Lantern Pharma (LTRN) Gets FDA Green Light to Begin Human Trials for New Breast Cancer Drug

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Lantern Pharma (LTRN) just announced a major milestone - the FDA has officially cleared the company’s Investigational New Drug (IND) application for LP-184, a new therapy designed to treat triple-negative breast cancer (TNBC), one of the most aggressive and difficult-to-treat forms of breast cancer.

This clearance allows Lantern to launch a Phase 1b/2 clinical trial, which will evaluate LP-184 in human patients for the first time. The trial will include two cohorts:

• One testing LP-184 on its own (monotherapy)
• One combining it with the FDA-approved drug olaparib, which is already used in treating cancers with BRCA mutations.

Why this matters:

TNBC is fast-moving, hard to treat, and lacks targeted therapies. The average survival for patients with metastatic TNBC is just 12–18 months. Lantern’s drug, LP-184, is uniquely designed using AI to target cancers with DNA repair issues - a common feature of TNBC. Early preclinical results are promising, with tumor regressions observed in models, including those resistant to current treatments.

This isn’t Lantern’s first regulatory win with LP-184.
The drug has already received:

• Orphan Drug Designation from the FDA (2023)
• Fast Track Designation (2024)

These designations are aimed at speeding up development and giving the company potential perks like longer exclusivity and faster review times.

The opportunity ahead:

Lantern is targeting a global market worth $4 billion+ annually, with over 300,000 new TNBC cases diagnosed every year. The trial will take place in the U.S., India, and Nigeria - countries with high TNBC incidence - giving the company global data and impact potential.

LP-184 has also shown signs it can cross the blood-brain barrier, which could open the door to treating brain metastases that arise from TNBC - another major challenge in TNBC care.

About Lantern Pharma:
Lantern Pharma is a clinical-stage oncology company using precision medicine and advanced data analytics to develop new cancer drugs faster and more efficiently. The company’s proprietary platform, RADR®, analyzes billions of data points to help identify the best drug candidates and match them to the right patient populations.

What makes Lantern Pharma (LTRN) stand out to investors:

• Lean development model: Lantern advances programs from early discovery to clinical trials in just 2–3 years, at a fraction of traditional costs.
• Multiple pipeline opportunities: In addition to LP-184, the company is developing other oncology candidates - including those targeting brain and CNS cancers through its subsidiary, Starlight Therapeutics.
• Regulatory momentum: LP-184 isn’t Lantern’s only program with FDA designations, and the company continues to position itself in high-value, high-unmet-need cancer markets.

For investors seeking exposure to small-cap biotech with platform-driven efficiency, global trial reach, and regulatory traction, Lantern Pharma is a name to watch.

The bottom line:

This is a big step forward for Lantern Pharma and LP-184. With FDA clearance secured, human trials are now set to begin. Investors watching the cancer therapy space, especially those focused on data-driven or precision oncology, may want to keep a close eye on how this program unfolds.

Read the full PR Here: Lantern Advances Drug Candidate LP-184 with IND Clearance for Phase 1b/2 Clinical Trial in Triple Negative Breast Cancer (TNBC)

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