EXCLUSIVE: Lantern Advances Breast Cancer Drug Candidate With FDA Clearance For Early-Stage Trial

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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