http://www.oncoinvent.com/files/Quarterly-Report-Q3-2018.pdf

Two images from the successful in-vivo test of gamma camera imaging of
Radspherin® distribution in the peritoneal cavity of rats

QUARTERLY REPORT – 3rd QUARTER 2018
Highlights
• Successful imaging of Radspherin® in pre-clinical study
• Radspherin® clinical formulation for phase 1 selected
• Oncoinvent hires two new key team members

Operational Review
Work towards moving Radspherin® into clinical trials in Q1 of 2019 continued during the third
quarter of 2018. A key priority for the company was the preparation for the planned inspection of
the Radspherin® production facilities by the Norwegian Medicines Agency in early Q4. The
company also focused efforts on completing work necessary to send in a clinical trial application
(CTA) during Q4.
Successful imaging of Radspherin® in pre-clinical study
The company performed imaging studies in rats using gamma cameras and SPECT CT scanners to
test the feasibility of using these imaging modalities to measure the distribution of Radspherin® in
human peritoneal (abdominal) cavities during the phase 1 clinical trials. Radspherin® particles
were imaged by gamma cameras from 1 up to 96 hours after injection. Results from the imaging
studies indicate the feasibility of using gamma camera images to confirm the distribution of
Radspherin® in the abdominal cavity after administration in patients. Further imaging studies are
being carried out to confirm this finding.
Radspherin® clinical formulation for phase 1 selected
Oncoinvent has selected a formulation for the Radspherin® drug product candidate that will be
used during the upcoming phase 1 clinical trials based on the results of formulation development
studies carried out in 2018 and completed in Q3 of 2018. GMP productions of the Radspherin®
clinical drug product formulation will be carried out during Q4.
Oncoinvent hires two new key team members
The company is pleased to announce that Hans Matthias Hild and Helén Johansen Blanco have
joined the Oncoinvent team during the 3rd quarter of 2018.
Dr. Hans Matthias Hild, Ph.D., has been hired as Head of Production and will be responsible for
ensuring the supply of Radspherin® drug product during the clinical trials. Dr. Hild has over fifteen
years of experience with international pharmaceutical companies including Avecia Biotechnology
and GE Healthcare. He has successfully led large scale-up and technology transfer projects and
has a strong, hands-on background in manufacturing science, GMP/Quality Assurance and
production of radiopharmaceuticals.

Dr. Hild holds a Ph.D. in Biochemical Engineering from the Imperial College of Science, Technology
and Medicine, London, England.
Helén Johansen Blanco has been hired as Head of Clinical Operations and will be responsible for
the Radspherin® clinical trials. Ms. Blanco has eighteen years of international clinical trial
experience ranging from phase 1 to phase 3 registration studies and has worked for major
pharmaceutical companies including Astra Zeneca, Mylan, and Celgene as well as the
internationally recognized clinical research organisation Covance. Ms. Blanco holds an M.Sc. from
NTH in Trondheim.