Proposals are invited for biological therapies for non-cancerous diseases that are on the fast track towards clinical testing. These are drugs of the future, to help treat many rare and severe diseases, and in particular provide an important advance in the treatment of inflammatory disease.

Health Innovation Challenge Fund: Biological Therapeutics

Biological therapeutics are the drugs of the future. These medicines help treat many rare and severe diseases including heart attacks, stroke, multiple sclerosis, diabetes, rheumatoid arthritis and other autoimmune diseases.In the past ten years, biologics in general have accounted for one third of new medicine approvals. Biological drugs, in particular, have provided an important advance in the treatment of inflammatory disease such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease and ulcerative colitis. The HICF is seeking proposals for biological therapies for non-cancerous diseases that are on the fast track towards the clinical testing. For example, these could include:

• therapeutic proteins, such as signalling substances, enzymes and monoclonal antibodies for treating immune disorders, infections, and other diseases excluding cancer. This may include, but are not limited to, bi-specific mAbs, multi-specific fusion proteins, peptides, antibody conjugates, synthetic antibodies, aptamers
• DNA, RNA or microRNA based therapies including gene therapy and antisense therapy
• cell based therapies
• therapeutic vaccines unrelated to cancer

Specifically out of scope for this call are:

• anti-cancer therapeutics
• biologics used to prevent or diagnose disease
• tissue engineering based regenerative therapies

All proposals must meet the essential requirements of the HICF scheme and address at least one of its specific themes, addressing either a single theme within the current call or spanning several themes. Project teams must contain strong clinical representation and will preferably be clinically led. Projects must advance to first testing in man within the duration of the HICF project and have the potential to benefit patients within the following 3-5 years having demonstrated efficacy and received regulatory approvals. Projects must have already demonstrated ‘proof-of-principle’ supported by experimental and, where feasible, in vivo data. Projects must include a plan to progress the technology or intervention to the stage at which it is sufficiently validated, de-risked or developed to be attractive to commercial organisations, not-for-profit organisations and/or healthcare providers. Proposals must include a commercial strategy that takes into account the regulatory pathway, IP management, commercial barriers, health economics and routes to market. The HICF will not fund

• early stage/ basic research
• clinical trials
• health delivery research by the NHS
• delivery or provision of health services by or within the NHS;
• projects that could secure funding from industry or venture capital
• drug development
• regenerative medicine or vaccine development programs

Forms and guidance notes can be found on the Wellcome Trust website.