orellanine (ONC175) / Oncorena - LARVOL DELTA

Oncorena receives FDA approval to initiate studies in the US (PRNewswire) - "Oncorena is pleased to announce that the FDA has approved the Company's IND application to initiate the Phase I/II study Oncorella-1: A Phase 1/2, open label, single arm study on safety, tolerability and anti-tumor efficacy of orellanine treatment in patients with metastatic clear-cell or papillary renal cell carcinoma (NCT05287945, ONC001-CL-001)...In the study Oncorella-1, up to 75 patients with severe metastatic renal cancer requiring dialysis will be enrolled. These patients have exhausted their treatment options and ONC175 represents a potentially new first-in-class treatment for patients with urgent unmet medical need...The study is currently being conducted at Karolinska University Hospital in Stockholm, Sweden."

Trial status • Clear Cell Renal Cell Carcinoma • Papillary Renal Cell Carcinoma

A phase I/II, open label, single arm study on safety, tolerability and anti-tumour effiacy of orellanine treatment in patients with metastatic clear-cell or papillary renal cell carcinoma. (ASCO-GU 2024) - P1/2 | "Enrollment has started and since the occurrence of end stage renal disease in patients with metastatic RCC is uncommon, patients in this first in man study are recruited both from western Europe and north America. The study is performed in the Centre for Clinical Cancer Studies (CKC) at Karolinska University Hospital, Stockholm, Sweden."

Clinical • Metastases • P1/2 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Oncorena treats first renal cancer patient with ONC175 in Phase I/II trial (Clinical Trials Arena) - "Sweden-based Oncorena has successfully treated its first renal cancer patient with ONC175 in a Phase I/II trial. The company announced the milestone one month after the treatment was conducted at the Center for Clinical Cancer Studies at Karolinska University Hospital, Sweden. Oncorena plans to treat additional patients with ONC175 later this year....According to the ClinicalTrials.gov registry, the study completion is expected in August 2025."

Trial completion date • Trial status • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Oncorena's first patient treated with ONC175 (orellanine) in clinical phase I/II trial in patients with metastatic renal cancer and dialysis at Karolinska University Hospital in Stockholm, Sweden (PRNewswire) - "Oncorena announces first patient treated in the Phase I/II trial of the first-in-class compound, ONC175 (orellanine), in patients with metastatic renal cancer and dialysis. The first treatment was conducted on August 8 without any complication at the Center for Clinical Cancer studies at Karolinska University Hospital, Stockholm, Sweden. The study examines safety, tolerability, pharmacokinetics and anti-tumor effect when treated with ONC175."

Trial status • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Evaluation of peritoneal dialysis prescriptions in uremic rats. (PubMed, Perit Dial Int) - "Rats were chemically nephrectomised using orellanine to render them uremic...In conclusion, the PD system described in this study can be used for long-term studies of PD on uremic dialysis-dependent rats mimicking the human setting. To maintain whole body homeostasis of highly uremic rats, intense PD is needed during both day and night."

Journal • Preclinical • Chronic Kidney Disease • Nephrology • Renal Disease • Transplantation

Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Oncorena AB | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2025 ➔ Aug 2025 | Trial primary completion date: Oct 2024 ➔ Feb 2025

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=40 | Not yet recruiting | Sponsor: Oncorena AB | Trial completion date: Jul 2024 ➔ Apr 2025 | Trial primary completion date: Nov 2023 ➔ Oct 2024

Metastases • Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=40 | Not yet recruiting | Sponsor: Oncorena AB | Trial completion date: Feb 2024 ➔ Jul 2024

Trial completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Oncorena Initiates the Phase I-II Clinical Trial with Orellanine in Advanced Kidney Cancer Patients at Karolinska University Hospital in Sweden (PRNewswire) - "Oncorena today announced the initiation of the Phase I-II clinical trial of the first-in-class compound orellanine in patients with advanced kidney cancer on dialysis. The company is dedicated to developing a unique and potential breakthrough therapy for advanced kidney cancer....The Phase I-II clinical study will include up to 40 patients and may include patients from other European countries."

Trial status • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma

Oncorena Secures Financing of the Company’s Continued Development of Orellanine, a Potential Breakthrough Therapy for Advanced Renal Cancer (PRNewswire) - "Oncorena...receives a capital injection of MSEK 66 from one of the company's principal shareholders together with two new investors. Under the terms of the agreement, Oncorena can receive an additional SEK 94 million in the future. The capital will primarily fund Oncorena's first clinical study, a phase I/II study with orellanine in patients with advanced kidney cancer undergoing dialysis. The current shareholder HealthCap has together with the two new investors, Linc AB and Fåhraeus Startup and Growth AB, invested a total of MSEK 66 in new capital to finance the first part of the Oncorena's Phase I/II study. If the first part of the Phase I/II study shows positive results (Proof of Concept), the parties intend to invest an additional sum of MSEK 94 in the second part of the study."

Financing • New P1/2 trial • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Oncorena Receives Approval of First in Patient Trial with Orellanine as a Potential Breakthrough Therapy in Metastatic Renal Cancer Patients (PRNewswire) - "Oncorena...announces the Swedish Medical Products Agency's approval of the Phase 1/2 of First in Patient trial of the first-in-class compound, orellanine in patients with metastatic renal cancer in dialysis. Preclinical evidence shows that orellanine, a well known fungus toxin, specifically exerts powerful anti-tumor effects on metastatic renal cancer in different preclinical models."

Non-US regulatory • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma