Come learn more about cancer

The Radium Hospital Research Foundation is part of the Oslo Innovation Week and Forskningsdagene with no less than three seminars on cancer together with the Norwegian Cancer Society, Oslo Cancer Cluster and IBM Norge

Come join us for updates from a broad range of Nordic experts on three vital topics related to cancer; the threat from antibiotic resistance, past and future innovations within cancer treatment and how Big Data may transform the way cancer treatments are developed. All seminars are free and open for all.

Wednesday 27.september 8:00 – 10:30 (am)
Breakfast meeting on “Antibiotic resistance and cancer”

Cancer patients need antibiotics to survive treatment. However, on the basis of some preliminary investigations, the knowledge of how antibiotic resistance will affect cancer treatment is limited.

Antibiotic resistance is considered one of the world’s biggest threats to public health. On a global scale, antibiotic resistance could mean 10 million annual deaths in the year 2030 according to WHO.

Wednesday 27. september 17:00 – 21:00 (pm)
Evening seminar on “Cancer innovation and benefit for patients”

Globally, nearly 1 in 6 deaths is due to cancer. The number of new cases is expected to rise by about 70% over the next 2 decades, according to the World Health Organisation, WHO. Even though the future may look look grim, more people than ever survive cancer due to new innovations within diagnostics, treatment and the use of technology.

Spend some time with us in the Norwegian Cancer Society’s Science Centre to get popular scientific, down to earth explanations from Nordic experts on what breakthroughs we will see within cancer care and treatment. We urge the audience to ask questions, comment and discuss with the presenters.

This event is supported by the Research Council of Norway.

Thursday 28.september 8:00 – 10:30 (am)
How Big Data may transform the development of cancer treatments

In this seminar we address how Big Data and data analytics may transform the way cancer treatments are developed. Is the use and implementation of technology based on Big Data the key to treat cancer in the near future? What are the benefit for the cancer patients? How may start-ups contribute? Can Norway adopt the Finnish model?

Representatives from Innovation Norway and Research Council in Norway and and the private sector, will debate how the public and private sector may work together to maximize the potential Big Data represents to drive innovations within the cancer field.

Photocure with revenue growth of 55% in the US

Our portfolio company Photocure reports a Hexvix/Cysview revenue growth of 10% to NOK 37.6 million in the second quarter of 2017 . The company reported a revenue growth of 55% for the important US market, were Photocure recently has announced several significant developments.

“Our second quarter report shows significant progress for our US business. US is a market of strategic importance for Photocure and we were delighted to present in May positive results from our Phase 3 study in the bladder cancer surveillance setting at the AUA meeting. These data formed the basis for our recent sNDA filing aimed at expanding the label for BLC with Cysview in the US to include the broader surveillance segment. Furthermore, after the quarter, we were very pleased to learn that CMS proposes to reimburse Blue Light Cystoscopy with Cysview from 2018, with a final decision expected later this year. We and our supporters have worked tirelessly to secure better reimbursement for Cysview in US and believe it will lead to increased access and allow better management for bladder cancer patients in the future,” says Kjetil Hestdal, President and Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 39.3 million in the second quarter of 2017 (35.5), with a recurring EBITDA of NOK -4.4 million (-2.3). Net profit was NOK -4.7 million (18.1), while the cash position ended at NOK 137.0 million. Global in-market unit sales of Hexvix/Cysview decreased 2% in the second quarter, impacted by a reduction of the partner business of 6% in the quarter. The sales development in the US was strong with a unit sales increase of 37%. The EBITDA for the Hexvix/Cysview commercial franchise ended at NOK 4.7 million in the second quarter of 2017.Photocure has built considerable experience in the urology sector through its Hexvix/Cysview franchise and sees significant long-term value creation potential in this market segment.

The company aims to capitalize on the inclusion in the AUA guidelines, as well as the increased patient awareness and the possible changes to reimbursement of Cysview, to significantly increase penetration in the US market.Photocure reported in the second quarter that the Phase 3 study of Hexvix/Cysview in the surveillance patient segment met its primary endpoint and other major endpoints. Based on this, the company has submitted an sNDA to the US FDA, with a possible approval in 2018, for use of Blue Light Flexible Cystoscopy with Cysview in this out-patient surveillance setting.CMS (United States Centers for Medicare & Medicaid Services) released in July the Proposed Rule outlining its 2018 plan to reimburse hospital outpatients departments using Blue Light Cystoscopy with Cysview. The comment period for the proposed rule closes in early September, and CMS is expected to issue a Final Rule in the fourth quarter of 2017 effective on 1 January 2018.

