In October 2020, we entered into a collaboration with Novartis to develop, manufacture and commercialize our DARPin candidates for COVID-19, including ensovibep the first trispecific clinical DARPin candidate, that can simultaneously engage all three units of the spike protein trimer to potently inhibit ACE2 interaction. The cooperative binding of the individual modules enables ensovibep to retain inhibitory pan-variant potency against all frequent SARS-CoV-2 variants, including Omicron. As DARPin therapies, our candidates offer a unique approach for the treatment of COVID-19, with the possibility for high-yield manufacturing at scale, one shot administration and with the potential to bypass cold storage. Under the agreement, Molecular Partners conducted Phase 1 clinical trials for ensovibep with Novartis leading all later-stage clinical development as well as commercialization activity upon option exercise.

Following the results of the Phase 2 global EMPATHY clinical study, Novartis has informed Molecular Partners of its intent to in-license ensovibep. Upon completion of the applicable license agreement, Molecular Partners will receive a milestone payment of CHF 150 million and be entitled to a 22% royalty on sales of ensovibep in commercial territories. Novartis will be responsible for all further development and commercialization activities. The companies will work together to scale-up manufacturing capacity, in collaboration with Sandoz, to provide supply for patients around the world.

In December 2021, Molecular Partners entered into a separate research and collaboration agreement with Novartis to develop, manufacture and commercialize RadioDARPin Therapies (RDTs). The collaboration combines Molecular Partners’ industry-leading ability to rapidly generate high-affinity DARPins and the radioligand capabilities and expertise of Novartis.

Under the agreement, both parties will collaborate on the discovery and optimization of the therapeutic candidates. Novartis will be responsible for all clinical development and commercialization activities. Novartis paid $20 million upfront to Molecular Partners, with total potential development, regulatory and commercialization milestone payments of up to $560 million, and up to low double-digit percent of royalties.

In 2018, we entered into a collaboration and license agreement with Amgen for the clinical development and commercialization of MP0310. MP0310 is a molecule designed to locally activate immune cells in the tumor by binding to fibroblast activation protein, or FAP (a localizing target) on tumor stromal cells and co-stimulating T cells via 4-1BB (an immune modulatory protein).

Under the terms of the collaboration, we agreed to conduct the Phase 1 clinical trial and Amgen would have had the right to progress the program into later stage development, including into combination trials. The Phase 1 clinical study was initiated in October 2019 in patients with solid tumors. Initial data from patient biopsies demonstrated the potential of MP0310 to colocalize with FAP and activate 4-1BB in the tumor microenvironment after a first dose.

In April 2022, Molecular Partners regained global rights to MP03010, following a strategic pipeline review from Amgen. The Phase 1 trial of MP03010 remains ongoing and we expect to share full results from the study in 2022.

AbbVie and Molecular Partners have an ongoing discovery alliance focused on the selected DARPins for use in ophthalmology through AbbVie’s subsidiary, Allergan. In 2018, Allergan exercised the last of its three options upon which we granted Allergan an exclusive license to the selected multi-DARPin product candidates.