News regarding Personalized Cancer Medicine in Norway

Content looking woman to the left and man to the right, head shots put together

Eli Lilly & Company in the IMPRESS study

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Eli Lilly & Company is now part of the national Norwegian IMPRESS study.

Eli Lilly & Company is already part of CONNECT, the national collaboration on implementing precision medicine in Norway. Now, the international pharmaceutical company is offering participants of the IMPRESS study a new and promising medicine. This is good news for cancer patients in Norway.

Read more about CONNECT on their website.

The IMPRESS study is a national clinical study looking into the effect of cancer precision medicine. Patients with advanced, incurable cancer will – through the study – get the opportunity to test new treatments for their type of cancer.

Finding new and effective forms of treatment

The goal of the IMPRESS study is to test whether so-called off-label medications can be effective on new patient groups, based on their type of cancer and genetic mutations (molecular profile). This means that the participants of the study are testing out medications approved for the treatment of other diseases to fight their specific cancer disease. In other words, it’s not the type of cancer, but the genes that determine which medicine the patient receives.

“Impress is an important study for Norwegian researchers, not to mention for Norwegian cancer patients,” said Lars-Petter Strand, Medical Director Oncology in Eli Lilly Norway, in a press release from the company.

The intention is to find effective forms of treatment adapted to each individual’s cancer – a form of precision medicine. CONNECTs partner, Eli Lilly & Company, is now offering the participants of the study a new medication. This is great news for all the participants.

Up to 24 patients

Eli Lilly & Company is giving up to 24 participants the opportunity to try out the lung cancer medication Selpercatinib, sold under the product name Retsevmo. In previous studies, this medication has shown very good effects.

In order to treat as many patients as possible, access to medication is crucial. A wider range of medications to test contributes to more patients being able to receive treatment. Eli Lilly & Company’s support for IMPRESS is therefore of great importance.

“We are thrilled that Lilly supports IMPRESS Norway! We are seeing very good effects from the use of Selperkatinib through the completed studies, and we are pleased to be able to offer this medication to the patients participating in the IMPRESS study,” said Åslaug Helland Nasjonal, Project Leader for IMPRESS-Norway, in the press release.

In the same press release, Lars-Petter Strand emphasizes the importance of the IMPRESS study.

“Impress is an important study for Norwegian researchers, not to mention for Norwegian cancer patients, where the benefit and risk of tumor agnostic-targeted treatment will be investigated,” Strand said, and added:

“IMPRESS also emphasizes the importance of the hospitals and the pharmaceutical industry having an open dialogue about data and research, in order to contribute to the best possible treatment for Norwegian cancer patients.”

En forsker undersøker et celler fra en kreftsvulst. Illustrasjonsfoto: AstraZeneca

Nye kreftbehandlinger krever nye samarbeidsformer

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I et debattinnlegg i Aftenposten beskriver Sigbjørn Smeland, Steinar Thoresen og Ketil Widerberg hvordan Norge er i en internasjonal særstilling for godt samarbeid i helsesektoren.

This opinion piece was originally printed in the daily newspaper Aftenposten and is only available in Norwegian. / Debattinnlegget sto først på trykk i Aftenposten mandag 9. august, og kan også leses på aftenposten.no.

 

Innføring av nye legemidler for små pasientgrupper tar unødvendig lang tid. Noen blir ikke tatt i bruk i Norge i det hele tatt. Det er en utfordring.

Direktørene i helseforetakene mener hovedgrunnen er at legemiddelprisene er for høye i forhold til nytten for pasientene. Legemiddelindustrien (LMI) mener at store utviklingskostnader gjør at medisinene er dyre. Pasientorganisasjonene påpeker at byråkrati og prestisje går foran alvorlig syke.

Alle har rett. Likevel er ikke løsningen å argumentere videre i hver sin retning. Det trengs et nytt samarbeid mellom industri, myndigheter og pasientorganisasjoner.

