Ønsker virtuelle studier til Norge

This article was originally published on our member Inven2’s website and written by Elisabeth Kirkeng Andersen in Norwegian. Oslo Cancer Cluster supports this member’s initiative of introducing virtual clinical studies to Norway.

Inven2 håper at vi snart kan starte såkalte virtuelle kliniske studier på oppdrag fra industri i Norge. Virtuelle kliniske studier innebærer utstrakt bruk av digitale verktøy for å samle inn dataene som er nødvendig for at et legemiddel kan godkjennes. Oslo universitetssykehus og legemiddelfirmaet Bristol Myers Squibb (BMS) er veldig positive.

–Vi har alle forutsetninger for å lykkes med virtuelle studier og det kan være et stort fortrinn for å tiltrekke flere kliniske studier til Norge, sier Siri Kolle. Hun er ansvarlig for kliniske studier i Inven2.

Virtuelle studier kalles også «Decentralised Clinical Trials», og går blant annet ut på å ta i bruk digitale verktøy og avstandsoppfølging av studiedeltakere.

Det svenske Läkemedelsverket er i gang med en kartlegging i Sverige for å finne ut hva som kreves for å  gjennomføre virtuelle kliniske studier på en sikker og effektiv måte, og hva som allerede er på plass.

Jenny Söderberg er prosjektleder for dette og påpeker i en pressemelding at nær 70% av potensielle deltagere til kliniske studier er utelukket på grunn av geografiske hensyn.

–Jeg vil tro det samme gjelder for Norge. Dette viser hvilket enormt potensiale for bedre pasientbehandling som ligger i virtuelle studier. Ikke minst kan virtuelle studier bety bedre, bredere og raskere rekruttering til en studie, noe som er det viktigste får både firmaene og pasientene, sier Kolle.

Siri Kolle, ansvarlig for kliniske studier i Inven2.

Legemiddelindustrien på ballen

Kolle synes det svenske pilotprosjektet er spennende, og følger spent med på det og andre initiativ rundt virtuelle studier. Hun og kollegaene i Inven2 har allerede gjennomført en forundersøkelse ved Oslo universitetssykehus, basert på at de i starten av 2020 fikk flere henvendelser fra legemiddelfirmaer om hva som er mulig å gjøre innen virtuelle studier i Norge i dag.

–Både videoløsninger for pasientkonsultasjon og elektronisk samtykke kan enkelt tas i bruk allerede. I tillegg har vi sendt flere store legemiddelfirmaer kravspesifikasjonene som Oslo universitetssykehus har, på bruk av informasjonssystemer, så de er informert om retningslinjene sykehuset har på dette, sier Kolle.

Det setter Susanne Hedenstedt stor pris på. Susanne er senior prosjektleder for kliniske studier i Norden i biopharma selskapet BMS, hvor hun også er med i en intern, global, arbeidsgruppe innen virtuelle kliniske studier.

–Virtuelle studier bobler i verden. Det er mange legemiddelfirmaer som ser på muligheten for å gjennomføre hele eller deler av studiene sine digitalt. BMS planlegger å starte opp en virtuell oppfølgingsstudie innen kreft i løpet av 2020, og vi håper å få med et norsk sykehus i den studien, sier Hedenstedt.

Hedenstedt er tydelig på at BMS ønsker å gå i gang med virtuelle kliniske studier, og tror dette kan være en «gamechanger» for pasientene og for utvikling av nye behandlinger, i alle fall innen noen sykdommer.

– Pasientrekruttering er en av de største utfordringene i kliniske studier. Det tar lang tid og forsinker hele prosessen med eventuelt å få godkjent en ny behandling. I tillegg skjer det ofte at en del av pasientene ikke fullfører hele studieperioden. Det kan være på grunn av sykdommen eller andre faktorer, som reisevei. Det er tøft for svært syke pasienter å reise tur-retur til et sykehus hvor studiene gjennomføres. Gjennom virtuelle studier kan vi involvere pasienten på en mer hensiktsmessig måte i deres eget hjem, sier Hedenstedt.

Koronapandemien har satt fortgang i arbeidet med virtuelle studier i BMS. Den globale unntaktstilstanden har ført til at BMS, som ett av mange legemiddelfirmaer, har satt en midlertidig pause for oppstart av nye studier og rekruttering av pasienter til kliniske studier.

– Vi har tatt disse proaktive grepene for å beskytte og ta vare på sikkerheten til både studiedeltakere, våre ansatte og de ansatte på sykehusene som jobber med kliniske studier, sier Hedenstedt.

Hun påpeker at pausen også er satt for å sikre at studiene gjennomføres i tråd med regulatoriske retningslinjer og at dataene holder høy vitenskapelig kvalitet.

–Koronapandemien kommer til å føre til en eksplosjon av virtuelle studier. Det er veldig positivt at Inven2 ønsker å bidra til å innføre dette i Norge, sier Hedenstedt.

