Lantern Pharma(US:LTRN)2025-03-27 20:05Oncology Drug Candidates - The company has three lead clinical-stage oncology drug candidates: LP-300, LP-184, and LP-284, targeting multiple cancer indications including solid tumors and blood cancers [23]. - LP-300 is currently in a Phase 2 clinical trial (Harmonic™ trial) for never-smoking patients with NSCLC in combination with chemotherapy [28][42]. - LP-184, now referred to as STAR-001 for CNS indications, is advancing in a Phase 1A clinical trial and has shown promising activity against glioblastoma and other CNS cancers [27][42]. - LP-284 is also in a Phase 1A clinical trial, demonstrating promising in-vitro and in-vivo anticancer activity in multiple hematological cancers [28][42]. RADR Platform - The RADR platform consists of over 100 billion data points, integrating various data types to identify genomic signatures correlated to drug response, aiming to reduce the time and cost of drug development [22][25]. - The RADR platform has powered the development of new drug candidates and the advancement of new indications for existing drugs, covering over 135 cancer subtypes [43]. - The RADR platform has analyzed over 100 billion oncology-specific clinical and preclinical data points, covering more than 135 cancer subtypes and over 130,000 patient records [63]. - The RADR platform achieved an average historical accuracy of over 80% in distinguishing responders from non-responders in a population of 10 case studies [64]. - The RADR platform is designed to reduce the development timeline and costs associated with oncology drug development by validating predictive biomarkers [51]. - The RADR platform's workflow reduces approximately 18,000 features to about 200 significant genes, ultimately generating a targeted set of less than 50 candidate biomarkers [58]. - The RADR platform integrates biological knowledge and data-driven feature selection to generate hypothesis-free biomarker signatures, aiding in drug development [60]. - The RADR platform is being utilized to identify biomarkers that may correlate with heightened sensitivity to LP-300, potentially guiding patient selection for clinical trials [123]. Clinical Trials and Efficacy - The ongoing HARMONIC™ Study aims to enroll approximately 90 patients, focusing on never smokers with relapsed advanced primary adenocarcinoma of the lung [81]. - LP-300 demonstrated a 13.6 month improvement in overall survival for female never smokers compared to placebo, with a p-value of 0.0167 and a hazard ratio of 0.367 [78]. - The Phase 3 NSCLC adenocarcinoma trial showed an overall survival of 25.0 months for females receiving LP-300, with a 2-year survival rate of 51.4% [83]. - LP-300 has been administered to over 1,000 subjects in clinical trials and has been generally well-tolerated [78]. - The Phase 3 trial indicated that LP-300 could protect against chemotherapy-induced kidney toxicity and anemia, conditions that disproportionately affect females [83]. - The Phase 3 trial did not meet overall survival endpoints for all patients, but showed significant benefits for never smokers, especially females [84]. - For never-smoking women with adenocarcinoma, the overall survival in the LP-300 arm was 27.0 months versus 13.4 months in the control arm, indicating a statistically significant benefit [106]. Market Opportunity and Drug Development - The overall estimated Phase 1-to-approval probability of success for oncology drug development is just 3.3%, with an estimated mean cost of $4.4 billion to deliver a new oncology medicine [45]. - Biopharma AI spending is projected to reach $3 billion by 2025, driven by the shift towards AI-enhanced drug discovery and development [47]. - The company plans to expand its pipeline by identifying new drug candidates that have been abandoned or failed in late-stage clinical trials [74]. - The market opportunity for LP-300 is substantial, as it targets a growing indication of never-smokers with NSCLC, particularly among women [101]. - Approximately 226,650 new cases of lung cancer are expected in the US in 2023, with 110,680 in men and 115,970 in women [93]. - The incidence of non-small cell lung cancer (NSCLC) is estimated to be 192,653 in the US for 2025, accounting for approximately 85% of all lung cancer cases [96]. Drug Mechanism and Safety - LP-300 may enhance antitumor activity by modulating key signaling pathways and enzymes critical for DNA synthesis and repair [117]. - LP-300 inhibits human ALK and MET kinase activities, which are important in NSCLC adenocarcinoma [118]. - Treatment-related adverse events included fatigue (22% to 82%) and nausea (12% to 67%) in patients receiving LP-300 [109]. - Serious adverse events (SAEs) occurred in 11% to 49% of patients receiving LP-300, compared to 7% to 42% in control groups [112]. - LP-300's metabolites may protect against severe forms of chemotherapy-induced toxicities, including hearing loss and dehydration [110]. Future Studies and Collaborations - Future studies for LP-184 include a Phase 1b/2 dose expansion study in advanced triple-negative breast cancer and other solid tumors, focusing on safety and preliminary efficacy [135]. - The company plans to evaluate LP-184 in combination with olaparib for advanced HR-negative and HER2-negative breast cancer, aiming to determine optimal dosing regimens [136]. - A potential study of LP-184 in combination with nivolumab and ipilimumab for specific non-small cell lung cancer mutations is also planned, focusing on safety and clinical activity [137]. - The company is collaborating with the Danish Cancer Society Research Center to explore LP-100's clinical potential across nine solid tumor types with known DNA repair deficiencies [209]. Orphan Drug Designation - LP-184 has received Orphan Drug Designation from the FDA for pancreatic cancer, glioblastoma, and ATRT, indicating its potential in addressing significant unmet medical needs [128]. - LP-284 has received Orphan Drug Designation from the FDA for mantle cell lymphoma and high-grade B-cell lymphoma, indicating its potential in treating these aggressive cancers [182]. - STAR-001 has been granted Orphan Drug Designation for glioblastoma and other malignant gliomas by the FDA [141].