The U.S. Food and Drug Administration (FDA) on Monday cleared Lantern Pharma Inc.’s (NASDAQ:LTRN) Investigational New Drug Application (IND) for a Phase 1b/2 trial for LP-184 in triple-negative breast cancer (TNBC).

The dual approach in the clinical trial is designed to evaluate LP-184 in recurrent, advanced-stage TNBC patients through:

• Monotherapy Arm: An open-label study involving approximately 30 patients with advanced-stage TNBC, focusing on dose optimization to evaluate, enhance, and optimize safety and potential efficacy for TNBC patients.
• Combination Therapy: Evaluation of LP-184 in combination with olaparib in second-line settings for patients with advanced-stage TNBC harboring BRCA1 or BRCA2 alterations, with primary endpoints including safety and efficacy parameters that could support a pathway to regulatory approval.In preclinical studies, treating an animal model with BRCA-1 LOH and an HRD score of 63 resistant to the PARP inhibitor showed evidence of resensitization in combination with LP-184.
• The combination phase 1b/2 trial design provides for LP-184 to be evaluated in a second-line setting in patients with advanced-stage TNBC whose primary tumor harbors alterations in BRCA1 or BRCA2.

In 2024, LP-184 received Fast Track Designations from the FDA for GBM (Glioblastoma Multiforme) and TNBC.

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Additionally, LP-184 received three Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors, in addition to its existing designation for ATRT, an ultra-rare pediatric brain tumor with the genetic hallmark of loss-of-function or deletion of the SMARCB1 gene.

Lantern is conducting a Phase 1a trial that is on cohort 11, and early indications of clinical activity have been observed at higher dose levels, consistent with preliminary PK data.

• Dose levels 7, 8, and 9 were cleared without safety concerns during Q4 of 2024, and preliminary PK data suggest dose proportionality with exposure.
• Enrollment at dose levels 9 and above is focused on including advanced solid tumor patients who have identified DNA damage repair mutations.
• A broader clinical data update is slated for Q2 2025, when recruitment for the trial is expected to be finished, and complete safety and dose-response data are expected to be available.

The global TNBC market is estimated at $3-$5 billion annually, with over 300,000 new cases diagnosed worldwide yearly. While homologous recombination-deficient TNBCs are often initially treated with PARP inhibitors, resistance inevitably develops, underscoring the critical need for novel therapeutic approaches.

Price Action: LTRN stock closed at $3.54 on Friday.

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This article EXCLUSIVE: Lantern Advances Breast Cancer Drug Candidate With FDA Clearance For Early-Stage Trial originally appeared on Benzinga.com

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