Oslo universitetssykehus er positivt innstilt

Så hva er egentlig den største forskjellen på en vanlig klinisk studie og en virtuell, desentralisert klinisk studie?

Begrepet desentralisert er beskrivende, fordi hovedforskjellen er at studieoppfølgingen flyttes så mye som mulig fra et sykehus hjem til den enkelte pasienten. Han eller hun bruker sitt lokale legekontor for blodprøver, og ulike digitale løsninger for å rapportere inn data i studien. Mer avanserte undersøkelser som MR, PET-skan og røntgen må fremdeles gjennomføres på sykehus.

I Norge har begrepet telemedisin gjerne blitt brukt om denne typen oppfølging av pasienter

Telemedisin er et område Norge er langt framme på internasjonalt, på grunn av vår spredte befolkning som i store deler av landet bor langt unna sykehus eller fastlegekontor.

–Det norske helsevesen sin lange erfaring med telemedisin innebærer at vi har alle forutsetninger for å være et foregangsland innen virtuelle studier, sier Kolle.

Noen flere elementer må på plass for å gå fra telemedisin til virtuell gjennomføring av kliniske studier.

–Elektronisk samtykke fra pasientene til å delta i en studie er et element, videokonsultasjoner med lege eller studiepersonell er et annet, og i tillegg kommer utstrakt innsamling av pasientrapporterte data. I dette ligger det at pasienten selv rapporterer om egen fysisk og psykisk helse basert på egen erfaring og helsedata hentet fra ulike former for «wearables», det vil si en pulsklokke eller lignende som måler blodtrykk og andre vitale funksjoner, sier Kolle.

Alle disse tre elementene er i bruk i helsevesenet i dag, sier Peder Utne. Utne leder avdeling for administrativ forskningsstøtte ved Oslo universitetssykehus.

–Digitale verktøy brukes i stor grad i forskerinitierte studier, og det er ingenting i veien for å ta det i bruk i industrisponsede studier. Det som må være på plass er selvfølgelige datasikkerhet, det vil si at de digitale løsningene er trygge i bruk for deltagerne og i tråd med internasjonale retningslinjer for personvern, sier Utne.

Et eksempel på en pågående, virtuell studie i Norge, er koronastudien der Oslo universitetssykehus kartlegger risiko for å bli smittet av koronaviruset. Her bruker de både elektronisk samtykke og spørreskjema for å innhente egenrapporterte data. Så langt har studien over 100.000 deltagere.

–Vi er veldig positive til virtuelle kliniske studier. På et generelt grunnlag mener jeg det meste er på plass for å gjennomføre dette. Det vil være noen utfordringer som er avhengig av den enkelte studiens design. Dette kan gjelde de spesifikke systemene som skal tas i bruk for å hente inn data, samt utfordringer knyttet til personvern og datasikkerhet, samt hvordan endringer i en virtuell studie skal rapporteres til Regional Etisk Komite´(REK), som er ansvarlig for å godkjenne studien, sier Utne.

Han mener at koronapandemien kan være enkelthendelsen som sparker i gang et stort digitalt løft innen helsektoren som en helhet.

–Det er nok på mange måter sånn at legemiddelindustrien har vært for tradisjonell når det gjelder gjennomføringen av kliniske studier, så det blir spennende å se hva som kommer nå, sier Utne.

Les en god beskrivelse av forskjellene på en vanlig kliniske studie og en virtuell kliniske studie i denne forskningsartikkelen «Virtual clinical trials: Perspectives in Dermatology».

Korona med digitalt dytt

Koronapandemien har ført til at videkonsultasjoner har blitt tatt i bruk som aldri før ved norske sykehus. Det fortalte flere av landets fremste kreftleger på et webinar Dagens Medisin arrangerte i mars, om hvordan koronapandemien har påvirket kreftbehandlingen i Norge.

–Pandemien har tvunget oss alle til å tenke nytt og ta i bruk digitale verktøy på en annen måte en før. Se på skolesektoren hvordan lærerne fra én dag til en annen måtte ta i bruk videoverktøy for å undervise. Det samme har skjedd med de ansatte i helsesektoren, som fra en dag til en annen måtte forholde seg til pasienter som ikke ønsket å møte opp på sykehuset i frykt for å bli smittet der eller på reisen, eller pasienter som ikke burde utsette seg for risikoen. I noen tilfeller er videokonsultasjon med pasienter enklere og mer effektivt, for både pasient og behandler, sier Kolle.

Hun mener Norge bør utnytte det digitale momentumet koronapandemien har medført, til å endre praksis innen kliniske studier og utføre så mye som mulig digitalt framover.

