Reports Q1: Favorable Setup For H2 Catalysts In '819 (ccRCC) And '541 (Gyn)

研报英文原文证据摘录

Reports Q1: Favorable Setup For H2 Catalysts In '819 (ccRCC) And '541 (Gyn)

inal results were presented at DDW

that largely confirmed the prior interim analysis. The estimated terminal half-life was 74.1 days,

which continues to support Q12W dosing. Immunogenicity appeared manageable and more

favorable than first-gen TL1As – including tulisokibart (MRK), afimkibart (DNA), and duvakitug

(SNY). Modeling also predicts the 942 could maintain higher exposure vs first-gen TL1As, leading

to greater efficacy, and greater TL1A inhibition.

Early pharmacodynamic data validate XmAb942's high potency and sustained TL1A

suppression, with robust dose-dependent increases in total TL1A for at least 16 weeks after a

single-dose.

Final Phase I HV data will be presented at Digestive Disease Week in May.

Preclinical Data For XmAb412 (TL1A x IL-23p19 Bispecific) Are Promising And A Phase I HV

Study Is Expected To Initiate In Q3

Recall, beyond 942, the company is also advancing its second TL1A program, now XmAb412

(XmAb TL1A x IL-23p19 bispecific antibody). This program is from the company's XenLock

platform. This platform leverages a native IgG-based 1+1 Fab bispecific format without relying

on common light chain (CLC) or single-domain (i.e.,VHH) approaches, enabling full-domain

antibody generation. Preclinical data for 412 was presented in a poster at the DDW. The

company reported that 412 demonstrated femtomolar affinity for TL1A (single-digit pM) and sub-

picomolar affinity for IL-23p19, with potency comparable to or exceeding leading clinical TL1A

and IL-23 antibodies (discussed here).

The 1+1 format halves the number of binding domains, reducing drug mass requirements

and minimizing large immune complex formation typically associated with 2+2 bispecifics,