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FDA Grants Lantern Pharma Orphan Drug Designation for Drug Candidate LP-284 in High-Grade B-cell Lymphomas (HGBL)
The Orphan Drug Designation strengthens LP-284’s clinical development path and can provide for additional market exclusivity and commercial protection.
About this update from Lantern Pharma Inc.
[{"type":"text","content":"\n\nThe Orphan Drug Designation strengthens LP-284’s clinical development path and can provide for additional market exclusivity and commercial protection.\n\n\n\nLantern has initiated a first-in-human Phase 1 trial (NCT06132503) for LP-284 in B-cell non-Hodgkin’s lymphomas (NHL), including high-grade B-cell lymphoma (HGBL) and mantle cell lymphoma (MCL).\n\n\n\nThis Orphan Drug Designation marks the second such designation for drug-candidate LP-284 this year.\n\n\n\n DALLAS--(BUSINESS WIRE)--\nLantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (“AI”) company developing targeted and transformative cancer therapies using its proprietary RADR® AI and machine learning (“ML”) platform with multiple clinical-stage drug programs, today announced that the U.S. Food and Drug Administration (FDA) has granted LP-284 Orphan Drug Designation (ODD) for the treatment of high-grade B-cell lymphoma with MYC and BCL2 rearrangements.\n\n\nHGBL represents a rare and aggressive form of B-cell non-Hodgkin's lymphoma (NHL) with no established standard of care treatment approach. Typically, frontline intervention involves a combination of chemo-immunotherapies such as R-CHOP or DA-R-EPOCH. However, approximately 20-30% of HGBL patients stop responding to these therapeutic agents and continue cancer progression. For those with relapsed or refractory (R/R) disease, the survival prognosis is 8.6 to 16 months (Laude et al., 2021). This underscores the pressing clinical need for novel and effective therapies in treating HGBL and improving patient outcomes.\n\n\nLP-284 is a novel small molecule agent that damages DNA in cancer cells leading to the death of cancer cells. Lantern is developing LP-284 for several aggressive B-cell NHL, including MCL and HGBL, where LP-284 has shown potent anti-tumor activity in preclinical models. Lantern has been able to advance LP-284 from initial RADR® A.I. insights regarding anti-cancer activity and potential mechanisms of action in hematological cancers, to selection of specific subtypes of lymphomas with superior response, to late-stage IND enabling studies and initiation of first-in-human clinical trials in a short span of approximately 2.5 years.\n\n\n\"Receiving Orphan Drug Designation is an important milestone for our latest drug candidate, LP-284, and further validates our data-driven approach to oncolog...