–Koronapandemien påvirket fra midten av mars av gjennomføringen av pågående studier og særlig oppstart av nye kliniske studier i Norge, siden de store sykehusene alle var i gul beredskap. I en slik global krisesituasjon er digitale verktøy gull verdt for å gjennomføre kliniske studier som normalt på tross av unntakstilstanden, det er det beste for pasientene, sier Kolle.

Nå melder sykehusene i Norge at de er i gang igjen med både pågående studier og oppstarten av nye. Det er ikke tilfellet i verden generelt, særlig land som har blitt sterkt rammet av koronapandemien som Italia, Spania, Storbritannia og USA, melder om store forsinkelser.

–Oppsiden med å ta i bruk virtuelle studier er så mange, så dette må vi få til. I tillegg må vi ta inn over oss at ønsker vi flere kliniske studier til Norge i fremtiden, er vi helt avhengige av å være med på utviklingen og ta i bruk nye verktøy, sier Kolle.

Hun har på vegne av Inven2 spilt inn nødvendigheten av å satse på virtuelle kliniske studier til den nye handlingsplanen for kliniske studier som Helse- og omsorgsdepartementet arbeider med nå.

New member: Ledidi

Image of Oslo Cancer Cluster Innovation Park

In this article series, we will introduce the new members that have joined our oncology ecosystem in the last six months. Follow us for a new article next week!

One of the latest additions to our cluster organisation is Ledidi, a Norwegian technology start-up that wants to revolutionize how data is processed in clinical research.

Ledidi was founded in 2016 by three software engineers and two academic clinicians in cancer research. The company has since then developed a software solution that will help hospital personnel and medical researchers to sort, organise and analyse real-time data.

We talked to Jakob Markussen, VP Business Development and Sales at Ledidi, to learn more about how they are changing the field of cancer and why they wanted to belong to Oslo Cancer Cluster.

Could you briefly describe Ledidi and the role it is taking in cancer?

“Ledidi AS has developed and is marketing Prjcts, which is an end-to-end software solution designed for clinical research. Ledidi was founded in 2016 by three software engineers and two academic clinicians with long track-record within cancer research, cellular immunology and cancer surgery. Prjcts is a cloud-based solution that integrates data registry with statistical analyses and table and graph production in one package with a user-friendly interface. Pjrcts is an ideal cloud solution for all kinds of collaborative research projects from small internal quality registries to multicenter international studies. By integrating the complete workflow, Prjcts provide a platform that enables all project members to take part in the data analysis and presentation, and not only data acquisition,” said Markussen.

Why did Ledidi join Oslo Cancer Cluster?

“Oslo Cancer Cluster represents a unique partner for an exchange of expertise, partnership and networking. The spectrum of companies, institutions and organizations that Oslo Cancer Cluster brings together gives Ledidi a valuable opportunity to contribute to cancer research and stimulate research collaborations,” said Markussen.

 

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Reports from the third quarter from our members have been published. Photo: Unsplash

What’s new in Q3?

Two persons working in front a two laptops.

Positive results from clinical trials, revenue growth and new clinical collaborations … Read some of the third quarter developments from our members below.

BerGenBio logo

BerGenBio

  • BerGenBio showed results from their clinical trial for patients with non-small cell lung cancer, who have previously been treated with chemotherapy. The results showed they met primary and secondary endpoints.
  • The company presented interim safety data from a Phase Ib/II trial. They are testing their drug bemcentinib in combination with pembrolizumab on melanoma patients. The data shows the combination is well tolerated by patients.
  • The U.S. Food and Drug Administration (FDA) has granted bemcentinib Fast Track Designation. This means they will do an expedited review of the investigational drug. The designation is for the treatment of elderly patients with acute myeloid leukemia (AML), who have relapsed.

Read more in the press release from BerGenBio

Nordic Nanovector logo

Nordic Nanovector

  • Nordic Nanovector raised approximately NOK 243 million in private placement of new shares. This will provide further funds to continue the clinical development of their drug Betalutin, manufacturing and other commercial activities.
  • The company presented new results from a clinical trial, testing their drug Betalutin on patients with non-Hodgkins lymphoma (a type of blood cancer). The median duration of response was 13.6 months for all responders and 32.0 months for complete responders.
  • The company reported 3 out of 3 patient responses in the first patient cohort in one of their clinical trials. The patients were given Betalutin in combination with rituximab to treat 3rd-line relapsed or refractory follicular lymphoma (also a type of blood cancer).

Read more in the press release from Nordic Nanovector

Photocure logo

Photocure

  • Photocure reported a revenue growth of 42% in local currency for the US market.
  • The revenues in the Nordics declined 7% to NOK 9.9 million (NOK 10.6 million) in the third quarter.
  • The company entered into a licensing agreement with Asieris Meditech Co. to commercialize the product Cevira to the global market. Cevira is a non-invasive photodynamic therapy for HPV-related (cervical) diseases.