“Photocure believes that in order to increase market shares in the US, an investment in the US salesforce is required. As stated previously, the company plans to double its salesforce from 2016 and increase sales and marketing expenses towards the end of 2017. The goal of these efforts is to quadruple the revenues from the US operations to a range of USD 15 million by 2020. The company is fully funded for this market strategy”, says Hestdal.

Source: Photocure

Nordic Nanovector on track to start PARADIGME

Our portfolio company Nordic Nanovector reports that all operations are on track, strong data presented at ICML confirm Betalutin®’s promising efficacy and safety profile in recurrent iNHL patients and pivotal Phase 2 study, PARADIGME will start in 2H 2017.

Nordic Nanovector reported continued solid operational progress during the second quarter, with very encouraging clinical results from the ongoing Phase 1/2 study with Betalutin® presented at the International Conference on Malignant Lymphoma (ICML) in June.

These results continue to highlight the significant potential of single dose Betalutin® for the treatment of recurrent indolent non-Hodgkin’s lymphoma (iNHL) and provide confidence that the company is on track to initiate the pivotal Phase 2 study, PARADIGME, in the second half of 2017. A phase 1 dose-escalation study in diffuse large B-cell lymphoma (DLBCL) is actively enrolling patients, and initial preparations for Phase 2 combination study of Betalutin® and rituximab as well as a Phase 1 study of Humalutin™ in iNHL patients are progressing.

 “We are very pleased with progress made during the first half of 2017 and we continue to be very encouraged by the strong data presented at ICML in June, which support Betalutin®’s potential in the treatment of patients with iNHL. The team has worked hard to lay a strong foundation for a busy and exciting second half to the year, when we anticipate initiating several new clinical studies, including the Phase 2 PARADIGME study,” comments Luigi Costa, CEO of Nordic Nanovector.

Operational Highlights Q2’17

• Progress continues as planned towards start of the pivotal Phase 2 study, PARADIGME in 2H 2017, to investigate Betalutin® in patients with relapsed FL

• Results presented at ICML in June highlight strong clinical profile of single dose Betalutin® in recurrent iNHL patients
o Single dose Betalutin® is highly active in recurrent iNHL, especially in FL
o Well-tolerated, no unexpected safety findings, predictable and manageable safety profile

• Safety Review Committee recommends enrolling new patients into a Phase 2 expansion cohort of Arm 4
o To validate whether a higher lilotomab pre-dosing regimen may enable the use of a higher dose of Betalutin®

• Recruitment of DLBCL patients into Phase 1 dose-escalation study with Betalutin® ongoing
o The study is actively enrolling patients in the US and Europe

• Preparations advancing for Phase 2 clinical trial to investigate the potential of Betalutin® combined with rituximab in 2nd line FL
o Phase 2 trial expected to begin in 2H 2017

• Preparations advancing for Phase 1 clinical study to investigate potential of Humalutin™ for treating 1st line NHL
o Phase 1 trial expected to begin in 2H 2017

Events after Q2’17

• Dr. Reza Safaei, former Head of Medical Affairs, Europe with Seattle Genetics, appointed as Head of Medical Affairs

Financial Highlights Second Quarter 2017
(Figures in brackets = same period 2016 unless otherwise stated)
• Revenues for the second quarter amounted to NOK 0.1 million (NOK 0.1 million). Revenues for the first half of 2017 were NOK 0.1 million (NOK 0.2 million).
• Total operating expenses for the second quarter were NOK 76.3 million (NOK 48.1 million). Total operating expenses for the first half of 2017 amounted to NOK 142.1 million (NOK 100.9 million)
• Comprehensive loss for the second quarter amounted to NOK 66.3 million (loss of NOK 51.1 million). Comprehensive loss for the first half was NOK 122.1 million (NOK 115.2 million)
• Cash and cash equivalents amounted to NOK 881.4 million at the end of June 2017 (NOK 933.3 million at 31 March 2017 and NOK 1 018.2 million at 31 December 2016)

Outlook
Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers. It intends to achieve this by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Nordic Nanovector’s operations remain on track. The company intends to maximise the value of Betalutin® across all stages of NHL and other haematological cancer indications. The company has made initial steps in preparing for the commercialisation of Betalutin®. A further element of Nordic Nanovector’s strategy is to selectively extend its pipeline of novel targeted biopharmaceutical candidates to support future growth.