Et nasjonalt samarbeid

Hoveddelen av nye legemidler innføres innen kreft. Her er det nylig etablert et nasjonalt samarbeid som heter Connect. Det skal nettopp forbinde alle oss som jobber med kreft, som legemiddelfirmaer, regulerende myndigheter, Kreftforeningen og sykehusleger.

Målet er å finne løsninger for å få tilgjengelig ny medisin til små pasientgrupper. Det kalles presisjonsmedisin. Connect omfatter både avansert diagnostikk og nye behandlingsmetoder. Det har som ambisjon å løfte frem nye prinsipper for finansiering av nye legemidler.

Innføring av presisjonsmedisin er på mange måter et puslespill. Vårt mål er å sette brikkene sammen til et helhetlig bilde som både er bra for pasientene, men som også skaper innovasjon og er innenfor rammene og prioriteringene vi har i Helse-Norge.

Presisjonsmedisin for små pasientgrupper innebærer at utviklingskostnadene deles på færre pasienter. Dette driver kostnadene oppover.

Dagens gullstandard ved innføring av nye medikamenter er randomiserte kliniske studier. Randomisering innebærer at behandlingene vi sammenligner i en studie, blir tildelt deltagerne helt tilfeldig. Det krever store pasientgrupper og er derfor ikke egnet som eneste grunnlag ved innføring av presisjonsmedisin.

Det illustrerer også en fordel med presisjonsmedisin: Kun et utvalg av pasientene vil bli tilbudt behandlingen, basert på analyser av kreftsvulsten. Det hindrer overbehandling, som vi ser i utstrakt grad i dag.

Lære fra hver pasient

Det er derfor nødvendig med felles utvikling av nye løsninger. Det betyr ikke at firmaer får automatisk godkjenning, eller at klinikere får alt de ønsker til pasientene. Regulerende myndigheter får nok heller ikke jobbe på den samme trygge måten som før. Dette blir et krevende samarbeid for alle parter.

Innføring av presisjonsmedisin i helsevesenet er en utfordring de fleste land sliter med. Samtidig er det en enorm mulighet for kostnadsbesparelser og forbedret omsorg. Et stikkord er «midlertidig godkjenning» under forutsetning av fortsatt kunnskapsgenerering.

For vi må lære fra hver eneste pasient. I Norge gjør vi fremskritt, for eksempel gjennom samarbeid om helsedata, tidlig innføring og ny nasjonal handlingsplan for kliniske studier. Myndigheter og industri finner i økende grad løsninger sammen.

Norge i en særstilling

I Norge kan vi etter samtykke samle informasjon fra blodprøver og overskuddsvev. Dette kan kobles opp mot helseopplysninger fra våre unike kvalitetsregistre. Ett eksempel er Kreftregisteret.

Her er vi internasjonalt i en særstilling. Det kan gi oss interesse fra legemiddelfirmaer og bidra til at flere kliniske studier kommer til Norge.

Men det vil kreve en satsing fra våre politikere. I dag mangler infrastruktur i storskala, og da spesielt drift av biobanker. Dette må på plass. Først da kan vi hevde at vi oppfyller målsetningen om at vi skal lære av hver eneste pasient.

Samarbeid mellom offentlig og privat sektor kan gjøre Norge mer interessant for klinisk utprøvning. Det kan igjen gjøre flere legemidler tidlig tilgjengelig for norske pasienter.

Alene redder det ikke liv. Alene skaper det heller ikke en ledende helsenæring i Norge. Men det hjelper betydelig på veien.

 

Artikkelforfattere:

Sigbjørn Smeland, Klinikkleder ved Oslo universitetssykehus, styreleder i Connect

Steinar Thoresen, Leder av Oncology I Norden og Baltikum i Merck, styremedlem i Connect

Ketil Widerberg, Leder av Oslo Cancer Cluster, styremedlem i Connect

Smiling and looking into the camera is Lars-Petter Strand, Head of Medical & Country Manager Norway og Gry Lønne Eriksson, Medical Advisor Hematology and Oncology, Novartis.Novartis

Novartis enters IMPRESS

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One of the largest pharmaceutical companies enters the precision cancer study IMPRESS in Norway.