Read more in the press release from Photocure

 

Targovax logo

Targovax

  • Targovax presented new data from the first part of the clinical trial of their oncolytic virus. The trial has shown clinical responses in three out of nine patients. This treatment targets patients with refractory advanced melanoma (skin cancer).
  • The company announced an expansion of the clinical trial of the oncolytic virus ONCOS-102 in combination with the checkpoint inhibitor Imfinzi. This trial is open for patients with advanced peritoneal malignancies (a rare cancer that develops in the tissue that lines the abdomen).
  • The company publicised that Oslo University Hospital will become a site for the clinical trial of their oncolytic virus ONCOS-102.

Read more in the press release from Targovax

 

Ultimovacs logo

Ultimovacs

  • Ultimovacs presented long-term results from the clinical study of their therapeutic cancer vaccine UV1. The patients have non-small cell lung cancer and the trial has shown a 4-year overall survival rate of 39% (7 of 18 patients are still alive).
  • New data from their prostate cancer trial showed a 5-year overall survival rate of 50% (11 of 22 patients are still alive).
  • A phase II clinical trial for patients with malignant melanoma (skin cancer) is projected to start in the first quarter of 2020.

Read more in the press release from Ultimovacs

 

More third quarter reports from our other members are or will be made available on their respective websites.

 

New report: Cancer in Norway 2018

Cancer Registry of Norway has released the report Cancer in Norway. These are the main points. 

Since the 1950s, Cancer Registry of Norway has published statistical reports of the cancer incidence in Norway almost annually. The past 14 editions of these reports can be found online on the Cancer Registry’s official report page.

In 2018, 34 190 new cancer cases were reported. In order to understand how cancer changes over time in the population, the Cancer Registry examines rates over five-year periods.

Differences between men and women

18 321 men were diagnosed with cancer in 2018.

These are the most common cancer types among men:

  • Prostate cancer, 27,9%
  • Lung cancer, 9,3%
  • Colon cancer, 7,9%
  • Cancer in the urinary tract, 6,9%
  • Skin cancer, non-melanoma, 6,1%

In men, the rates for all cancers combined have been stable. Rates for prostate and lung cancer are decreasing, and so are the rates for rectum cancer, while the trend for colon cancer points slightly upwards.

15 869 women were diagnosed with cancer in 2018.

These are the most common cancer types among women:

  • Breast cancer, 22,3%
  • Colon cancer, 10,1%
  • Lung cancer, 10,0%
  • Melanoma, 6,8%
  • Skin cancer, non-melanoma, 6,4%

There has been a 5,6% increase in the rates among women from the previous five-year period to the most recent one. This reflects increased rates of breast, colon, lung and skin cancer.

Cancer rates by immigrant group

This year the report Cancer in Norway presents cancer rates by immigrant group for the first time.

At the beginning of 2019 immigrants represented 14,3% of the Norwegian population. According to Statistics Norway, about 48% of the immigrants are from Europe, 14% from Africa and 34% from Asia, leaving another 4% from the rest of the world.

Immigrants from outside Europe tend to have lower cancer rates than people born in Norway, the report shows.

In the report foreword Giske Ursin, Director of Cancer Registry of Norway, writes:

“Cancer is predominantly a disease caused by western lifestyle and environment, and many immigrants bring with them a healthier lifestyle associated with lower cancer rates. We may all profit from learning and adapting to a healthier lifestyle.”

Although long-term trends among immigrants tend to be favourable, there are some noteworthy exceptions, according to the report. Immigrants from countries with high smoking prevalence, such as a number of the Eastern European countries, have higher rates of lung cancer.

Socioeconomic factors also matter

The special issue of the report goes in depth on rates among immigrants and also by socioeconomic factors. These factors also matter, according to Giske Ursin:

“We know that socioeconomic status plays a role for several cancers, and a key question is whether there are independent effects linked to income, education and immigrant status. We therefore examine all three factors. We found that a number of cancers are more common among those who have short education or low income. However, we found that the differences between immigrant groups remain after adjustment for socioeconomic factors.”

This information can be used to reduce cancer risk, according to the Cancer Registry – but one size does not fit all in terms of prevention. Ursin writes:

“We need a more targeted approach if we are to prevent cancer in all population subgroups at higher risk of cancer.”

Read the report

  • Cancer in Norway 2018 – Cancer incidence, mortality, survival and prevalence in Norway is available in a printed version. The report is free of charge, and can be ordered by sending an email to kreftregisteret@kreftregisteret.no
  • Or download the report, in English and Norwegian, from the website of the Cancer Registry of Norway
  • The special issue part about immigrants and socioeconomic factors is only available in Norwegian for the time being

 

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Geir Harstad, CEO of Smartfish, is encouraged by clinical study results indicating that the company's medical nutrition has the potential to enhance the efficacy of standard cancer treatments. Photo: Smartfish

Smartfish with clinical study results

Geir Harstad, CEO of Smartfish,

A new clinical study indicates that medical nutrition can improve overall survival in lung cancer patients. 

