Oncoinvent - Q3 - det går fremover


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.

Google translate:

To bilder fra den vellykkede in vivo-testen av gammakameraavbildning av
Radspherin®-fordeling i rotens peritoneale hulrom

KVARTALSRAPPORT - 3. KVARTAL 2018
Høydepunkter
• Vellykket bildebehandling av Radspherin® i preklinisk studie
• Radspherin® klinisk formulering for fase 1 valgt
• Oncoinvent ansetter to nye nøkkelpersoner

Operasjonell gjennomgang
Arbeidet med å bevege Radspherin® i kliniske forsøk i 1. kvartal 2019 fortsatte i løpet av det tredje
kvartalet 2018. En nøkkelprioritet for selskapet var forberedelsene til den planlagte inspeksjonen av
Radspherin® produksjonsanlegg av Lægemiddelstyrelsen tidlig i 4. kvartal. De
Selskapet fokuserte også på å fullføre arbeidet som var nødvendig for å sende inn en klinisk prøveapplikasjon
(CTA) i 4. kvartal.
Vellykket bildebehandling av Radspherin® i preklinisk studie
Selskapet har utført bildebehandling på rotter som bruker gamma kameraer og SPECT CT skannere til
teste muligheten for å bruke disse bildemodellene for å måle distribusjonen av Radspherin® i
humane peritoneale (bukhulen) hulrom under fase 1 kliniske studier. Radspherin® partikler
ble avbildet av gamma kameraer fra 1 til 96 timer etter injeksjon. Resultater fra bildeteksten
studier indikerer muligheten for å bruke gammakamerabilder for å bekrefte distribusjonen av
Radspherin® i bukhulen etter administrasjon hos pasienter. Videre bildebehandling er
blir utført for å bekrefte dette funnet.
Radspherin® klinisk formulering for fase 1 valgt
Oncoinvent har valgt en formulering for Radspherin®-legemiddelproduktkandidaten som vil bli
brukt i de kommende fase 1 kliniske studier basert på resultatene av formuleringsutvikling
studier utført i 2018 og ferdigstilt i 3. kvartal 2018. GMP-produktioner av Radspherin®
klinisk legemiddelproduktformulering vil bli utført i løpet av 4. kvartal.
Oncoinvent ansetter to nye nøkkelpersoner
Selskapet er glad for å kunngjøre at Hans Matthias Hild og Helén Johansen Blanco har
ble med i Oncoinvent-teamet i 3. kvartal 2018.
Dr. Hans Matthias Hild, Ph.D., har blitt ansatt som produksjonsleder og vil være ansvarlig for
Sikring av tilførsel av Radspherin® narkotikaprodukt i kliniske studier. Dr. Hild har over femten
års erfaring med internasjonale farmasøytiske selskaper, inkludert Avecia Biotechnology
og GE Healthcare. Han har med hell ledet storskala- og teknologioverføringsprosjekter og
har en sterk, praktisk bakgrunn i produksjon av vitenskap, GMP / kvalitetssikring og
produksjon av radiofarmaka.

Dr. Hild har en Ph.D. i biokjemisk ingeniørfag fra Imperial College of Science, Technology
og medisin, london, england.
Helén Johansen Blanco er ansatt som leder av klinisk operasjon og vil være ansvarlig for
Radspherin® kliniske studier. Fru Blanco har atten år med internasjonal klinisk prøve
erfaring fra fase 1 til fase 3 registreringsstudier og har jobbet for større
farmasøytiske selskaper som Astra Zeneca, Mylan, Celgene samt
internasjonalt anerkjent klinisk forskningsorganisasjon Covance. Fru blanco har en msc fra
NTH i Trondheim.

Ja, dette ser veldig bra ut! Snart i klinikk!!

Snart og det vil si?

