Zurich-Schlieren, Switzerland (Press Release) – Molecular Partners AG (SIX:MOLN), a clin­i­cal-stage bio­tech com­pany pioneering the use of DARPin® thera­peutics to treat serious dis­eases, announces the receipt of Orphan Drug Desig­na­tion by the US Food and Drug Admin­istra­tion (FDA) for its novel thera­peutic, MP0250, for the treat­ment of multiple myeloma.

MP0250 is a first-in-class, tri-specific multi-DARPin® drug can­di­date neutralizing VEGF-A and HGF and is binding to human serum albumin to in­crease plasma half-life. The unique mech­a­nism of action of MP0250 rep­re­sents a new ap­proach to targeting the tumor microenvironment and in­crease patients' re­sponse­s to already approved ther­a­pies for multiple myeloma, poten­tially even after pro­gres­sion.

The mission of the FDA's Office of Orphan Products Development (OOPD) is to ad­vance the evaluation and devel­op­ment of prod­ucts that dem­onstrate prom­ise for the diag­nosis and/or treat­ment of rare dis­eases or con­di­tions that affect fewer than 200,000 people in the U.S. In fulfilling that task, the OOPD eval­u­ates scientific and clin­i­cal data sub­missions from sponsors to identify and designate prod­ucts as promising for rare dis­eases and to further ad­vance scientific devel­op­ment of such promising medical prod­ucts. Orphan drug desig­na­tion provides incentives for sponsors to de­vel­op prod­ucts for rare dis­eases. These incentives may in­clude a partial tax credit for cer­tain clin­i­cal trial ex­pen­di­tures, the waiver of cer­tain FDA user fees, and poten­tial eligibility for seven years of orphan drug mar­ket­ing exclusivity, if approved.

Financial Calendar

February 6, 2020 - Publication of Full-year Results 2019 (unaudited)
April 29, 2020 - Annual General Meeting

http://investors.molecularpartners.com/financial-calendar-and-events/

About the DARPin® Difference

DARPin® thera­peutics are a new class of protein thera­peutics opening an extra dimension of multi-specificity and multi-functionality. DARPin® can­di­dates can engage more than five targets, offering poten­tial benefits over those offered by con­ven­tional mono­clonal anti­bodies or other cur­rently avail­able protein thera­peutics. The DARPin® tech­nology is a fast and cost-effective drug discovery engine, producing drug can­di­dates with ideal properties for devel­op­ment and very high pro­duc­tion yields.

With their low immuno­gen­icity and long half-life in the bloodstream and the eye, DARPin® thera­peutics have the poten­tial to ad­vance modern med­i­cine and sig­nif­i­cantly im­prove the treat­ment of serious dis­eases, in­clud­ing cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to ad­vance clin­i­cal pro­grams in ophthalmology and is ad­vanc­ing a pro­pri­e­tary pipe­line of DARPin® drug can­di­dates in on­col­ogy and immuno-oncology. The most ad­vanced global prod­uct can­di­date in part­ner­ship with Allergan is abicipar, a molecule for which phase 3 data have been filed to the re­spec­tive­ regulators in both the US and in Europe. Several DARPin® molecules for various ophthalmic in­di­ca­tions are also in pre­clin­i­cal devel­op­ment. The most ad­vanced DARPin® thera­peutic can­di­date wholly owned by Molecular Partners, MP0250, is in phase 2 clin­i­cal devel­op­ment for the treat­ment of hema­to­logical tumors. MP0274, the second-most ad­vanced DARPin® can­di­date owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads to induction of apop­tosis. MP0274 is cur­rently in phase 1. The com­pany's lead immuno-oncology prod­uct can­di­date MP0310 is a FAP x 4-1BB multi-DARPin® thera­peutic can­di­date designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator). Molecular Partners has closed a col­lab­o­ration agree­ment with Amgen for the ex­clu­sive clin­i­cal devel­op­ment and com­mer­cial­iza­tion of MP0310. The molecule has entered in phase 1 of clin­i­cal devel­op­ment in H2 2019. Molecular Partners is also ad­vanc­ing a growing pre­clin­i­cal and re­search pipe­line in immuno-oncology that features its "I/O toolbox" and addi­tional devel­op­ment pro­grams such as novel thera­peutic designs to target peptide-MHC complexes. DARPin® is a registered trademark owned by Molecular Partners AG.

About Molecular Partners AG

Molecular Partners AG is a clin­i­cal-stage bio­tech com­pany that is devel­op­ing a new class of ther­a­pies known as DARPin® thera­peutics. The com­pany con­tinues to attract talented in­di­vid­uals who share the passion to de­vel­op break­­through med­i­cines for serious dis­eases. Molecular Partners has com­pounds in various stages of clin­i­cal and pre­clin­i­cal devel­op­ment and several more in the re­search stage, with a current focus on on­col­ogy and immuno-oncology. The com­pany estab­lish­es re­search and devel­op­ment part­ner­ships with leading pharma­ceu­tical com­pa­nies and is backed by estab­lish­ed bio­tech in­vestors.

For more in­for­ma­tion re­gard­ing Molecular Partners AG, go to: www.molecularpartners.com.

Disclaimer

This communication does not con­sti­tute an offer or invitation to subscribe for or purchase any se­cu­ri­ties of Molecular Partners AG. This pub­li­ca­tion may con­tain cer­tain for­ward-looking state­ments and assess­ments or intentions con­cern­ing the com­pany and its business. Such state­ments in­volve­ cer­tain risks, un­cer­tainties and other factors which could cause the actual results, fi­nan­cial con­di­tion, per­for­mance or achieve­ments of the com­pany to be ma­teri­ally dif­fer­en­t from those ex­pressed or im­plied by such state­ments. Readers should there­fore not place reliance on these state­ments, particularly not in connection with any contract or investment de­ci­sion. The com­pany disclaims any obli­ga­tion to update these for­ward-looking state­ments, assess­ments or intentions.

Source: Molecular Partners.