paltimatrectinib (PBI-200) / Biohaven - LARVOL DELTA

Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors (clinicaltrials.gov) - P1 | N=29 | Terminated | Sponsor: Pyramid Biosciences | Phase classification: P1/2 ➔ P1

Metastases • Phase classification • Brain Cancer • Glioma • Oncology • Soft Tissue Sarcoma • Solid Tumor • EWSR1 • NTRK • WT1

Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=29 | Terminated | Sponsor: Pyramid Biosciences | N=74 ➔ 29 | Trial completion date: Jun 2024 ➔ Jul 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2024 ➔ Jul 2023; Sponsor terminated development of PBI-200

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Brain Cancer • Glioma • Oncology • Soft Tissue Sarcoma • Solid Tumor • EWSR1 • NTRK • WT1

Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors (clinicaltrials.gov) - P1/2 | N=74 | Active, not recruiting | Sponsor: Pyramid Biosciences | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • Glioma • Oncology • Soft Tissue Sarcoma • Solid Tumor • EWSR1 • NTRK • WT1

"PBI-200 is being studied for refractory cases." (@BrunoBastosMD)

Clinical

Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors (clinicaltrials.gov) - P1/2; N=74; Recruiting; Sponsor: Pyramid Biosciences; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Brain Cancer • Glioma • Oncology • Soft Tissue Sarcoma • Solid Tumor • EWSR1 • NTRK • WT1

A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: Pyramid Biosciences

New P1 trial

A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: Pyramid Biosciences

New P1 trial

A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200 (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Pyramid Biosciences | Recruiting ➔ Completed

Trial completion

Pyramid Biosciences Receives Orphan Drug Designation for PBI-200 From FDA (Businesswire) - "Pyramid Biosciences, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for PBI-200, a next-generation, highly brain penetrant inhibitor of the neurotrophic tyrosine receptor kinase (NTRK) currently in clinical development for the treatment of NTRK fusion-positive solid tumors."

Orphan drug • Oncology • Solid Tumor

Pyramid Biosciences and Caris Life Sciences Announce MI Trials Collaboration for Clinical Trial Matching in Support of Study for Patients with NTRK Fusion Solid Tumors (PRNewswire) - "Pyramid Biosciences, Inc., and Caris Life Sciences® (Caris), today announced a collaboration to enhance identification of potential patients with NTRK fusion-driven cancers for participation in the ongoing Phase 1/2 trial (PBI-200-101) of Pyramid's lead oncology program PBI-200, a best-in-class, next-generation, highly CNS-penetrant TRK inhibitor...Caris' tailored MI Trials offering helps match the right patients to the right biopharma trials based on both the individual patient's molecular tumor profile and the eligibility requirements of a given study."

Diagnostic • Licensing / partnership • Trial status • CNS Tumor • Oncology • Solid Tumor

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200 (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Pyramid Biosciences

New P1 trial

A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200 (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Pyramid Biosciences | Recruiting ➔ Completed

Trial completion

A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200 (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Pyramid Biosciences

Clinical • New P1 trial

PBI-200: in vivo efficacy of a novel, highly CNS-penetrant next generation TRK inhibitor (SNO 2021) - P1/2 | "A BaF3 xenograft model encoding the LMNA-NTRK1 gene fusion and G595R solvent front mutation showed superior efficacy with PBI-200 relative to first-generation compounds larotrectinib and entrectinib, and equivalent efficacy to the second-generation compound selitrectinib, in terms of tumor growth inhibition. Together, these data suggest that PBI-200 has potential as a best-in-class, highly CNS-penetrant next generation TRKi. A Phase 1/2 clinical trial evaluating PBI-200 in NTRK fusion-positive patients, including patients with PBT, is ongoing (NCT04901806)."

Preclinical • Brain Cancer • Glioma • Immunology • Oncology • Solid Tumor • LMNA • NTRK • NTRK1

Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors (clinicaltrials.gov) - P1/2; N=74; Not yet recruiting; Sponsor: Pyramid Biosciences

Clinical • New P1/2 trial • Brain Cancer • Glioma • Oncology • Soft Tissue Sarcoma • Solid Tumor • EWSR1 • NTRK • WT1