Access to a broad portfolio of different medicines that can match molecular findings in a patient is important to succeed with the precision medicine approach of IMPRESS, Norway’s largest cancer study.

“We are very happy that Novartis is now contributing several of their medicines in the IMPRESS-Norway study. This means that Norwegian cancer patients can have more treatment opportunities in the study and that we can treat more patients based on molecular diagnostics. Novartis has many very interesting medicines. We count on more companies joining the study with their medicines soon,” said Åslaug Helland, National coordinator for IMPRESS-Norway and Head of Research at Oslo University Hospital.

 

Åslaug Helland is looking into the camera with a content smile, wearing a blue jacket and glasses.

Åslaug Helland is National coordinator for IMPRESS-Norway and Head of Research at Oslo University Hospital.

 

Six new medicines

Novartis is happy to support the IMPRESS study with six of its cancer medicines to treat up to one hundred patients. The first two Novartis medicines are ready for use this summer and the last four will probably be introduced during the autumn.

A broad collaboration with pharma partners for IMPRESS is important, both to Norwegian cancer patients who have run out of other treatment options, and to build stronger collaborations between public and private actors in the healthcare sector.

“Novartis is proud to contribute to the solutions of the challenges we are facing in the health ecosystem, including the implementation of personalized medicine. Through IMPRESS-Norway and the public-private collaboration in CONNECT, we wish to contribute to a culture for innovative and trusting partnerships with the health service – partnerships that are greater than the capacity and resources of each side alone. We are stronger together,” said Tarje Bergdahl, Nordic Medical Director Oncology Novartis.

Testing off-label treatments

IMPRESS-Norway is a national clinical study in precision cancer medicine, which is testing off-label treatments on cancer patients based on molecular changes in the patient’s tumour. Patients with advanced cancer disease can receive molecular diagnostics through InPreD (Infrastructure for Precision Diagnostics) and are discussed in a national molecular tumour board to provide optimal treatment for the individual patient. Patients who are eligible for the treatments available in IMPRESS are then offered to participate in the clinical study.

All the Norwegian hospitals that are treating cancer patients are part of IMPRESS, in total 17 hospitals, including the university hospitals. Of these sites, 8 are currently open for the study, the rest are opening in August and September. As of 1 July, 40 patients were included in the molecular profiling with a 500 gene panel, 18 patients were discussed in the national molecular tumour board and 7 patients were included with different treatments in the IMPRESS study.

Read more

  • The consortium CONNECT is linked to the clinical study IMPRESS and the Infrastructure for Precision Diagnostics InPreD. CONNECT has facilitated dialogue meetings between industry representatives and the two mentioned national initiatives IMPRESS and InPreD. CONNECT is coordinated by Oslo Cancer Cluster. Read more about CONNECT, the partners and recent activities here: The CONNECT website
  • Dagens Medisin has written about Novartis entering IMPRESS (in Norwegian) here: Flere legemidler tilgjengelig i IMPRESS-studien

 

Photo of Richard Stratford and Trevor Clancy in OncoImmunity.

Machine-learning for immunotherapy

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A prestigious EU-grant will advance OncoImmunity’s machine-learning approach to develop personalized cancer immunotherapy.

The bioinformatics company OncoImmunity AS is empowering cancer immunotherapy with artificial intelligence. They use innovative software solutions to guide the discovery of neoantigen-based personalized immunotherapies and biomarkers. What does this really mean?

It means that the software they have developed helps to identify neoantigens, also known as immunogenic mutations, in a patient’s cancer cells. Cancer cells deceive the immune system by looking like healthy cells. But they still express cancer-specific markers, known as neoantigens. (See facts box for explanation.)

