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Terns scores FDA orphan designation for CML therapy
12 Mar 2024
Phase 1Orphan DrugGene TherapyPhase 2
TERN-701 is an oral allosteric BCR-ABL tyrosine kinase inhibitor (TKI). Image Credit: crystal light / Shutterstock.
TERN-701ood and Drug AdministraBCR-ABL tyrosine kinase inhibitor (TKI)esignation to Terns Pharmaceuticals’s TERN-701 for the treatment of chronic myeloid leukaemia (CML).
The orpFood and Drug Administration (FDA) credits from clinical trials, exemption frTerns PharmaceuticalsoteTERN-701ven years of market exchronic myeloid leukaemia (CML) approval.
TERN-701 is an oral allosteric BCR-ABL tyrosine kinase inhibitor (TKI) and is one of the two therapies that Terns plans to focus its resources on this year. The treatment is being evaluated in a Phase I CARDINAL trial (NCT06163430) in participants with chronic phase CML who experienced treatment failure on at least one prior second-generation TKI. Interim data from the trial is expected in H2 2024.
TERN-701r drug, TERN-601, whichBCR-ABL tyrosine kinase inhibitor (TKI)obesity, is in a Phase I first-in-human trial, with topline data expected in H2.chronic phase CML
CML therapies arTERN-601ed to generate $3.5bn in sales across eight maobesityrmaceutical markets (the US, France, Germany, Italy, Spain, UK, Japan, and Canada), as per a GlobalData report. The current market leaders in the field include Bristol Myers Squibb’s Sprycel (dasatinib) and Novartis’ Tasigna (nilotinib). Sprycel and Tasigna generated $1.4bn and $1.8bn in global sales in 2023, according to the companies’ financials.
Pearl Bio and Merck partner for discovery of cancer therapies
GlobalData is the parent company of Pharmaceutical Technology.
Selecta BiosciencesTerns paused the development of its most advanced candidate, the oral thyroid hormone receptor-beta (THR-β) agonist, TERN-501, as a treatment for nonalcoholic steatohepatitis (NASH), despite reporting positive data from the Phase IIa DUET trial (NCT05415722). The company cited the current regulatory and developmental MASH landscape for limiting funding for the NASH therapy.
Meanwhile, Terns said it plans to evaluate TERN-501, as a combination therapy for obesity.
The company also has additional earlPharmaceutical Technology pipeline for obesity. TERN-800, an oral small molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) modulator, is currently in the discovery stage as an obesity treatment.
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