Lantern Pharma Reports Additional Positive LP-184 Phase 1a Results Showing Durable Disease Control in Heavily Pre-Treated Advanced Cancer Patients as Company Advances Precision Oncology Program into Multiple Biomarker-Guided Phase 1b/2 Trials

Core Insights - Lantern Pharma Inc. has reported positive results from its Phase 1a dose-escalation study of LP-184, demonstrating durable disease control in patients with advanced solid tumors, particularly those with DNA damage repair (DDR) pathway deficiencies [1][2] - The company is advancing a precision oncology strategy with multiple biomarker-guided Phase 1b/2 clinical trials targeting triple-negative breast cancer (TNBC), glioblastoma multiforme (GBM), non-small cell lung cancer (NSCLC), and advanced urothelial carcinoma, with an estimated market opportunity exceeding $10 billion annually [1][2] Phase 1a Clinical Trial Results - The Phase 1a trial enrolled 63 heavily pre-treated patients, achieving a 54% disease control rate at therapeutic dose levels, indicating promising activity in DDR-deficient cancers [1][2] - The recommended Phase 2 dose (RP2D) was established at 0.39 mg/kg, with a favorable safety profile characterized by manageable adverse events [1][2] - Over 87% of patients exceeded the PTGR1 bioactivation threshold, validating the biomarker's utility for patient selection [1][2] Patient Durability and Efficacy - Notable patient cases included individuals with stage 4 cancers who have shown ongoing clinical benefits for over 12 to 23 months after treatment with LP-184, highlighting its potential in difficult-to-treat cancers [1][2] - The drug demonstrated activity in both homologous recombination (HR)-deficient and nucleotide excision repair (NER)-deficient tumors, suggesting a broader patient applicability compared to existing therapies [2] Regulatory Support and Designations - LP-184 has received multiple FDA designations, including Fast Track and Orphan Drug designations for various cancers, which facilitate accelerated development and potential expedited approval pathways [2][3] - These designations enhance the company's ability to interact with the FDA and may allow for rolling submissions of New Drug Application (NDA) sections [2] Future Development Plans - Lantern Pharma is planning multiple biomarker-guided Phase 1b/2 trials, including combinations with other therapies for TNBC, NSCLC, and GBM, targeting high unmet medical needs [2][3] - The company is also exploring additional indications, such as post-radiation pancreatic cancer, which may benefit from enhanced PTGR1 expression due to prior treatments [2][3] Company Overview - Lantern Pharma is a clinical-stage biotechnology company focused on using artificial intelligence and genomic data to develop precision oncology therapies [3] - The company's RADR® AI platform integrates extensive data to identify biomarkers and predict drug responses, streamlining the drug development process [3]