News regarding Norwegian oncology clinical trials

Attracting clinical trials to Norway

Dr. Jon Amund Kyte at Oslo University Hospital (OUH) and Oslo Cancer Cluster share the common goal of bringing more clinical trials to Norway.

 

Jon Amund Kyte is the new Head at the Department of Experimental Cancer Treatment at OUH. He also runs three separate clinical trials and is the leader of a research group at the Department of Cancer Immunology, where he develops novel CAR T cell therapy and conducts translational studies.

Kyte aims to increase the number of and improve the quality of clinical trials in Norway. He says this will contribute to more patients gaining access to novel cancer treatments and to improving the efficacy of cancer therapies.

“The only way to improve cancer treatment is to have clinical trials,” said Kyte.

Oslo Cancer Cluster also wants to bring more clinical trials to Norway to develop innovative cancer medicines. The ambition is to enable faster patient recruitment from across the Nordic region, so that many more can benefit from new treatments, such as immunotherapy.

 

CAR T cells are produced by isolating specific cells of the immune system (T cells) from a cancer patient and modifying them so that they become more effective at recognizing and killing cancer cells.

 

Promising advances

Immunotherapy represents a new type of cancer treatment, which activates the patient’s immune-system to fight off the cancer cells. It gives doctors the opportunity to help patients that previously had limited treatment options. Most types of immunotherapy also cause less side effects than traditional cancer treatments.

“The important point is that immunotherapy can have a long-term effect,” said Kyte.

“Most patients that experience a recurrence or progression of the disease cannot be cured. The traditional treatments only have a limited, short-term effect on them. But immunotherapy may have a long-term effect on the patient – and, in some cases, even cure the disease.”

 

Two big challenges

Immunotherapy may sound like a miracle drug, but researchers still have a long way to go to perfect the treatment for all cancer patients. Kyte highlights two of the biggest barriers that remain.

“One challenge is to develop immunotherapy so that it works efficiently on all types of cancer. The other challenge is to learn how to choose personalised treatment plans: to identify an individual’s biomarkers and find out which treatment will be effective for that specific patient.”

A biomarker is a biological molecule in the patient’s body and these may be used to see how well a patient will respond to a certain treatment. Kyte said that to develop immunotherapy, there needs to be more clinical trials. It is the only way for researchers to find out how to activate an immune response in the patient’s body.

“A big potential for development lies in trying different possible combinations of cancer treatments. In my clinical trials, for example, we combine immunotherapy with immunogenic chemotherapy or radiation therapy,” Kyte explained.

 

Jon Amund Kyte presenting the Clinical Trial Unit.

The Clinical Trial Unit are experts in assisting companies and researchers to conduct clinical trials in Norway.

 

Welcome, companies

OUH has a long history of conducting clinical trials and is an appealing option for both researchers, doctors and companies that wish to initiate their own trials. Kyte welcomes more companies to conduct clinical trials at OUH:

“The more clinical trials that are conducted here by companies, the stronger our clinical research environment becomes and our ability to run our own studies is also strengthened.”

The Clinical Trial Unit in Kyte’s department offers its services to companies that want to run a clinical trial at OUH. They have extensive background knowledge of how the hospital is organised and which approvals are needed to conduct a clinical trial in Norway. They can step in as project coordinator for companies that need help to get their clinical trials up and running.

“We are highly experienced in applying for approvals in Norway. When you run a clinical trial, there are regulations from the Norwegian Medicines Agency and the ethical committee and other governmental agencies. A clinical trial also involves many different parts of the hospital – the departments of pathology and radiology, the laboratories, the infusion unit, the hospital wards and out-patient clinic and the administrative offices that oversee different agreements, data management and biobanking.”

 

Nordic clinical trials

All these administrative obstacles may appear discouraging, but there are many convincing reasons to conduct a clinical trial in Norway.

“The Oslo University Hospital is a good place to run a clinical trial, because in terms of the number of cancer patients, it is one of the largest hospitals in Europe. Norwegian healthcare is also extremely well-organised. Patients are rarely lost to follow-up, because there are no private healthcare alternatives and patients rarely move out of the country,” Kyte explained.

The Clinical Trial Unit is also taking part in the development Nordic Nect, a collaboration to recruit patients from the entire Nordic region to clinical trials. The plan is to have one hospital where the clinical study is conducted and to involve patients from Sweden, Denmark, Finland and Norway. There will then be a population of 25 million people from which to recruit patients, which opens the possibility for larger clinical trials.

“This is a good thing for the companies that want to run clinical trials in Norway. It is also good for the researchers. But most of all, it is good for the patients – who have the opportunity to take part in more novel cancer treatments,” said Kyte.

 

 

 

 

Hands cradling female reproductive system

New collaboration aims to treat cervical cancer

The companies Vaccibody and Roche have started a new collaboration to investigate a drug combination to treat patients with advanced cervical cancer.

Both companies are members of Oslo Cancer Cluster and are involved in the development of novel cancer treatments.

Martin Bonde, CEO of Vaccibody, said: “We are very pleased with this collaboration. This is an important study as it explores a novel targeted treatment approach that addresses the high medical need of patients with advanced cervical cancer.”

Cervical cancer is the most commonly occurring cancer among women in developing countries and is the second most commonly occurring cancer amongst women worldwide.

Vaccibody is a vaccine company that aims to develop and discover new immunotherapies to treat difficult forms of cancer. They have developed a therapeutic DNA vaccine that treats cancers caused by HPV (the human papillomavirus).

Cervical cancer is caused by high risk HPV. HPV16 is the type that most frequently causes cancer.

Immunotherapy is a type of cancer treatment that aims to switch on a patient’s immune system to kill cancer cells.

Roche is a healthcare company that has developed an immune-checkpoint inhibitor. Now Vaccibody wants to test their vaccine in combination with the immune-checkpoint inhibitor designed by Roche.

An immune checkpoint inhibitor is a type of drug that blocks certain proteins made by some types of cancer cells. When these proteins are blocked, the “brakes” on the immune system are released and T cells are able to kill cancer cells better.

Agnete Fredriksen, President and CSO of Vaccibody, said that the combination of the two drugs build on the positive results seen when their vaccine has been used on patients with cervical cancer. Therefore they now expect to see positive results when they combine the vaccine with an immune checkpoint inhibitor.

During the second half of 2019, Vaccibody expects to begin the phase II study, which will involve 50 patients. It will assess the safety of the drug, its ability to invoke a response in the immune system, how the patients tolerate it and how efficient the drug is. The group for this new drug combination involves patients with advanced cervical cancer.

 

Raised NOK 230 million

Vaccibody also raised NOK 230 million (EUR 23.6 Million) in a private placement the same week. The sum was indeed placed all within one day, according to Agnete Fredriksen.

The proceeds from the share sales will be used to conduct the phase II clinical study of the drug combination from Vaccibody and Roche. The money will also go to the preparation of expansion patient groups in Vaccibody’s clinical trials and to generate corporate purposes.

 

For more information, read the press release from Vaccibody.

 

PCI Biotech granted NOK 13.8 million from the Research Council

Our member PCI Biotech has been granted NOK 13.8 million to the project “Photochemical vaccination – novel immunotherapy concept for treatment of cancer and infectious diseases”.

The main goal of the project is to document in a proof-of-principle clinical study in cancer patients that PCI Biotech’s photochemical internalization (PCI) technology can be used to improve the efficacy of a therapeutic cancer vaccine. Other important aspects of the project is to develop the PCI technology for use in vaccination against certain types of viral and bacterial infections, and to explore the technology for use with mRNA-based vaccination.

‘This grant supports further development of the promising fimaVacc technology, as well as the important vaccination application of the fimaNAc technology. Both of these applications are well suited for the development of new types of immunotherapy against cancer, and also for the prevention and treatment of some types of infectious diseases, including certain types of chronic virus infections. We are very pleased to see that the expert evaluators and the Research Council share our view on the potential of these technologies.’ says CEO in PCI Biotech, Per Walday.

The project will be initiated in Q3 2017 and run for three and a half years. The grant will cover up to 35% of the project costs and the project will be implemented in the company’s current plans. The grant is subject to final contract negotiations.

Established in 2006, the BIA programme is the largest industry-oriented programme at the Research council of Norway (Forskningsrådet). This broad-based programme supports high-quality R&D projects with good business and socio-economic potential.

About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fimaChem (enhancement of chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery).

www.pcibiotech.no

Doctor caring for elderly patient.

Help define gene panel

The Norwegian Research Council-financed project NCGC are joining forces with Norwegian Cancer Registry to establish a research platform for tumor-profiling in recruiting patients for clinical trials.

The objective is to make Norway an even more attractive location for the industry and to meet the industries specific needs. The first step in this work is to define a gene panel. In this connection the project team wants to get in contact with Oslo Cancer Cluster members who can give feedback on what targets should be included.

For more information, please contact:

More about NCGC here: cancergenomics.no 

PCI Biotech with positive opinion for Orphan Drug Designation

Oslo Cancer Cluster member PCI Biotech has received positive opinion from the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) for its lead product candidate, fimaporfin. Firmaprofin is intended to be used in the treatment of bile duct cancer,  cholangiocarcinoma.

Fimaporfin (AmphinexTM) is in clinical phase I/II development for inoperable bile duct cancer, a disease without approved medicinal treatment and a high need of better local treatment alternatives.

 

About bile duct cancer (cholangiocarcinoma)  
The bile duct drains bile from the liver into the small intestine. Biliary tract sepsis, liver failure and/or malnutrition and cachexia due to locoregional effects of the disease are the most important causes of death. Currently, surgery is the only curative option for these patients; yet the majority of the tumors are inoperable at presentation. Inoperable patients are treated with stenting to keep the bile duct open and with chemotherapy. The combination of gemcitabine and cisplatin has shown promising results and has become standard treatment in some regions, but there is still a need for better treatments to increase overall survival and quality of life.

 

About PCI Biotech         
PCI Biotech is a cancer focused biopharmaceutical company headquartered in Norway and listed on the Oslo Stock Exchange (Axess). The company is developing therapeutic products based on its proprietary photochemical internalisation (PCI) technology. The PCI technology works by inducing triggered endosomal release and may be used to unlock the true potential of a wide array of therapeutic modalities, such as small molecules, vaccines and nucleic acids.  The company has a clinical Phase I/II program in bile duct cancer.

The company is also developing PCI as a vaccination technology. When applied in the emerging field of cancer immunotherapy, PCI can be used to enhance the important cytotoxic effect of therapeutic cancer vaccines. The PCI technology is also very well suited for intracellular delivery of nucleic acids, such as RNA therapeutics. By releasing nucleic acid compounds from endosomes where they are trapped following administration, PCI addresses one of the major bottlenecks facing this emerging and exciting field.  PCI Biotech follows a strategy to create value by improving the effect of existing cancer drugs and by realising the large potential in new therapeutics.

 

Targovax presents encouraging preclinical data on ONCOS-102

The International Journal of Cancer has recently published preclinical in vivo data in a mesothelioma xenograph model, demonstrating synergy of ONCOS-102 with pemetrexed and cisplatin, the current standard of care in malignant pleural mesothelioma. 

 

“These findings give a strong rationale for the clinical testing of ONCOS-102 in combination with pemetrexed and cisplatin in patients suffering from malignant mesothelioma. In fact, we recently started a clinical trial in malignant mesothelioma where this combination will be evaluated” says Lukasz Kuryk of Targovax Research & Development.

Malignant mesothelioma is a rare cancer type, often caused by exposure to asbestos. There are no curative treatments, although surgery, chemotherapy and radiotherapy can sometimes help to improve patient prognosis and life expectancy. Pemetrexed and cisplatin is the standard of care chemotherapy for malignant mesothelioma, but the median PFS/OS (progression-free survival/overall survival) from the initiation of treatment is only approximately 12 months.

ONCOS-102 is a purposefully engineered human serotype 5/3 adenovirus coding for human GM-CSF optimized to induce a systemic anti-tumor T-cell response in cancer patients. In a previous Phase I trial, ONCOS-102 treatment induced tumor specific immune activation both at systemic and lesional level. The immune activation was associated with clinical benefit.

In the present preclinical study, an evaluation was made of the antitumor activity of combination treatment with chemotherapy (pemetrexed, cisplatin, carboplatin) and ONCOS-102 in a xenograft BALB/c model of human malignant mesothelioma. The study demonstrated that ONCOS-102 is able to induce immunogenic cell death of human mesothelioma cell lines in vitro and showed anti-tumor activity in the treatment of the in vivo xenograft model. While chemotherapy alone showed no anti-tumor activity in the xenograph model, ONCOS-102 slowed down the tumor growth. When both ONCOS-102 and chemotherapy were combined, a synergistic anti-tumor effect was observed.

Targovax is currently studying ONCOS-102 in combination with pemetrexed and cisplatin in a randomized Phase Ib/II clinical trial of up to 30 patients with malignant pleural mesothelioma. The trial has a phase Ib safety lead-in cohort of 6 patients. The trial dosed its first patient in June 2016. During 2016, Targovax will also initiate three other clinical trials in various solid tumor indications to study ONCOS-102 in combination with other treatments such as immune checkpoint inhibitors and DC therapy.

