EU Calls 2016-2017 just published

Horizon 2020

The draft SC1 Work Programme for 2016-17 has been pre-published at https://ec.europa.eu/programmes/horizon2020/en/draft-work-programmes-2016-17.

 

Please note that this draft is published for transparency purposes and is not yet legally valid.

The adoption and the publication of the work programme by the Commission are expected in mid-October 2015. Only the adopted work programme will have legal value. This adoption will be announced on the Horizon 2020 website and on the Participant Portal.

Vaccibody with vaccination of first patient

Vaccibody AS announced today vaccination of the first patient in its multicentre trial VB C-01 – an exploratory, open-label, multicenter phase I/IIa study VB10.16 immunotherapy for the treatment of high grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV 16).

 

Patients will receive intramuscular vaccinations of VB10.16 at three different time points. Two different dosing schedules will be evaluated during the first phase of the study in patients diagnosed with CIN 2, the best vaccination schedule will then be evaluated in the second phase in both CIN 2 and CIN 3 patients.

The primary objective of the study is to evaluate the safety and tolerability of three doses of 3 mg VB10.16. The secondary objectives are to assess T cell mediated immune responses in the peripheral blood as well as in the pre-malignant tissue of the CIN 2/3 lesions and to evaluate early signs of efficacy by means of HPV clearance and CIN regression.

Martin Bonde, CEO of Vaccibody, commented: We are pleased to announce commencement of patient treatment in this first clinical trial with Vaccibody’s lead product VB10.16. Surgery is currently the only available therapy to remove abnormal cervical lesions caused by human papillomavirus and thereby stop the progression to cervical cancer. We are hopeful that VB10.16 immunotherapy can help change this treatment paradigm by offering a safe and efficacious alternative in the form of a therapeutic HPV vaccine.

Principal investigator,  Prof. Dr. med. Karl Ulrich Petry, Department of Obstetrics & Gynaecology Klinikum Wolfsburg commented:  The scientific approach of this well designed clinical study offers the chance to get a thorough understanding on how patients respond to VB10.16 immunotherapy. The first dosing of a patient has just been performed successfully in our hospital . We are convinced that patients with CIN 2 and CIN 3 will be very motivated to participate in the study to test this therapeutic vaccination as it might offer a non-invasive treatment option avoiding the side effects associated with surgical excision of the affected tissue and potentially also cure the underlying HPV infection and prevent recurrence. Furthermore, VB10.16 could also protect from other HPV16 induced cancers.

 

About VB10.16

The company’s lead product, VB10.16, is a therapeutic DNA vaccine developed to treat human papillomavirus type 16 (HPV16) induced pre-malignancies and malignancies.

About Cervical Intraepithelial Neoplasia (CIN) and Cervical Cancer

Per year approximately 530,000 women are diagnosed with cervical cancer worldwide and over 275,000 women die of the disease annually. Invasive cervical cancer is preceded by a long phase of pre-invasive disease called Cervical Intraepithelial Neoplasia (CIN). Globally the number of high grade lesions (CIN 2/3) the immediate precursors to malignancy, is estimated to be in the range of 10 million.

Virtually all cervical cancers are caused by high risk HPV types. Among the different high risk HPV types known, HPV16 has been reported to be the most common genotype in high grade cervical intraepithelial neoplasia. It can be detected in up to 60 % of all cervical cancers, especially in younger women and it has also been found to play an essential role in the development of several other cancer types (approximately 90% of anal cancers; 40% of penile, vaginal, and vulvar cancers; 25% of oral cavity cancers and 35% of oropharyngeal cancers).

Current standard therapy for CIN 2/3 varies between countries and regions and often involves surgical removal of the affected tissue. These invasive procedures are associated with bleeding, infection, cervical stenosis, scarring and most importantly pre-term deliveries in subsequent pregnancies. As a result, there is a significant need for an effective therapeutic vaccine to treat existing HPV infection and associated pre-malignancies and malignancies of the cervix and thereby prevent the development of cervical cancer caused by human papillomavirus.

