IPN01203 / Ipsen, Marengo - LARVOL DELTA

Development of IPN01203, a dual T cell agonist activating Vβ6/Vβ10 TCR-expressing T cells (AACR 2026) - P1/2 | "These findings position IPN01203 as a promising next gen immuno-oncology bi-specific antibody for selective in vivo T cell modulation with durable antitumor efficacy, clonotype-specific engagement and memory T cell formation, supporting its advancement in clinical development. A Phase I FIH study received IND approval and is recruiting patients (NCT07213830)."

IO biomarker • Oncology • CD4 • CD8 • IL2 • IL2RA

Marengo Reports Late-Breaking Initial Phase 2 Clinical Results from Invikafusp Alfa Plus TRODELVY and Unveils Partnered Novel IPN01203/STAR0501 STAR Program in Phase 1 at AACR 2026 (PRNewswire) - "To date, invikafusp alfa with TRODELVY has shown a safety profile consistent with the known profiles of the individual agents. Pharmacodynamic analyses further confirmed that invikafusp alfa maintains its mechanism of action in a combination regimen, driving robust and selective expansion of Vβ6/Vβ10 T cells. The STARt-002 Phase 1b/2a trial is actively enrolling patients at select cancer centers across North America, with enrollment expected to be completed later this year....The next clinical candidate, IPN01203/STAR0501, has been selected for an oral presentation during the New Drugs on the Horizon session."

Late-breaking abstract • P1/2 data • Pipeline update • Trial status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Solid Tumor • Triple Negative Breast Cancer

CLIN-01203-450: A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies (clinicaltrialsregister.eu) - P1/2 | N=38 | Recruiting | Sponsor: Ipsen Pharma | Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Enrollment open • First-in-human • Oncology • Solid Tumor

Marengo Therapeutics Announces First Drug Candidate Nomination from Oncology Collaboration with Ipsen (PRNewswire) - "Marengo Therapeutics, Inc...announced that Ipsen...has nominated the first clinical drug candidate (DC) of two from its multi-year strategic partnership in oncology....This nomination represents the first of two selective T cell activation repertoire (STAR) T cell bi-functional activator programs that Marengo and Ipsen will advance as part of the collaboration."

New molecule • Oncology • Solid Tumor

CLIN-01203-450: A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies (clinicaltrialsregister.eu) - P1/2 | N=38 | Not yet recruiting | Sponsor: Ipsen Pharma

Checkpoint inhibition • First-in-human • New P1/2 trial • Oncology • Solid Tumor

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies (clinicaltrials.gov) - P1/2 | N=102 | Recruiting | Sponsor: Ipsen | Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Enrollment open • First-in-human • Oncology • Solid Tumor

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity of IPN01203 in Adults With Locally Advanced or Metastatic Solid Tumours Exposed to Immune Checkpoint Inhibitor Therapies (clinicaltrials.gov) - P1/2 | N=102 | Not yet recruiting | Sponsor: Ipsen

Checkpoint inhibition • First-in-human • New P1/2 trial • Oncology • Solid Tumor