LP-184 Earns FDA Fast Track Designation in Glioblastoma

• The FDA granted fast track designation to LP-184 (STAR-001) for the treatment of glioblastoma (GBM).
• Fast track designation is intended for agents that treat serious conditions and fill unmet medical needs.
• A phase 1b/2a trial to evaluate LP-184 in recurrent GBM will commence in late 2024 or early 2025.

LP-184 has been granted FDA fast track designation in GBM, and a phase 1b/2a study begin late this year or early next year to evaluate the agent in patients with recurrent GBM.¹

FDA fast track designation is given to agents that treat serious conditions and fill unmet medical needs. The designation facilitates the development and expedites the review of these drugs.

“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 [central nervous system] cancers, where patients have a critical need for novel and life extending therapies” said Panna Sharma, president and chief executive officer of Lantern Pharma, in a press release.

LP-184 is a molecule that demonstrates synthetic lethality when combined with other agents that cause DNA damage repair deficiency.

A phase 1a study (NCT05933265) is currently evaluating LP-184 in patients with advanced solid tumors, including GBM. The goal of this study is to identify the maximum tolerated dose.

The planned phase 1b/2a study will assess LP-184 as a monotherapy and in combination with spironolactone in patients with recurrent GBM. The end points of the study will include safety, pharmacokinetics, and efficacy.

Other Designations for LP-184

In September 2024, the FDA granted 3 rare pediatric drug designations to LP-184 in malignant rhabdoid tumors, rhabdomyosarcoma, and hepatoblastoma.² The FDA also previously granted another rare pediatric drug designation to LP-184 in teratoid rhabdoid tumors.

In August 2021, the FDA granted orphan drug designation to LP-184 in GBM and other malignant gliomas.³

LP-184 is also being investigated for the treatment of pancreatic cancer, a tumor type with a relatively high incidence of DNA repair pathway mutations, similar to GBM.⁴

REFERENCES:

1. Lantern Pharma’s investigational drug-candidate, LP-184, receives fast-track designation in glioblastoma from the FDA. News release. Lantern Pharma, Inc. October 15, 2024. Accessed October 17, 2024. https://tinyurl.com/5n7devsu

2. Lantern Pharma announces three U.S. FDA rare pediatric disease designations granted to LP-184 in multiple ultra rare children’s cancers. News release. Lantern Pharma, Inc. September 23, 2024. Accessed October 17, 2024. https://tinyurl.com/5bxvfzxd

3. FDA Grants Lantern Pharma additional orphan drug designation for drug candidate LP-184 in glioblastoma multiforme & malignant gliomas. News release. Lantern Pharma, Inc. August 30, 2021. Accessed October 17, 2024. https://prn.to/2V0aKF4

4. Restifo D, McDermott JR, Cvetkovic D, et al. Conditional dependency of LP-184 on prostaglandin reductase 1 is synthetic lethal in pancreatic cancers with DNA damage repair deficiencies. Mol Cancer Ther. 2023;22(10):1182-1190. doi:10.1158/1535-7163.MCT-22-0818