About Vaccibody AS

Vaccibody is a biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, prophylactic and therapeutic vaccines which target cancer and infectious diseases, for human and veterinary use. Vaccibody’s lead program is focused on VB10.16, a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. The first-in-human study will evaluate the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).

 

 

 

PCI Biotech signs research collaboration with top-10 large pharma company

Doctor and nurse assessing the treatment of a cancer patient.

Oslo Cancer Cluster member PCI Biotech has signed an agreement with an undisclosed top-10 large pharma company, with the aim to evaluate synergistic effects of the PCI technology with their therapeutic nucleic acid technology. Initially, the purpose of the pre-clinical research program is to determine whether PCI has the potential to enhance the therapeutic effect of their nucleic acid technology platform.

The current pre-clinical research agreement covers evaluation of technology compatibility and synergy based on in vitro studies. The costs related to the research collaboration will be covered by the pharma company, which is one of the global leaders in nucleic acid therapeutics. The companies will evaluate the data generated in this research collaboration and based on this explore the potential for a further partnership. The original evaluation period spans over 9 months, but may be further extended.

“I’m delighted to announce this research agreement with one of the largest pharma companies in the world. We believe that the PCI technology has the potential to play a role in the realisation of several new therapeutic modalities, including cancer immunotherapy and mRNA therapeutics. This agreement shows that external players share this view”. Per Walday, CEO.

 

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 internalization (PCI) technology. Originating from world leading research at the Norwegian Radium Hospital, 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 currently has a bile duct cancer program in phase I/II clinical development. Bile duct cancer is an orphan indication without any approved medicinal products and a high medical need for better local treatments. It is an indication well suited for PCI treatment, with easy light access for intraluminal surface illumination through routine endoscopic methods and an active generic drug (gemcitabine) significantly enhanced by PCI.

The company is also developing PCI as a CTL (Cytotoxic T Lymphocyte) induction technology for therapeutic and prophylactic vaccination. It has been demonstrated both in vivo and ex vivo that PCI significantly increases the number of activated antigen-specific CTLs by enhancing the MHC I antigen presentation of antigen presenting cells. When applied in the emerging field of cancer immunotherapy, PCI can be used to enhance the important cytotoxic effect of therapeutic cancer vaccines.

PCI Biotech follows a strategy to create value by improving the effect both of existing cancer drugs and by realizing the large potential in new therapeutics, including therapeutic vaccines.

For more information visit: www.pcibiotech.com

NLSDays 2015: Meet international life science leaders and discuss the sector’s future at the Nordic region’s largest partnering meeting

NLSDays September 9-10 at Stockholm Waterfront is the Nordic region’s premier life science event. The global life science sector is undergoing major structural changes, and as part of a strong established hub, companies in Sweden and the Nordic countries are of great interest when international investors and corporations are looking for new partners.

The entire value chain from basic research to the introduction of new therapies is subject to transformation – not least due to rapid developments in digital health. Life science companies therefore need to find new ways to collaborate and fund their projects. Since the Nordic region offers a modern, competitive environment for academia and research companies alike, the region has become highly attractive for the global life science industry.

  • NLSDays has become the most important meeting place for global investors and corporations that are looking for new collaborations in the Nordic region. The event is on course for record numbers and deals such as the recent one between Alligator Bioscience and Janssen Biotech which illustrates that Swedish companies offer major value to partners, says Jonas Ekstrand, CEO SwedenBIO, the Swedish national life science industry organization which founded the event three years ago.

Overall, the life science sector is currently very active in the Nordic countries. For example, the Oslo Cancer Cluster Innovation Park, an investment of around 100 million Euros opens today (24 August). Furthermore, AstraZeneca recently announced a Euros 260 million investment in a new plant for bio-pharmaceutical production and from January 2014, 18 life science companies across all subsectors from medtech to biopharma have been listed on Nasdaq Nordic at a combined value of about Euros 250 million (Source Nasdaq). Furthermore, initiatives and companies in new areas such as personalized medicine, digital health and outcomes based provision are emerging at an accelerating pace.

