GB-4362 (MMAE neutralizer)
Generate:Biomedicines: company profile
Phase 1 registry
Since , the date of the source that reports this phase.
Summary
GB-4362 is a MMAE neutralizer from Generate:Biomedicines. The source describes it as biologic (MMAE-neutralizing protein, given with enfortumab vedotin and pembrolizumab). It is being developed for locally advanced or metastatic urothelial cancer (reducing enfortumab vedotin MMAE toxicity). ClinicalTrials.gov lists it at Phase 1 (recruiting) under NCT07484022. The AI role named in the source is molecule design. Registry records: NCT07484022, Phase 1, recruiting, updated Oct 13, 2026. About the company, based in United States: Flagship-founded generative biology platform that designs protein therapeutics computationally; lead asset GB-0895 (anti-TSLP, golukibart) is in Phase 3 for severe asthma. No efficacy data yet. All patients enrolled and initial patients dosed in first cohort; FDA Fast Track; trial-in-progress poster at ESMO 2026 (Oct 23 to 27, 2026). The latest dated source is from Aug 6, 2026.
Built only from the sources listed on this page.
Facts
- Company
- Generate:Biomedicines
- Indication
- Locally advanced or metastatic urothelial cancer (reducing enfortumab vedotin MMAE toxicity)
- Therapeutic area
- Oncology
- Modality
- Biologic (MMAE-neutralizing protein, given with enfortumab vedotin and pembrolizumab)
- AI role
- Molecule design
- Phase in the source
- Phase 1, as of Aug 6, 2026
- Phase source
- Confirmed
- Board column
- Phase 1
Key readouts in the source
No efficacy data yet. All patients enrolled and initial patients dosed in first cohort; FDA Fast Track; trial-in-progress poster at ESMO 2026 (Oct 23 to 27, 2026).
AI evidence
AI source: Company
“To discuss how this AI-enabled approach shaped GB-4362”
Trial records
- NCT07484022 on ClinicalTrials.gov (opens in new tab) Phase 1 Recruiting Updated
Milestone timeline
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NCT07484022 first posted on ClinicalTrials.gov
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Company release: Phase 1
No efficacy data yet. All patients enrolled and initial patients dosed in first cohort; FDA Fast Track; trial-in-progress poster at ESMO 2026 (Oct 23 to 27, 2026).
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NCT07484022 record updated
Phase 1, Recruiting
About Generate:Biomedicines
Flagship-founded generative biology platform that designs protein therapeutics computationally; lead asset GB-0895 (anti-TSLP, golukibart) is in Phase 3 for severe asthma.
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