Lantern Pharma (LTRN) Gets FDA Clearance for Clinical Trial Targeting Treatment-Resistant, Genomically-Defined Lung Cancer with AI developed LP-184

This is sponsored content.  Barchart is not endorsing the websites or products set forth below.

Lantern Pharma (LTRN) just announced another major win: FDA clearance to begin a Phase 1b/2 clinical trial of its lead drug candidate LP-184, this time targeting a deadly and hard-to-treat form of non-small cell lung cancer (NSCLC).

This clearance allows Lantern to initiate human testing in biomarker-defined NSCLC patients, specifically those with KEAP1 and/or STK11 mutations and low PD-L1 expression. These patients typically respond poorly to existing treatments, including immunotherapy and chemotherapy, leaving them with few viable options.

What’s Happening in the Trial

The study will evaluate LP-184 in combination with the immune checkpoint inhibitors nivolumab and ipilimumab. The aim is to determine whether this approach can improve outcomes in a patient population where average survival is often just 6 to 15 months, depending on the stage of treatment resistance. Lantern believes its AI-developed drug-candidate, LP-184, can add meaningful benefit to this combination by selectively targeting tumors that overexpress the PTGR1 enzyme, a feature common in these genetically defined cancers.

Why This Matters

Lantern Pharma isn’t chasing crowded markets. It is going after the hardest-to-treat cancers, where success could mean first-mover advantage, market exclusivity, and real-world impact.

• High-risk NSCLC patients with KEAP1 and STK11 mutations have poor response to current standards of care and are often excluded from clinical trials.
• These mutations drive overexpression of PTGR1, the enzyme LP-184 needs to activate its cancer-killing mechanism. This makes the drug a natural fit for these otherwise untreatable tumors.
• Preclinical data has shown that LP-184 can remain effective even in tumors with additional resistance mutations like TP53.
• Lantern is preparing to file for Fast Track or Accelerated Approval designation based on biomarker strategy and early-stage results in the planned clinical trial.

The AI Edge Behind LP-184

LP-184 is not just another experimental drug. It was developed through RADR, Lantern’s proprietary AI platform, which has analyzed more than 200 billion oncology data points to design precision therapies. RADR helps predict which patients are most likely to respond, allowing Lantern to match the right therapy to the right target, faster and at lower cost than traditional biotech.

The company has moved drug candidates from early discovery to clinical trials in just two to three years, at a cost of only one to two and a half million dollars per program. That level of speed and efficiency is rare in oncology.

Investor Takeaways

• LP-184 now has FDA-cleared trials in very targeted areas of both breast and lung cancer, showcasing versatility and broad potential.
• The addressable market for KEAP1/STK11-mutated NSCLC is estimated to be over $2 billion annually.
• RADR is proving itself with multiple drugs in the clinic and more in the pipeline.
• Lantern continues to validate its AI platform with real-world progress, not just theoretical models.

The Bottom Line

This latest FDA clearance reinforces Lantern Pharma’s position as a leader in precision oncology. By blending advanced AI with deep clinical insight, the company is developing therapies built for speed, specificity, and impact. With LP-184 advancing across multiple high-need cancers, Lantern is showing that its platform is not only working, but could redefine how cancer drugs are discovered and delivered.

Read the full press release here: Lantern Pharma Secures FDA Clearance for Planned Phase 1b/2 Trial of LP-184 in Biomarker-Defined, Treatment-Resistant NSCLC Patients with High Unmet Clinical Need

The above is sponsored content. Barchart was paid up to six thousand dollars for placement and promotion of the content on this site and other forms of public distribution covering the period of May 2025.  For more information please view the Barchart Disclosure Policy here.