During Nordic Life Science Days 2015 the main theme is “The New Value Chain”. The 2 day program covers several sessions in which international life science leaders will discuss strategies on how new partnerships can be established and how medical research and the life science industry in the Nordics can contribute.

Super Sessions from the program:

  • International Investors (9 September at 11.30 – 12.30)

International life science investors talk about their investment models and what they look for from entrepreneurs.

  • Personalized Healthcare – Matching Medicines to Patients (September 10 at 08:45 – 09-45)

How will big data and new diagnostic methods impact the future of medical research and treatment modalities? Listen to how the Digital Doctor Watson can revolutionize health care.

  • Oncology 2025 (10 September 11.30 – 12.30)

Immuno-oncology is hotter than ever and there is an ongoing competition between the big global companies to take on the most promising projects. Representatives from several of the major players talk about their strategies.

Currently, 800 delegates are registered for this year’s NLSDays, which is 33% more than at the corresponding time last year. This strongly indicate that the meeting will attract over 1,000 participants, outnumbering last year’s number of delegates.

The conference is organized September 9-10, 2015 at Stockholm Waterfront Congress Centre, Nils Ericssons Plan 4 in Stockholm. More info on www.nlsdays.com.

 

About NLSDays

Founded in 2012 the Nordic Life Science Days has grown rapidly to become the largest Nordic partnering conference for the global life science industry. In 2014, 890 delegates from 28 countries attended the meeting. The 580 companies attending offered 490 licensing opportunities in the partnering system and during the two days 1600 one-on-one meetings were scheduled. Among the investors and big pharma already registered for the meeting in September 2015 are AbbVie, Alexion, Almi Invest, Astellas, AstraZeneca, Bayer HealthCare, Boehringer Ingelheim, Bristol-Myers Squibb, Cadila Pharma, Johnson & Johnson, HealthCap, Industrifonden, Karolinska Development, Merck-MSD, Novartis, Pfizer, Pierre Fabre, P.U.LS. AB, Recipharm, Roche, Seventure Partners, SR-One.

In addition to partnering, NLSDays also offers an exhibition and a seminar program with 10 super session and four topic specific workshops. Speakers include senior representatives from the global life science companies, investors, and academic leaders who will all share their expertise and views for the future.

About SwedenBIO

SwedenBIO who is the founder and organizer of the Nordic Life Science Days is the Swedish life science industry organization. Our nearly 200 members operate across all sub-sectors from pharmaceutical, biotechnology, medical technology to diagnostics. SwedenBIO serves to the benefit the entire life science industry in Sweden and is a member-driven, private, non-profit organization. The main objective is to improve the conditions for the life science industry for the benefit of industry growth and business development.

 

45 MNOK to innovative cancer treatments and diagnostics

The Norwegian Research Council and Norwegian Cancer Society are teaming up to make the results of medical and biotechnical research faster available for cancer patients.

The call on 45 MNOK will be administered through the Research Council’s program for biotechnology (BIOTEK21) and commercialization (FORNY2020).

– This is an exciting and unique collaboration between the Norwegian Cancer Society and the Norwegian Research Council. There is a long way from scientific idea to finished product. The process before the product is on the market and used by many patients are demanding and costly. These funds will provide important impetus to future-oriented Norwegian research. There is enormous potential in research and innovation in health, says the Norwegian Cancer Society General Anne Lise Ryel.

Arvid Hallén, CEO of the Norwegian Research Council agrees:

– I think it can mean much that the Norwegian Cancer Society and the Norwegian Research Council will work together on this. To be successful it is important that we also work closely with Norwegian companies that develop products and services for cancer diagnosis and cancer treatment. Fortunately, we have not only excellent researchers and clinics in health and biomedicine, we also have many companies that have shown that they can develop innovative products and services that can help cancer patients, says Hallén.

