LUND, Sweden--(BUSINESS WIRE)--Regulatory News:
Study to be conducted by Cancer Research UK expected to commence in second half of 2015
BioInvent International (OMXS: BINV) has today reached an agreement with Cancer Research UK, Cancer Research Technology (CRT), the charity’s development and commercialisation arm, and Leukaemia & Lymphoma Research (LLR) to take its investigational drug, BI-1206, into a collaborative phase I/II trial for patients with chronic lymphocytic leukaemia (CLL) and non-Hodgkin lymphoma (NHL).
The first in man study will be funded and conducted by Cancer Research UK, CRT and LLR. BioInvent has been granted the option to take up an exclusive license to the study data, subject to payment of milestones and royalties to Cancer Research Technology.
BI-1206 is a fully-human anti-CD32b antagonistic antibody that in addition to directly killing tumour cells is thought to work by maintaining CD20 antibodies on the cell membrane of cancer cells, preventing them from becoming resistant to the current state-of-the-art treatment, rituximab. The antibody has shown promise both in combination with CD20 antibodies and as a single agent in chronic lymphocytic lymphoma (CLL) and other types of NHL, in an extensive package of preclinical studies carried out by Leukaemia & Lymphoma Research-funded scientists at the University of Southampton. The potential development opportunity for BI-1206 may extend well beyond NHL.
The open label Phase I/ll study will enroll between 50 and 60 patients who will receive either BI-1206 alone or BI-1206 in combination with rituximab. The study will primarily enroll CLL patients but smaller cohorts of patients with other types of NHL, such as mantle cell lymphoma, follicular lymphoma and diffuse large B-cell lymphoma, may also be recruited. The study is expected to commence in the second half of 2015.
Each year in the UK approximately 12,800 people are diagnosed with NHL and 3,200 people are diagnosed with CLL. In Europe and North America around 157,000 people are diagnosed with NHL yearly and approximately 35,000 people are diagnosed with CLL. 1,2,3)
“We are very pleased that Cancer Research UK and Leukaemia & Lymphoma Research have chosen to conduct and fund the BI-1206 Phase I/ll trial. Cancer Research UK is one of the world’s leading cancer research charities with in-house clinical, regulatory and medical capabilities and an established network of clinical cancer centres and leading clinicians in the UK. This agreement provides BioInvent with an ideal resource to execute the first-in-man study for BI-1206 whilst preserving the commercial value in the project,” said Michael Oredsson, CEO of BioInvent.
Professor Chris Bunce, Research Director at Leukaemia & Lymphoma Research, said “Monoclonal antibodies have boosted survival rates for many types of lymphoma and leukaemia in recent years, but patient responses remain varied. BI-1206 has shown great promise in reducing treatment resistance in the laboratory. Leukaemia & Lymphoma Research has funded research into this treatment at the University of Southampton since 2008 and we’re very excited that through this partnership patients could benefit from it soon.”
Dr Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said “BI-1206 has performed well in preclinical studies making it an ideal candidate for our Clinical Development Partnerships program, which helps industry run trials of potential new cancer treatments that would otherwise never progress beyond the lab. There is a real need for new blood cancer drugs that help boost the effectiveness of conventional chemotherapy drugs, as many patients cannot tolerate or become resistant to these treatments over time. Consequently, we look forward to seeing the results of this trial.”
BI-1206 will be developed under Cancer Research UK’s Clinical Development Partnerships (CDP) program, a joint initiative between Cancer Research UK’s Centre For Drug Development (CDD) and CRT, to develop promising anti-cancer agents, which pharmaceutical companies do not have the resources to progress through early phase clinical trials.
It is the first drug to be entered into a new partnership through which Cancer Research UK and Leukaemia & Lymphoma Research will be jointly funding early phase clinical trials for patients with blood cancers.
Cancer Research UK’s CDD will manage and sponsor the study through the Experimental Cancer Medicine Centre (ECMC) network, with Leukaemia & Lymphoma Research providing the majority of the funding.
1) Cancer Research UK, Cancer statistics. URL accessed 19-01-2015. http://www.cancerresearchuk.org/cancer-info/cancerstats/
2) National Cancer Institute, Cancer statistics. URL accessed 19-01-2015. http://www.cancer.gov/statistics
3) Globocan 2012, URL accessed 19-01-2015. http://globocan.iarc.fr/Default.aspx
To the editors:
About BioInvent
BioInvent International AB is a research-based pharmaceutical company focused on the discovery and development of innovative antibody-based drugs against cancer.
