Oncopeptides kommer att ansöka om villkorat - Stockaboo
FDA GER VILLKORAT GODKÄNNANDE TILL MELFLUFEN
The product is a first-in-class aminopeptidase-targeting peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to deliver an entrapped hydrophilic alkylator payload. STOCKHOLM — April 16, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the Company has submitted an application to the European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based on the (1) Oncopeptides soon will seek conditional approval of melflufen (melphalan flufenamide) in the EU for the treatment of relapsed or refractory multiple myeloma. The development of melflufen, stems from work originally undertaken by Dr Joachim Gullbo at Uppsala University, Sweden, on a molecule initially known as ‘J1’. Backed by funding from a leading venture capital firm, Industrifonden, and the Karolinska Institute, Oncopeptides embarked on a pre-clinical development journey.
The U.S. FDA has granted priority review for Oncopeptides´ New Drug Application seeking accelerated approval of melflufen in combination with dexamethasone for treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody, i.e., triple-class refractory multiple myeloma patients. Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The company is focusing on the development of the lead product candidate melflufen, a first-in-class anti-cancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. About Oncopeptides Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases.
Om Oncopeptides Oncopeptides är ett läkemedelsföretag med inriktning på utveckling av riktade terapier för svårbehandlade hematologiska sjukdomar.
v. 45 Oncopeptides vd om hur melflufen kan nå USA
The company is focusing on the development of the lead product candidate melflufen, a first-in-class peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. Oncopeptides är ett läkemedelsföretag som utvecklar riktade terapier för svårbehandlade hematologiska sjukdomar. Den ledande produktkandidaten melflufen är först i en ny klass av peptidlänkade läkemedel som riktas mot aminopeptidaser och frisätter alkylerande cellgifter inne i tumörceller.
Oncopeptides presenterar nya data från fas 1/2-studien ANCHOR
PEPAXTO is approved for patients with triple-class refractory Melphalan flufenamide is an investigational drug. Its safety and efficacy have not been established and it has not been approved by any regulatory authority. Oncopeptides, maker of PEPAXTO expects to have the intravenous drug to be available to physicians and patients within two weeks. Melflufen is the very first anti-cancer peptide-drug conjugate to be approved by the FDA, representing a new way to tackle multiple myeloma and cancer in general.
The lead product candidate melflufen, is a first in class peptide-drug conjugate that targets aminopeptidases and releases alkylating agents into tumor cells.
Metall konst
29 augusti 2020 Företaget grundades 2000 och har sitt säte i Stockholm. Oncopeptides har utvecklat melflufen, det första peptidaspotentierade cytostatikat mot multipelt myelom.
Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases.
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First-in-human, phase I/IIa clinical study of the peptidase
Oncopeptides. Accessed October 19, 2020. https://oncopeptides.se/en/section/our-clinical-trials/ 2. Safety and efficacy of melflufen and dexamethasone in relapsed and/or relapsed-refractory multiple myeloma patients. ClinicalTrials.gov Identifier: NCT01897714. Updated August 24, 2020. Accessed October 19, 2020.