18 Jul MKC Biotherapeutics
Madhusudan Peshwa, CEO
Oct. 5 | 2:15pm | FLW Ballroom G
Jacksonville, FL
(Private)
Our objective is to develop/commercialize therapeutics ATMPs for chronic conditions, that halt or reverse disease progression. Our business model is to search for technologies / assets with substantial human clinical data from ex-US geographies; and in-license IP/technology; for clinical/commercial development in US & Europe. Our first in-licensed platform is allogeneic pooled donor Mesenchymal Stromal Cells, which has resulted in commercially approved products for three indications in India. In the US, we have identified & selected donors, manufactured (at US CDMO) and released GMP Master & Working Cell Banks. Drug Product GMP WCB was demonstrated to have CQAs comparable to that of the India commercial product. All of the data was submitted / reviewed with US FDA in a pre-IND meeting, and following alignment are on path to file an IND to initiate US Phase 2 clinical study designed as adequately sized, RCT with active control arm.