The company has unique expertise in antibody drug development from initial concept to late clinical phase. The screening tool, F.I.R.S.T.TM, and the antibody library, n-CoDeR®, are two patented tools that enable identification of relevant human antibodies and disease targets during the discovery phase. BioInvent has also considerable experience in and a facility for process development and production of antibodies for clinical studies. The scope and strength of this platform is also used to develop antibody-based drugs in collaboration with partners who finance the development of the new drug, and provide BioInvent with the right to milestone payments and royalties on sales. These partners include Bayer Pharma, Daiichi Sankyo, Les Laboratoires Servier and Mitsubishi Tanabe Pharma. More information is available at www.bioinvent.com.
About Leukaemia & Lymphoma Research
Leukaemia & Lymphoma Research is a leading UK charity dedicated to improving the lives of patients with all types of blood cancer, including leukaemia, lymphoma and myeloma. Its life-saving work is focused on finding causes, improving diagnosis and treatments, and running groundbreaking clinical trials for all blood cancer patients.
The charity champions patients’ needs by influencing relevant policy and decision makers. Its communities give blood cancer patients and their families a place where they can find support and information and share their journey with other people who can relate to what they are going through.
Around 38,000 people of all ages, from children to adults, are diagnosed with blood cancers and related disorders every year in the UK. For more information visit beatingbloodcancers.org.uk.
About Cancer Research UK’s Centre for Drug Development
Cancer Research UK has an impressive record of developing novel treatments for cancer. It currently has a portfolio of around 30 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Since 1982, the Cancer Research UK Centre for Drug Development, formerly the Drug Development Office, has taken over 120 potential new anti-cancer agents into clinical trials in patients, five of which have made it to market and many others are still in development. These include temozolomide, a drug discovered by Cancer Research UK scientists, that is an effective treatment for brain cancer. Six other drugs are in late developmentPhase III trials. This rate of success is comparable to that of any pharmaceutical company.
About the ECMC network
Conducting the majority of early-phase cancer clinical trials in the UK, experimental cancer medicine centres (ECMCs) provide infrastructure funding to enhance the quantity and quality of research in developing new medicines to help beat cancer. Each ECMC brings together lab-based experts in cancer biology with cancer doctors to speed up the flow of ideas from the lab bench to the patient’s bedside. Launched in 2007, the network of 18 ECMCs is jointly supported by Cancer Research UK, the National Institute for Health Research in England, and the Departments of Health of Scotland, Wales and Northern Ireland who, together, have provided £35 million from 2007-2012 and a further £35 million from 2012 to 2017. Find out more at www.ecmcnetwork.org.uk
About Cancer Research Technology
Cancer Research Technology (CRT) is a specialist commercialisation and development company, which aims to develop new discoveries in cancer research for the benefit of cancer patients. CRT works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. CRT facilitates the discovery, development and marketing of new cancer therapeutics, vaccines, diagnostics and enabling technologies. CRT is a wholly owned subsidiary of Cancer Research UK, the world’s leading cancer charity dedicated to saving lives through research. Further information about CRT can be found at www.cancertechnology.com.
About Cancer Research UK
· Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
· Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
· Cancer Research UK receives no government funding for its life-saving research. Every step it makes towards beating cancer relies on every pound donated.
· Cancer Research UK has been at the heart of the progress that has already seen survival rates in the UK double in the last forty years.
· Today, 2 in 4 people survive cancer. Cancer Research UK’s ambition is to accelerate progress so that 3 in 4 people will survive cancer within the next 20 years.
· Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
· Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured.
For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter (http://twitter.com/CR_UK) and Facebook (http://www.facebook.com/cancerresearchuk).
The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same was as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.
Information disclosed in this press release is provided herein pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication at 8.30 a.m. CET, on 20 January, 2015.
This information was brought to you by Cision http://news.cision.com
BioInvent International AB (publ) Co. reg. No. 556537-7263 Visiting address: Sölvegatan 41 Mailing address: 223 70 LUND Phone: +46 (0)46 286 85 50 info@bioinvent.com www.bioinvent.com
Contacts
BioInvent
Michael Oredsson
President and CEO
+46 (0)46 286 85 67
+46 (0)707 16 89 30
michael.oredsson@bioinvent.com
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