Lantern Pharma Advances AI-Guided Drug into Phase 1b/2 Trial for Triple Negative Breast Cancer

Lantern Pharma announced FDA clearance of its Investigational New Drug (IND) application for LP-184 in the treatment of triple negative breast cancer (TNBC). The planned Phase 1b/2 trial will evaluate LP-184 both as monotherapy and in combination with the PARP inhibitor olaparib in patients with recurrent or advanced-stage TNBC.

The clinical program is based on LP-184's mechanism as a synthetically lethal small molecule that induces DNA double strand breaks via PTGR1-mediated activation. Preclinical data suggest LP-184 may benefit patients with DNA damage repair (DDR) gene alterations, including those with resistance to current PARP inhibitors. LP-184 also demonstrated brain penetration and activity in TNBC models with brain metastases.

In lab models of triple negative breast cancer (TNBC), LP-184 reduced tumor size—even in cases where other treatments like PARP inhibitors had stopped working. These results suggest LP-184 could help treat hard-to-treat forms of TNBC linked to DNA repair problems.

The monotherapy arm of the trial will enroll approximately 30 patients and assess safety, efficacy, and pharmacokinetics across two dose levels. The combination arm will evaluate LP-184 plus olaparib in BRCA1/2-altered TNBC patients in a second-line setting, with primary endpoints including safety and efficacy.

The trial will be conducted in the U.S., India, and Nigeria—regions with high TNBC incidence—through academic and clinical research sites. This follows the FDA's Orphan Drug Designation for LP-184 in TNBC in 2023 and Fast Track Designation in 2024.

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Lantern developed LP-184 using its proprietary AI platform which integrates oncology datasets and machine learning to optimize development of targeted cancer therapies. Additional clinical programs for LP-184 in lung, bladder, pancreatic, and ovarian cancers are in planning stages.

TNBC, according to Lantern, accounts for a significant global disease burden with an estimated $3-5 billion market opportunity. Median survival in newly diagnosed metastatic TNBC is estimated between 10 and 18 months.

Topics: Clinical Trials