Photocure: Green light for phase 3 in the U.S

Photocure ASA, a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, announces the conclusion of the Phase 2 program, and FDA clearance to prepare Phase 3 protocol for the clinical development of Cevira, the innovative breakthrough for the treatment of precancerous lesions of the cervix.

The conclusion of a Phase 2 meeting with the FDA confirmed that the Phase 2 data supports the proposed Phase 3 program, and are sufficiently robust to continue the development of Cevira. Following a guidance meeting with FDA in December 2014, Photocure completed the re-analysis of the Phase 2b data as requested by the Agency. The re-analysis included a new panel read pathology assessment and applying new clinical success criteria in the end-point definition. The re-analysis demonstrated that Cevira provides improved treatment efficacy compared to placebo among patients with cervical high grade lesions (HSIL). Photocure discussed the results, including target population and statistical sample size, in the FDA meeting in early December.

Kjetil Hestdal, President and CEO of Photocure, said:  “With End of Phase 2 achieved for Cevira in the U.S., together with the support achieved through Scientific Advice in key European markets to progress to Phase 3 in women with HSIL (CIN2), Photocure has reached an important milestone in the development of Cevira.

Cevira has the potential to treat HPV induced cervical high grade disease and prevent the development of cervical cancer which affects more than 500 000 women annually. We will continue discussions with leading companies in women’s healthcare to secure a strategic partnership that will assist in the Phase 3 development and commercialization of Cevira.“

Following the positive outcome of the meeting with the FDA, Photocure plans to submit the proposed Phase 3 protocol for a detailed Special Protocol Assessment (SPA) to the FDA first half 2015.

www.photocure.com

Oslo Cancer Cluster`s start-ups highlighted in investor report

A recent analysis from the audit and advisory company EY is cautiously optimistic on behalf of startup companies in the Nordic Life Science industry – and points to possibilities within Oslo Cancer Cluster.

The analysis, which was commissioned by Norwegian Investinor and Swedish Industrifonden, points to four segments in the Nordic life science market that has the most mature startup companies, and thus are believed to be most attractive for investments: oncology (cancer treatment), inflammation treatment, niche products and imaging. From these segments, several startup companies have already appeared. They have also raised substantial capital.

Some Norwegian examples are Nordic Nanovector, BerGenBio and Targovax, which has raised a total of NOK 485 million in 2014 .These companies are all members of Oslo Cancer Cluster, developing cancer treatments using different technologies.

Excellent quality of research
The strength of the Nordic life science industry is the quality of the research performed, especially in some selected clusters, such as the Oslo Cancer Cluster. Scientific development is a key driver for innovation in the highly regulated pharmaceutical industry.

The biggest concern among life science industry players interviewed in the survey is however, the attention from investors, especially from professional investors with industry insights, which can handle the risks of investing in the earliest stages of company development.

─ The early phase of life science involves great risk, but can also give great returns, so investors should pay close attention to what is now happening in Oslo Cancer Cluster and corresponding clusters, says Ann- Tove Kongsnes, Investment Director of Investinor.

Investinor actively works to attract more foreign investors to Norwegian life science industry, and has also made ​​two investments together with Swedish Industrifonden in Oslo Cancer Cluster members Smartfish and Pharmalink.

 

 

 

 

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.

 

 

BerGenBio Completes NOK90 Million Fundraising

Oslo Cancer Cluster member BerGenBio AS, a biopharmaceutical company focused on developing innovative drugs for aggressive drug resistant cancers, announces that it has raised NOK90 million (c. $15 million) in a private placing from new and existing investors.

BerGenBio will use the proceeds from the financing to support the development of its pipeline of innovative cancer therapeutics, in particular an enlarged clinical development program for its lead drug candidate, BGB324, a first-in-class selective Axl kinase inhibitor, which is currently in Phase 1b clinical trials for patients with acute myeloid leukaemia (AML).

Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

“I am delighted we have received continued funding support for the Company and our clinical development plans for BGB324. Our recent research findings have shown broader potential clinical application for BGB324, and we intend to evaluate these in additional Phase 1 and Phase 2 clinical trials starting in 2015. In aggressive drug resistant cancers our on-going Phase 1b trial in AML is expected to report towards the end of 2015 and in non-small-cell-lung-cancer we will start enrolling patients very soon.”