 

About Targovax:
Arming the patient’s immune system to fight cancer

Targovax is a clinical stage immuno-oncology company developing targeted immunotherapy treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio and aims to become a world leader in its area. The company is currently developing two complementary and highly targeted approaches in immuno-oncology.

ONCOS – 102 is a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors. This treatment is designed to reactivate the immune system’s capacity to recognize and attack cancer cells.

TG01 and TG02 are part of a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of pancreatic cancers, 50% of colorectal cancer and 20-30% of all cancers. Targovax is working towards demonstrating that TG vaccines will prolong time to cancer progression and increase survival.

These product candidates will be developed in combination with multiple treatments, including checkpoint inhibitors in several cancer indications. Targovax also has a number of other cancer immune therapy candidates in the early stages of development.

Find more info on www.targovax.no 

 

Targovax recruits the first patient in a trial with the oncolytic virus ONCOS-102 in malignant pleural mesothelioma

Oslo 1 July 2016: Targovax today announced that the first patient has been dosed in a phase Ib/II clinical trial evaluating ONCOS-102 for the treatment of malignant pleural mesothelioma (MPM), a rare type of cancer in the lining of the lung, in combination with pemetrexed and cisplatin.

 

“New therapies are needed to provide better care for patients with mesothelioma, a highly malignant cancer with poor prognosis” says Dr Magnus Jaderberg, CMO of Targovax. “This clinical trial will provide data to evaluate the efficacy and safety of ONCOS-102 in first and second line mesothelioma patients, and we hope that our immunotherapy can provide additional benefit to chemotherapy, the existing standard of care.,

 

“In addition, treating the first patient in the first oncolytic virus trial of the merged company is of course an exciting moment for Targovax and all its stakeholders” adds Dr Jaderberg.

 

The trial is a randomized phase I/II clinical trial of 30 patients, with a phase Ib safety lead-in cohort of six patients, in first line and second line MPM patients who are eligible for treatment with pemetrexed and cisplatin. The trial’s main objectives are determination of safety, immune activation at lesional level and in peripheral blood, clinical response and the correlation between clinical outcome and the immunological activation. Several investigational sites in Europe will participate in this study. In addition to this trial, Targovax plans to initiate three immunotherapy combination trials with ONCOS-102 and one with its RAS peptide vaccine TG02 during the second half of 2016.

 

Malignant mesothelioma is a rare type of cancer often caused by exposure to asbestos. There are no curative treatments although surgery, chemotherapy and radiotherapy can sometimes help to improve patient prognosis and life expectancy. Pemetrexed and cisplatin is the only standard of care chemotherapy for malignant mesothelioma, but the median PFS/OS (progression-free survival/overall survival) from the initiation of treatment is only approximately 12 months.

 

ONCOS-102 is a purposefully engineered human serotype 5/3 adenovirus coding for human GM-CSF optimized to induce systemic anti-tumor T cell response in cancer patients. In a previous Phase I trial, ONCOS-102 treatment induced tumor specific immune activation both at systemic and lesional level. The immune activation was associated with clinical benefit.

For further information, please contact:

 

Gunnar Gårdemyr, CEO
Phone: +46 73 083 77 79
Email: ggardemyr@targovax.com

 

Øystein Soug, CFO
Phone: +47 906 56 525
Email: oystein.soug@targovax.com

 

Arming the patient’s immune system to fight cancer
Targovax is a clinical stage immuno-oncology company developing targeted immunotherapy treatments for cancer patients. Targovax has a broad and diversified immune therapy portfolio and aims to become a world leader in its area. The company is currently developing two complementary and highly targeted approaches in immuno-oncology.

 

ONCOS – 102 is a virus-based immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes targeting solid tumors. This treatment is designed to reactivate the immune system’s capacity to recognize and attack cancer cells.

 

TG01 and TG02 are part of a peptide-based immunotherapy platform targeting the difficult to treat RAS mutations found in more than 85% of pancreatic cancers, 50% of colorectal cancer and 20-30% of all cancers. Targovax is working towards demonstrating that TG vaccines will prolong time to cancer progression and increase survival.

 

These product candidates will be developed in combination with multiple treatments, including checkpoint inhibitors in several cancer indications. Targovax also has a number of other cancer immune therapy candidates in the early stages of development.

