On November 30, 2023 Lantern 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, reported 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 (Press release, Lantern Pharma, NOV 30, 2023, View Source [SID1234638072]).

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HGBL 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.

LP-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.

"Receiving Orphan Drug Designation is an important milestone for our latest drug candidate, LP-284, and further validates our data-driven approach to oncology drug discovery and development," stated Panna Sharma, President & CEO of Lantern Pharma. "At SOHO 2023, we reported positive preclinical data demonstrating LP-284’s potent anti-tumor activity as a monotherapy as well as in combination with FDA-approved lymphoma targeting antibody Rituximab in High-Grade B-cell Lymphoma (HGBL). These findings hold significant importance given the elevated rate of relapse and the unfavorable prognosis observed in the majority of HGBL patients," continued Sharma.

"This marks the second Orphan Drug Designation (ODD) granted by the FDA for LP-284. The initial ODD for LP-284 was granted in January 2023, and with this most recent ODD for LP-284 announced today, a total of five orphan designations have now been granted to Lantern, with the other three granted for our drug candidate LP-184. Acquiring these orphan designations is a key element of our business model as they provide a number of benefits including seven years of market exclusivity and eligibility for expedited drug development programs. Looking forward, these designations further position Lantern to advance our discussions with biopharma companies for partnering and collaborative development opportunities."

The FDA’s Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. ODD is designed to provide drug developers with various benefits to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of marketing registration application fees, reduced annual product fees, clinical protocol assistance and qualification for expedited development programs.

Reference:

Laude MC, Lebras L, Sesques P, et al. First-line treatment of double-hit and triple-hit lymphomas: Survival and tolerance data from a retrospective multicenter French study. Am J Hematol. 2021;96(3):302-311. doi:10.1002/ajh.26068