PM 8001
Alternative Names: PM-8001Latest Information Update: 11 Oct 2022
At a glance
- Originator Biotheus
- Class Antineoplastics; Bispecific antibodies; Immunotherapies
- Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants; Transforming growth factor beta modulators
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase II Solid tumours
Most Recent Events
- 14 Sep 2022 Biotheus plans a phase I trial for Solid tumours (Late-stage disease, Combination therapy) in Australia in December 2022 (NCT05537051)
- 03 Jun 2022 Efficacy, adverse events, pharmacokinetics and pharmacodynamics data from a phase I/IIa trial in Solid tumors presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022)
- 03 Dec 2021 The US FDA approves IND application for PM 8001 for Solid tumours