News from external sources

First demonstration of universal cancer vaccine

New data shows 27% improved survival for malignant mesothelioma patients in the NIPU trial.

Positive results from the NIPU trial announced last night show the combination of a universal cancer vaccine and checkpoint inhibitors in patients with malignant mesothelioma reduces the risk of death by 27%.

“For patients with malignant mesothelioma, few treatment options are available after first-line chemotherapy. The NIPU study showed that patients receiving UV1 vaccination as add-on to nivolumab and ipilimumab experienced an increased objective response rate and a clinically meaningful prolonged survival. These encouraging results provide a foundation for advancing further clinical development with UV1 vaccination in mesothelioma patients,” said Principal Investigator of the NIPU clinical trial, Professor Åslaug Helland, MD Ph.D.

Åslaug Helland, Principal Investigator of the NIPU clinical trial. Photo: Per Marius Didriksen, Oslo University Hospital

The ‘gold standard’

This is the first demonstration of the efficacy and therapeutic impact of a universal cancer vaccine in a Phase II trial. The universal cancer vaccine is the lead product of the Norwegian biotech company Ultimovacs, which is developing novel immunotherapies against cancer. The vaccine is currently being tested in five Phase II trials on different cancer indications.

“We are thrilled to announce the highly advantageous results from the first randomized UV1 Phase II trial, marking a major milestone for Ultimovacs. Overall survival is the ‘gold standard’ in cancer treatment. We believe these data support further development in mesothelioma, and we are looking forward to discussing the results with the regulatory authorities,” said Carlos de Sousa, CEO of Ultimovacs.

Carlos de Sousa, CEO of Ultimovacs. Photo: Ultimovacs

Since malignant mesothelioma is a hard-to-treat cancer, the positive results from the NIPU trial give cause for optimism in the ongoing Ultimovacs’ trials for other cancer indications too, including malignant melanoma, head and neck cancer, ovarian cancer, and non-small cell lung cancer.

In October 2023, the FDA ranted Orphan Drug Designation for UV1 in the treatment of mesothelioma, but there is still a way to go before the drug reaches the market. The treatment has to be assessed in a Phase III trial and undergo regulatory approval before becoming widely available.

Improved survival and response rate

Oslo University Hospital leads the NIPU study with support from Ultimovacs and Bristol-Myers Squibb. It includes 118 patients from Norway, Sweden, Denmark, Spain and Australia. The patients are in second-line treatment, which means they already received chemotherapy without beneficial results and have no other treatment options.

The patients were divided into two randomized groups: 59 patients received the universal cancer vaccine in combination with checkpoint inhibitors, and the other group received only checkpoint inhibitors. Results show that patients who received the universal cancer vaccine had a prolonged survival rate and a significantly better objective response rate. This means the patients lived longer and more patients’ tumours shrunk than in the control arm. In addition, the treatment showed no added side effects.

“We want to extend our gratitude to the patients and their families, as well as the dedicated investigators and all our supporters whose invaluable contributions made this study possible,” Helland commented.

For more information, please read the press release from Ultimovacs or follow the company’s webcast on Mon, Oct 23 2023 at 14:30 (CET).

Åslaug Helland receives cancer award

Norwegian cancer researcher dedicated to clinical trials receives prestigious prize.

Professor Åslaug Helland is the recipient of the King Olav Vs Cancer Research Award 2023. Helland is an oncologist and Research Director at Oslo University Hospital (Comprehensive Cancer Centre).

“This is a great honour, and I am very happy about this recognition of the research environment involved. I have been very fortunate working with lots of very talented people over the years!” Helland commented.

The cancer prize is awarded annually by the Norwegian Cancer Society, and it is the highest honour for Norwegian cancer researchers.

The international experts that evaluated the nominated for the prize, emphasized how Helland through her clinical studies has contributed to developing a more personalised treatment for cancer patients.

Innovation for patients

When asked what the biggest challenge right now for the development of cancer diagnostics and treatments in Norway is, Helland responded:

“The developments in cancer diagnostics and treatment over the past few years have been very good, and we need to continue securing the competence and development in all health regions. It is in many ways a new field, and building competence takes time.

“In addition, we need to find ways to offer new and innovative treatments to our patients, and to encourage more clinical trials in Norwegian hospitals. This is an obvious goal from both the public health care system and from the pharmaceutical and diagnostic industry, and by working together we achieve more!”

Leading the way for change

Helland is the Principal Investigator for IMPRESS-Norway, a national clinical study in cancer precision medicine, and Director of MATRIX, the Norwegian Centre for Clinical Cancer Research, as well as Leader for Nortrials. Helland’s key roles in these trailblazing initiatives show her commitment to continually improving cancer care.

“In the future, we have more options in diagnostics and treatment. The field is developing very rapidly, and the public healthcare system will develop to offer new and innovative treatments and diagnostics in a sustainable way. We also have improved decision support systems and improved follow-up programs for our patients,” said Helland.

Helland received the prize in the University Aula from His Majesty King Harald of Norway and in the presence of family, friends, colleagues and the general cancer research community.

