On September 18, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted and transformative cancer therapies using its proprietary AI and machine learning (ML) platform, RADR, with multiple clinical stage drug programs, reported that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for LP-284 (Press release, Lantern Pharma, SEP 18, 2023, View Source [SID1234635224]). LP-284 is being developed for the treatment of relapsed or refractory non-Hodgkin’s lymphoma (NHL), including mantle cell lymphoma (MCL) and double hit lymphoma (DHL) and other high-grade B-cell lymphomas (HGBL). Lantern expects to commence enrollment of patients for the first-in-human Phase 1 trial for LP-284 during the fourth quarter of 2023.
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"This is now our second novel drug candidate to receive IND clearance from the FDA in the past 100 days, further validating our approach of leveraging AI and machine learning to accelerate the development of our pipeline," stated Panna Sharma, Lantern’s President and CEO. "LP-284 holds blockbuster potential, and we have been able to expedite its journey from a concept to a first-in-human clinical trial in a highly efficient and cost-effective manner – less than 2.5 years and under approximately $2.7 million – underscoring the power and potential of our AI platform RADR to accelerate oncology drug discovery and development. RADR was used to unravel the mechanism of action of LP-284, prioritize its cancer indications, and generate machine-learning biomarker signatures that may be pivotal in selecting patients for future phases of the clinical trials. Our success-to-date with LP-284 reaffirms our commitment to harnessing the power of AI to transform cancer treatment and save lives."
LP-284 is a novel small molecule with a synthetically lethal mechanism of action that preferentially damages cancer cells that harbor mutations in DNA damage repair pathways. Lantern’s LP-284 program has been accelerated and focused using AI insights and biological modeling powered by RADR.
NHL is the leading hematological malignancy in the US and remains one of the leading causes of cancer deaths globally, with an estimated 500,000 new cases annually worldwide. Despite advances in NHL using combination and targeted therapies, nearly 20% to 40% of patients with certain subtypes still relapse after treatment. In aggressive subtypes of NHL, like MCL, nearly all patients relapse from standard-of-care (SOC) therapies. Globally, the annual market potential of LP-284 in NHL is estimated to be approximately $4 billion USD.