On October 15, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company dedicated to developing cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development, reported that the FDA has granted Fast Track Designation for investigational drug candidate, LP-184, for treatment of Glioblastoma (Press release, Lantern Pharma, OCT 15, 2024, View Source [SID1234647216]). LP-184 is currently in a Phase 1A clinical trial designed to evaluate the safety and tolerability of the synthetically lethal investigational drug candidate in a broad range of solid tumors, including Glioblastoma (GBM). LP-184 was optimized and advanced in part with Lantern’s AI platform, RADR, to aid in the validation of mechanisms that could be exploited in the clinical setting to eradicate challenging cancers, and uncover insights in targeted patient populations. RADR is Lantern’s AI platform for cancer therapy discovery, development and rescue with over 100 billion data points and aiding in the development of both Lantern’s portfolio and development initiatives with Lantern’s collaborators.
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About GBM and the need for improved and novel therapies.
Glioblastoma (GBM) affects nearly 13,000 patients annually in the US and approximately 300,000 globally, with a mortality rate of 94%. Current standard of care therapies result in a life expectancy in GBM patients of less than 15 months. A major limitation to development of new drugs in the treatment of GBM is the need for potential drugs to have the ability to cross the blood brain barrier (BBB) as well as the ability to counteract the inherent and adaptive resistance of GBM cancer cells to temozolomide, the current standard of care in GBM. This resistance is largely derived from the expression of the DNA repair enzyme MGMT1. LP-184 activity is agnostic to MGMT expression, meaning it does not depend on the under or over-expression of MGMT in GBM and has shown in-vivo, preclinical activity in both types of GBM models.
No new drugs for GBM have been approved in over two decades. Lantern Pharma is advancing LP-184, a molecule which demonstrates synthetic lethality when combined with agents that cause DNA damage repair deficiency.2 Additionally, LP-184 has shown that it causes double-stranded breaks in the DNA of recurrent GBM (rGBM) cancer cells in multiple in-vivo models and is currently being advanced in early clinical stage studies.
"Receiving FDA Fast Track Designation for Lantern Pharma’s LP-184 in GBM reinforces our belief that this drug-candidate can help in the critical need to find effective treatment options for patients with GBM and further supports the potential of LP-184 to address the challenges in aggressive CNS cancers, where patients have a critical need for novel and life extending therapies" said Panna Sharma, President and CEO of Lantern Pharma.
Current status of LP-184 & STAR-001 in clinical trials & development
LP-184 is currently being studied in a phase 1A clinical trial to evaluate the safety, tolerability and maximum tolerated dose (MTD) of the potential therapy in a wide range of tumors, including GBM. The full study design can be viewed here (clinicaltrials.gov). Once the MTD has been established, Lantern has plans to advance the drug-candidate LP-184 as STAR-001 through its wholly owned subsidiary, Starlight Therapeutics, in GBM and other CNS and brain cancers.
Lantern also anticipates further using RADR to determine potential additional suitability for LP-184 in combination with other approved agents for the control of cancer progression in multiple other patient subgroups. Lantern has provided information on the development of LP-184 in GBM and has also discussed its plan to advance STAR-001 (LP-184 for CNS cancers) in multiple publicly available webinars, including on:
June 26, 2024 — STAR-001 in Multiple Brain and CNS Cancers with Dr. Marc Chamberlain, and
July 31, 2024 — Born from AI, Lighting The Way in CNS Cancer Treatment with Mr. Panna Sharma.
The proposed goals for the development of Phase 1b/2a clinical studies are targeting a rGBM specific trial to begin in late 2024 or early 2025. This trial is being planned to assess LP-184 in a Phase 1b/2a study as mono-therapy and in combination with spironolactone in rGBM to assess safety, pharmacokinetics and preliminary efficacy. Concurrently, Lantern will conduct a retrospective correlative analysis of multiple key markers of DNA damage as exploratory endpoints. EGFR expression or mutation status, MGMT status and expression of DNA damage repair pathway are also planned to be studied as potential response predictors to help inform and guide future late-stage trials and to stratify enrollment.
About the FDA Fast Track process
The FDA’s Fast Track process is designed to facilitate development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially bring important new medicines to patients sooner. Companies whose programs are granted Fast Track Designation are eligible for more frequent interactions with the FDA during clinical development. For more information on Fast Track designation, please visit the FDA’s website at www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.