Heidelberg Pharma gains FDA ODD for ATAC candidate
Betsy Goodfellow | March 27, 2024 | News story | Research and Development | FDA, Oncology, heidelberg pharma, multiple myeloma
Heidelberg Pharma has announced that it has gained Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for HDP-101 for the treatment of multiple myeloma.
The candidate is currently being investigated in a phase 1/2a clinical trial for the treatment of relapsed and refractory multiple myeloma (RRMM).
HDP-101 is an antibody-drug conjugate (ADC), comprising an anti B-cell maturation antigen (BCMA) antibody, a linker and the toxin amanitin.
Heidelberg Pharma are expected to present early safety and preliminary efficacy data at an upcoming annual meeting of the American Association for Cancer Research (AACR), taking place from 5-10 April 2024 in San Diego, California, US.
Professor Dr Andreas Pahl, spokesman of the executive board of Heidelberg Pharma, commented: “We are very pleased that our ATAC candidate HDP-101 has received ODD designation from the FDA, further confirming its potential benefit as a therapeutic agent for patients with multiple myeloma. This indication represents a major unmet medical need for which new, more effective therapies are urgently needed. In addition, ODD provides us with a number of important benefits, including potential seven-year market exclusivity if HDP-101 is approved by the FDA.”
Betsy Goodfellow
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