Lantern Pharma(US:LTRN)2022-03-10 21:06AI and Drug Development - The company has developed an A.I. platform, RADR, which includes over 18 billion data points to streamline drug development and identify cancer patients who may benefit from targeted therapies [22]. - The RADR platform aims to reduce the cost and time of drug development, which typically exceeds $1 billion per successful oncology drug, with a success rate of only 4% to 8% [40]. - The RADR platform has analyzed over 18 billion oncology-specific clinical and preclinical data points, achieving an average historical accuracy of over 80% in distinguishing responders from non-responders [56]. - The RADR platform integrates biological knowledge and data-driven feature selection to generate hypothesis-free biomarker signatures, aiding in drug development [53]. - The RADR platform utilizes a combination of over 20,000 gene expression values and drug sensitivity data to predict drug responses and stratify patient responses [48]. - The RADR platform is being utilized to identify biomarkers and actionable insights from LP-300 clinical trial data, aiming to accelerate its clinical development [112]. - The company emphasizes the importance of its proprietary RADR platform, which leverages AI to select and license drugs with a well-tolerated safety profile, aiming to bring drugs to market quickly and cost-effectively [213]. - The company acknowledges the rapid advancements in AI for drug development, which increases competition in both drug and biomarker development [213]. Clinical Trials and Drug Candidates - The current portfolio consists of four compounds and an Antibody Drug Conjugate (ADC) program, with two drug candidates in clinical phases and one in preclinical studies [27]. - LP-100 is in a Phase II clinical trial for metastatic, castration-resistant prostate cancer, while LP-300 is preparing for a targeted Phase II trial in never-smoking patients with NSCLC [27]. - The company plans to launch a Phase I clinical trial for LP-184 later in 2022, targeting multiple indications using machine learning and genomic data [28]. - The upcoming Phase II clinical trial (HARMONIC™ Study) for LP-300 will enroll approximately 90 patients, focusing on progression-free survival and overall survival [71]. - The Phase III trial showed that female never smokers experienced a 12-month improvement in overall survival with LP-300 treatment, achieving a p-value of 0.0167 and a hazard ratio of 0.367 [75]. - The Phase II trial for LP-100 in metastatic castration-resistant prostate cancer has enrolled 9 out of a targeted 27 patients, with enrollment slowed due to the COVID-19 pandemic [160]. - Clinical studies have involved over 1,300 patients across more than 38 Phase I or II trials for various solid tumors, including prostate, ovarian, and pancreatic cancers [158]. Drug Efficacy and Safety - LP-300 demonstrated a significant increase in survival for female patients with advanced adenocarcinoma, from 13 months to 25 months, with a 2-year survival rate of 51.4% in the subgroup receiving LP-300 [12][75]. - LP-300 targets key molecular pathways, including ALK and EGFR alterations, which are more prevalent in female non-smokers, indicating a tailored therapeutic approach [12][77]. - LP-300 exhibited potential to reduce chemotherapy-induced anemia and kidney toxicity, conditions that disproportionately affect females [12][74]. - LP-300's mechanism of action includes enhancing tumor-directed chemosensitivity and protecting against organ damage from chemotherapy [101]. - LP-300 has shown potential to protect against chemotherapy-induced kidney toxicity and anemia, enhancing the safety profile in treated patients [98]. - Adverse events in patients receiving LP-300 included gastrointestinal disorders with incidences ranging from 22% to 83%, and blood disorders ranging from 12% to 83% [99]. - Serious adverse events (SAEs) occurred in 11% to 49% of patients receiving LP-300, with common SAEs including pneumonia and hypersensitivity reactions [102]. - The incidence of adverse events related to LP-300 treatment included fatigue (22% to 82%) and peripheral neuropathy (14% to 54%) among patients [99]. Intellectual Property and Market Strategy - The company holds over 80 active patents across 14 patent families related to its drug candidates and their development [33]. - As of March 2022, the intellectual property portfolio includes over 45 issued patents and over 36 pending patent applications across 14 patent families [192]. - The nominal expiration for patents related to LP-100 and LP-184 is August 2026, while LP-300 patents expire in March 2028 [196]. - The company plans to rely on data exclusivity, market exclusivity, and patent term extensions to protect its intellectual property rights [193]. - The company retains worldwide commercialization rights for LP-184, LP-300, LP-100, and LP-284, with plans to explore out-license and collaboration opportunities [187]. Market Opportunity and Competition - The company identifies a significant market opportunity in pancreatic cancer, noting that currently, no adequate treatment options are available for approximately 76% of advanced stage pancreatic cancer patients [214]. - The competitive landscape includes major pharmaceutical companies with greater financial resources and expertise, which poses a challenge for the company in drug development and market entry [209]. - The company faces competition from various sources, including academic institutions and governmental agencies, which may impact its market position [208]. - The company is aware that any drug candidates developed will compete with existing therapies that may be safer, more effective, and less expensive [210]. Future Development Plans - The company plans to pursue collaborations with other biotech and pharma companies to leverage its AI and precision oncology expertise for accelerated development programs [64]. - The company is actively developing new agents for prostate cancer, focusing on leveraging AI and biomarker data to discover specific subtypes and treatments [218]. - The company is exploring additional molecular biomarkers to enhance the efficacy of LP-300 in patients who respond well to the combination treatment [77]. - The company plans to launch a new Phase II clinical trial targeting never smokers with adenocarcinoma, aiming to further explore the benefits of LP-300 [77]. - The company has entered into multiple strategic academic collaborations to enhance the development of LP-184, focusing on its efficacy in various cancers [147].