AI-Powered Cancer Drug LP-184 Receives FDA Fast-Track Designation for Glioblastoma

Developed by AI, Lantern Pharma's investigational drug LP-184 has received FDA Fast-Track Designation for glioblastoma  (GBM). LP-184, optimized using Lantern's AI platform RADR®, bypasses GBM’s resistance to current treatments and shows promise in preclinical trials. If approved, LP-184 could become the first new glioblastoma treatment in over 20 years.

Lantern Pharma announced that its investigational drug candidate, LP-184, has been granted Fast-Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of glioblastoma (GBM), an aggressive form of brain cancer. This designation is significant as it aims to expedite the review process for drugs addressing serious conditions with limited treatment options, highlighting LP-184’s potential to meet an unmet need in glioblastoma therapy.

Lantern Pharma’s CEO, Panna Sharma, expressed optimism about the FDA's Fast-Track designation for LP-184, emphasizing its potential to address the urgent need for novel treatments in aggressive central nervous system (CNS) cancers like GBM.

AI-Powered Innovation in Drug Development

Lantern Pharma has leveraged its artificial intelligence (AI) platform, RADR®, to accelerate the discovery and optimization of LP-184. RADR® analyzes vast datasets—over 100 billion data points—to uncover insights into cancer biology and identify patient subgroups that could benefit from specific therapies. This AI-driven approach has been instrumental in validating LP-184’s mechanisms of action and potential clinical applications.

For over two decades, there have been no new FDA-approved drugs for GBM. This makes the development of LP-184, which can bypass the MGMT1-related resistance, a crucial advancement in the field. Unlike other treatments, LP-184's effectiveness does not rely on the expression levels of MGMT, offering new hope for patients who are unresponsive to existing therapies.

LP-184: A Promising Candidate

LP-184, now known as STAR-001 for its neuro-oncology applications, is a synthetically lethal agent designed to induce DNA damage in cancer cells. Preclinical studies have demonstrated its effectiveness in causing double-strand breaks in the DNA of recurrent GBM cells, including those resistant to current treatments. These promising results have propelled the drug into early-stage clinical trials.

Currently, LP-184 is being studied in a Phase 1A trial to assess its safety and tolerability in a variety of solid tumors, including GBM. The next phase of clinical development, a Phase 1b/2a trial, is expected to begin in late 2024 or early 2025, targeting recurrent GBM (rGBM). This trial will explore LP-184 as both a monotherapy and in combination with spironolactone, an existing drug with the potential to enhance LP-184's efficacy.