The profile of Betalutin® is well differentiated within the competitive landscape. Promising preliminary results and good progress in the LYMRIT 37-01 clinical study give the company confidence that it is on track to initiate the pivotal Phase 2 PARADIGME trial during the second half of 2017. Management will continue to focus its efforts on the efficient execution of its plans and to meet clinical milestones.

Current cash resources are expected to be sufficient to take the company beyond a first regulatory submission for Betalutin® in FL in the first half of 2019 and to meet value-generating clinical milestones in its other programmes.

About Nordic Nanovector:
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The company aspires to become a leader in the development of targeted therapies for haematological cancers.

Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37-targeting Antibody-Radionuclide-Conjugate (ARC) designed to advance the treatment of non-Hodgkin’s Lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 20 billion by 2024.

The Company aims to rapidly develop Betalutin®, alone and in combination with other therapies, for the treatment of major types of NHL, targeting first regulatory submission in relapsed/refractory follicular lymphoma in 1H 2019. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.

The Company is also advancing a pipeline of ARCs and other immunotherapies for multiple cancer indications.

Further information about the Company can be found at www.nordicnanovector.com

Vi er på Arendalsuka

Jónas Einarsson, administrerende direktør i Radiumhospitalets Forskningsstiftelse skal delta på tre debatter under Arendalsuka.

Det er viktige og aktuelle temaer som kliniske studier, et todelt helsevesen og norske kreftpasienters tilgang til den best mulige kreftbehandling, som Einarsson skal være med å debattere.

Hør Einarsson her i Arendal: 

Sustainable, Innovative Healthcare
Tirsdag 15. aug kl 15 – 16:30 på Clarion Hotel Tyholmen

Et bredt panel skal her diskutere hvordan vi kan oppnå et bærekraftig helsevesen, ikke kun i Norge, men også internasjonalt.
Program og mer info finner du her.

Kliniske studier i Norge
Torsdag 17. aug kl 9:00 – 11:00 på Arendal sykehus

Dagens Medisin Arena på Arendal sykehus tar for seg status for kliniske studier i Norge og presenterer blant annet en ny rapport om kliniske helseforskning i Norge.
Program og mer info finner du her.

Et Columbi egg for folkehelsa og velferdssamfunnet
Torsdag 17.august kl 11:00 – 12:00 på Blom restaurant

Seminaret skal diskutere hvordan legemiddelnæringen kan bidra positivt til både økt sysselsetting og innovasjon i helsevesenet i en framtid hvor den norske velferdsmodellen er under press.
Program og mer info finner du her.

Vi tvitrer fra alle debattene – følg oss på Twitter på @radforsk.

Nordic Nanovector: Results from first quarter 2017

Our portfolio company Nordic Nanovector shows  continued progress in clinical development programmes with Betalutin® in their first quarter 2017 presentation. 

Luigi Costa, CEO of Nordic Nanovector, comments: “In the first quarter of 2017 we continued the positive momentum of 2016. I am pleased to report the excellent progress Nordic Nanovector is making to advance its clinical development programmes with Betalutin® in FL and now in DLBCL. We are also excited at the prospect of starting new clinical trials later in the year, which potentially could significantly expand the market opportunities for our novel ARCs.”

Nordic Nanovector reported continued operational progress during the first quarter. The Phase 1/2 clinical trial with Betalutin® in relapsed indolent non-Hodgkin’s Lymphoma (iNHL) advanced according to schedule. Safety Review Committee (SRC)’s approval of continued clinical evaluation of 20 MBq/kg Betalutin® with 100 mg/m2 lilotomab enables the company to build a robust database of clinical data. Management is confident on plans to initiate the pivotal Phase 2 PARADIGME study in the second half of 2017. The first patient was dosed in a Phase 1 dose-escalation study of Betalutin® in relapsed refractory DLBCL. The company also made the decision to expand investigations of its ARC therapeutics with initial preparations underway for a Phase 2 combination study of Betalutin® and rituximab, and a Phase 1 study of Humalutin™, a chimeric anti-CD37 Antibody Radionuclide Conjugate (ARC). Both studies are expected to start during the second half of 2017.

Please read the full press release and report here.

Photocure: Results for the first quarter 2017

Our portfolio company Photocure reported a Hexvix/Cysview revenue growth of 9% to NOK 36.5 million in the first quarter of 2017 (Q1 2016: NOK 33.5), with an EBITDA of NOK 4.9 million for the Hexvix/Cysview commercial franchise. The company reported a growth of 32% for the important US market, were the company recently unveiled the new growth strategy towards 2020.

