Groundbreaking Milestone: Oncorena Administers First Dose of ONC175 (orellanine) in Clinical Trial for Metastatic Renal Cancer and Dialysis Patients at Karolinska University Hospital in Stockholm, Sweden

LUND, Sweden, Sept. 4, 2023 /PRNewswire/ — Oncorena, the vanguard of medical innovation, is thrilled to announce a remarkable milestone—the first patient has received treatment in our Phase I/II trial featuring ONC175 (orellanine). This groundbreaking trial is aimed at patients grappling with the dual challenge of metastatic renal cancer and dialysis, and the inaugural treatment took place on August 8 without a hitch. The stage is set at the prestigious Center for Clinical Cancer Studies within Karolinska University Hospital in Stockholm, Sweden.

The ambitious study delves into the realms of safety, tolerability, pharmacokinetics, and the potential anti-tumor prowess of ONC175. As we navigate this uncharted territory, the ultimate goal is to provide more effective therapies for patients who urgently need them.

Börje Haraldsson, the visionary CEO and CSO at Oncorena AB, shared his elation, stating, “I am thrilled to announce the commencement of our clinical phase I/II trial, Oncorella-1, featuring ONC175 (orellanine). This marks a monumental moment for Oncorena as we accelerate our development plan to cater to the pressing needs of these patients.”

The Oncorella-1 clinical study unfolds against the backdrop of the Center for Clinical Cancer Studies at Karolinska University Hospital, a hub where patients also receive hemodialysis. Given that the study cohort relies on dialysis, the hospital is uniquely equipped to provide the necessary care.

The first patient was administered ONC175 via a 30-minute infusion, and preparations are already underway to treat additional patients in the upcoming autumn season. Each patient’s progress will be meticulously monitored, with an independent Data Review Committee guiding potential dose escalations based on their findings.

ONC175, our groundbreaking drug candidate, operates with a unique mode of action. It holds the promise of becoming a potential lifeline for patients battling metastatic renal cancer while grappling with dialysis-dependent renal failure. Early preclinical studies have offered tantalizing glimpses of ONC175’s potential, demonstrating its highly selective organ-targeted chemotherapy with potent anti-tumor effects on metastatic renal cancer.

Dr. Jeffrey Yachnin, the stalwart driving this study at the Center for Clinical Cancer Studies, Karolinska University Hospital, shared his excitement, stating, “We are embarking on a journey with a truly exceptional and groundbreaking medicine, offering hope to patients grappling with advanced kidney cancer. We eagerly await the results of this crucial study.”

Please note that this press release pertains to a drug candidate under development. It does not seek to make any premature claims about its effectiveness or safety. The purpose of clinical trials is to objectively evaluate the safety, tolerability, and efficacy of drug candidates. While there are no guarantees, our dedicated team remains committed to advancing the development program and seeking approval from relevant authorities.

About ONC175

In the relentless battle against metastatic renal cancer, ONC175 emerges as a beacon of hope, armed with an entirely novel mode of action. This groundbreaking therapeutic, meticulously crafted for organ-specific chemotherapy, carries the promise of a potential cure for patients facing this formidable adversary.

At its core, ONC175 is a synthetically produced marvel, with orellanine as its active component. Orellanine, a compound naturally occurring in mushrooms of the Cortinarius family, carries a remarkable story of accidental ingestion. These mushrooms, often mistaken for funnel chanterelles, have unwittingly led some to taste their deadly secret. Orellanine’s clinical effects are as distinctive as they are devastating, with a singular penchant for targeting the kidneys.

ONC175 represents a ray of hope for patients battling the two most prevalent forms of renal cancer—the clear cell and papillary types, which together account for approximately 90 percent of cases. As we stand on the cusp of a new era in cancer treatment, ONC175 holds the promise of rewriting the narrative for those who need it most.

About the Phase I/II clinical trial

Welcome to Oncorella-1, the Phase I/II clinical trial of ONC175 (orellanine), where hope meets innovation. This trailblazing study is dedicated to patients battling metastatic renal cancer while relying on dialysis due to renal failure. Located at the prestigious Centre for Clinical Cancer Studies within the Karolinska University Hospital in Stockholm, Sweden, this trial goes beyond the ordinary.

Oncorella-1 is not your average clinical study—it’s a quest for answers. It delves into the realms of safety, tolerability, pharmacokinetics, and the tantalizing potential of ONC175 to combat tumors. We’re not just aiming to treat; we’re seeking to transform lives.

With a target of enrolling up to 40 patients, this Phase I/II trial isn’t confined by borders. It’s a global effort, one that may extend its reach to patients beyond Sweden’s borders. As we embark on this journey, the possibilities are as vast as the hope we carry in our hearts.

About kidney cancer

In a world where nearly 400,000 souls grapple with the harsh reality of kidney cancer, the World Health Organization (WHO) sounds the alarm. This silent predator can often be vanquished with early detection and surgical heroics, but its sinister metastatic form casts a long, daunting shadow. Today, our arsenal against this adversary is brimming with targeted therapies and immune-boosting elixirs, yet the elusive cure remains out of reach. It’s a desperate plea that reverberates across borders—an urgent cry for new, potent, and safe weapons in this battle for life.

About Oncorena

Nestled in the vibrant city of Lund, Sweden, Oncorena AB stands as a beacon of hope in the realm of pharmaceutical innovation. Our mission is crystal clear: to forge a groundbreaking treatment path for those battling metastatic renal cancer, one that holds the promise of changing lives forever.

Behind this noble endeavor lies the vision of Professor Börje Haraldsson, a luminary at the University of Gothenburg, Sweden. His pioneering research has illuminated the path we now tread—a path laden with hope and potential.

The journey began with the unwavering support of Vinnova, Sweden’s Innovation Agency, and the guiding hand of GU Ventures at the University of Gothenburg, with additional support from compassionate business angels who believed in our cause.

Today, our mission continues to thrive, fueled by the unwavering backing of esteemed investment firms like HealthCap, Linc AB, Fåhraeus Startup and Growth AB, and the trailblazing biotech entity, AQILION AB.

At Oncorena, we are not just developing treatments; we are sculpting the future of cancer care, one patient at a time.

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