10 February 2023

Oncoinvent updates: Phase I dose escalation completed successfully in two indications Phase 2 A inclusion has started

Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, today announced strong progress with clinical trials, including patient recruitment and efficacy signals.  Further updates will be provided in an upcoming investor conference call.

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  • Successful completion of the dose escalation stage of both ongoing Phase 1/2A clinical studies RAD-18-001 (ovarian cancer) and RAD-18-002 (colorectal cancer); Radspherin® has demonstrated attractive biodistribution, favorable tolerability and potential signals of efficacy.
  • Ovarian cancer study includes new centers in Spain that have already treated their first patients with Radspherin.
  • The 12 Patients that received the recommended clinical dose of 7 MBq in the RAD-18-002 study remain disease free in the peritoneal cavity at the 12-months read out time point.
  • 15-month and 18-month progression free survival data from RAD-18-002 to be published later this year
  • Company to host investor conference call on February 17 at 9:00 CET

“We are pleased with the progress of our Radspherin® clinical studies, particularly with the progression of the RAD-18-002 study where we are now beginning to see potential signs of efficacy. Peritoneal carcinomatosis is an area of high unmet medical need, and we continue to believe in the potential of Radspherin® as an adjuvant therapy to cytoreductive surgery in metastatic colorectal cancer patients suffering from peritoneal carcinomatosis” said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. “The initial efficacy data along with the preliminary safety results published at ASCO last year, which showed that all dose levels were well tolerated without any dose limiting toxicity, are quite encouraging.  We are looking forward to the completion of the RAD-18-002 phase 1/2A study and to the progression free survival data at 15-months and 18-months from the study.”

The company intends to publish 15-month and 18-month  progression free survival data in the same group of patients at conferences later this year The company will also provide an update of the RAD-18-001 clinical study in ovarian cancer patients suffering from peritoneal carcinomatosis and plans for the further clinical development of Radspherin® during the conference call.

 

About RAD-18-001

The phase 1/2A open-label clinical trial is designed to assess the dose, safety and tolerability of Radspherin®, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from ovarian cancer following complete cytoreductive surgery. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.

 About RAD-18-002

The phase 1/2A open-label clinical trial is designed to assess the dose, safety and tolerability of Radspherin®, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from colorectal cancer following complete cytoreductive surgery and HIPEC. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.

About Radspherin®

Radspherin® is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin® has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially be used to treat several forms of metastatic cancer.

 About Oncoinvent

Oncoinvent AS is a clinical stage company developing innovative radiopharmaceutical technology that delivers precise, alpha-emitting particles across various cancers. By leveraging internal manufacturing and supply chain capabilities to enable a clinical supply of radioisotopes, the company is advancing therapy based on alpha particles, a higher Linear Energy Transfer (LET) form of radiation, that can potentially eradicate cancer cells. Oncoinvent’s lead candidate, Radspherin®, is designed for treatment of metastatic cancers in body cavities, and its versatility allows it to be deployed for the treatment of a variety of cancer indications. Radspherin® is in two ongoing clinical studies to treat peritoneal carcinomatosis from both ovarian cancer and colorectal cancer.

For further information, please contact:
Jan A. Alfheim, CEO
Cell: +47 46 44 00 45
Email: alfheim@oncoinvent.com

 

IR enquiries:

Courtney Turiano, Stern Investor Relations
Email: Courtney.Turiano@sternir.com

 

Øystein Soug

Chief Executive Officer

soug@oncoinvent.com

Oystein Soug has over 15 years of experience in biotechnology, holding several management positions. Most recently, Mr. Soug was CEO of Arxx Therapeutics, where he led the company to initiate the clinical programme and was responsible for the merger with Dutch pharma company Oxitope Pharma to create Calluna Pharma. Prior to Arxx, he served as CFO and then CEO of Targovax, an Oslo listed biotechnology company, which went public during Mr. Soug’s tenure. Mr. Soug started his career in biotech as CFO of Oslo-listed radiopharmaceutical company Algeta. During this period, the company conducted a successful phase 3 trial, launched its radium-223 based prostate cancer drug Xofigo® and out-licensed the drug. Mr. Soug co-led the sale of the company to Bayer in 2014.  

Mr. Soug holds an MSc in Economics and Financial Markets from Universität St. Gallen in Switzerland in 1997

Anders Månsson

Chief Executive Officer

mansson@oncoinvent.com

Anders Månsson is a business executive with over 25 years of experience from management roles in the pharmaceutical industry, focusing on commercialisation and M&A + licensing. Mr. Månsson has held leading roles in the industry both in his native Sweden and in other European countries, and he has worked extensively with the USA and Asia as focus markets in global roles.

Mr. Månsson holds a B.Sc. degree in Business & Economics from Lund’s University in Sweden as well as an MBA from Business School Lausanne in Switzerland. He has a broad-based industrial experience, featuring both large multinational companies such as Meda, Ferring & LEO Pharma, and including leading roles in start-ups and smaller biotech companies. On top of his executive role in Oncoinvent, Mr. Månsson holds two non-executive director positions serving on the board of EQL Pharma AB as well Immetric AB, the latter being an investment company focusing on life science.