Immix Biopharma Awarded European Union Orphan Drug Designation for NXC-201 in Multiple Myeloma
Orphan DrugCell TherapyClinical StudyImmunotherapyIND
European Orphan Drug Designation (“ODD”) qualifies NXC-201 for:
10 years of market exclusivity once authorized in the EU
Access to the EU centralized authorization procedure
Reduced fees for: EU protocol assistance, marketing authorization applications, inspections before authorization, applications for changes to marketing authorizations made after approval, and reduced annual fees
April 29, 2024 -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of multiple myeloma.
“Frail patients, heavily represented in our NEXICART-1 clinical trial, remain an area of unmet medical need and are a significant portion of the relapsed/refractory multiple myeloma population,” said Ilya Rachman, MD PhD, Chief Executive Officer, Immix Biopharma. “We believe EU orphan drug designation for NXC-201 affirms the potential clinical impact of NXC-201 in this sizable population.”
Gabriel Morris, Chief Financial Officer, Immix Biopharma added, “We believe NXC-201’s observed favorable tolerability profile and ‘Single Day CRS’ across a robust clinical dataset could enable an attractive option for frail relapsed/refractory multiple myeloma patients in addition to our lead indication, relapsed/refractory AL Amyloidosis, and our active NXC-201 expansion into other autoimmune diseases.”
According to Davis et al., 2023 Transplantation and Cellular Therapy, commercial CAR-Ts produced 6.9 months median progression free survival in frail relapsed/refractory multiple myeloma patients in a real-world setting. 61% of patients in the dataset were considered frail.
Orphan drug designation in the European Union (EU) is granted by the EC based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products. To qualify for orphan drug designation, a candidate therapy must be intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease that occurs in not more than five in 10,000 people in the EU. The designation provides regulatory, financial and commercial incentives to develop therapies for rare diseases where there are either no satisfactory treatment options or significant benefit to those affected by the disease.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases. Our lead cell therapy is FDA IND cleared next generation CAR-T NXC-201, currently being evaluated in our ongoing Phase 1b/2 NEXICART-1 (NCT04720313) clinical trial, initiated in February 2021. NXC-201 has the potential to be the world’s first “Single-Day CRS” CAR-T (CRS median onset day 1, median duration 1 day), enabling the potential for a faster return home for patients and supporting ongoing expansion into autoimmune indications. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma, and ODD by the European Commission (EMA) in AL Amyloidosis. Learn more at www.immixbio.com and www.BeProactiveInAL.com.
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