Leukaemia and L...
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BioInvent’s BI-1206 antibody to enter collaborative Phase I/II trial funded and conducted by Cancer Research UK, CRT and Leukaemia & Lymphoma Research

Leukaemia and L...
Posted by
20 Jan 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 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 Leukaemia & Lymphoma Research. 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 CLL and various 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.

Michael Oredsson, CEO of BioInvent, said: “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."

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.

Comments

Anonymous
20.01.2015

This sounds like good news, let us hope it brings positive results for the patients. What concerns me is the licensing of the drug to a private company. CR UK did the same thing with prostrate cancer drug Abriaterone. When the drug was put on the market NICE said it was too expensive and it was rationed, sad for those who were suffering with the disease and quite disheartening for those who had given their time and hard earned money to develop it. What safeguards will there be in place to prevent this happening again with this drug if it is found to be effective?

21.01.2015

This is fantastic potential news for CLL and NHL patients. Here's hoping that the trial is a success and that we're able to get this on to the market in the not too distant future. It's also great that we're working in partnership with Cancer Research on this. Collaboration can only be a good thing going forwards for blood cancer patients and their families.

Anonymous
21.01.2015

This is exciting times. I truly hope this trial proves a great success and then is able to get to the patients who need this to make a difference to their lives.. To see Mantle Cell mentioned in this way is very touching and emotional. For LLR to work along side with Cancer Research on something so important is (fingers crossed) very positive. So much admiration to the incredible Scientist and professors who are making this a reality.

23.01.2015

Hi Graham,

I've spoken to our research team and I've got some information that I hope goes some way towards answering your question -

The need to develop a broad range of intelligent treatments that are better tailored to patients can have many challenges - not least the affordability of new drugs.

At LLR, we have constructed our own drug pipeline that will permit the translation of our discoveries into new medicines in a way that we and our partners, including CRUK and CRT, underwrite much of the risk by funding the early research and drug testing. With reduced risk and costs to pharmaceutical companies as a result, it is hoped that those successful drugs that emerge from this pathway will be priced to make them available to patients in the UK and all around the world.

We need to work with all our partners to build a workable financing model around the drug discovery pipeline that balances an incentive to those involved to see a return on their investments with the goal at all stages of the process to develop treatments that are affordable.

 

 

Anonymous
26.01.2015

Hi Andy
It was lovely of you to write to me. The drug I am going to be on is IDELALISIB. I was supposed to start today but the funding wasn't available so I am going back in 4 weeks to start. Fingers crossed.
The drug in your article sounds very promising. I hope you have some great success with it. Thanks again for writing to me.
Kind regards
Jan