Provention Bio Inc. scored approval from the U.S. FDA of the BLA for Tzield (teplizumab-mzwv), an intravenously given, anti-CD3-directed antibody, as the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients ages 8 and older with stage 2 T1D.
It’s been a rough year at Macrogenics Inc., but times may be changing. Having terminated a phase II study due to fatalities, dropped 15% of its workforce and closed research and manufacturing sites in the past year, the company has taken the helping hand of Gilead Sciences Inc. The pair have agreed to develop the bispecific MGD-024, which has a CD3 component for minimizing cytokine release syndrome, as an oncology candidate along with two additional bispecific research programs, a potential treatment for certain blood cancers, including acute myeloid leukemia and myelodysplastic syndromes.
Preclinical data on a novel T-cell therapy based on engineered autologous regulatory T cells (GNTI-122, EngTregs) for the potential treatment of type 1 diabetes (T1D) were presented by Gentibio Inc.
Researchers at Northwestern University and COUR Pharmaceutical Development Company Inc. have shown that biodegradable carboxylated poly(D,L-lactic-co-glycolic acid) (PLGA) nanoparticles containing encapsulated Ag (tolerance-inducing microparticles [TIMPs] or COUR nanoparticles [CNPs]) are able to prevent and treat type 1 diabetes (T1D) induced by transfer of monospecific diabetogenic CD4 and CD8 transgenic T cells to NOD.scid mice.
Insulet Corp. got the U.S. FDA’s nod to extend use of its Omnipod 5 automated insulin pump to children aged 2 years and up with type 1 diabetes. The expanded indication, just seven months after FDA cleared Omnipod 5 for patients 6 years and older, represents the first time a tubeless automated insulin delivery (AID) system has been authorized for use in children this young.
Carmot Therapeutics Inc. has raised $160 million in series D financing to support a trio of early to midstage clinical programs focused on treating diabetes and obesity with peptide-based small-molecule incretin receptor modulators.
Diabeloop SA has just closed a series C funding round, securing $73 million to ramp global expansion for its DBL1 integrated smart system for patients with type 1 diabetes. “This will allow us to boost commercial roll-out and continue pursuing our growth strategy into Europe, the U.S. and Asia,” Erik Huneker, CEO of Diabeloop, told BioWorld.
Abbott Laboratories received FDA clearance for its Freestyle Libre 3 continuous glucose monitoring system (CGM) just before the kickoff of the American Diabetes Association (ADA) annual meeting June 3 followed by breakthrough device designation for a combined CGM and continuous ketone monitoring system.
