On March 18, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, reported operational highlights and financial results for the fourth quarter and fiscal year ended December 31, 2023 (Press release, Lantern Pharma, MAR 18, 2024, View Source [SID1234641233]).
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"This past quarter and the entire year of 2023 was a period of meaningful and remarkable progress for our programs and our AI platform at Lantern Pharma. Our team demonstrated how combining emerging AI technologies, cancer biology models and experiments, chemical, molecular, and multiomic biomarker data, along with large-scale patient data holds the promise of transforming timelines and costs in drug development for oncology. We are very enthusiastic about 2024 and will be actively focused on meeting and possibly exceeding the milestones ahead of us, which include potential initial data from our LP-184 Phase 1A trial; advancing the new company born from AI – Starlight Therapeutics, which is focused wholly on CNS cancers; and progressing our ADC oncology program." said Panna Sharma, President and CEO of Lantern Pharma."
Sharma continued, "Computational and AI-driven approaches are increasing their value-driving impact on oncology drug development, and our team continues to increase the capabilities and usefulness of our platform while also helping to de-risk and sharpen the focus of our existing clinical drug candidates. Our leadership in the innovative use of AI and machine learning to transform costs and timelines in the development of precision oncology therapies has guided three drug development programs in active clinical trials. We believe this pace of development with our focused team and resources should yield significant future benefits for investors and patients as our industry matures, adopts and accepts a data and AI-centric approach to drug development."
Highlights of AI-Powered Pipeline:
Ø LP-284 – Launched the first-in-human Phase 1 clinical trial with LP-284 targeting recurrent non-Hodgkin’s lymphomas (NHL) and other cancers. Lantern also announced recently that initial patients had been dosed in the LP-284 clinical trial.
LP-284 has shown nanomolar potency across multiple published in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit lymphoma (DHL), and other advanced NHL cancer subtypes with DNA damage response deficiencies, notably those with compromised functioning of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions.
Nearly all MCL, DHL, and High Grade B-Cell Lymphoma (HGBL) patients relapse from the current standard-of-care agents and there is an urgent and unmet need for novel improved therapeutic options for these patients. In the US and Europe, MCL, DHL, and HGBLs are diagnosed in 16,000-20,000 patients each year and have an estimated annual market potential of over USD 3+ billion.
Ø LP-184 – Several cohorts of patients have been dosed in the ongoing Phase 1 clinical trial – a first-in-human Phase 1 basket trial across multiple solid tumor indications that are advanced and refractory to existing standard-of-care therapies. The trial is enrolling patients that have relapsed/refractory advanced solid tumors, such as pancreatic cancer, glioblastoma (GBM), brain metastases (brain mets.), lung cancer, triple-negative breast cancer, and multiple other solid tumor types with DNA damage response deficiencies. Lantern expects to continue Phase 1A enrollment throughout the first half of 2024 across a growing number of US clinical trial sites, including Fox Chase Cancer Center, Johns Hopkins Medicine, and other leading centers, with the potential for an initial readout in Phase 1A during late summer or early fall.
The dosage and safety data obtained in the Phase 1A trial are expected to be used to advance the central nervous system (CNS) indications for a future Phase 1b/2 trial to be sponsored by Lantern’s wholly owned subsidiary, Starlight Therapeutics. Additionally, AI and preclinical studies are ongoing to further refine drug combination studies supporting the use of LP-184 to improve the durability of response and/or the overall response rates in combination with FDA approved drugs that are widely used in cancer treatment. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $12+ billion, consisting of $4.5+ billion for CNS cancers and $7.5+ billion for solid tumors.
Ø LP-300 – Twelve sites for the Phase 2 Harmonic trial have been activated in the US, and 3 Asian countries are in various phases of regulatory allowance for clinical trial commencement. This strategy should increase the potential for dosing additional patients in the Phase 2 Harmonic trial during 2024, which should help address the patient enrollment challenges Harmonic has faced in the US. In these Asian countries, Japan, South Korea and Taiwan, the incidence of never-smokers with NSCLC (non-small cell lung cancer) is double or higher than that of patients in the US. The Harmonic trial is assessing the effect of LP-300 in combination with standard-of-care chemotherapy in never-smoker patients with relapsed NSCLC.
Globally, never-smokers with NSCLC are a growing population of patients and do not respond well to PD-1/PD-L1-based therapies, leaving them with reduced treatment options. In the US, there are approximately 20,000-40,000 never-smokers with NSCLC diagnosed annually, representing an estimated US annual market potential of $1.5 billion and a global estimated annual market potential of over $2.6 billion. Additional information on the Harmonic trial can be found at the Harmonic website and clinicaltrials.gov.
RADR Platform Growth and Development:
Ø RADR continues to advance in size, scope, and capabilities and is also progressing towards becoming a standard for AI-driven drug development in oncology – for both early-stage development and later-stage patient biomarker and combination therapy identification. RADR has now surpassed 60+ billion oncology-focused datapoints and is projected to reach over 100 billion datapoints by the end of 2024. The scope of RADR’s data has broadened with a strategic focus on additional classes of compounds, detailed data on chemical and biochemical features and drug-interaction data. Additionally, data from clinical studies such as those being obtained from liquid biopsy, and data from preclinical combination studies that aim to define drug interaction and optimal dosage are being incorporated into the datapoints and data sets powering RADR.
Lantern will potentially focus additional data growth efforts of the RADR platform on: drug sensitivity data, combination treatment outcome data, and biomarker data in rare cancers, and on emerging synthetic lethal targets that are aimed at accelerating the development of new therapies for Lantern and its partners. Additionally, the RADR platform’s generative AI capabilities, focusing on molecular optimization and automated feature extraction to improve understanding and prediction of molecular dynamics, safety, and drug-drug interactions are planned to increase in functionality and scope in the coming quarters.