Oncopeptides announces 26% Overall Response Rate of melflufen in triple-class refractory multiple myeloma patients from the pivotal HORIZON study Regulatory
March 26, 2020
STOCKHOLM — March 26, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announces today the final topline results from the pivotal phase 2 HORIZON study evaluating melflufen in relapsed refractory multiple myeloma (RRMM) patients. These results will form the basis for the upcoming NDA for accelerated approval in the US. The application is on track for a submission to the FDA at the end of Q2 2020. Oncopeptides will host a webcast today to provide an update on the final study results at 14.00 (CET)
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The Lancet Haematology Publishes Results from Oncopeptides’ Multicenter, International Phase 1/2 Study (O-12-M1)
March 23, 2020
Stockholm — March 24, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announced today the publication of results from its O-12-M1 study, melflufen plus dexamethasone in relapsed/refractory multiple myeloma (RRMM), a multicenter, international, open-label, phase 1/2 study in The Lancet Haematology (http://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(20)30044-2/fulltext). Melflufen is a first-in-class anti-cancer peptide-drug conjugate currently in development by Oncopeptides with activity in a variety of cancers. Current clinical development is focused on the treatment of RRMM
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Oncopeptides provides update regarding COVID-19 impact on the melflufen clinical program Regulatory
March 20, 2020
STOCKHOLM — March 20, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announced today measures the company is taking in response to the global spread of the novel coronavirus (COVID-19) pandemic. Most importantly, the pivotal phase 2 HORIZON study will not be affected and FDA submission plans are on track for a filing late Q2. The phase 3 OCEAN study with 423 out of 450 planned patients enrolled will remain open for patient enrolment. Topline results are expected to be only slightly delayed. Recruitment for other ongoing clinical studies will be put on temporary pause for patient safety reasons, including the phase 2 ANCHOR and BRIDGE studies and the recently started AL Amyloidosis study. The initiation of new studies including LIGHTHOUSE is expected to be delayed. Treatment will continue for all patients currently enrolled in clinical studies
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Oncopeptides strengthens its organization by appointing Karolina Vilval as General Counsel
March 2, 2020
STOCKHOLM — March 2, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announced today that Karolina Vilval has been appointed as General Counsel of Oncopeptides. Karolina has 15 years of experience from different positions at Swedish Orphan Biovitrum. Prior to joining Oncopeptides, she served as Associate Legal Director at Gilead Sciences Sweden AB for business area Oncology, HIV and Inflammation. She will be a member Oncopeptides’ Management Team and will start today
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INTERIM REPORT Q4 2019 Regulatory
February 20, 2020
Summary Financial overview October 1 – December 31, 2019 Net sales amounted to SEK 0.0 M (0.0) Loss for the period was SEK 244,9 M (loss: 112.0) Loss per share, before and after dilution, was SEK 4.42 (loss: 2.54) On December 31 cash and cash equivalents amounted to SEK 926.2 M (375.6)
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Oncopeptides will host a webcast on Monday, January 27[th] at 11.00 (CET)
January 24, 2020
STOCKHOLM — January 24, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announces today that it will host a webcast at 11am (CET) on Monday, January 27[th] 2020 where CEO Jakob Lindberg will present and explain melflufen’s mechanism of action
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Oncopeptides strengthens its regulatory function by appointing Karin Eklund Vanderpol as Head of Regulatory Affairs
January 7, 2020
STOCKHOLM — January 7, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announced today that Karin Eklund Vanderpol has been appointed as head of regulatory affairs of Oncopeptides. Karin has 20 years of experience from senior positions in regulatory affairs. Prior to joining Oncopeptides, she served as Global Regulatory Director at Swedish Orphan Biovitrum. She will be a member Oncopeptides’ Management Team and will start today. Elisabeth Augustsson, who has been responsible for Oncopeptides’ regulatory function since 2015 will continue in a senior role in the regulatory team
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Bulletin from the Extraordinary General Meeting in Oncopeptides AB (publ) Regulatory
December 17, 2019
Stockholm, Sweden – 17 December 2019 – An Extraordinary General Meeting in Oncopeptides AB (publ) (ONCO) was held today, at Tändstickspalatset in Stockholm. At the Extraordinary General Meeting, the following principal resolutions were passed
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Oncopeptides presents promising data from the Phase 2 ANCHOR combination study in patients with RRMM at ASH Annual Meeting 2019 Regulatory
December 8, 2019
STOCKHOLM — December 8, 2019 — Oncopeptides AB (Nasdaq Stockholm: ONCO) will today present updated data from the ongoing Phase 2 ANCHOR (OP-104) triple combination study at the ASH Annual Meeting 2019. In the data presented, melflufen and dexamethasone demonstrated positive efficacy in combination with daratumumab or bortezomib in patients with relapsed/refractory multiple myeloma (RRMM). Preclinical data supporting clinical development of melflufen in AL amyloidosis will also be presented for the first time
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Oncopeptides presents updated efficacy and safety data from pivotal Phase 2 HORIZON study in patients with RRMM at ASH Annual Meeting 2019 Regulatory
December 7, 2019
STOCKHOLM — December 7, 2019 — Oncopeptides AB (Nasdaq Stockholm: ONCO) will today present follow-up data from the pivotal Phase 2 HORIZON (OP-106) study at the ASH Annual Meeting 2019. Melflufen showed an overall response rate (ORR) of 29% and clinical benefit rate (CBR) of 37% in patients with late-stage relapsed/refractory multiple myeloma (RRMM). The safety profile remained consistent with prior reports from the HORIZON study. These data reinforce Oncopeptides’ view that melflufen can play a role in the treatment of patients with RRMM and the Company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2020
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