Oncopeptides AB (publ) was formed in 2000 to develop anti-cancer drugs based on research by some of Sweden’s leading cancer researchers and cancer research institutions. Development of melflufen The development of melflufen, stems from work originally undertaken by Dr Joachim Gullbo at Uppsala University, Sweden, on a molecule initially known as ‘J1’.

Oncopeptides lämnar in ansökan om villkorat marknadsgodkännande för melflufen i EU. fre, apr 16, 2021 08:00 CET. STOCKHOLM — 16 april 2021

The most common adverse reactions include fatigue, nausea, diarrhea, pyrexia and respiratory tract infection. Melphalan flufenamide is a peptidase enhanced cytotoxic (PEnC) that exerts a targeted delivery of melphalan in cells with high expression of aminopeptidases, such as 2020-11-04 For more information on melflufen contact the Medical Information department directly by phone at 1-866-522-8894 or by email at medinfo@oncopeptides.com. Melflufen is an investigational agent and not currently approved by the US FDA. 1 US National Institutes of Health. Oncopeptides AB (publ) (Nasdaq Stockholm: (FDA) has approved PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen, in combination with dexamethasone, About Oncopeptides Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases.

{{ chapter.num }}. {{ chapter.name }} 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. Melflufen is the lead candidate coming out of the Oncopeptides' proprietary PDC-platform. 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.

Oncopeptides AB: FDA beviljar en prioriterad granskning av melflufen för patienter med trippelklassrefraktärt multipelt myelom. 29 augusti 2020

As an R&D stage pharmaceutical company focused on developing drugs for the treatment of cancer, Oncopeptides has developed a product called Melflufen for the treatment of MM. As a lipophilic peptide conjugated alkylator, Melflufen rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. STOCKHOLM — May 14, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announces today that data from the pivotal phase 2 study HORIZON, and additional clinical and preclinical data that further evaluate the therapeutic peptide-drug conjugate platform, have been accepted by the European Hematology Association (EHA). The abstracts are now published online.

Safety and efficacy of melflufen and dexamethasone in relapsed and/or relapsed-refractory multiple myeloma patients. ClinicalTrials.gov Identifier: NCT01897714. Updated August 24, 2020.

00:30 Oncopeptides vd Jakob Lindberg01:42 Börsvärden för utvalda bolag inom multipelt myelom07:32 Horizon-studien i fas 2 och vägen till ett marknadsgodkänna 2 dagar sedan · "Following Oncopeptides´ launch in the US, we are broadening our geographical footprint and submitting an application for conditional marketing authorization of melflufen in Europe ahead of 2. Titel: Melflufen efficacy in multiple myeloma cell lines with TP53 aberrations. Presentatör: Ana Slipicevic, Oncopeptides AB, Stockholm. Melflufen kan orsaka myelomcellers död oavsett cellernas TP53-status och övervinna p53-brist-medierad melphalan-resistens. Svarsfrekvensen för melflufen i patientpopulationen med 17p-deletion från fas Safety and efficacy of melflufen and dexamethasone in relapsed and/or relapsed-refractory multiple myeloma patients. ClinicalTrials.gov Identifier: NCT01897714.

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. Melphalan flufenamide is a peptidase enhanced cytotoxic (PEnC) that exerts a targeted delivery of melphalan in cells with high expression of aminopeptidases, such as aminopeptidase N, which has been described as over-expressed in human malignancies.
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Updated August 24, 2020. Accessed October 19, 2020. 2020-10-01 2 days ago Melflufen is the first drug candidate coming out of the company´s proprietary Peptide Drug Conjugate platform, PDC. Oncopeptides has recently submitted an Investigational New Drug application for its second drug candidate from this technology platform, OPD5.

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.
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It is an important milestone for Oncopeptides, and a major step in making melflufen available for patients with multiple myeloma, who desperately need new treatment options,” says Marty J Duvall, CEO of Oncopeptides.

Stockholms län, SverigeFler än 500 kontakter. FDA ger godkännande till Oncopeptides och melflufen. (Direkt) Läkemedelsbolaget Oncopeptides har fått ett villkorat godkännande av den STOCKHOLM - 4 november 2020 - Oncopeptides AB (publ) (Nasdaq Oncopeptides AB: Oncopeptides meddelar att nya data för melflufen Bolagets främsta produktkandidat är Ygalo, med den aktiva substansen melflufen.

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2020-06-17

Conference call for investors, analysts and the media, Monday, January 27th 2020, at 11 (CET) Oncopeptides Announces New Clinical and Preclinical Melflufen Data at the Upcoming European Hematology Association Meeting PRESS RELEASE PR Newswire May. 14, 2020, 03:13 PM About Oncopeptides 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 peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. Oncopeptides has one U.S. FDA approved product, PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen. 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.

2020-11-04

About Oncopeptides Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The lead product candidate melflufen, is a first in class peptide-drug conjugate that targets aminopeptidases and releases alkylating agents into … 2020-04-06 2020-09-04 Oncopeptides Announces New Clinical and Preclinical Melflufen Data at the Upcoming European Hematology Association Meeting PRESS RELEASE PR Newswire May. 14, 2020, 03:13 PM Melphalan flufenamide, sold under the brand name Pepaxto, is an anticancer medication used to treat multiple myeloma.. The most common adverse reactions include fatigue, nausea, diarrhea, pyrexia and respiratory tract infection. Melphalan flufenamide is a peptidase enhanced cytotoxic (PEnC) that exerts a targeted delivery of melphalan in cells with high expression of aminopeptidases, such as 2020-11-04 For more information on melflufen contact the Medical Information department directly by phone at 1-866-522-8894 or by email at medinfo@oncopeptides.com. Melflufen is an investigational agent and not currently approved by the US FDA. 1 US National Institutes of Health. Oncopeptides AB (publ) (Nasdaq Stockholm: (FDA) has approved PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen, in combination with dexamethasone, About Oncopeptides Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases.

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. Oncopeptides will host a webcaston Monday, January 27th 2020 were CEO Jakob Lindberg will present and explain melflufen’s mechanism of action.