Oslo Cancer Cluster member Smartfish AS presented the results from a randomized, double-blinded, placebo-controlled trial in the beginning of September. It evaluated one of the company’s medical nutrition products in patients with non-small-cell lung cancer (the most common type of lung cancer) suffering from cachexia.

Cachexia is a complex wasting syndrome, known to have a negative impact on clinical outcomes in patients with cancer and several other chronic diseases.

It is characterised by an ongoing loss of muscle and weight, that eventually can kill the patient.

The results show that the nutrition has a favorable safety profile and indicate a number of positive effects on clinical outcome, for instance that the patients who received the nutrition experienced numerically fewer adverse events from their chemotherapy treatments than the comparator group.

The clinical study

In the pilot study, lung cancer patients who received the nutrition while being pre-cachectic had a statistically significant higher survival after 12 months from baseline compared to the comparator group. 56 patients from 16 clinical sites in Sweden, Italy, Slovakia and Croatia were randomized to receive either Smartfish’s medical nutrition product or a milk-based isocaloric drink.

“This study shows the potential of Remune as an important enhancer of standard cancer care and clinical data like this helps to build awareness of what targeted medical nutrition can do for patients. We are encouraged to continue our research and development to ensure that the best possible nutrition is delivered to the patients who need it.” Geir Harstad, CEO of Smartfish

The medical nutrition product that was tested is called Remune, and is a juice-based drink produced with a proprietary emulsion technology containing unique high levels of Omega 3 fatty acids, vitamin D and whey protein.

The study was recently published online in the journal Nutrition and Cancer and can be read following this link: “Safety and Tolerability of Targeted Medical Nutrition for Cachexia in Non-Small-Cell Lung Cancer: A Randomized, Double-Blind, Controlled Pilot Trial” .

About Smartfish AS

Smartfish AS is active in the research, development, production and marketing of advanced and clinically documented nutritional drinks within medical nutrition and sports nutrition. All Smartfish products are produced on its proprietary juice-based emulsion technology platform with the marine DHA and EPA fatty acids as important ingredients. Smartfish has a number of ongoing clinical development projects and studies in close collaboration with researchers and institutions both in Norway and internationally. The company was founded in 2001 and is located in Oslo, Norway and Lund, Sweden. Smartfish’s main shareholders are Investinor (Norway) and Industrifonden (Sweden). For more information, visit SmartFish official website.

For more information about the study and the company, please contact Jens Nordahl, VP Sales & Marketing, tel +47 996 299 99.

The company’s press release can be read as a PDF in this link.

 

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Meet our new members

Oslo Cancer Cluster proudly presents the new members that have joined our organisation during the second quarter of 2019.

The new members represent a valuable addition to our non-profit member organisation, which encompasses the whole oncology value chain. By being a part of Oslo Cancer Cluster, our members are connected to a global network with many relevant key players in the cancer research field. Our members contribute to this unique ecosystem and ensure the development of innovative cancer treatments to improve patients’ lives.

 

theradex logo

 

Theradex Oncology

Theradex Oncology provides global clinical development services exclusively to companies developing new cancer treatments. The company has a strong emphasis on early drug development. It provides regulatory and medical support for companies taking cancer treatments into clinical development in the US and Europe.

Theradex Oncology staff has participated in educational events at Oslo Cancer Cluster for a number of years. This is how they became familiar with the cluster.

“Oslo Cancer Cluster provides a unique opportunity to share knowledge with other professionals dedicated to developing new cancer treatments.” Meg Valnoski, President Theradex Oncology

Meg Valnoski explains how the company has been supporting the development of cancer treatments for over 30 years and experienced the advancements in cancer treatments over that time.

 “We are always working to expand our knowledge and experience in cancer drug development to support our partnerships with companies developing new therapies for cancer treatment.”

Catapult life science logo

Catapult Life Science

Catapult Life Science is a centre established to bridge the gap between the lab and the industry, providing infrastructure, equipment and expertise for product development and industrialisation in Norway. It has been formed as a result of joint efforts from a range of different players with a common goal of enabling more industrialisation of life science research in Norway, truly what the Norwegians call a dugnad.

“We see Oslo Cancer Cluster as a key partner for realising our purpose, which is to create new opportunities for product development and industrialisation in Norway.” Astrid Hilde Myrset, CEO Catapult Life Science

Myrset adds:

“Our vision is ‘Bringing science to life’, which implies enabling new ideas to a be developed in Norway for new employment in the pharma industry, new growth in the Norwegian economy, and last but not least, new products to the market, enabling a longer and healthier life for patients.”

 

This post is part of a series of articles, which will introduce the new members of our organisation every three months.