“Hexvix/Cysview delivered strong growth in major markets, outside the Nordic regions, during the first quarter. In particular, we saw good momentum in the US, driven by strong demand for Cysview. As planned, we are increasing our investments in sales and marketing in the US in order to drive further awareness for Cysview and growth in the region,” says Kjetil Hestdal, president and CEO.

Full report and presentation may be found here.

Targovax ASA: First quarter 2017 results

Targovax is a clinical stage company focused on developing immuno-oncology therapies to target solid tumors. On april 25th, the company announced its first quarter 2017 results.

 
HIGHLIGHTS FOR THE FIRST QUARTER 2017:

  • Targovax announced encouraging top line two-year survival data from the phase I/II TG01 clinical trial in resected pancreatic cancer patients – 68%[1] of evaluated patients (13/19) were still alive after two years
  • Erik Digman Wiklund was appointed CFO of Targovax, taking over from Øystein Soug, who was promoted last year to CEO. Erik took on the role post-period in April 2017
  • Targovax upgraded its share listing from Oslo Axess to Oslo Børs, the main Oslo Stock Exchange

POST-PERIOD HIGHLIGHTS

  • Targovax was accepted to present clinical data from its phase I/II TG01 clinical trial in resected pancreatic cancer patients at the 2017 ASCO Annual Meeting in Chicago, Illinois in June
  • Targovax initiated an exploratory Phase Ib clinical trial of TG02 in patients with locally recurrent RAS-mutated rectal cancer scheduled to have surgery

Øystein Soug, CEO said: “2017 is looking to be a transformational year for Targovax. In the first quarter we reached a central value inflection point when we announced encouraging top-line survival data from our phase I/II TG01 trial in resected pancreatic cancer patients. We will be presenting survival, safety and immune activation data from this study in a poster presentation at the ASCO Annual Meeting in June. During the quarter we were pleased to appoint Erik Digman Wiklund as CFO, who joins us from Aker BioMarine Antarctic. This quarter our listing was upgraded to Oslo Børs, the main board at the Oslo Stock Exchange – another exciting milestone for the company.”

For more information: www.targovax.com

OncoImmunity wins prestigious EU grant

OncoImmunity AS was ranked fourth out of 250 applicants for the EU SME Instrument grant.

OncoImmunity is one of the portfolio companies of the Radium Hospital Research Foundation and is developing innovative software solutions to guide the discovery of neoantigen-based personalized immunotherapies and biomarkers.

We applied for the SME instrument grant as it represents an ideal vehicle for funding groundbreaking and innovative projects with a strong commercial focus. 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.

Read more bout the grant they received here on Oslo Cancer Cluster´s website and more about the company here on the company website.

Targovax ASA: Fourth quarter and full year 2016 results

Our portfolio company Targovax ASA has announced its fourth quarter and full year 2016 results. Targovax is a clinical stage company focused on developing immuno-oncology therapies to target solid tumors,

Highlights:

  • Targovax was granted a European Patent for the ONCOS platform lead product, ONCOS-102, extending patent coverage following the award of a similar US patent in June. These patents expire in 2029
  • Øystein Soug was appointed as CEO on 1 November
  • Targovax presented at a number of scientific and investor conferences in the period, including the European Society of Gene and Cell Therapy in October in Florence, Biotech and Money in November in London, and the DNB Nordic Healthcare Conference in December in Oslo
  • Net loss for the fourth quarter 2016 was NOK 32 million (USD 4 million), compared with a net loss of NOK 44 million (USD 5 million) in corresponding quarter in 2015
  • Cash and cash equivalents at 31 December 2016 was NOK 172 million (USD 20 million) vs NOK 193 million (USD 24 million) at 30 September 2016

Subsequent events:

  • Targovax announced encouraging top line two-year survival data from TG01 clinical trial in resected pancreatic cancer patients
  • Erik Digman Wiklund was appointed CFO of Targovax, succeeding Øystein Soug, the Company’s new CEO, and will take up this role in April 2017

 

Øystein Soug, CEO said: “2016 was a successful year for Targovax. During the year we listed our shares on Oslo Axess, we successfully raised funds to finance the clinical trial program and we were granted European and US patents for ONCOS-102, extending the protection till 2029. Furthermore, in 2016 we prepared and set up five new clinical trials in five indications. 2017 will be an even more important year as we start harvesting the data from these trials. We have already generated good momentum as we recently announced encouraging overall survival data in our TG01 proof of concept trial. We also expect to start a proof of concept trial of ONCOS-102 in checkpoint inhibitor refractory melanoma, where key interim data are expected later in the year.”