Applicants for this call will be commercial players who are affiliated research institutions. The announcement will be available on the Research Council’s website from the end of June and has a deadline of 9 September.

Find more information here:

 

Vaccibody aquaculture collaboration granted 10 MNOK

News4

The research collaboration “New Targeting Vaccines for Sustainable Aquaculture” has received a grant of NOK 10 Million through the Norwegian Research Council’s program Biotek2021. Oslo Cancer Cluster member Vaccibody is a partner in the project together with The Norwegian Veterinary Institute, Pharmaq AS, Kjeller Innovasjon and Kongla AS. 

 

The purpose of the project is to develop customized targeted fish vaccines based on the Vaccibody principle.  The NOK 10 million will be awarded over 3 years.

Tom Pike, Chairman and Acting CEO of Vaccibody, commented: “We are very pleased to be a part of this collaboration and for the funding it will receive from the Norwegian Research Council .The fish farming industry are facing a number of challenges related to infections and the Vaccibody technology is well suited to attack these challenges in a sustainable manner, without the global issues associated with antibiotics. We are also proud to work with a consortium of well qualified partners.  The project fits well with Vaccibody’s strategy to develop its technology platform together with partners while focusing the main share of its internal resources on the development of VB10.16, a therapeutic DNA vaccine to treat precancerous lesions of the cervix currently entering Phase I/IIa.”

 

About Vaccibody AS

Vaccibody is a biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, prophylactic and therapeutic vaccines which target cancer and infectious diseases, for human and veterinary use. Vaccibody’s lead drug candidate VB10.16 is a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. The company is currently entering it’s first-in-man study that will evaluate the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).

Large Oslo Cancer Cluster delegation to BIO2015

More than 15 Oslo Cancer Cluster members will be present at BIO2015 in Philadelphia in June. BIO is the world´s largest biotech fair and a very important partnering event for the cluster.

The companies attending BIO from the cluster are: BerGenBio, Lifandis, Lytix Biopharma, Nextera, Nordic Nanovector, Normetrix, Pharmalink Oncology, Inven2, BTO, Targovax, Ultimovacs, Vaccibody, The Radium Hospital Research Foundation, Chiltern and DNB Healthcare.

International Advisor Jutta Heix will represent Oslo Cancer Cluster Managment Team.

International Cancer Cluster Showcase
Oslo Cancer Cluster will also this year arrange International Cancer Cluster Showcase at BIO, together with other world-leading cancer clusters.  New partners are OBN, UK with a strong international investor network and the Wistar Institute from Philadelphia as local partner.

Member companies pitching at the International Cancer Cluster Showcase are Inven2, Ultimovacs and Nordic Nanovector.

Inven2, Norway´s largest TTO, will pitch their portfolio of early projects which is really strong in immuno-oncology, Ultimovacs will present the clinical development of their universal cancer vaccine, whilst Nordic Nanovector will present the clinical development of their targeted radiopharmaceutical treatment of lymphoma. Nordic Nanovector went public this March with one of the biggest IPO´s in European biotech so far this year.

We are very proud to have two Oslo Cancer Cluster members sponsoring the International Cancer Cluster Showcase this year: Chiltern and DNB Healthcare.

DNB Healthcare is also hosting a special healthcare event in New York on June 12 prior to BIO.

 

PCI Biotech starts collaboration in siRNA therapeutics

PCI Biotech, a Norwegian cancer focused biopharmaceutical company, announced that it is initiating a pre-clinical research collaboration with RXi Pharmaceuticals (NASDAQ: RXII). RXi is an American biotechnology company focused on discovering and developing innovative therapeutics, that address high-unmet medical needs primarily in the area of dermatology and ophthalmology.

The partnership is governed by a pre-clinical research collaboration agreement. Initially, the purpose of the pre-clinical research collaboration is to utilize the companies’ complementary scientific platforms to explore potential synergies.

In brief the pre-clinical research collaboration will evaluate technology compatibility based on in vitro and in vivo studies. The costs related to the research collaboration will be covered by each company separately. The companies will evaluate results achieved from this research collaboration and then explore the potential for a closer collaboration.

