PEGylated camptothecin (PEEL-224) / PEEL Therap - LARVOL DELTA

PHASE 1/2 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF PEEL-224 IN COMBINATION WITH VINCRISTINE AND TEMOZOLOMIDE IN ADOLESCENTS AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY SARCOMAS (CTOS 2025) - P1/2 | "Pre-clinical data in EWS, DSRCT and RMS demonstrate significantly improved efficacy over irinotecan. This is a prospective, open-label, single-arm, non-randomized, phase 1/2 clinical trial conducted at Dana-Farber Cancer Institute and three external sites (NCT06709495). N/A"

Clinical • Combination therapy • P1/2 data • Ewing Sarcoma • Oncology • Osteosarcoma • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • TOP1

Phase 1/2 trial to evaluate the safety and efficacy of PEEL-224 in combination with vincristine and temozolomide in adolescents and young adults with relapsed or refractory sarcomas (AACR-NCI-EORTC 2025) - P1/2 | "Conventional topoisomerase 1 (TOP1) inhibitors like irinotecan are active agents in each of these diseases but have numerous shortcomings including poor bioavailability, susceptibility to resistance and often intractable diarrhea. Phase 1 and 2 include tumor sequencing and ctDNA analysis to assess ctDNA burden over time as well as genomic markers of sensitivity and resistance. The trial is now open and enrolling (NCT06709495)."

Clinical • Combination therapy • P1/2 data • Ewing Sarcoma • Oncology • Osteosarcoma • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • TOP1

PEEL-224-001: A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=65 | Recruiting | Sponsor: Peel Therapeutics Inc | N=42 ➔ 65 | Trial primary completion date: Mar 2025 ➔ Dec 2025

Enrollment change • Trial primary completion date • Oncology • Solid Tumor

PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors (clinicaltrials.gov) - P1/2 | N=59 | Recruiting | Sponsor: Theodore Laetsch | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Tumor • Neuroblastoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination with Vincristine and Temozolomide in Adolescents and Young Adults with Relapsed or Refractory Sarcomas (clinicaltrials.gov) - P1/2 | N=63 | Recruiting | Sponsor: David S Shulman, MD | Not yet recruiting ➔ Recruiting

Enrollment open • Ewing Sarcoma • Oncology • Osteosarcoma • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors (clinicaltrials.gov) - P1/2 | N=59 | Not yet recruiting | Sponsor: Theodore Laetsch

Combination therapy • New P1/2 trial • CNS Tumor • Neuroblastoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination with Vincristine and Temozolomide in Adolescents and Young Adults with Relapsed or Refractory Sarcomas (clinicaltrials.gov) - P1/2 | N=63 | Not yet recruiting | Sponsor: David S Shulman, MD

Combination therapy • New P1/2 trial • Ewing Sarcoma • Oncology • Osteosarcoma • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

PEEL-224-001: A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Peel Therapeutics Inc | Trial completion date: Dec 2024 ➔ Mar 2026 | Trial primary completion date: Apr 2024 ➔ Mar 2025

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

AN EARLY PHASE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ANTITUMOR ACTIVITY OF PEEL-224 IN PATIENTS WITH ADVANCED SOLID TUMORS (CTOS 2023) - P1 | "Not applicable."

Clinical • Metastases • PK/PD data • Ewing Sarcoma • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor • TOP1

Peel Therapeutics to Present Data on its TOP1 Inhibitor PEEL-224 at the Connective Tissue Oncology Society Annual Meeting and Society for Immunotherapy of Cancer Annual Meeting (Yahoo Finance) - "On Nov. 2, Dr. Robert Maki...will present 'An early phase study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PEEL-224 in patients with advanced solid tumors' during the Trials in Progress Poster Session at the Connective Tissue Oncology Society (CTOS) 2023 Annual Meeting in Dublin, Ireland. Dr. Maki will discuss PEEL-224-001, a first-in-human, dose escalation, repeat-dose, multi-center, open-label study in the United States."

Media quote

100% complete response to PEEL-224 in combination with PD-1 blockade in a syngeneic mouse model of colon cancer (SITC 2023) - P1 | "PEEL-224 is currently in early-phase clinical trials to determine the single-agent recommended phase 2 dose (NCT05329103). This data supports future testing of PEEL-224 in combination with PD-1 blockade for solid tumors."

Combination therapy • Preclinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • TOP1

Peel Therapeutics to Present Data on its TOP1 Inhibitor PEEL-224 at the Connective Tissue Oncology Society Annual Meeting and Society for Immunotherapy of Cancer Annual Meeting (PRNewswire) - "On Nov. 4, Dr. Aleah Caulin...will present '100% Complete Response to PEEL-224 in Combination with PD-1 Blockade in a Syngeneic Mouse Model of Colon Cancer' during the poster session at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in San Diego. Dr. Caulin will describe the results of combined PEEL-224 and PD-1 blockade in a syngeneic mouse model of colon cancer: Vehicle (0% Complete Response [CR]), PD-1 inhibitor only (30% CR), PEEL-224 only (80% CR), PEEL-224 + PD-1 inhibitor (100% CR). Based on these findings, PEEL-224 combined with immunotherapy may be a promising approach for difficult-to-treat tumors and translation to human clinical trials are being considered."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Peel Therapeutics to Present Data on its TOP1 Inhibitor PEEL-224 at the Connective Tissue Oncology Society Annual Meeting and Society for Immunotherapy of Cancer Annual Meeting (PRNewswire) - "On Nov. 2, Dr. Robert Maki, medical oncologist at Memorial Sloan Kettering Cancer Center and Interim Medical Director at Peel Therapeutics, will present 'An early phase study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of PEEL-224 in patients with advanced solid tumors' during the Trials in Progress Poster Session at the Connective Tissue Oncology Society (CTOS) 2023 Annual Meeting in Dublin, Ireland. Dr. Maki will discuss PEEL-224-001, a first-in-human, dose escalation, repeat-dose, multi-center, open-label study in the United States."

Clinical data • P1 data • Oncology • Solid Tumor

Peel Therapeutics Initiates Clinical Trial of PEEL-224 in Patients with Advanced Solid Tumors (PRNewswire) - "Peel Therapeutics...has initiated a first-in-human clinical study of PEEL-224 in patients with advanced solid tumors. This follows recent acceptance of the company's Investigational New Drug (IND) Application by the U.S. Food and Drug Administration (FDA)....The company is evaluating PEEL-224, a novel topoisomerase I inhibitor, in a Phase 1 dose escalation, repeat-dose, multi-center, open-label study in patients with advanced solid tumors. The trial will evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of PEEL-224."

IND • Trial initiation date • Oncology • Solid Tumor

PEEL-224-001: A Study to Evaluate PEEL-224 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Peel Therapeutics Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor