FDA clearance of IND application for solid tumour drug 


Lantern Pharma, an AI company developing targeted and transformative cancer therapies, has received clearance from the US Food and Drug Administration (FDA) for the investigational new drug (IND) application for LP-184, which is being developed for multiple advanced solid tumours and central nervous system (CNS) cancers.  

The first-in-human Phase Ia trial for LP-184 is anticipated to launch and dose its first patient during the current quarter. 

LP-184 is the first of Lantern’s drug candidates to be developed entirely internally, with the assistance of Lantern’s AI and ML platform RADR, to advance to a first-in-human Phase Ia trial. The Phase Ia trial will assess the safety and tolerability of escalating doses of LP-184 to determine the maximum tolerated dose (MTD) in patients with advanced pancreatic cancer, recurrent high-grade gliomas/glioblastoma (GBM), metastatic brain and CNS cancers, and other solid tumours with DNA damage response (DDR) deficiencies. Lantern anticipates the Phase Ia trial to be completed by the first half of 2024. 

After the Phase Ia trial is completed, Lantern will advance LP-184 into additional clinical trials for multiple solid tumour indications, and Lantern’s subsidiary, Starlight Therapeutics, will advance the clinical development of LP-184 for all brain and CNS indications under the name STAR-001. Globally, the aggregate annual market potential of LP-184/STAR-001’s programs is estimated to be approximately $11-13 billion, consisting of $6-7 billion for solid tumours and $5-6 billion for CNS cancers. 

“The clearance of the IND application is a significant milestone for our LP-184 program and validates our approach of leveraging AI and machine learning to advance our pipeline of novel drug candidates,” stated Panna Sharma, Lantern’s CEO and President. “Insights from our AI platform RADR were instrumental in our development of LP-184 and aided in discovering its mechanism of action, identifying and prioritising its cancer indications, and generating machine learning biomarker signatures to assist with future clinical trial patient selection. We believe LP-184 has blockbuster potential for patients with multiple types of advanced solid tumours and CNS cancers, many of which have no or limited effective therapeutic options,” continued Sharma. 

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