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Generate Biomedicines—GB-0895 (anti-TSLP)Generate Biomedicines—

GB-0895 (anti-TSLP)

by Generate BiomedicinesUS

DeployStage 4 of 5

Phase 3 in severe asthma since Jan 2026; early trial in COPD.

Updated Jan 2026Checked 25 Sep0 updates this week

Milestones

Next · Phase 3 fully enrolled (~1,600 patients)
  1. Phase 1 in healthy people and asthma2024Complete.
  2. First patient in Phase 3Jan 2026Complete.
  3. Phase 3 fully enrolled (~1,600 patients)Target 2028Current milestone.

Most important updates

  • Jan 2026

Upcoming

  1. 2028Phase 3 fully enrolled (~1,600 patients) (next)

Current obstacles

  • Crowded fieldAn existing drug (tezepelumab) already blocks TSLP; GB-0895 must match it and win on fewer shots.

Physics limits

  • Antibodies can only last so long in the bodyThe body recycles antibodies through a receptor (FcRn); normal ones last about three weeks. Engineering can extend that a few-fold, but not indefinitely.
  • Shots under the skin carry limited volumeAbout 2 mL can be injected under the skin at once, and very concentrated antibody becomes too thick to push through a needle. That caps the dose per shot.
  • Blocking inflammation can weaken defencesThe same signals that drive asthma help fight infections. Blocking them strongly and for long risks side effects, which limits how far such drugs can go.

How it works

3 parts
Steel bioreactors: antibodies like GB-0895 are made by cells growing in tanks like these
Steel bioreactors: antibodies like GB-0895 are made by cells growing in tanks like thesePhoto: RickLawless · CC BY 3.0 (opens commons.wikimedia.org)
Target

Block an early alarm

TSLP is a signal released by the airway lining when irritated; it switches on several kinds of inflammation that drive asthma.

Design

AI-tuned antibody

Generative models proposed antibody variants to bind TSLP tightly; the best were tested and refined in the lab.

Dosing

Built to last

The antibody is engineered to stay in the blood longer, aiming for a shot every six months instead of every month.

Update log

1 update

Jan 2026

  • Minor: FilingTest

About Generate Biomedicines

The team behind GB-0895 (anti-TSLP)

Generate Biomedicines

AI-designed proteins, antibodies

Flagship Pioneering company that designs protein drugs with AI. Its Chroma model was published in Nature in 2023. Its lead antibody, GB-0895, a long-lasting asthma drug, entered Phase 3 in 2026. Listed on Nasdaq in Feb 2026.

  • IPO on 27 Feb 2026 raised $400M at $16 per share.
  • GB-0895 was built to last longer in the body, aiming for a shot every six months instead of monthly.

generatebiomedicines.com (opens generatebiomedicines.com)Company profile →

Founded
20188 yrs
Headquarters
United States
Status
Public
Listed
GENB (opens google.com)NASDAQ
Valuation
public
Works in
BiotechAI drug discoveryAI
Coverage
1 program · 3 updateslatest 27 Feb 2026checked 25 Sep
Partners
Amgen (opens amgen.com)Novartis (opens novartis.com)
Investors
Flagship Pioneering (opens flagshippioneering.com)
People
Mike Nally (opens generatebiomedicines.com)CEO
Primer