1 mnd eller 2 år :)
Panis
31.10.2018 kl 11:32 2380

Nano Rekyl,
Du finner svaret på spørsmålet ditt i første linjen under avsnittet Operational Review:
Work towards moving Radspherin® into clinical trials in Q1 of 2019 continued during the Third quarter of 2018.
ruter7
14.02.2019 kl 08:22 1574

Ny CFO i Oncoinvent:

Press Release 02.2019. Oncoinvent is pleased to announce it has appointed Tore Kvam as Chief Financial Officer. Mr. Kvam has a extensive experience as CFO with several years also within the life science industry. He holds an MBA from the Norwegian Business School, BI and is a Certified European Financial Analyst (CEFA) from the Norwegian School of Economics.

http://www.oncoinvent.com/news/496/Oncoinvent-announces-appointment-of-new-Chief-Financial-Officer
ruter7
15.02.2019 kl 14:05 1473

Avtale med IFE på plass

Press Release 02.2019: Oncoinvent has signed an agreement with the Institute of Energy Technology (IFE) for the distribution of Radspherin (investigational medicinal products) to sites and institutions as part of the company’s clinical trial program.

"We are very pleased to have the distribution agreement in place as it is a vital part of our infrastructure going forward. The agreement enables us to provide sites and patients participating in the clinical trial program access to Radspherin in a timely and predictable manner without geographical boundaries.” said Jan A. Alfheim, Oncoinvent’s CEO.

http://www.oncoinvent.com/news/497/Oncoinvent-signs-distribution-agreement-with-radiopharmaceutical-wholesaler

Redigert 15.02.2019 kl 14:05 Du må logge inn for å svare
ruter7
19.02.2019 kl 09:51 1356

Grønt lys for produksjon!

Press Release 03.2019: Oncoinvent is pleased to announce that it has received a manufacturing authorization (GMP certificate) for production of Radspherin® clinical trial material from the Norwegian Medicine Agency.

Jan A. Alfheim, Oncoinvent CEO commented, “We are very pleased to have accomplished this important milestone in such a short time after the inauguration of our production facility. The approval provides Oncoinvent with the necessary capacity and flexibility with full control over the production of clinical trial material of Radspherin® for the upcoming clinical studies expected to start later this year. After having sent in the clinical trial application earlier this month the company is now fully prepared to start the clinical development of Radspherin®”

http://www.oncoinvent.com/news/498/Oncoinvent-receives-manufacturing-authorization-for-clinical-trial-material

Nå går det unna i svingene :)

Hvorfor får vi ikke nyhetsbrev om disse gode nyhetene??
ruter7
26.02.2019 kl 09:31 1090

Oncoinvent awarded 4,6 MNOK in Innovation Funding

Press Release 04.2019: Oncoinvent is pleased to announce that the Oslo University Hospital and Oncoinvent have each been awarded Innovation Funding to develop Radspherin® as a treatment for colorectal cancer patients suffering from peritoneal carcinomatosis. The two awards make for a combined total of 7,9 million NOK where Oncoinvent will receive 4,6 MNOK and Oslo University Hospital 3,3 MNOK. The Innovation Norway grants will allow Oncoinvent to expand the clinical use of Radspherin® from the current planned study in ovarian cancer patients and enables the company to carry out phase 1 clinical trials to assess the clinical safety of Radspherin® in colorectal cancer patients as well.

Jan A. Alfheim, Oncoinvent CEO commented, “We are very grateful for this support from Innovation Norway. The Innovation funding will allow Oncoinvent to expand Radspherin® ’s potential indications for use and to reach many more patients suffering from peritoneal carcinomatosis more quickly than would have otherwise been possible. We now plan to initiate two phase I trials, one in ovarian cancer patients, and a second in colorectal cancer patients.”

http://www.oncoinvent.com/news/499/Oncoinvent-awarded-46-MNOK-in-Innovation-Funding

Ingen grunn til å klage på nyhetsstrømmen her for tiden!
Kvikk33
26.02.2019 kl 23:57 1018

Ny krefttype i pipeline. Tykktarms- og endetarmskreft.
Redigert 26.02.2019 kl 23:59 Du må logge inn for å svare

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