  • To find out who else is involved in Oslo Cancer Cluster, view the full list of members
  • Follow us on Facebook or subscribe to our newsletter to always stay up to date!

 

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The High Throughput Screening Lab at SINTEF. Photo: Thor Nielsen / SINTEF

SINTEF to develop methods in immuno-oncology

The Cell Lab at SINTEF. Photo: Thor Nielsen / SINTEF

SINTEF and Catapult Life Science are looking for new partners to develop methodology for cancer immunotherapy.

“We want to develop methods within immunotherapy, because this is currently the most successful strategy for improving cancer treatments and one of the main directions in modern medicine,” says Einar Sulheim, Research Scientist at SINTEF.

The Norwegian research organization SINTEF is an Oslo Cancer Cluster member with extensive knowledge in characterisation, analysis, drug discovery and development of conventional drugs.

The new project on methodology for cancer immunotherapy recently started in April 2019 and is a collaboration with Catapult Life Science, a new Oslo Cancer Cluster member. The aim is to help academic groups and companies develop their immunotherapy drug candidates and ideas.

Help cancer patients

Ultimately, the main aim is of course that the project will benefit cancer patients. Immunotherapy has shown to both increase life expectancy and create long term survivors in patient groups with very poor prognosis.

“We hope that this project can help streamline the development and production of immunotherapeutic drugs and help cancer patients by helping drug candidates through the stages before clinical trials.” Einar Sulheim, Research Scientist at SINTEF

 

Develop methodology

The project is a SINTEF initiative spending NOK 12,5 million from 2019 to 2023. SINTEF wants to develop methodology and adapt technology in high throughput screening to help develop products for cancer immunotherapy. This will include in vitro high throughput screening of drug effect in both primary cells and cell lines, animal models, pathology, and production of therapeutic cells and antibodies.

 

High throughput screening is the use of robotic liquid handling systems (automatic pipettes) to perform experiments. This makes it possible not only to handle small volumes and sample sizes with precision, but also to run wide screens with thousands of wells where drug combinations and concentrations can be tested in a variety of cells.

 

The Cell Lab at SINTEF. Photo: Thor Nielsen / SINTEF

The Cell Lab at SINTEF. Photo: Thor Nielsen / SINTEF

 

Bridging the gap

Catapult Life Science is a centre established to bridge the gap between the lab and the industry by providing infrastructure, equipment and expertise for product development and industrialisation in Norway. Their aim is to stimulate growth in the Norwegian economy by enabling a profitable health industry.

“In this project, our role will be to assess the industrial relevance of the new technologies developed, for instance by evaluating analytical methods used for various phases of drug development.” Astrid Hilde Myrset, CEO Catapult Life Science

A new product could for example be produced for testing in clinical studies according to regulatory requirements at Catapult, once the centre achieves its manufacturing license next year.

“If a new method is intended for use in quality control of a new regulatory drug, Catapult’s role can be to validate the method according to the regulatory requirements” Myrset adds. 

SINTEF and Catapult Life Science are now looking for partners.

Looking for new partners

Einar Sulheim sums up the ideal partners for this project:

“We are interested in partners developing cancer immunotherapies that see challenges in their experimental setups in terms of magnitude, standardization or facilities. Through this project, SINTEF can contribute with internal funding to develop methods that suit their purpose.”

 

Interested in this project?

Meet our new members

Oslo Cancer Cluster proudly presents the new members that have joined our organisation during the first quarter of 2019.

 

The new members represent a valuable addition to our non-profit member organisation, which encompasses the whole oncology value chain. By being a part of Oslo Cancer Cluster, our members are connected to a global network with many relevant key players in the cancer research field. Our members contribute to this unique ecosystem and ensure the development of innovative cancer treatments to improve patients’ lives.

 

HalioDx

HalioDx is an immuno-oncology diagnostic company providing immune-based services, which guide cancer care and contribute to precision medicine. HalioDx executes biomarker studies and develop diagnostic devices, in accordance with regulations and in partnership with biopharmaceutical companies. By being a member of Oslo Cancer Cluster, HalioDx can collaborate with academia and industry to deliver clinical research and diagnostic tools that help find the right therapy for the right patient.

“Immuno-oncology and precision medicine are two main focuses of interest for Oslo Cancer Cluster and this is the reason why HalioDx decided to become a part of Oslo Cancer Cluster.” 

“We are convinced that this collaboration will be of mutual benefit and we hope that HalioDx’s comprehensive clinical research platform will represent a great tool for the academic and pharma members who would like to better understand drugs mechanisms of action and identify the right patients for the right therapy.”
Aurélie Fugon, Associate Director, HalioDx

 

 

 

MultiplexDX

MultiplexDX is a biotech corporation with the aim to eliminate misdiagnosis of cancer disease. The company’s idea is to create 100% reliable, quantitative, affordable and personalised diagnostic tests. By combining tissue visualisation and sequencing technologies, they can accurately quantify 7 or more cancer markers, generating a specific “barcode”. This unique barcode can then specify the type of cancer and suggests which personalised treatment and medicines to be used, and how long the therapy should last.