Promising early data from Exact Therapeutics’ study

The company is investigating a new ultrasound technology for improved drug delivery.

Exact Therapeutics shared early data from two patients treated in the clinical study ACTIVATE at a Science and Technology event in Oslo this week.

The patients have colorectal cancer with liver metastases, a patient group with a high unmet medical need. They receive chemotherapy in combination with the company’s technology called ACT (short for Acoustic Cluster Therapy). The early results show that the patients had better responses to chemotherapy when their tumours were exposed to ACT.

“Results of the Phase I study have given us several insights, most importantly that the treatment did not reveal any unexpected side effects either on its own or worsen the side effects of chemotherapy in the treated patients. The results also suggest a positive tumour response associated with the ACT treatment. This trial will set the stage for diversifying the use of this technology platform to a wide range of systemic therapies across multiple tumour types,” commented Prof. Dr. Udai Banerji, the principal investigator of the ACTIVATE study.

Seven patients have been recruited to the study, currently active at The Royal Marsden Hospital and Newcastle Hospital. The company is also collaborating with radiologists at Oslo University Hospital to open another study site for Norwegian patients.

What is ACT?

Acoustic cluster therapy is a method for improved drug delivery, by using ultrasound technology and the company’s proprietary product consisting of microbubbles and microdroplets. The microbubbles and microdroplets have opposite charges and therefore form small clusters, which are injected into the patient’s blood.

When these clusters are exposed to ultrasound vibrations, the droplets evaporate into the bubbles and turn into larger “ACT bubbles”. These are temporarily trapped in the patients’ capillaries, the smallest blood vessels in the body. The ACT bubbles can then be manipulated with a different ultrasound wavelength that makes them oscillate. This stretches the wall of the blood vessel and creates shear forces and streaming in the tissue, so that the cancer drug can be delivered effectively to the tumour.

“Targeted ultrasound is an emerging treatment modality with a lot of interest. You need better methods for efficient delivery of drugs to the disease areas. Targeted ultrasound with ACT is non-invasive and can potentially be done for a number of treatments and indications,” commented Per Walday, CEO of Exact Therapeutics.

The Norwegian ultrasound story

There is a solid Norwegian research tradition within ultrasound, both in medical technology and pharmaceutical diagnostics.

For example, the company Vingmed Ultrasound was built on Norwegian science and technology, and established as a start-up in 1986 developing medical ultrasound diagnostic equipment. The company was later acquired by GE Healthcare and this segment today generates 3 billion dollars in revenue.

Another success story is the company Nycomed, which was also founded on deep science in Norway, and created contrast agents in a variety of forms for diagnostic purposes. Nycomed ended up achieving market leadership and was acquired by GE Healthcare. Today, this is a 2-billion-dollar revenue business.

“Norway is a true global leader in this field, not only in technology and science, but also in business. The medtech and pharmaceutical components are key to us. Exact Therapeutics was spun-off from the pharma business in GE Healthcare. We have agreements with GE Healthcare on development and manufacturing. These are the two building blocks and the foundation for Exact,” commented Anders Wold, Chairman of the Board, Exact Therapeutics.

Potential with immunotherapy

The potential of the technology to enhance the effect of a range of cancer immunotherapies will now also be explored, thanks to a grant of NOK 16 million from the Norwegian Research Council.

“The tumour microenvironment plays a key role in the response to cancer therapies, especially immunotherapy. The majority of cancer patients still do not respond to immunotherapy. The holy grail in this field is to make cold tumours hot and the key is to modify the tumour microenvironment. We hope to achieve this with the ACT treatment,” commented Walday.

Per Walday, CEO, at Exact Therapeutics’ Science and Technology event. Photo: Sofia Linden / Oslo Cancer Cluster

The research project will be performed in collaboration with the Norwegian University of Science and Technology (NTNU), the Institute of Cancer Research at the Royal Marsden Hospital in London and the Translational Genomics Research Institute, part of City of Hope, in Phoenix.

EU wants more Comprehensive Cancer Centres

Oslo University Hospital will help in the preparation and creation of more Comprehensive Cancer Centres.

There are significant inequalities across Europe in cancer prevention, diagnosis, treatment and care, and access to clinical trials. In addition, patients that are diagnosed and treated in research-active hospitals have better outcomes than patients treated in general hospitals.

This is why the European Union has an ambition that 90% of eligible patients have access to Comprehensive Cancer Centres by 2030. This is one of the goals in Europe’s Beating Cancer Plan, which was launched by the European Commission last year and has 4 billion euros earmarked for cancer.

As part of a Joint Action programme for the preparation and creation of more Comprehensive Cancer Centres, Oslo University Hospital has been selected, together with Institut National du Cancer in France, for a central work package, that will look at the framework for building Comprehensive Cancer Centres.

Oslo University Hospital is currently the only Comprehensive Cancer Centre in Norway.

Click here to read more about the Joint Action


About EU Cancer Mission

The Europe’s Beating Cancer Plan & the Mission on Cancer have the ambitious goal to improve the lives of three million Europeans by 2030. This will be achieved through better understanding of cancer, prevention, early diagnosis, personalised treatment, and improved quality of life during and after treatment.