FDA Grants Orphan Drug Designation to LP-284 for Treatment of HGBL With MYC, BCL2 Rearrangements

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Currently, there is no established standard of care treatment approach of HGBL, with frontline interventions consisting of chemo-immunotherapies.

The FDA has granted Orphan Drug Designation (ODD) for LP-284 for the treatment of high-grade B-cell lymphoma (HGBL) with MYC and BCL2 rearrangements. LP-284 is a novel small molecule agent that damages DNA in cancer cells, leading to the cancer cells’ death. The treatment has been developed for several aggressive forms of B-cell non-Hodgkin’s lymphoma (NHL), including MCL and HGNL, where LP-284 has demonstrated anti-tumor activity in preclinical models.

Concept of FDA Food and Drug Administration

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"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 and CEO of Lantern Pharma, in a press release. "At Society of Hematologic Oncology 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 HGBL. These findings hold significant importance given the elevated rate of relapse and the unfavorable prognosis observed in the majority of [patients with HGBL].”

HGBL, which is a rare and aggressive form of B-cell NHL, currently has no established standard of care treatment. Frontline intervention typically involves a combination of chemo-immunotherapies, such as the combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or a dose-adjusted combination of rituximab, etoposide, prednisolone, vincristine, cyclophosphamide, and doxorubicin (DA-R-EPOCH); however, approximately 20% to 30% of patients with HGBL stop responding to treatment regimens and experience cancer progression. The survival prognosis is about 8.6 to 16 months for those with relapsed or refractory disease.

ODD statuses are granted to drugs intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or conditions that affect fewer than 200,000 people in the United States. Further, ODD is designed to provide drug developers with various benefits to support the development of novel drugs.

“This marks the second 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…a total of 5 orphan designations have now been granted…with the other 3 granted for [the] drug candidate LP-184,” said Sharma in the press release. “Acquiring these ODDs is a key element of our business model, as they provide a number of benefits including 7 years of market exclusivity and eligibility for expedited drug development programs. Looking forward, these designations further position [us] to advance our discussions with biopharma companies for partnering and collaborative development opportunities.”

Reference

LanternPharma. FDA Grants Lantern Pharma Orphan Drug Designation for Drug Candidate LP-284 in High-Grade B-cell Lymphomas (HGBL). News release. November 30, 2023. Accessed December 5, 2023. https://ir.lanternpharma.com/news-events/press-releases/detail/143/fda-grants-lantern-pharma-orphan-drug-designation-for-drug

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