“We believe that Oslo Cancer Cluster is the best cancer cluster in the world representing the entire oncology value chain that we want to be part of.” Pavol Cekan, CEO, MultiplexDX

“We plan to create strategic partnerships with Oslo Cancer Cluster members to bring our breast cancer diagnostic test, Multiplex9+, to the market as soon as possible. In assistance with Oslo Cancer Cluster and its members, we want the breast cancer patients to benefit from our 100% accurate, reliable and diagnostic test at the earliest convenience.” 

 

Sanofi (Norway)

Sanofi is a global pharmaceutical company and one of their main areas of treatment concerns oncology. Every year, they invest 15% of their revenue into research and development. They do phase I, II and III clinical trials to get new medicines approved for treatment. They want to remain innovative, because they believe that the research they perform today will contribute to preventing and treating diseases in the future.

“Sanofi has a long legacy with R&D in oncology. In the years to come oncology and hematology will be one of the biggest therapeutic areas at Sanofi.

“By becoming a member of Oslo Cancer Cluster we believe that we are able to contribute to unlocking tomorrow’s science by supporting the latest advances in treating cancer in Norway and beyond.” Britt Moe, General Manager, Sanofi (Norway)

“This is especially interesting since in the treatment of cancer, new mechanisms of actions and developments, such as immune-oncology therapies, are very much in the focus.” 


Thommessen

Established in 1856, Thommessen is a leading commercial law firm with offices in Oslo, Bergen, Stavanger and London. The firm provides advice to Norwegian and international companies as well as organisations in the public and private sectors, ranging from start-ups, via small and medium size companies to large multi-national corporations. Thommessen covers all business related fields of law.

“We believe that early identification of potential legal issues before they arise is important.” Mirella Gullaksen, Head of Projects and Business Development, Thommessen

“Investing in early phase biotech/oncology companies should be about the relevant team, technology and product breakthrough. All other risks relating to the company, and investments should be reduced to a minimum”. 

 

  • This post is the first in a series of articles, which will introduce the new members of our organisation every three months.
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  • To find out who else is involved in Oslo Cancer Cluster, view the full list of members.

 

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Encouraging news from BerGenBio

A second group of patients have been added to an ongoing phase II clinical study of a drug combination to treat lung cancer.

 

The ongoing trial is a collaborative effort between two members of Oslo Cancer Cluster: Norwegian biopharmaceutical company BerGenBio and US-based pharmaceutical company Merck (known as MSD in Europe). It involves an kinase inhibitor called bemcentinib, developed by BerGenBio, in combination with an immunotherapy drug called Keytruda (also known as pembrolizumab) from MSD.

 

“Throughout 2018, we reported encouraging updates from our ongoing proof-of-concept phase II clinical trial assessing bemcentinib in combination with Keytruda in advanced lung cancer patients post chemotherapy.”
Richard Godfrey, Chief Executive Officer, BerGenBio

 

The second group will involve patients that have been treated with immunotherapy before, but that have experienced a progression of the disease. There are various treatments available for patients with non-small cell lung cancer, but patients often acquire resistance to treatment. New treatments that can overcome these resistance mechanisms are therefore urgently needed.

 

“I am pleased that we are now extending the ongoing trial to test our hypothesis also in patients showing disease progression on checkpoint inhibitors.”
Richard Godfrey, Chief Executive Officer, BerGenBio

 

The aim is to evaluate the anti-tumour activity of this new drug combination. Preliminary results from the second patient group of the study are expected later this year. BerGenBio is in parallel also developing diagnostic tools to see which patients are most likely to benefit from their drug.

 

The decision to extend the trial was based on new positive results from pre-clinical studies, which were presented at the American Association of Cancer Research (AACR) earlier this week. The results open for the possibility to use bemcentinib both as a monotherapy and in combination with other cancer treatments on a broad spectrum of cancers.

 

 

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Dr. Nadia Mensali (in the middle) and her colleagues from Oslo University Hospital in their cell lab at Oslo Cancer Cluster Incubator. Photo: Christopher Olssøn

Natural killer cells dressed to kill cancer cells

Oslo, Norway, 26.04.2017. Photographs from Oslo Cancer Cluster (OCC), an oncology research and industry cluster dedicated to improving the lives of cancer patients by accelerating the development of new cancer diagnostics and medicines. Photographs by Christopher Olssøn

New research: A new study may potentially enable scientists to provide cancer immunotherapy that is cheaper, faster and more manageable.

New work by researchers with laboratories at Oslo Cancer Cluster Incubator may help to dramatically improve a T cell-based immunotherapy approach so that it can benefit many more patients.

