Inolimomab (LEUKOTAC®) development plan
Already 2,300 patients treated with inolimomab until 2020: 250 children 280 adult patients in clinical trials > 2,000 patients under named patient Temporary Authorization for Use (“ATU nominative”), upon request from physicians
The French National Agency for the Medicines and Health Products Safety (ANSM) granted a Temporary Authorisation for Use (ATU) so-called cohort ATU (cATU) for LEUKOTAC® (inolimomab) for the treatment of graft-versus-host disease, corticosteroid-resistant or corticosteroid-dependent, with grade II-IV on December 24, 2019 (see press release issued January 9, 2020).
Inolimomab (LEUKOTAC®) received Orphan Drug Designation in Europe (March 2001) and in the U.S. (October 2002) and has been administreted in several hundred patients included in clinical trials or treated via named patient Temporary Authorization for Use (“ATU nominative”) until its production was suspended in November 2015.
Based on the outcomes of the INO107 Phase III clinical trial (see the poster presented at EBMT2018), notably a significant increase in overall survival at one year (+ 37%) and a significantly more favourable safety profile as compared to the off-label drugs currently used by clinicians, ELSALYS BIOTECH acquired the rights of inolimomab (LEUKOTAC®) in 2017 with the aim to quickly reach the market.
The monoclonal antibody has been analyzed for long-term Phase III survival data (published in Blood Advances in January 2019).
Considering that patients are currently facing a therapeutic emergency, based on these data and with the full support of many clinicians specialized in this pathology who have already administered inolimomab (LEUKOTAC®), ELSALYS BIOTECH aims at obtaining a conditional marketing authorisation (AMMc) in Europe by 2021. The Company will also submit a Biologics Licence Application (BLA) in 2020 to the Food and Drugs Administration (FDA) in the United States by 2020.
An Investigational New Drug application for a phase 3 study in pediatrics will be filed with the FDA in Q1 2020.
ElsaLys is currently opening its capital to new investors in order to prepare the commercialization phase of inolimomab (LEUKOTAC®) in Europe. ElsaLys is also in discussions with partners for its commercialization in the United States and in China.