Photocure: First patient enrolled in Hexvix®/Cysview® Phase 3 study on bladder cancer

Oslo Cancer Cluster member Photocure announces that the first patient has been enrolled in the Hexvix/Cysview Market Expansion Phase 3 study on bladder cancer. The study will investigate the use of Hexvix/Cysview in the outpatient / surveillance setting and is designed to fulfill the FDA post marketing commitments. Results from the Phase 3 study are expected to be available in 2017.

The study is a prospective, multicenter Phase 3 study comparing the detection and potential positive impact on patient management of bladder cancer in the outpatient setting with Hexvix/Cysview using Blue Light enabled flexible cystoscopy versus white light flexible cystoscopy. Eighteen top rated cancer hospitals in the USA will participate in the study, which is planned to enroll approximately 360 patients with non-muscle invasive bladder cancer.

There are approximately 1.2 million flexible cystoscopy procedures conducted on a yearly basis in the United States. The use of Blue Light Flexible Cystoscopy with Hexvix/Cysview in the outpatient / surveillance setting could allow Urologists to detect recurrences at an earlier stage, which is of great clinical benefit. Furthermore, as has been demonstrated with the current use of Hexvix/Cysview during bladder cancer resection with blue light rigid cystoscopes, the addition of Hexvix/Cysview in the surveillance of bladder cancer patients may lead to better and earlier patient management decisions resulting in improved clinical outcomes and health economic savings.

Dr. Raj Pruthi, Professor and Chair, Department of Urology, University of North Carolina, Chapel Hill said: “The positive benefits of Hexvix/Cysview are well documented in numerous trials for patients undergoing bladder cancer resections during cystoscopy examination in the operating room. We are looking forward to conducting the study with Blue Light Flexible Cystoscopy with Hexvix/Cysview to confirm the benefits of this technology also in the outpatient setting. Early detection of more lesions is expected to result in better treatment decisions as well as more appropriate referrals and follow-up regimens, which in turn will reduce the burden on patients and the health care system.”

Kjetil Hestdal, President & CEO said: “This is an important milestone for Photocure as we seek to expand the use of Hexvix/Cysview into the bladder cancer surveillance market. Enabling Blue Light flexible cystoscopy with Hexvix/Cysview in the surveillance setting will allow patients with non-muscle invasive bladder cancer access to optimal treatment earlier, resulting in improved long-term benefits for these patients. While this trial is ongoing in the USA, we will be obtaining additional clinical and health economic data in EU from the use of Hexvix/Cysview in the same setting in order to optimize best clinical practices and patient outcomes.”

For more information about the clinical trial: https://clinicaltrials.gov/ct2/show/NCT02560584

 

 

About Photocure ASA

Photocure ASA, headquartered in Oslo, Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology® platform, Photocure develops and commercializes highly selective and effective solutions in disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, colorectal cancer and skin conditions. Our aim is to provide solutions that can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.

About Hexvix®/Cysview®

Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an innovative breakthrough technology in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue-light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white-light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence. Hexvix®/Cysview® is approved in Europe, Canada and the USA.

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)

Great media interest in immunotherapy against cancer

On June 11 Oslo Cancer Cluster and  Norwegian Cancer Society arranged a breakfast meeting on immunotherapy against cancer. Norwegian media showed huge interest in the topic. Below we have collected some of the coverage – and we know more is coming.

Oslo Cancer Cluster events on World Cancer Day

February 4th is World Cancer Day. Oslo Cancer Cluster will pay tribute to this day by arranging a breakfast meeting at Litteraturhuset together with LMI. This breakfast meeting is the first of a series of three political breakfast meetings in 2015, addressing  the topic “Future cancer treatment – how to secure Norwegian cancer patients the best treatment in the future?”

Our first breakfast meeting on World Cancer Day, February 4th, address “clinical cancer studies”: Why is clinical cancer studies important to convey in Norway, what are the unique advantages for conducting studies in Norway and in what way are experimental cancer studies a vital part of access to the latest treatment available for cancer patients not responding to standard treatments.

The political breakfast meetings aim to contribute to ensure that Norwegian cancer patients receive a treatment that is on par with the best internationally, to ensure political involvement and come up with concrete proposals for improving the framework conditions for Norwegian cancer research- and treatment.

Target groups for the meetings are health politicians and authorities, members companies from Oslo Cancer Cluster and LMI, patients and everyone interested in the topics.

The meeting is open for the public and free of charge. Please register here.

 

Afternoon member meeting
On World Cancer Day we also arrange the first member meeting of 2015, addressing the topic og conjugated antibodies. Program will follow – but you may already register here. Please note that this is a meeting only for members of the Oslo Cancer Cluster.