Aridis signs deal for commercial licenses for pan-Ebola, pan-Marburg programs

Aridis Pharmaceuticals signed an exclusive term sheet to secure international development and global commercial rights upon licensure for the pan-Ebola and pan-Marburg monoclonal antibody programs from Mapp Biopharmaceutical. Aridis and MappBio have committed to work exclusively with each other to expeditiously complete definitive licensing agreements MappBio’s pan-Ebola and pan-Marburg mAb programs are currently in Phase 1 clinical studies and both products have shown best-in-class protection against live virus challenges in non-human primates. The Strategic National Stockpile is a federally funded program that acquires, stores, and distributes medical countermeasures in the event of a public health emergency. The pan-Ebola program, MBP134, is a two mAb cocktail that has demonstrated effectiveness against Sudan virus, Zaire Ebola virus, Bundibugyo virus, Tai Forest virus, Reston virus and Bombali ebolavirus in laboratory studies to date, suggesting it has potential to serve as a broad-spectrum Ebolavirus countermeasure. MBP134 fully protected non-human primates from lethal Sudan Ebola virus challenge and is currently in Phase 1 studies in healthy adults. MappBio was recently awarded $110 million by BARDA to further advance the program, including the development of a lyophilized formulation of MBP134 in order to reduce the need for cold-chain storage and improve its transportability. The funding under this new award covers activities necessary to request regulatory approval of MBP134, including support for manufacturing, efficacy and safety evaluations, and regulatory submissions. MBP134 is the first SUDV therapeutic in BARDA’s portfolio. MBP134 is eligible for a Priority Review Voucher. MBP091 is a single human mAb that is being developed as an anti-Marburg virus therapeutic for the treatment of hemorrhagic fevers caused by Marburg virus disease and it has also been shown to be active against the closely related Ravn virus. MBP091 has been evaluated in numerous preclinical experiments and has demonstrated the ability to neutralize Marburg virus in vitro and fully protect from lethal challenge of Marburg in vivo. A Phase 1 clinical study evaluating the safety and pharmacokinetics of MBP091 in healthy adults is underway. MappBio was recently awarded $80 million in funding from BARDA to continue to advance the development of MBP091 towards licensure. The funding under this new award covers activities necessary to request regulatory approval of MBP091. MBP091 is the first Marburg virus therapeutic in BARDA’s portfolio. MBP091 is eligible for a Priority Review Voucher.