Both companies will retain exclusive ownership rights to existing registered intellectual property. However, any inventions arising from the collaboration will be jointly owned by the companies.

 

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 internalization (PCI) technology. Originating from world leading research at the Norwegian Radium Hospital, the PCI technology works by inducing triggered endosomal release and may be used to unlock the true therapeutic potential of a wide array of modalities, such as small molecules, ADCs and siRNA. Two programs are currently in clinical development in patient populations with a high unmet medical need; recurrent head and neck cancer (phase II) and bile duct cancer (phase I/II).

The company is also developing PCI as a CTL induction technology for therapeutic and prophylactic vaccination. It has been demonstrated both in vivo and ex vivo that PCI significantly increases the number of activated antigen-specific CTLs (Cytotoxic T Lymphocytes) by enhancing the MHC I antigen presentation of antigen presenting cells. When applied more specifically to the emerging field of cancer immunotherapy, PCI can be used to enhance the important cytotoxic effect of therapeutic cancer vaccines. PCI Biotech follows a strategy to create value by improving the effect both of existing cancer drugs and by realizing the large potential in new therapeutics, including therapeutic vaccines.

www.pcibiotech.com

Nordic Nanovector raised MNOK 500

Oslo, 20 March 2015. Nordic Nanovector ASA (“Nordic Nanovector”, the “Company”, OSE ticker code: “NANO”) announces the successful completion of the bookbuilding period for its initial public offering (the “Offering”), which was multiple times oversubscribed for the full amount of the Offering (including over-allotment) throughout the narrowed indicative price range.

In summary:
• Nordic Nanovector will issue 15,625,000 new shares in connection with the Offering, raising gross proceeds of NOK 500 million. There will in total be 42,175,291 shares in issue following the issuance of the new shares.
• The Managers (as defined below) have over-allotted 2,343,750 shares, representing 15% of the number of shares issued and sold in the Offering before over-allotments, and exercised their option to borrow an equal number of shares from HealthCap VI L.P. for the purpose of covering such over-allotments.

• The shares are priced at NOK 32 per share. The price implies a market capitalisation of Nordic Nanovector of approximately NOK 1,350 million (excluding shares that may be issued in connection with the over-allotment).

• Trading of the shares in Nordic Nanovector on the Oslo Stock Exchange will commence on 23 March 2015.

Approximately 91% of the shares in the Offering have been allocated to investors in the institutional offering and approximately 9% of the shares have been allocated to investors in the retail offering. Following the Offering, Nordic Nanovector is expected to have approximately 1,200 shareholders.

Luigi Costa, CEO of Nordic Nanovector, said: “We are delighted with the positive support Nordic Nanovector and its team has received by domestic and international investors. This has enabled us to upsize our IPO and raise additional funds to advance the development of Betalutin™, our first-in-class Antibody-Radionuclide-Conjugate, beyond the first regulatory submission planned in 2017”.

Luigi Costa continued: “Betalutin™ is specifically designed to deliver better treatment outcomes for patients with non-Hodgkin lymphoma by improving and complementing current therapy options. Betalutin™ targets CD37, a different antigen compared to standard CD20-targeted therapies with a short-range radiotherapy effecting tumour cell death while minimizing exposure to healthy cells. Based on this mechanism of action and promising clinical results to date, we have designed a robust development plan through to commercialisation.”

Notifications of allocated shares and the corresponding amount to be paid by investors are expected to be communicated to investors today (20 March 2015). Investors having access to investor services through their VPS account manager will be able to check the number of shares allocated to them from approximately 09:00 hours (CET) on 20 March 2015. The Managers may also be contacted for information regarding allocations.

