NGM Bio Announces Clinical Data From Trial Of NGM707 In Advanced Solid Tumors And Outlines Evolved Strategy For Aldafermin And NGM120

Author: Benzinga Newsdesk | January 09, 2024 08:05am

• Encouraging findings in heavily pretreated patients in multiple solid tumor indications, including MSS colorectal cancer (CRC), in ongoing Phase 1 Part 1b study evaluating NGM707, a dual ILT2/ILT4 antagonist antibody, in combination with KEYTRUDA® (pembrolizumab)
• Aldafermin, an engineered FGF19 analog, has been granted Orphan Drug Designation by the FDA for the treatment of primary sclerosing cholangitis (PSC), a rare liver disease
  • Initiating design of a potential registrational trial of aldafermin in PSC and in discussion with the FDA on utilizing proposed surrogate endpoints with the goal of obtaining accelerated approval
  • Large body of clinical data, including from NGM Bio's prior Phase 2 study in PSC, supports aldafermin's differentiated potential to address the bile acid dysregulation underpinning PSC
• NGM120, a GDF15/GFRAL antagonist, has strong biologic rationale for the treatment of hyperemesis gravidarum
  • Discussing design of an acceptable toxicology package to support clinical trials in hyperemesis gravidarum patients in ongoing dialogue with the FDA
  • Recent evidence suggests this rare, devastating condition is linked to higher levels of, and greater sensitivity to, GDF15 during pregnancy
    • NGM Bio is a long-time pioneer in elucidating GDF15 biology, including identifying its cognate receptor, GFRAL

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