 

T cell assassins

T cells are the professional killers of the immune system – they have a unique capability to specifically recognize ‘foreign’ material, such as infected cells or cancer cells. This highly specific recognition is achieved through receptors on the surface of T cells, named T cell receptors (TCRs). Once its receptor recognizes foreign material, a T cell becomes activated and triggers the killing of the infected or cancerous cell.

T cell receptors (TCRs): receptors on the surface of T cells, that recognize foreign material and activate the T cell. This triggers the killing of the infected or cancerous cell by the T cell.

 

Adoptive cell therapy 

Unfortunately, many cancers have adapted fiendish ways to avoid recognition and killing by T cells. To combat this issue, an immunotherapy approach known as adoptive cell therapy (ACT) has been developed in recent years. One such ACT approach is based on the injection of modified (or ‘re-directed’) T cells into patients. The approach is further explained in the illustration below.

 

Illustration from the research paper ‘NK cells specifically TCR-dressed to kill cancer cells’.

 

The left side of the illustration shows how redirected T-cell therapy involves:

1) Harvesting T cells from a cancer patient

2) Genetic manipulation of T cells to make them express an ideal receptor for recognizing the patient’s cancer cells

3) Growing T cells in culture to produce high cell numbers

4) Treating patients with large quantities of redirected T cells, which will now recognize and kill cancer cells more effectively

 

An alternative approach 

Adoptive T cell therapy has delivered very encouraging results for some cancer patients, but its application on a larger scale has been limited by the time consuming and costly nature of this approach. In addition, the quality of T cells isolated from patients who have already been through multiple rounds of therapy can sometimes be poor.

Researchers have long searched for a more automated form of adoptive cell therapy that would facilitate faster and more cost-effective T cell-based cancer immunotherapy.

One approach that has seen some success involves the use of different immune cells called Natural Killer cells – NK cells in brief.

Despite their great potential, NK cells have unfortunately not yet been proven to provide a successful alternative to standard T cell-based cancer immunotherapy. One major reason for this may be that, because NK cells do not possess T cell receptors, they are not very effective at specifically detecting and killing cancer cells.

NK cell lines: Natural Killer cells (NK cells) have the ability to recognise and kill infected or cancerous cells. Scientists have been able to manipulate human NK cells so that they grow without restriction in the lab. This is called a cell line. It enables a continuous and unlimited source of NK cells that could be used to treat cancer patients.

 

Cells dressed to kill

The group led by Dr. Sébastien Wälchli and Dr. Else Marit Inderberg at the Department of Cellular Therapy aimed to address this issue and improve NK cell-based therapies.

They reasoned that by editing NK cells to display anti-cancer TCRs on their cell surface they could combine the practical benefits of NK cells with the potent cancer killing capabilities of T cells. This is shown in the right hand side of the illustration above.

The researchers found that by simply switching on the production of a protein complex called CD3, which associates with the TCR and is required for T cell activation, they could indeed induce NK cells to display active TCRs. These ‘TCR-NK cells’ acted just like normal T cells, including their ability to form functional connections to cancer cells and subsequently mount an appropriate T cell-like response to kill cancer cells.

This was a surprising and important finding, as it was not previously known that NK cells could accommodate TCR signaling.

This video shows TCR-NK cell-mediated killing of cancer cells in culture. The tumour cells are marked in green. Tumour cells that start dying become blue. The overlapping colours show dead tumour cells.

 

The researchers went on to show that TCR-NK cells not only targeted isolated cancer cells, but also whole tumours.

The method was proven to be effective in preclinical studies of human colorectal cancer cells in the lab and in an animal model.  This demonstrates its potential as an effective new form of cancer immunotherapy.

 

Paving the way

Lead researcher Dr. Nadia Mensali said:

“These findings pave the way to the development of a less expensive, ready-to-use universal TCR-based cell therapy. By producing an expansive ‘biobank’ of TCR-NK cells that detect common mutations found in human cancers, doctors could select suitable TCR-NK cells for each patient and apply them rapidly to treatment regimens”.

Whilst further studies are needed to confirm the suitability of TCR-NK cells for widespread treatment of cancer patients, the researchers hope that these findings will be the first step on the road towards off-the-shelf immunotherapy drugs.

 

  • Read the whole research paper at Science Direct. The paper is called “NK cells specifically TCR-dressed to kill cancer cells”.
  • The researchers behind the publication consists of Nadia Mensali, Pierre Dillard, Michael Hebeisen, Susanne Lorenz, Theodossis Theodossiou, Marit Renée Myhre, Anne Fåne, Gustav Gaudernack, Gunnar Kvalheim, June Helen Myklebust, Else Marit Inderberg, Sébastien Wälchli.
  • Read more about research from this research group in this article from January.
  • Read more about Natural Killer cells in this Wikipedia article.

 

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