The Company has granted the Managers an over-allotment option, exercisable by ABG Sundal Collier as stabilisation manager within 30 days from the first day of listing to cover over-allotments and short positions in connection with the Offering. A separate disclosure will be issued by the stabilisation manager regarding the over-allotment and stabilisation activities.
ABG Sundal Collier and DNB Markets, a part of DNB Bank ASA, are acting as Joint Global Coordinators for the Offering and ABG Sundal Collier, Carnegie and DNB Markets are acting as Joint Bookrunners for the Offering. The Joint Global Coordinators and Joint Bookrunners are herein referred to as the “Managers”.

 

About Nordic Nanovector

Nordic Nanovector is a biotech company focusing on the development and commercialization of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin™, the first in a new class of Antibody-Radio-Conjugates (ARCs), designed to improve upon and complement current options for the treatment of Non-Hodgkin’s Lymphoma (NHL).

NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market worth over $12 billion by 2018.
Betalutin™ comprises a tumor-seeking anti-CD37 antibody conjugated to low intensity radionuclide (Lutetium 177). It has shown promising efficacy in Phase 1 studies in a difficult-to-treat NHL patient population and as well as a very favourable tolerability. Betalutin™ is fast advancing through clinical development and with first approval anticipated in 2018.
Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialization of Betalutin™ in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its ARC pipeline to treat a number of select cancer indications.

 

 

NLSDays 2015 – Early Bird through March 31

Oslo Cancer Cluster is one of the supporting organizations for this years Nordic Life Science Days in Stockholm, as we were last year. This means that members of the cluster benefit from special rates on participation. Through March 31 you may also get early-bird discount.

In collaboration with other healthcare industry actors in Norway, Oslo Cancer Cluster will have a stand at NLSDays to promote Norwegian Healthcare Industry and the cluster members.

Questions regarding this conference may be directed to Jutta Heix, International advisor or Elisabeth Kirkeng Andersen, Head of Communicaton.

Read the latest newsletter from NLSDays 2015 below.

 

Why registering now?
Benefit from our Early Bird rates by registering before March 31st, 2015. Book and secure your company presentation slot when registering.

Benefit from an exclusive discount on all NLSDays’ registration rates. Please contact your organization to get your promotion code.

 

Why attending NLSDays 2015?

NLSDays annually attracts the best from pharma, biotech, medtech and finance the Nordic region has to offer for two days of intense networking. NLSDays’ Super Sessions, topical workshops and vibrant exhibition along with thousands of prescheduled face-to-face meetings make this event the place to be for companies across the Life Science value chain to meet and do business.

Attend NLSDays and take advantage of the opportunity for more partnering meetings in two days than in the rest of the year.

Based on attendance at previous events, NLSDays 2015 will bring together more than 1000 executives from biotechnology, medtech, pharmaceutical and finance companies from the Nordic region and from around the world, who will engage in some 2,000+ face-to-face meetings.

 

Why presenting at NLSDays 2015?

Presenting at NLSDays gives you a chance to increase your visibility and attract more potential partners. Pitch your company’s profile, pipeline and strategy to a selected audience representing over 30 countries. Be visible by business development executives, investors, media, and increase your activity in the partneringONE platform.

NB: Company presenters receive much more requests and schedule more meetings than non-presenting companies! Presenting companies are also spotlighted in NLSDays marketing material leading up to the event, as well as onsite.
Don’t miss the opportunity to book your presentation slot when registering.

Benefit from Early Bird rate on Company Presentation fees through March 31, 2015.

 

Why exhibiting at NLSDays?

The 2015 NLSDays Exhibition reflects our 2015 manifesto: “The Life Science Value Chain”.

Regional and country pavilions, from the Nordic Region and Europe, will showcase and host many companies from their regions or countries. Pharma, biotech, medtech and servives providers will join NLSDays exhibition as well.
About partneringONE™, the leading conference networking solution

partneringONE™ powered by EBD Group increase your ROI at the Nordic Life Science Days conference, reduce your overall business development costs and enhance your partnering effectiveness before, during and after the event. partneringONE allows you to:

• Search companies to source potential collaborations and funding opportunities

• Communicate directly with potential investors and/or partners

• Pre-schedule 30-minute face-to-face meetings to be organized onsite.