Dec. 6 at 7:43 PM
$CRVS — ASH 2025 Preview + Cross-Read for Autoimmune (AD) Program (Scheduled on Dec 8th at 11:15 am (EST)).
• CRVS presents final Ph1/1b data for soquelitinib (selective ITK inhibitor) in relapsed PTCL.
– ORR ~39%, CR ~26% at 200 mg BID
– Median PFS ~6.2 mo, nearly 2× standard single-agent chemo (belinostat/pralatrexate)
– Clean tolerability, no DLTs, low G3/4 tox → strong profile for chronic oral use
• Immune rewiring is the story:
Soquelitinib consistently shows ↑ Th1 skewing, ↑ CD8+ TEMRA, ↓ Tregs, ↓ and exhaustion markers.
These aren’t just tumor effects — they validate ITK as a master regulator of pathologic T-cell signaling.
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🔥 Why this ASH biology matters BEYOND oncology — big read-through to AD
The same immune biomarkers driving responses in PTCL directly map onto the pathology of atopic dermatitis:
• AD is a Th2-dominant inflammatory disease
• ITK inhibition rebalances toward Th1
• Treg reduction + decreased exhaustion = improved T-cell fitness
• These signatures could serve as translatable biomarkers for autoimmune trials
If ASH confirms robust Th1 shift + Treg suppression, that becomes mechanistic proof-of-concept for CRVS’s non-oncology programs, especially AD, where rebalancing Th1/Th2 is clinically meaningful.
This is how a small oncology readout ends up validating a much larger autoimmune pipeline.
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📌 Big Picture for investors
• Soquelitinib looks best-in-class for R/R PTCL if durability holds
• Phase 3 (soq vs SOC) now has strong biological footing
• Biomarker cross-read gives free upside in autoimmune indications
Good luck longs, looking forward to Monday’s data drop, hopefully positively impactful.
