LP-184

FDA approves 420-mg trastuzumab-strf for HER2-overexpressing cancers, and zolbetuximab for CLDN18.2-positive gastric/GEJ adenocarcinoma. FDA delays decision on sotorasib plus panitumumab for KRAS G12C-mutated CRC to Jan 2025. LP-184 granted fast track designation for glioblastoma treatment.

Lantern Pharma to host two October webinars highlighting RADR® AI platform's role in advancing cancer therapies, including collaborations with Actuate Therapeutics and discussions on drug candidates LP-184 and LP-284.

FDA fast track designation granted to LP-184 for glioblastoma treatment; phase 1b/2a trial to start late 2024 or early 2025. LP-184 targets DNA damage repair deficiency and has other FDA designations for pediatric cancers and pancreatic cancer.

The FDA granted fast track designation to LP-184 for treating glioblastoma (GBM). LP-184, a small-molecule alkylating agent causing tumor cell death via DNA damage, is under investigation in a phase 1a trial (NCT05933265) to assess its safety, tolerability, and maximum tolerated dose (MTD) in patients with solid tumors, including GBM. Once the MTD is determined, Lantern Pharma plans to advance LP-184 as STAR-001 for GBM and other CNS cancers.

FDA grants Fast Track Designation to Lantern Pharma's LP-184 for treating Glioblastoma, targeting a phase 1b/2a clinical trial for recurrent GBM to start in late 2024/early 2025.

In September 2024, the FDA approved multiple oncology treatments, including subcutaneous atezolizumab, ribociclib for early breast cancer, isatuximab for multiple myeloma, selpercatinib for medullary thyroid cancer, and osimertinib for advanced NSCLC. Other approvals included OBX-115 for melanoma, FoundationOne CDx and Liquid CDx for prostate cancer, subcutaneous bortezomib, IBI363 for melanoma, 212Pb VMT01 for melanoma, ABD-147 for neuroendocrine carcinoma, certepetide for cholangiocarcinoma, tebapivat for myelodysplastic syndromes, elraglusib for soft tissue sarcoma, VNX-101 for leukemia, P-BCMA-ALLO1 for multiple myeloma, adjuvant ribociclib for breast cancer, pembrolizumab for mesothelioma, ICT01 for leukemia, CF33-hNIS for cholangiocarcinoma, trastuzumab-strf, amivantamab for NSCLC, CD-001, isatuximab for multiple myeloma, EO-3021 for gastric cancer, camrelizumab for HCC, LP-184 for rare pediatric tumors, osimertinib for NSCLC, and selpercatinib for medullary thyroid cancer.

LP-184, a next-gen alkylating agent, received 3 rare pediatric disease designations from the FDA for treating malignant rhabdoid tumors, rhabdomyosarcoma, and hepatoblastoma. The agent leverages synthetic lethality to target tumor cells and is currently in a phase 1 trial for advanced solid tumors.

Lantern Pharma received FDA's rare pediatric disease designation for LP-184 in Malignant Rhabdoid Tumors, Rhabdomyosarcoma, and Hepatoblastoma, bringing the total to 4. LP-184 showed tumor regression and extended event-free survival in pediatric preclinical models, with potential for a Priority Review Voucher upon FDA approval.