Articles tagged with: Relapsed Multiple Myeloma
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Applications supported by positive results from the Phase 3 APOLLO study, which demonstrated longer progression-free survival in patients receiving the subcutaneous formulation of daratumumab1
RARITAN, N.J., Nov. 12, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of the daratumumab subcutaneous (SC) formulation, known as DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S. and as DARZALEX® SC in the European Union (EU). The applications seek approval of the combination of DARZALEX FASPRO™ / DARZALEX® SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple …
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Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), for OPD5 – a second drug candidate based on the proprietary Peptide Drug Conjugate platform (PDC).
Oncopeptides plans to initiate clinical development of OPD5 with an open-label phase 1, dose escalation study on safety and tolerability of OPD5 as a myeloablative regimen followed by autologous stem cell transplantation in patients with relapsed refractory multiple myeloma. The specific formulation enables administration of high …
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Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has informed the European Medicines Agency, EMA, about its intention to submit an application for a conditional marketing authorization of melflufen (INN melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma (RRMM).
The decision to submit an application for conditional approval has been grounded on an in-depth analysis of the regulatory environment and is endorsed by key opinion leaders in the EU. Previously the Company intended to await …
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With the start of its second clinical trial, NexImmune expands development of its unique non-genetically engineered T cell immunotherapies across a range of hematologic malignancies
Gaithersburg, MD (Press Release) – NexImmune, a clinical-stage biotechnology company developing a portfolio of unique non-genetically-engineered T cell immunotherapies, announced today that it has dosed the first patient in its Phase 1/2 clinical trial for NEXI-002. NEXI-002 is a patient-derived cellular product that contains populations of naturally-occurring CD8+ T cells directed against several multiple myeloma (MM)-specific antigen targets. It is the second clinical product NexImmune has generated with its AIM nanoparticle technology.
“While the primary objective in this trial with NEXI-002 is to demonstrate safety and tolerability, we also hope to see initial …
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Fifth industry collaboration to evaluate nirogacestat as a BCMA potentiator across modalities
Stamford, CT (Press Release) – SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that the company has entered into a clinical trial collaboration agreement with Pfizer Inc. (NYSE: PFE) to evaluate SpringWorks Therapeutics’ investigational gamma secretase inhibitor (GSI), nirogacestat, in combination with Pfizer’s anti-B-cell maturation antigen (BCMA) CD3 bispecific antibody, PF‐06863135, in patients with relapsed or refractory multiple myeloma.
Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of myeloma cells. In preclinical …
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Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) announced today that the open-label Expanded Access Program, sEAPort, for eligible U.S. patients, is formally open. Melflufen (INN melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma. The sEAPort program is available to adults, age 18 and older, who have received at least two prior lines of therapy and whose multiple myeloma is refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody, (i.e., triple-class refractory …
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Wilmington, DE (Press Release) – Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced that the first patient has been dosed in its first-in-human Phase 1 open-label, multicenter, dose-escalation study of PRT1419 in patients with relapsed / refractory hematologic malignancies. PRT1419, the Company’s third clinical candidate, is designed to be an orally available, potent and selective MCL1 inhibitor.
The dose escalation portion of the study will be conducted across two groups, including in patients with relapsed / refractory high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) (Group A), as well as …