Tuesday, June 13, 2023
Lantern Pharma Inc. (NASDAQ: LTRN) has announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for LP-184. LP-184 is being developed by the company for the treatment of advanced solid tumors and central nervous system (CNS) cancers. The Phase 1A trial for LP-184 is expected to launch and enroll its first patient in the current quarter.
The clearance of the IND application is seen as a significant milestone for Lantern Pharma and confirms the value of their AI and machine learning approach in advancing their pipeline of cancer therapies. The company's AI platform, RADR®, played a crucial role in the development of LP-184 by providing insights into its mechanism of action, identifying suitable cancer indications, and generating biomarker signatures to aid in future patient selection for clinical trials. Lantern Pharma believes that LP-184 holds great potential as a treatment option for patients with various advanced solid tumors and CNS cancers, especially for those with limited therapeutic alternatives.
LP-184 is the first drug candidate developed entirely in-house by Lantern Pharma with the assistance of their AI and machine learning platform, RADR®, to progress to a first-in-human Phase 1A trial. The primary objective of the Phase 1A trial is to evaluate the safety and tolerability of escalating doses of LP-184 and determine the maximum tolerated dose in patients with advanced pancreatic cancer, recurrent high-grade gliomas/glioblastoma (GBM), metastatic brain and CNS cancers, and other solid tumors with deficiencies in DNA damage response (DDR). Lantern Pharma expects the Phase 1A trial to be completed by the first half of 2024.
Following the completion of the Phase 1A trial, Lantern Pharma plans to advance LP-184 into additional clinical trials for various solid tumor indications. Their subsidiary, Starlight Therapeutics, will lead the clinical development of LP-184 for all brain and CNS indications under the name STAR-001. The global market potential for LP-184/STAR-001's programs is estimated to be around $11-13 billion per year, with approximately $6-7 billion for solid tumors and $5-6 billion for CNS cancers.
LP-184 is a unique small molecule that utilizes synthetic lethality, a powerful mechanism of action, to exploit vulnerabilities in solid tumor and CNS cancers with deficiencies in DNA damage repair (DDR). LP-184 has demonstrated anti-tumor potential in numerous in-vitro and in-vivo cancer models, including pancreatic, bladder, triple-negative breast cancer (TNBC), glioblastoma (GBM), brain metastases, and
ATRT. Additionally, LP-184 has the potential to enhance its anti-tumor effects when used in combination with existing FDA-approved agents and other treatment modalities such as spironolactone, PARP inhibitors, and radiation therapy. The promising results of LP-184 have been presented at leading conferences and published in reputable journals, including the American Association for Cancer Research annual meeting, the Society for Neuro-Oncology annual meeting, the San Antonio Breast Cancer Symposium, and the Frontiers in Drug Discovery Journal.