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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - GAIT (From symptom relief to disease modifying allergy treatment with Glycan-Allergen Immunotherapy)

Teaser

Summary

The annual increase in prevalence of allergy related diseases develops at an alarming pace worldwide. Responsible disease mechanisms are characterised by unwanted immune responses to substances which do not harm healthy individuals. The allergy therapeutics market is now dominated by symptom alleviating antihistamines, decongestants and corticosteroids. The main patient need is to get cured with a disease modifying medicine instead of the chronic use of symptom relieving products. Allergen-specific Immunotherapy (AIT) attempts to treat the underlying cause by inducing allergen-specific immune tolerance. However, currently used AIT with high doses of extract is not effective enough (only 20% better than placebo), risks severe side effects and requires 5 years of treatment.

DC4U is developing a new generation of disease modifying allergy treatment with the potential to replace symptom relieving products and current AIT. We apply a new and unique technology to present allergens to the immune system as being SELF and SAFE, using glycans as endogenous human protein recognition elements. Our lead product, â€œsia-GPâ€, is a grass pollen allergy treatment for life long protection, achieved in a short treatment course. The overall objective is to develop this proprietary product up to and including Phase IIa clinical trials, followed by out-licensing it as a risk-reduced asset to a pharmaceutical company. This will generate early stage income by milestone payments and royalties to fund other pipeline products. Allergy patients represent the end-user group of our product. Effective curative tolerance inducing therapy will contribute to global medical needs and reduction of healthcare costs.

Work performed

In this SME-1 we have elaborated and refined our clinical plans, IPR strategy, market analysis, a cost-of-goods and profitability analysis. Furthermore, we have initialized discussions and negotiations with several possible investors and pharmaceutical licensing partners. All is incorporated in an elaborated European business plan with best suited to out-license sia-GP after Phase IIa clinical trials.

Final results

Once clinically proven in a first indication (e.g. cowâ€™s milk allergy, asthma), our technology will be an attractive licensing option for several other relevant allergy indications, and new application areas like auto-immune diseases.
Our strategy is to establish early stage industrial collaborations with companies that are actively developing allergen based product. These collaborations will pave the way to strategic alliances, licensing agreements and generating joint IP with these companies. In these early stage development projects with industrial partners, the partners either contribute for a large share to the development costs or become partner in a subsidized project. In these projects we aim for preclinical proof-of-concept for the cancer vaccine application and for the allergy applications. Follow-up early stage development with early stage partners will be settled in a R&D/IP contract, where funding is based on a cost-plus model. In this model the industrial partner bears the cost for further development plus an additional payment to allow revenues. Reimbursement schedules will differ for each contract, depending on the stage of development, further development program, type of end product envisioned and the negotiation position of the parties.

The early stage collaboration with prospective clients will contribute to an important early cash flow through revenues from upfront payments and success milestones, related to the phasing fo the development process. Proceeds will be employed to further expand the DC4U\'s GlycoDC technology, to fund new allergy pipeline applications and the growth of the company with respect to number of employees and expand the research laboratories.