Drugs / MP0250
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | non-small cell lung carcinoma | 2019-05-09 | “leading to a partial clinical hold” molecularpartners.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03418532 | Mar 2018 → Aug 2019 | non-small cell lung carcinoma | Molecular Partners AG | Terminated | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03136653 | May 2017 → Oct 2020 | plasma cell myeloma | Molecular Partners AG | Completed | No outcome recorded |
| Phase 1/2 | NCT02194426 | Jul 2014 → Feb 2018 | neoplasm | Molecular Partners AG | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2019-12-27 | Molecular Partners AG | Regulatory Molecular Partners Receives Orphan Drug Designation for MP0250 for Multiple Myeloma molecularpartners.com ↗
Molecular Partners AG (SIX:MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics to treat serious diseases, announces the receipt of Orphan Drug Designation by the US Food and Drug Administration (FDA) for its novel therapeutic, MP0250, for the treatment of Multiple Myeloma. |
| 2019-12-07 | Molecular Partners AG | Results Molecular Partners Presents Updated Results of MP0250 in Patients with Relapsed/Refractory Multiple Myeloma (MM) at American Society of Hematology Annual Meeting molecularpartners.com ↗
Poster highlights Overall Response Rate (ORR) of 45% in heavily pretreated MM population |
| 2019-05-09 | Molecular Partners AG | Regulatory INTERIM STATEMENT BY MANAGEMENT – Q1 2019: Positive MAPLE data for abicipar, promising research data for Molecular Partners’ innovative oncology DARPin® candidates presented; Recruitment hold in MP0250 NSCLC trial; Ongoing focus on multiple myeloma for MP0250 clinical development molecularpartners.com ↗
The company is working with the FDA to lift the hold by examining the relationship between the dose and duration of exposure to MP0250 and risk of renal injury. |
| 2019-02-07 | Molecular Partners AG | Results Molecular Partners reports key financials for FY 2018 and corporate highlights for Q4 2018 molecularpartners.com ↗
Early data from eight patients of the expansion part as per cut-off date of January 31, 2019, support the data observed in the first patient cohort. |
| 2018-06-15 | Molecular Partners AG | Results Molecular Partners presents updated results from its ongoing Phase 2 combination study of its lead oncology drug MP0250 at EHA in Stockholm molecularpartners.com ↗
Five of eight patients (62.5%) with relapsed/refractory multiple myeloma showed an objective response to MP0250 plus VelDex |
| 2018-05-16 | Molecular Partners AG | Results Molecular Partners to present final MP0250 Phase 1 data at ASCO Annual Meeting 2018 molecularpartners.com ↗
MP0250 was well tolerated and about half of the patients stayed on treatment for three months or longer, with the longest treatment duration beyond one year. |
| 2018-04-21 | Molecular Partners AG | Results Molecular Partners presented preliminary results from the ongoing phase 2 study of MP0250 at the European Myeloma Network Meeting in Turin molecularpartners.com ↗
Eight patients were treated with 8 mg/kg of MP0250 and five out of these eight patients showed a documented response: Four patients reached a partial response (PR) and one patient reached a very good partial response (VGPR) at the cut-off date. |
| 2018-01-08 | Molecular Partners AG | Results Molecular Partners reports promising initial safety and efficacy data from its ongoing phase 2 study of MP0250 in multiple myeloma molecularpartners.com ↗
Molecular Partners AG (ticker: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin® therapies*, today announced initial safety and efficacy data from its ongoing phase 2 study of MP0250 in multiple myeloma (MM). |
| 2017-08-30 | Molecular Partners AG | Regulatory Molecular Partners reports key financials and corporate highlights for H1 2017: Pipeline development on track with several key milestones ahead molecularpartners.com ↗
In August 2017, Molecular Partners submitted to the FDA an Investigational New Drug Application (IND) for a phase 1b/2 study of MP0250 in combination with osimertinib (Tagrisso®) in patients with EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) pretreated with osimertinib. |
All press releases naming this drug 16 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MP0250 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03418532 ↗ |
| Action | Inhibit | “MP0250 specifically inhibits both vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) with the aim of disrupting the tumor microenvironment.” PMID 33301375 ↗ Dec 2020 |
| Modality | Protein / enzyme biologic | “A first-in-human study was performed with MP0250, a DARPin drug candidate.” PMID 33301375 ↗ Dec 2020 |
| Route | Intravenous | “Intravenous application by infusion of MP0250” NCT02194426 ↗ |