Scale-up manufacturing of microneedle stamp for peanut allergen immunotherapy

The following contains proprietary/privileged information that Moonlight Therapeutics requests not be released to persons outside the government, except for purposes of review and evaluation Scale-up manufacturing of microneedle stamp for peanut allergen immunotherapy Food allergies affect 30 million people in the USA and 17 million in Europe. Six million children, roughly 1 in 13, in the USA have at least one food allergy; this equates to at least 1 in every classroom. Currently, there is only one FDA approved therapy in the USA for food allergies. Food allergies are expected to grow 10% annually until at least 2022. It is also common for someone to have more than one allergy. This is a growing, underserved global market that has few treatment options. A meaningful initial therapy would be one that reduces the chance for anaphylactic reaction after accidental exposure. Such a therapy will help bring peace of mind to families, allow for children affected by food allergies to have better quality of life, feel less socially out casted and most importantly reduce the potential for death from accidental procedure. Moonlight Therapeutics is developing a targeted way to administer allergens into the top skin layers to desensitize an allergic patient, using microneedles applied to the skin for only a few minutes. Microneedles can deliver into topmost skin layers, near immune cells, with high precision and reproducibility. The company’s first treatment is focused on peanut allergy and is called MOON101. We have demonstrated efficacy of our approach in a pre-clinical mouse model of peanut sensitization, completed a pre-IND meeting with the FDA and received a U44 clinical trial grant to conduct the first ever clinical study to evaluate the safety and tolerability of MOON101 in peanut allergic subjects. The objective of the CRP grant is to improve the current microneedle coating method so that large-scale clinical trials for safety and efficacy can be conducted. There are 2 main improvements that will be the focus of the new drop-on-demand coating system: (1) An automated coating method for microneedles to allow for increased production rate and (2) the ability to concurrently coat different allergens onto a single microneedle array. We have identified a particular piece of equipment that can be customized to suit our needs. Our approach will be to purchase this equipment, set it up and demonstrate that it can be used for clinical production of MOON101. We will first evaluate it for coating of peanut allergens, and then determine if we can coat multiple allergens simultaneously. This will address future needs of treating multiple allergies concurrently. Overall, this grant will enable Moonlight Therapeutics to advance the production capabilities of their platform. It will set the stage to evaluate the efficacy of MOON101 to treat peanut allergy in a Phase 2 clinical trial and begin to address treatment of multiple food allergies.