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MRC/UCB Antibody Discovery Initiative (ADI)

  • Status: Closed
  • Open date: 2 Aug 2017
  • Closing date: 27 Sep 2017 16:00 GMT+1
  • Type: Calls

Introduction

The MRC/UCB Antibody Discovery Initiative aims to support academic researchers seeking to develop antibody-based therapeutics. It is intended to accelerate the transition from discovery research to translational development projects by enabling generation of novel antibodies suitable for testing in models of disease. A clear line-of-sight to therapeutic use will be required to secure funding.

Following production of the antibodies, MRC will provide a limited amount of funding to support a (set of) proof-of-concept experiment(s) to enable the applicants to generate data that will enable them to seek follow-on funding through the MRC’s Development Pathway Funding Scheme (DPFS).

Background

It is over 30 years since the commercial development of the first therapeutic monoclonal antibody. Today monoclonal antibodies are approved for the treatment of a wide range of diseases, including orphan indications. The number of approved products for commercial sale has grown steadily in recent years, with 3-5 new antibody products expect to be approved each year. As of January 2017, 68 therapeutic antibodies were approved by the FDA for the treatment of disease, including 5 of the 10 best selling drugs in 2016.

UCB has developed a novel platform capable of identifying rare functional antibodies within an immune repertoire, suitable for humanisation to obtain therapeutic antibodies or for the generation of surrogate anti-rodent antibodies.

This platform is capable of efficiently sampling an immune repertoire through culturing B-cell pools, and characterising identified binders through carefully selected functional assays. Recombinant antibodies with the desired specificity can then be generated. UCB have automated several early stages of the process to expand the capacity, increase the speed and improve the consistency of the antibody discovery process.

For more details and background on the automated system, see UCB’s core antibody discovery process.

Funding available

The MRC will initially provide funding to support up to 3-5 projects per year. In the first instance, the competition will be run once a year and as capacity is limited, projects will be prioritised for funding and for timeslots within the facility. Accordingly, the timeframe for commencement of the studies conducted within the Research Organisation using the discovered antibodies will vary; although the expectation is around 9 months post award. If further assay development is required this timeframe could be extended.

UCB may offer to fund a project in its entirety if, based on the application, it considers that route to be the most appropriate funding mechanism for that individual study. In such cases, these will be taken forward through direct collaboration with the company without further MRC involvement. Applicants who do not wish to accept this offer may continue to seek MRC support through the initiative.

The antibody discovery and production activities will be conducted at the UCB facility in Slough with costs met by MRC; applicants will not be able to request costs associated with this component of the project.

Applicants can request costs from MRC to conduct proof-of-concept experiments with the generated antibodies. Costs will be limited and the studies will need to be delivered and reported on within a 6 month window.

The MRC Panel, in consultation with technical input from UCB, may also provide funding to support additional assay optimisation prior to transition to the UCB antibody platform. Careful choice of immunogen is necessary to generate a robust immune response to the desired antigen/epitope. Discriminatory functional assays, ideally compatible with the B-cell culture media, are necessary to identify functional antibodies of the required potency. If this work is conducted within the Research Organisation, UCB will nominate a contact to provide advice and enable transition to the UCB facility.

Who can apply

This call follows standard RCUK eligibility criteria and is open to UK-based researchers who can show they will direct the proposed research and be actively engaged in carrying it through.  Eligible institutions include UK higher education institutions, Research Council Units and Institutes, and eligible Independent Research Organisations (IROs). All IROs listed on the RCUK web page are eligible to apply.

Research proposals that are led by commercial entities are not eligible. Applications may not include collaborations with additional commercial parties.

Application process

Proposals must be submitted using the Research Council’s Joint electronic Submission (Je-S) System.

Applicants should read the MRC/UCB Antibody Discovery Initiative Application Guidance before preparing their proposal. To submit an application, the applicants must complete the MRC/UCB Antibody Discovery Initiative Case for Support form, and submit this as a PDF, along with all other documentation detailed in the application guidance.

Please bear in mind that all proposals have to be submitted via your research organisation’s administrative department. Please ensure sufficient time to complete their parts of the proposal before the MRC deadline dates. Standard MRC terms and conditions will apply to this scheme.

Assessment

Applications will be assessed by expert peer-review and prioritised for funding by the MRC, via a bespoke expert assessment Panel including members of MRC’s DPFS Panel, MRC’s Research Boards and external experts.  UCB  will provide guidance to confirm that projects are technically feasible, that there are no 3rd party agreements preventing UCB from undertaking the project, and that no equivalent antibody exists within the UCB pipeline or is available commercially.

The Panel will consider all applications against the criteria outlined below:

  • Need: Does the identified need exist? Would meeting this need significantly reduce disease burden and/or provide a valuable commercial opportunity and/or alleviate an important development bottleneck? If the need is not significant now, will it become so in the future? Is the need met or unmet? If unmet, will it likely be unmet at the time that the proposed solution is in place? Has the applicant identified the key competing solutions and their status or are you aware of other similar or complementary research underway elsewhere? Has the applicant identified the key competitive advantages of their proposed solution? How likely is it that the proposed solution, if achieved, would be widely adopted?
  • Rationale: Is there a good medical/scientific rationale for the project? Is there a reasonable body of evidence to support the proposed rationale?
  • Deliverability: Is the approach technically feasible and is there a reasonable prospect of generating a functional antibody to the proposed target? If successful, will the proposal make a significant contribution demonstrating proof-of-principle that the approach could meet the identified need? Will it achieve an endpoint that has a reasonable chance of attracting any required additional investment? Are upstream or downstream development hurdles surmountable?

The Panel will, independent of UCB input, determine the applications that merit support and rank them by order of priority. If modifications to the approach or provision of additional data would potentially make a re-application worthy of support, declined applications may receive ‘Positive Feedback’. The decision of the Panel is final and will not be open to appeal and the MRC reserves the right to amend the application process.

Post-award scheduling

Applications will be supported in order of priority, taking into account the view of a subsequent joint UCB and technical review sub-Panel meeting. Applicants may be required to provide further information in advance of this Meeting, and to potentially join by telephone.

Intellectual property

All projects funded under this initiative will be collaborative studies between academic researchers and UCB. The investigators will work under a pre-agreed standard collaborative research agreement, jointly signed by the Research Organisation and UCB, based closely on the Lambert Agreement for preclinical studies. Release of funds will be contingent on receipt of the signed agreement by MRC.

The Research Organisation will own all arising project IP generated  under the collaboration. UCB will have the first right to negotiate for an exclusive licence to any arising IP owned by the Research Organisation. 

Timeline

Call open

2 August 2017

Call close

27 September 2017

Panel Meeting

tbc (Mid February 2018)

Technical Meeting

tbc (Mid March 2018

Screening

Q3/Q4 2018

 

Contact

You are encouraged to discuss your proposal with the MRC Programme Manager before submission:

Email: antibodydiscovery@headoffice.mrc.ac.uk

For further information please refer to the FAQ web page