On January 17, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported it has received guidance from the United States Food and Drug Administration (FDA) on Lantern’s clinical development plans for its LP-184 program (Press release, Lantern Pharma, JAN 17, 2023, View Source [SID1234626303]). LP-184 has shown nanomolar potency across a range of cancers including several solid tumors and multiple adult and pediatric central nervous system (CNS) cancers. The FDA feedback clears Lantern’s path for an IND submission and the targeted initiation of a first-in-human clinical trial in Q2 2023.
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During Q4 2022, Lantern requested a pre-investigational new drug (pre-IND) meeting with the FDA, requesting agency feedback in connection with its planned LP-184 IND application. The FDA’s responses and guidance have been aligned with the company’s clinical, CMC, and preclinical development plans and solidifies Lantern’s timeline for an IND submission and clinical trial initiation in Q2 2023. The upcoming LP-184 Phase 1 trial is expected to enroll patients with pancreatic cancer, select solid tumors with DNA damage repair deficiency, and malignant gliomas-including glioblastoma (GBM). The FDA previously granted Lantern Orphan Drug Designations (ODD) for LP-184 in both pancreatic cancer and malignant gliomas.
The upcoming LP-184 first-in-human Phase 1 trial is expected to include patients across a range of solid tumor types, including adult brain and central nervous system (CNS) cancers. CNS cancer patients have some of the lowest 5-year cancer survival rates and have had little to no meaningful treatment progress in nearly two decades. LP-184’s anti-tumor synthetic lethality mechanism of action, favorable blood brain permeability, and compelling pre-clinical efficacy for CNS cancers give it the potential to become the next generation standard-of-care agent for CNS cancer patients.
"We expect to have multiple cancer indications and sub-types in this upcoming LP-184 trial that have been identified with the help of our A.I. platform, RADR. The identification and preclinical validation of these indications has been accomplished in timelines that are typically unheard of in oncology drug development. This gives us a unique advantage of generating multiple meaningful and clinically needed programs that we can develop, partner, and monetize for the benefit of our shareholders and for cancer patients," stated Panna Sharma, Lantern’s President and CEO. "Our team has been very focused on aligning multiple workstreams to make for an impactful launch of our LP-184 Phase 1 program later this year across multiple cancer types that have the molecular characteristics for sensitivity to this exciting new drug candidate," continued Sharma.
Lantern’s LP-184 program has benefitted from involvement and collaboration with top academic centers including the Kennedy Krieger Institute at Johns Hopkins, Fox Chase Cancer Center, The Danish Cancer Society Research Center, and the Greehey Children’s Cancer Research Institute at University of Texas Health Science Center, San Antonio. These collaborations have been a key component of further validating and focusing the clinical potential of LP-184 for patient groups with high unmet need.