Ann-Tove Kongsnes, Investor Director at Investinor, commented:

“We are very satisfied with the development of BerGenBio and its exciting pipeline of first-in-class cancer therapies. In the near future we see attractive opportunities for value uplift in the Company and are pleased to support the business.”

Arctic Securities AS acted as sole bookrunner for the private placement.

About BGB324
BGB324 is a first-in-class, highly selective small molecule inhibitor of the Axl receptor tyrosine kinase. It blocks the epithelial-mesenchymal transition (EMT), which is a key driver in drug-resistance and metastasis.

About BerGenBio AS
BerGenBio AS is a clinical stage biopharmaceutical company. The Company is committed to developing innovative therapeutics that inhibit EMT, prevent the formation of cancer stem cells and disrupt the cellular mechanisms that drive acquired cancer drug resistance. The Company is founded on proprietary platform technology, CellSelect™, which uses information from RNAi screening studies to identify and validate novel drug targets and biomarkers. BGB324 is the first compound in BerGenBio’s pipeline to enter clinical trials in AML and soon NSCLC, with additional compounds and drug targets at different stages of preclinical development. www.bergenbio.com

Career Day at University of Oslo

News4

Real Karriere is the meeting arena for industry and companies and the students within technolgy and natural sciences at the University of Oslo. February 12 Real Karriere invites companies to have a stand, set up speed-dates with students and/or present them selves. 

Please find more information here:

You may register your company here: https://nettskjema.uio.no/answer/60769.html

Questions regarding this event may be adressed to:
Kristina E. Sæterdal, e-mail: realkarriere@mn.uio.no, mbile: +47 95819674 web page: uio.no/realkarriere

 


Real Karriere ved Universitetet i Oslo er en kontaktarena for bedrifter og våre studenter innen realfag og teknologi.

Ved å delta på Real Karriere kan du profilere din bedrift gjennom:
● Stand
● Speed-intervjuer i egne lokaler med påmeldte studenter
● Bedriftspresentasjoner

Alt vil skje i Vilhelm Bjerkes’ hus.

Opplegg for dagen:
12.00 Åpning av standområdet. Servering av kaffe og kake
16.00 Mingling i studentkjelleren med matservering, underholdning og premieutdeling.

For å gjøre denne dagen mer attraktiv for begge parter ønsker vi at:
● Dere har informasjon om mulige sommerjobber og/eller faste jobber om dette er mulig
● Dere er tydelige på kompetansen dere søker
● Hold gjerne egen konkurranse på standen, der premien blir delt ut under minglingen

Vi vil fra vår side forberede studentene best mulig for denne dagen.

Meld på din bedrift via nettskjema: https://nettskjema.uio.no/answer/60769.html

Ved spørsmål, kontakt: Kristina E. Sæterdal, realkarriere@mn.uio.no, 95819674 Nettside: uio.no/realkarriere

Priser
Prisene (ekskl. moms) inkluderer profilering av bedriften i forkant av arrangementet og matservering.
– Stand, 2 meter bred: 6 000,-
– Stand, 3 meter bred: 10 000,-
– Speed-intervju: 3000,-
– Bedriftspresentasjon (20 min): 5000,-

Profilering: Som deltaker på Real Karriere vil din bedrift profileres på nettsider og i brosjyren som deles ut til studentene.

The investment in proton therapy for cancer

Written by Prof. Stein Kvaløy, senior physician and Head of Research at the Division of Cancer, Surgery and Transplantation, Oslo University Hospital and University of Oslo.
First featured in forskning.no


In 2012 there were just above 30,000 new cancer cases in Norway. The number of cases is increasing by 1-2 percent each year, so that more than 40,000 cases are expected in 2030.

More cancer survivors

Fortunately, treatment results are improving. During my time as a cancer specialist (from 1976) the healing improved significantly – from 40 percent survival to 70 percent for both men and women. There are several reasons for this improvement.

We can roughly divide cancer treatments into three methods; surgery, radiation therapy and medication. Nowadays various specialists jointly discuss the treatment program and the best use of the three modalities of treatment for each case. Often will all three methods be used in a well-planned combination to best suit the patient. This is referred to as a multi-disciplinary approach.

Radiotherapy is used both as treatment for cancer cure and for symptomatic relief. This is a local treatment with photon beams that have high enough energy to reach tumors located deep inside the body. This procedure resembles the similar idea of surgery, sterilization and removal of the tumor with minimal damage to the healthy tissue located around a tumor. Modern radiation machines allow optimization of the radiation dose against the tumor and thus reduce the dose for the healthy tissue. Damage of the healthy tissue cannot, however, be completely avoided and is the “price” one must pay to stay healthy. My impression is that most patients understand and accept this if they are informed about it.

