Oncorena AB
Oncorena AB is a Swedish pharmaceutical company developing a first-in-class synthetic form of orellanine (ONC175) as a targeted, organ-specific therapy for metastatic renal (kidney) cancer. The company has completed preclinical work and initiated a Phase I/II clinical program focused initially on patients with metastatic clear-cell or papillary renal cell carcinoma who are dialysis-dependent. Development activities include preclinical research, CMC and stability testing of a synthetically produced active ingredient, clinical trial execution in collaboration with academic centers and CROs, and regulatory submissions in Europe and the US.
Industries
N/A
Nr. of Employees
small (1-50)
Patents
Products
ONC175 (synthetic orellanine)
An investigational synthetically produced active ingredient based on orellanine, developed as an organ-specific therapy targeting metastatic renal cell carcinoma; intended for intravenous administration.
ONC175 (synthetic orellanine)
An investigational synthetically produced active ingredient based on orellanine, developed as an organ-specific therapy targeting metastatic renal cell carcinoma; intended for intravenous administration.
Services
Sponsor-level planning and operational management of Phase I/II oncology studies, including coordination with clinical sites, dialysis units and CRO partners.
Preparation and submission of regulatory dossiers to national authorities and interaction support (examples include Swedish approvals and a US IND).
Development of synthetic active ingredient production processes, stability testing and planning for scale-up to commercial manufacturing.
Sponsor-level planning and operational management of Phase I/II oncology studies, including coordination with clinical sites, dialysis units and CRO partners.
Preparation and submission of regulatory dossiers to national authorities and interaction support (examples include Swedish approvals and a US IND).
Development of synthetic active ingredient production processes, stability testing and planning for scale-up to commercial manufacturing.
Expertise Areas
- Clinical trial management (Phase I/II oncology)
- Regulatory affairs and IND submissions
- CMC and formulation development
- Preclinical oncology research
Key Technologies
- Synthetic active compound production
- Intravenous infusion drug delivery
- Organ-specific targeting via solute carrier transporters
- Preclinical in vitro and in vivo tumor models
News & Updates
Initiation of the Phase I/II clinical trial of synthetic orellanine in patients with advanced renal cancer on dialysis; study to assess safety, tolerability, pharmacokinetics and signs of anti-tumor activity.
First patient received an infusion of ONC175 in August 2023 as part of the Oncorella‑1 Phase I/II study at Karolinska University Hospital.
US FDA approved an IND enabling initiation of the company’s Phase I/II study in the United States (MD Anderson Cancer Center site planned).
French and Portuguese regulatory authorities granted approvals to expand the Phase I/II clinical study to those countries.
Two abstracts were presented covering the clinical trial rationale/protocol (Oncorella‑1) and preclinical hyper-acute kidney injury data for orellanine.
Company presented clinical development program updates at a life science summit in Lund.
Initiation of the Phase I/II clinical trial of synthetic orellanine in patients with advanced renal cancer on dialysis; study to assess safety, tolerability, pharmacokinetics and signs of anti-tumor activity.
First patient received an infusion of ONC175 in August 2023 as part of the Oncorella‑1 Phase I/II study at Karolinska University Hospital.
US FDA approved an IND enabling initiation of the company’s Phase I/II study in the United States (MD Anderson Cancer Center site planned).
French and Portuguese regulatory authorities granted approvals to expand the Phase I/II clinical study to those countries.
Two abstracts were presented covering the clinical trial rationale/protocol (Oncorella‑1) and preclinical hyper-acute kidney injury data for orellanine.
Company presented clinical development program updates at a life science summit in Lund.