Lantern Pharma's LP-184 Gets Second FDA Fast Track for TNBC Treatment

Lantern Pharma Inc. (NASDAQ: LTRN), a company focused on using artificial intelligence (AI) to develop cancer treatments, has announced that its investigational drug candidate, LP-184, has received Fast Track Designation from the FDA for treating Triple Negative Breast Cancer (TNBC). This is the second Fast Track Designation for LP-184 in 2024, following its designation for Glioblastoma in October of the same year.

Currently, LP-184 is being evaluated in a Phase 1A clinical trial to assess its safety and tolerability across a variety of solid tumors, including TNBC. The development of LP-184 has been facilitated in part by Lantern's AI platform, RADR®, which has helped in identifying mechanisms that can be targeted to eliminate challenging cancers and gain insights into specific patient populations.

Panna Sharma, President, and CEO of Lantern Pharma, commented on the significance of the second Fast Track Designation, emphasizing the drug’s potential to address critical needs in aggressive cancers like TNBC, where patients have limited therapeutic options. Recent data presented at the Immuno-Oncology Summit highlighted LP-184's capability to sensitize TNBC tumors that do not respond to checkpoint inhibitors, suggesting new treatment possibilities for patients with few alternatives.

TNBC is a particularly aggressive form of breast cancer, accounting for about 20% of all breast cancer cases and affecting nearly 29,000 patients annually in the United States. The prognosis for TNBC patients is poorer compared to those with hormone receptor-positive breast cancers, with over 50% of TNBC patients experiencing relapse within the first three to five years. Metastatic TNBC patients have a median overall survival of less than one year, and there are limited treatment options available, especially for those who develop resistance to current therapies.

Preclinical data has shown LP-184 to be highly effective in TNBC, demonstrating significant anti-tumor activity in various patient-derived xenograft models. LP-184 has shown efficacy in both PARP inhibitor-resistant and PARP inhibitor-sensitive tumors, achieving complete tumor regression in all tested models. This suggests that LP-184 could be a valuable new treatment option for TNBC patients, including those resistant to existing PARP inhibitor treatments.

The unique mechanism of LP-184 involves its activation by the enzyme Prostaglandin Reductase 1 (PTGR1), which converts the drug into a potent cytotoxic form within cancer cells. Analysis using the RADR® platform and subsequent in-vivo validation studies have shown that PTGR1 is often elevated in TNBC tumors compared to normal tissue, making these cancers particularly susceptible to LP-184. This biomarker-driven approach may help in identifying patients who are most likely to respond to LP-184 therapy, in line with current and emerging precision medicine strategies in TNBC treatment.

LP-184 is a small molecule drug candidate designed to damage DNA in cancer cells that overexpress specific biomarkers or have mutations in DNA damage repair pathways. Lantern’s RADR® AI platform was instrumental in identifying patient populations and cancer subtypes that might respond to this treatment. LP-184 is being studied for multiple solid tumors and has shown strong potency and activity in drug-resistant cancers. The FDA has granted LP-184 Orphan Drug Designations for pancreatic cancer, glioblastoma (GBM), and ATRT, as well as a Rare Pediatric Disease Designation for ATRT.

Lantern Pharma is an AI-focused company aiming to transform oncology drug discovery and development. Using their proprietary AI and machine learning platform, RADR®, they leverage a vast database of oncology-focused data to address significant challenges in oncology drug development. Their pipeline includes therapies targeting multiple cancer types, both solid tumors and blood cancers, and an antibody-drug conjugate (ADC) program. Their lead programs are in Phase 2 clinical trials, with multiple Phase 1 trials ongoing, and they aim to provide new therapies for a broad range of cancer patients worldwide.