Radiation can cause damage

As more patients are cured and we gather observations over a long time period (more than 20 years), we see that patients can develop long-term side effects and damage due to the treatment they received a long time ago. This may often be as far back in time that one no longer sees the connection to previously given treatment. Such an example is patients who received radiation therapy for Hodgkin’s lymphoma.

Some of these patients may among other things suffer of heart disease which results in significant distress and reduced quality of life. It is important to emphasize that this is not due to errors in medical treatment.

Proton treatment reduces side effects

Other types of radiation therapy that can reduce side effects do exist nowadays. The development of radiation devices that can provide particle irradiation with protons or ions has been tremendous in recent decades. It is like shooting at the tumor with small bullets. The particles can be more precisely directed at the tumor, and the biggest benefit of this is that we can reduce the dose to the healthy tissue.

This reduces short-term and long-term side effects, which for some patients implies avoiding a new disease after being cured of cancer. However, it should be mentioned that not all cancer patients will benefit from this type of radiation therapy compared with current treatment.

Where radiation center be placed?

A national team of specialists have worked with the question of whether we should get proton therapy to Norway. The group agreed on the idea and has estimated that 8-10 percent of cancer patients who should have radiotherapy should get it as proton therapy.

This would be applicable for approximately 12-1500 of cancer patients each year. International estimates are somewhat higher. Benefits will probably be greatest for children and adolescents who have a long life expectancy.

Why not just do it? The health benefits seem obvious. The Ministry of Health and Care Services gave a remarkably quick positive signal to the establishment of costly buildings and equipment.

It is now being examined how construction should be carried out.  All regional health authorities are included in these plans. The South-Eastern Norway Regional Health Authority has a group working on plans to add such a facility to Oslo University Hospital.

The main question has been localization: Should the unit be established in hospitals that already offer radiotherapy (such as Radium Hospital or Ullevål Hospital), or should we adapt a new center with proton facility into the plans for the new OUS – Campus in Oslo? There are drafts for different exciting localization possibilities at Rikshospitalet. This is exciting plans.
It is clear that we must consider carefully the appropriate location for such a large investment (about two billion NOK). It is important that the plans for OUS-Campus, do not delay the establishment of a proton facility in Oslo University Hospital, which at the earliest could be completed in 2020.

This has great significance for the individual patient.

 

Winners of Immuno-Oncology Call are: BerGenBio, Targovax and Ultimovacs

By deadline November 15, Oslo Cancer Cluster had received 9 applications for collaborative innovation projects addressing our Immuno-Oncology call on MNOK 1, 2.  From these,  three winners have been chosen, and those are: BerGen Bio, Targovax and Ultimovacs. Each company will receive MNOK 0,4 from Innovation Norway.

 

BergenBio will use the funding to prove that Axl kinase inhibition may provoke anti-tumour immune response
BerGenBio receives funding for the project Enhanced tumor immune activation by clinical Axl‐targeting agents, with partners from the University of Bergen, Oslo University Hospital and University of Texas. The goal of this project is to demonstrate that Axl receptor inhibition potentiates anti-­‐tumor immune responses against poorly immunogenic cancers and to develop improved clinical immunotherapeutic strategies based on Axl targeting.

– BerGenBio are very pleased to be one of the three companies to win an I-O innovation project. The award will allow the company to demonstrate that Axl kinase inhibition can play a key role in provoking anti-tumour immune response, and thus may be a valuable immunotherapy target. BerGenBio is a leader in the field of Axl kinase biology and the Company’s clinical candidate, BGB324, is the first selective Axl kinase inhibitor to be tested in the clinic, says Richard Godfrey, CEO BerGen Bio.
Targovax awarded an immuno-oncology innovation prize
The Immuno-Oncology prize from Oslo Cancer Cluster will contribute to the funding of Targovax´s development of new cancer vaccines, with focus on the new peptide vaccine TG03 for treatment of RAS mutated malignant melanoma.

– Targovax is proud to receive this prize and wants to thank Oslo Cancer Cluster for the grant.  This is a great acknowledgement and support of Targovax’s work to develop the new cancer vaccines in pipeline towards clinical testing, says Hanne Mette Kristensen, CEO Targovax.

