Momenta Pharmaceuticals Announces Publication of New Data Supporting M281 as First Anti-FcRn Antibody to Inhibit Maternal-Fetal IgG Transfer in the Human Term Placenta
- Data supports M281’s potential to prevent placental transfer of disease-inducing antibodies from mother to fetus in alloimmune and autoimmune diseases of the fetus and newborn
- Global multi-center Phase 2 study of M281 in hemolytic disease of the fetus and newborn (HDFN) now active following regulatory approvals
The published study entitled, “M281, an anti-FcRn antibody, inhibits IgG transfer in a human ex vivo placental perfusion model,” was conducted in collaboration with the laboratory of Dr.
“This study in the gold standard model of the human term placenta showed that M281 has the potential to block the transfer of IgG from maternal to fetal circulation through late pregnancy. Prevention of maternal to fetal transfer of pathogenic antibodies through late pregnancy, the period with the highest placental IgG transfer, is a mechanism that may benefit alloimmune and autoimmune diseases of the fetus and newborn which can be potentially life threatening,” said
“We are also pleased to announce that we obtained appropriate regulatory approvals in the U.S.,
M281 is a fully human anti-neonatal Fc receptor (FcRn), aglycosylated immunoglobulin G (IgG1) monoclonal antibody, engineered to reduce circulating pathogenic IgG antibodies by blocking endogenous IgG recycling via FcRn. Momenta previously reported positive data showing safety, tolerability and proof of mechanism for M281 in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study of normal human volunteers. Over the 98-day MAD study, M281 exhibited no serious adverse events, was well tolerated, and decreased circulating IgG levels up to 89% with a mean reduction of 84%.1 M281 is currently being evaluated in Phase 2 studies in generalized myasthenia gravis2 and in early onset antenatal HDFN3 with plans for an additional Phase 2 autoimmune study later this year.
About Hemolytic Disease of the Fetus and Newborn (HDFN)
Hemolytic disease of the fetus and newborn is a rare and potentially life-threatening condition that affects approximately 4,000-8,000 pregnancies each year in the U.S. alone. The disease is caused by antibodies from the mother which target proteins (also called antigens) on the fetal red blood cells (a process known as red cell alloimmunization). The most common antigen is RhD, although other antigens such as Rhc, RhE and Kell may also be involved in the process.
During pregnancy, antibodies can cross the placenta and bind to the antigens on the surface of the fetus’ red blood cells, leading to fetal red blood cell destruction and anemia. Anemia causes less oxygen to be delivered to all the fetal tissues and can lead to organ damage and ultimately lead to fetal heart failure and even fetal death. In addition, severe HDFN can, in some cases, result in long-term neurodevelopmental delay including cerebral palsy and bilateral deafness. Intrauterine blood transfusions are the current standard of care, as there are no FDA-approved drugs to treat women at risk of HDFN.
Momenta is a biotechnology company with a validated innovative scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases. Momenta’s product candidate, M281, is a potentially best-in-class anti-FcRn antibody; M254, is a hyper-sialylated human immunoglobulin (hsIgG) designed as a high potency alternative to intravenous immunoglobulin (IVIg); and M230 (CSL730), is a potential first-in-class novel recombinant Fc multimer being developed in collaboration with CSL. Momenta also has a focused pipeline of two biosimilar candidates: M923, Momenta’s wholly-owned proposed biosimilar to HUMIRA®, and M710, a proposed biosimilar to EYLEA® being developed in collaboration with Mylan. Momenta’s two FDA-approved complex generic products, enoxaparin sodium injection and Glatopa® (glatiramer acetate injection), are marketed by its collaboration partner, Sandoz.
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MacDougall Biomedical Communications
1 Clinical Pharmacology & Therapeutics.
“M281, an Anti-FcRn Antibody: Pharmacodynamics, Pharmacokinetics, and Safety Across the
2Clinicaltrials.gov identifier NCT03772587
3Clinicaltrials.gov identifier NCT03842189
Source: Momenta Pharmaceuticals, Inc.