Drugs / MP0317
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05098405 | Oct 2021 → Jan 2024 | cancer | Molecular Partners AG | Terminated | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07036380 | Dec 2025 → Nov 2028 expected | biliary tract cancer | Centre Hospitalier Universitaire de Besancon | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-05-01 | Molecular Partners AG | Results Molecular Partners publishes Phase 1 MP0317 data in Nature Cancer demonstrating tumor-localized CD40 activation and tumor microenvironment remodeling molecularpartners.com ↗
The comprehensive biomarker data confirm proof-of-mechanism for MP0317, including tumor-localized activation of the CD40 pathway and evidence of TME remodeling in patients with advanced solid tumors. |
| 2024-11-07 | Molecular Partners AG | Results Molecular Partners Presents Preclinical Proof-of-Concept for CD3 Switch-DARPin T Cell Engager, Clinical Biomarker Analyses for MP0317 at SITC 2024 molecularpartners.com ↗
Comprehensive biomarker analyses from a Phase 1 study reveals marked tumor microenvironment modulation in patients with advanced solid tumors treated with MP0317, a FAP-localized CD40 agonistic DARPin |
| 2024-10-04 | Molecular Partners AG | Results Molecular Partners Announces upcoming poster presentations at the 2024 SITC Annual Meeting molecularpartners.com ↗
Biomarker data on completed phase 1 study of MP0317 (FAP x CD40) shows intended and marked tumor microenvironment modulation |
| 2024-06-01 | Molecular Partners AG | Results Molecular Partners Presents Positive Data From Completed Phase 1 Trial Of MP0317 (FAP X CD40 DARPin) Monotherapy In Patients With Advanced Solid Tumors At ASCO 2024 molecularpartners.com ↗
Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company pioneering the design and development of a new class of custom-built protein drugs known as DARPin therapeutics, today announced it had presented the final data from its Phase 1 dose-escalation study of MP0317 at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024, held in Chicago, IL, USA. |
| 2023-11-03 | Molecular Partners AG | Results Molecular Partners Presents Updated Positive Data from Ongoing Phase 1 Trial of MP0317 (FAP X CD40) Monotherapy in Patients with Advanced Solid Tumors at the 2023 SITC Annual Meeting molecularpartners.com ↗
The encouraging results presented at SITC provide clinical evidence of MP0317-induced, tumor-targeted CD40 activation. |
| 2023-05-25 | Molecular Partners AG | Results Molecular Partners to Present Positive Data from Ongoing Phase 1 Trial of MP0317 (FAP X CD40) Monotherapy in Patients with Advanced Solid Tumors at the 2023 ASCO Annual Meeting molecularpartners.com ↗
The data demonstrate that MP0317 shows evidence of tumor-localized CD40 activation (analyses in paired tumor biopsies). |
| 2022-11-10 | Molecular Partners AG | Results Molecular Partners Presents Positive Interim Safety and Mechanistic Data From Ongoing Phase 1 Trial of MP0317 for Treatment of Solid Tumors molecularpartners.com ↗ |
| 2022-03-24 | Molecular Partners AG | Results Molecular Partners Announces Publication of Preclinical Data from CD40 Therapeutic Candidate MP0317 in Cancer Immunology Research molecularpartners.com ↗
The published study confirms that MP0317 is inducing FAP-dependent CD40-mediated B and myeloid cell activation, thus supporting the candidate intended mechanism of action of tumor-localized immune activation without the systemic toxicity observed with other CD40-targeting agents. |
| 2021-04-10 | Molecular Partners AG | Results Molecular Partners Shares New Preclinical Data from its AML-Focused CD3 T-Cell Engager Program, CD40 Product Candidate MP0317, and Other Novel Immuno-oncology Approaches at AACR molecularpartners.com ↗
New data show that the FAP x CD40 product candidate, MP0317, led to a localized macrophage repolarization and reversion of T-cell suppression. |
| 2021-03-10 | Molecular Partners AG | Results Molecular Partners to Present Data from Localized Immune Agonist (MP0317), T-cell Engager, and Peptide-MHC Immunotherapy Programs at AACR Annual Meeting molecularpartners.com ↗
MP0317, a FAPxCD40 targeting multi-specific DARPin® therapeutic, drives immune activation and leads to macrophage repolarization in vitro and ex vivo |
| 2020-09-24 | Molecular Partners AG | Results Molecular Partners Presents Preclinical Data Supporting Tumor Localization Mechanism of its CD40 Agonist MP0317 at World Bispecific Summit molecularpartners.com ↗
Data presented demonstrate that a mouse surrogate MP0317 molecule induces FAP-dependent activation of B cells, dendritic cells and macrophages. |
| 2020-05-15 | Molecular Partners AG | Results Molecular Partners to Present Preclinical Data from MP0317, AMG 506 / MP0310 and Peptide-MHC Programs at AACR Annual Meeting molecularpartners.com ↗
Data to be presented on MP0317 (FAP x CD40) include in vitro and in vivo experiments which show that MP0317 displays significant tumor-localized immune activation without systemic toxicity seen with anti-CD40 antibody administration. |
All press releases naming this drug 16 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MP0317 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05098405 ↗ |
| Action | Activate | “α-FAPxCD40 activation of CD40 depends on binding to fibroblast activation protein (FAP)” PMID 35319751 ↗ May 2022 |
| Modality | Protein / enzyme biologic | “MP0317 (FAP x CD40 DARPin)” PMID 42067655 ↗ May 2026 |
| Route | Intravenous | “Study treatment will be administered as an intravenous (IV) infusion” NCT05098405 ↗ |
| Target | CD40 | “a DARPin® drug candidate targeting fibroblast activation protein (FAP) and CD40.” NCT05098405 ↗ |
| Target | FAP | “a DARPin® drug candidate targeting fibroblast activation protein (FAP) and CD40.” NCT05098405 ↗ |