NGM: Data from Ongoing Trial of NGM707 in Advanced Solid Tumors

 

• 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

https://www.globenewswire.com/news-release/2024/01/09/2806226/35057/en/NGM-Bio-Announces-New-Clinical-Data-from-Ongoing-Trial-of-NGM707-in-Advanced-Solid-Tumors-and-Outlines-Evolved-Strategy-for-Aldafermin-and-NGM120-to-Focus-on-Rare-Conditions-with-S.html