Ladenburg - Heidelberg Pharma AG (FWB: HPHA), a clinical developer of innovative antibody-drug conjugates (ADCs), announced today that it has received approval from the American Food and Drug Administration (FDA).

Orphan Drug Designation (ODD) for its lead candidate HDP-101 for the treatment of multiple myeloma. Heidelberg Pharma is investigating the candidate in a Phase I/IIa clinical trial for the treatment of relapsed and refractory multiple myeloma (RRMM).

HDP-101 is an antibody-drug conjugate (ADC) composed of an anti-BCMA antibody, a linker and the toxin amanitin. BCMA (B-cell maturation antigen) is a surface protein that is highly expressed in multiple myeloma and to which the BCMA antibody binds specifically.

Prof. Dr. Andreas Pahl, Spokesman of the Executive Board of Heidelberg Pharma, commented: 'We are very pleased that our ATAC candidate HDP-101 has received orphan drug designation from the FDA, further confirming its potential benefit as a therapeutic agent for patients with multiple myeloma becomes. This indication represents a major unmet medical need for which new, more effective therapies are urgently needed. Additionally, orphan drug designation provides us with a number of important benefits, including potential seven years of market exclusivity if HDP-101 is approved by the FDA.'

Orphan drug designation is granted to a drug or biological product intended for the prevention, diagnosis or treatment of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation provides significant incentives to encourage development of the drug, including tax credits for qualified clinical trials, exemptions from prescription drug fees, and potential seven years of market exclusivity following FDA approval.

The Heidelberg Pharma team will present early safety and preliminary efficacy data at the upcoming American Association for Cancer Research (AACR) Annual Meeting, April 5-10, 2024, in San Diego, California.

HDP-101 is an investigational drug that has not yet been approved by any regulatory authority, including the FDA. The safety and effectiveness of this investigational drug is currently being evaluated and has not yet been proven.

Contact:

Tel: +49 6203 1009-0

Email:info@hdpharma.com

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