives FDA Orphan Drug Designation for LP-284 in Soft Tissue Sarcomas

The U.S. Food and Drug Administration has granted Orphan Drug Designation to Lantern Pharma's LP-284 for the treatment of soft tissue sarcomas, representing the third orphan designation for this program and the sixth overall across the company's clinical pipeline. This regulatory milestone expands LP-284's therapeutic potential beyond hematologic malignancies into solid tumors, reflecting its synthetic lethal mechanism that targets DNA repair deficiencies commonly found in adult soft tissue sarcomas. The designation supports an accelerated regulatory pathway for LP-284 as the company continues Phase 1 evaluation in B-cell non-Hodgkin lymphomas and advances development in additional rare cancer indications.

Lantern Pharma is a clinical-stage biotechnology company that utilizes artificial intelligence, machine learning, and genomic data to streamline oncology drug development and deliver precision therapies to patients. The company's proprietary RADR(R) AI platform integrates hundreds of billions of data points to identify biomarkers, predict drug response, and design more efficient clinical trials. This technology-driven approach enables the company to develop targeted treatments for genomically defined patient populations, potentially improving outcomes while reducing development timelines and costs.

The orphan drug designation for LP-284 in soft tissue sarcomas is particularly significant because these cancers represent a diverse group of rare malignancies with limited treatment options. The synthetic lethal mechanism of LP-284 targets specific vulnerabilities in cancer cells with DNA repair deficiencies, offering a potentially more effective and targeted approach compared to conventional therapies. This designation provides Lantern Pharma with various development incentives, including tax credits for clinical testing, exemption from user fees, and potential market exclusivity upon approval.

The company's clinical-stage pipeline includes multiple drug candidates, with LP-284 now having orphan designations across multiple indications. This regulatory achievement demonstrates the versatility of Lantern's drug development platform and its ability to identify promising therapeutic applications for its compounds. The orphan drug status for soft tissue sarcomas comes as LP-284 continues its Phase 1 evaluation in B-cell non-Hodgkin lymphomas, indicating the drug's potential across different cancer types with shared molecular vulnerabilities.

For investors and stakeholders seeking additional information about Lantern Pharma, the latest news and updates relating to the company are available through various financial news platforms. The company's progress in developing targeted oncology therapies represents an important advancement in precision medicine, potentially offering new hope for patients with rare and difficult-to-treat cancers who have limited therapeutic options available.