 

Ultimovacs will use the funding to develop novel cancer therapy
Ultimovacs receives funding for the prjoect Re-targeting T-cells against cancer – development of T-cell receptors directed against telomerase, with partner Oslo University Hospital. The overall goal of the project is to develop novel cancer therapy by reprogramming immune cells to target the universal tumour antigen telomerase.

– Ultimovacs are very happy and proud to be one of the winners of this funding granted by Oslo Cancer Cluster and Innovation Norway. The funding gives us the opportunity to expand our technological platform. This project has the potential to combine vaccine technology and cell therapy in the treatment of patients with advanced cancer. The research is an example of the strength of collaboration between industry and academia, says Øyvind Arnesen, CEO Ultimovacs.

 

Strength within Immuno-Oncology in Norway proven
Jutta Heix, International Advisor in Oslo Cancer Cluster and project coordinator of the Norwegian Immuno-Oncology Consortium, is very pleased with this years call.

– We are very pleased about the significant interest and very positive feedback from our members for this funding opportunity. The number and quality of the applications and the breadth of the topics confirms the particular strength in the cancer immunotherapy area in Norway. Based on the feedback from last year’s winners we know that the funding despite the relatively small amount, truly makes a difference and helps to advance the immuno-oncology portfolio within the cluster. Therefore we continuously work to increase the funding available for our members, says Jutta Heix, International Advisor in Oslo Cancer Cluster.

 

 

Nordic Nanovector And Affibody Collaborate On Radio-Immunotherapies Program For Multiple Myeloma

Nordic Nanovector ASA and Affibody AB today announced that the companies have entered into a three-year collaborative research agreement to discover and develop new advanced radio-immunotherapies (RIT) for multiple myeloma.

Backed by a Eurostars grant, the project will combine Affibody’s proprietary platforms with Nordic Nanovector’s radioimmunotherapy technology. The project aims to provide documentation necessary to start GMP manufacturing of the Affibody®-based RIT and subsequently start clinical trials. The companies have also been awarded approximately €1m in total by Vinnova in Sweden and The Norwegian Research Council in Norway.

Upon a successful conclusion of the collaboration Nordic Nanovector will have the opportunity to license the global rights to the Affibody®-based RIT. The development of an Affibody®-based RIT treatment represents a distinct work stream to be carried out in parallel with Nordic Nanvector’s lead product candidate Betalutin™ for non-Hodgkin Lymphoma treatment.

Luigi Costa, Nordic Nanovector CEO commented, “The collaboration with Affibody will allow Nordic Nanovector to expand its product pipeline, while at the same time retaining full focus on the clinical development and commercialization of our lead product candidate, Betalutin™. This collaboration serves as an example of how the company intends to leverage its proprietary targeting technology to treat other hematological cancers in need of novel therapeutic approaches. “

David Bejker, Affibody CEO commented, ”We are delighted to enter into this agreement with Nordic Nanovector and see RIT’s as an area with great potential and a logical continuation of some of our research. The Eurostars platform offers an excellent way for two companies with complementary technologies to collaborate and bring novel therapeutics to market and for Affibody, this comes on top of a year of increased uptake for our platform.”

 

More information:

Affibody
Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™. Affibody is developing a portfolio of innovative drug projects and, in addition, offers the half-life extension technology, Albumod™, for outlicensing.

Affibody has ongoing commercial relationships with several companies including Algeta, Amylin, Sobi, Daiichi-Sankyo, Daewoong, GE, and Thermo Fisher.

Affibody was founded in 1998 by researchers from the Royal Institute of Technology and the Karolinska Institute and is based in Stockholm, Sweden. Major shareholders in the Company include HealthCap and Investor AB. Further information can be found at: www.affibody.com.

 

Nordic Nanovector

Nordic Nanovector ASA is a privately held company established in 2009. The company is developing innovative radioimmunotherapeutics to treat non-Hodgkin Lymphoma (NHL) and other difficult to treat cancers. Nordic Nanovector intends to commercialise its product candidates through strategic alliances and partnerships with experienced oncology businesses and by establishing its own sales and marketing capabilities in selected markets. The company is based and has offices and laboratories in Oslo, Norway.

The company’s lead product candidate, Betalutin™, is a radioimmunotherapeutic that aims to prolong and improve the quality of life of people who suffer from NHL. Further information can be found at: www.nordicnanovector.com.