 

Enables personalized medicine

The interesting part about neoantigens, is that every patient’s tumor expresses a unique combination. This enables truly personalized medicine to be applied, if the correct neoantigens are selected from the thousands of possible candidates in the genome of a tumor. Researchers using this technology can now solve this “needle in the haystack” challenge by analyzing a tumor genome to figure out the right cocktail of neoantigens, for each individual patient, and design a specific vaccine or cell therapy uniquely designed just for them.

Such personalized immunotherapy can for instance boost the immune system’s response by making the immune system better able to recognize and target the patient’s unique cancer cells.

 

Faster bespoke treatment

OncoImmunity’s flagship software, the ImmuneProfiler™, is a unique machine learning solution that makes it easier to instantaneously see and accurately select which neoantigens will be responsive in each patient.

It thereby helps biotech companies design neoantigen-based personalized cancer vaccines and cell therapies and enables bespoke treatments to be developed faster. Additionally, the technology allows clinical researchers to select which patients will likely respond to the wide range of cancer immunotherapies currently under development in the field.

In that sense, the OncoImmunity-approach to cancer treatment is exactly in line with Oslo Cancer Cluster’s main goal: to speed up the development of new cancer treatments for the benefit of cancer patients.

 

Prestigious EU-grant

Horizon 2020’s SME Instrument is a grant that is tailored for small and medium sized enterprises (SMEs). It targets innovative businesses with international ambitions — such as OncoImmunity.

The SME Instrument has two application phases. Phase one awards the winning company 50 000 Euros based on an innovative project idea. Phase two is the actual implementation of the main project. In this phase, the applicant may receive between 1 and 2,5 million Euros.

Oncoimmunity won the phase one project last year. Then, the founders of the bioinformatics company were happy about the opportunity to refine and optimize their machine-learning framework. Their goal has always been to facilitate personalized cancer vaccine design.

 

Fantastic funding

Now, they have won a considerably larger grant of 2,2 Million Euros that they are going to use to fund a project titled Machine-learning Engine for the Design of personalized Vaccines in Cancer (MEDIVAC).

The SME Instrument grant provides OncoImmunity the opportunity to further customise their machine-learning framework, called the ImmuneProfiler™,for specific vaccine platforms, facilitating the design of safer and more efficacious personalised cancer vaccines.

— We applied for the SME instrument grant as it represents a fantastic funding vehicle for cutting edge, innovative projects with huge commercial potential. The call matched our ambition to position OncoImmunity as the leading supplier of neoantigen identification software in the personalised cancer vaccine market, says Dr. Richard Stratford, Chief Executive Officer and Co-founder of OncoImmunity.

— This opportunity will also help us establish the requisite quality assurance systems, certifications, and clinical validation with our partners, to get our software approved as a medical device in both the EU and US, says Dr. Trevor Clancy, Chief Scientific Officer and Co-founder of OncoImmunity.

 

SMEs can apply

The SME Instrument is looking for high growth- and highly innovative SMEs with global ambitions. They are developing innovative technologies that have the potential to disrupt the established value networks and existing markets.

Companies applying for the SME Instrument must meet the requirements set by the programme. Please see the SME Instrument website for more information in English or the SME Instrument webpage of Innovation Norway for more information in Norwegian.

Curious about which companies have received the SME Instrument so far? Have look at this database with an overview of all the grant receiving companies in Europe.

Want to know which Norwegian companies received grants from The European Unions research programme Horizon2020 in 2018? Read this article from Innovation Norway (in Norwegian).

Oslo Cancer Cluster  supports members via the EU Advisor Program in collaboration with Innovayt, making them aware of relevant EU- and H2020 funding opportunities and helping them to identify the right calls for their development phase and goals. Oslo Cancer Cluster also assists with partner searches using national and international networks and provides direct support during the grant writing and submission process.