Oslo Cancer Cluster members will be featured in Nordic Life Science Database

Per Walday, CEO, PCI Biotech

Biotechgate welcomes the three Norwegian partners Innovation Norway, Oslo Cancer Cluster and Nansen Neuroscience Network. This partnership further completes the Nordic Life Sciences Database which allows users to search for companies in the Biotech, Pharma and Medtech area.

More than 170 Norwegian companies can currently be found in the Nordic Life Sciences Database (www.nordic-lifesciences.com). All profiles are updated continuously and the database will be further completed with new profiles over the next months. Due to the partnerships with Innovation Norway, Oslo Cancer Cluster and Nansen Neuroscience Network, the database can be used free of charge. It is also possible for companies to publish their profile at no cost.

Thanks to additional partners from Sweden and Denmark, also Swedish and Danish profiles can be found and viewed for free on the Nordic Life Sciences Database. The portal is part of Biotechgate, a global life science directory which provides information such as product pipelines, management contact details, financing information and much more of more than 30,000 companies in the Biotech, Pharma and Medtech space. Thanks to various search features the information is easily accessible.

“Being the primary government agency for industry development, it is a priority for Innovation Norway to promote our prosperous life science community. Norway has close to 200 companies depending on biotechnology in their daily business and a total of more than 400 companies when looking at life sciences at large. We are very pleased to enter into this collaboration with Biotechgate together with our most prominent biomedical clusters in oncology and neuroscience, respectively.”
Ole Jørgen Marvik, Sector Head, Health and Life Sciences, Innovation Norway

“Oslo Cancer Cluster is very pleased to have teamed up with Venture Valuation to profile our members through Biotechgate. We are reassured that this gives our SME-members a great exposure to the international VC and pharma milieu, which is important in our work to build a Norwegian Healthcare Industry.”
Ketil Widerberg, General Manager, Oslo Cancer Cluster

“Our companies work to address important and complex challenges. Success will require collaborations and partnerships, and we believe that Biotechgate can be a powerful tool to help build those. We look forward to offering this to our members.”
Leif Rune Skymoen, CEO of Nansen Neuroscience Network

“We are more than happy to close this gap in the Nordic Life Science Database. We are sure that having the Norwegian company profiles available on the database, will be a great contribution to all kind of actors active in the life sciences field – inside and outside of Norway and Scandinavia.”
Jost Renggli, COO, Venture Valuation / Biotechgate

 

Registration for Cancer Crosslinks 2015 is open

Norwegian Cancer Society would like to have more innovation from cancer research - for the best of the cancer patients

Cancer Crosslinks 2015 will be held January 15th at The Institute for Cancer Research at the Norwegian Radium Hospital. The program features several renowned international speakers as well as Norwegian experts. Main theme is “Novel insights into tumor heterogeneity and clonal evolution: how to design treatment and follow-up strategies”.

 

  • Program and registration form (close to the bottom of the page)
    Since the auditorium is usually fully booked for this event we limit the number of participants per company  to 2 people in the main auditorium. However,additional participants may follow the program from the seminar rooms and participate at lunch and networking parts. The meeting will also be streamed.

 

Exciting program bridging latest research and clinican implementation
In the first part of the program, international and Norwegian clinicians and researchers will discuss the clinical impact of approaches as single cell sequencing and liquid biopsies across different tumor types. We look forward to welcoming our keynote speakers Professor Nicholas Navin from MD Anderson and Professor Klaus Pantel from the University Hospital Hamburg–Eppendorf working at the international forefront in their fields

The second part deals with emerging treatment strategies integrating novel insights into tumor heterogeneity and building on both, molelularly targeted therapies and emerging cancer immunotherapies. You have the opportunity to hear recent insights from various tumor types and to discuss novel opportunities but also the challenges faced during the clinical implementation with our international and Norwegian speakers.

The third part is dedicated the patients perspective, where Anniken Golf Rokseth will share her story reminding all of us why we are putting our efforts into this area every day.

 

Welcome for the 7th time
Cancer Crosslinks 2015 is the seventh edition of this national meeting. This year’s event is hosted and developed in collaboration with BMS, Roche and the Norwegian Cancer Society. We thank our Program Committee with Bjørn Tore Gjertsen, Hans Petter Eikesdal, Christian Kersten and Ragnhild Lothe for their important contributions to the program development.