Orotecan (irinotecan oral) / Valent Tech, Edison Oncology - LARVOL DELTA

Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Valent Technologies, LLC | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Brain Cancer • Ewing Sarcoma • Hepatoblastoma • Medulloblastoma • Neuroblastoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Screening and identification of protein interacting with goose astrovirus. (PubMed, Front Cell Infect Microbiol) - "Further prediction of the binding residue sites revealed that seven residues of the GoAstV-P2 protein (THR124, ILE22, VAL24, TRP51, PRO66, GLN100, and VAL125) and twelve residues of the HSPA5 protein (ARG2, HIS3, LEU4, LEU6, ALA7, LEU8, LEU9, LEU10, LEU11, ASP411, VAL413, and LEU415) may be involved in the interaction between these two proteins. Our research results have preliminarily elucidated the interaction mechanisms between viral proteins and receptors, facilitating exploration from multiple angles of the roles of candidate protein in the process of GoAstV infecting host cells. This provides a theoretical basis for further identification of GoAstV receptors and clarification of its infection mechanisms."

Journal • Hepatocellular Cancer • Infectious Disease • Liver Cancer • Solid Tumor • ARG2 • CD5 • HSPA5 • SELL

A multicenter phase 1-2a clinical study of Orotecan® (oral irinotecan HCl, VAL-413) in patients with recurrent pediatric solid tumors (AACR 2025) - P1 | "An off-label regimen of IRN-IV administered as a 60-min i.v. infusion daily for 5-10 days, bi-weekly in combination with other agents such as temozolomide has been recommended for use in treating children with solid tumors (Blaney. A Phase 2 expansion is underway. Ongoing pharmacokinetic observations demonstrate similarity for the Orotecan (VAL-413) formulation and i.v. irinotecan given orally for both the parent compound and its active metabolites."

Clinical • Late-breaking abstract • P1/2 data • Brain Cancer • CNS Tumor • Colorectal Cancer • Ewing Sarcoma • Hepatoblastoma • Medulloblastoma • Neuroblastoma • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Valent Technologies, LLC | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Ewing Sarcoma • Hepatoblastoma • Hepatology • Medulloblastoma • Neuroblastoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

A multicenter phase 1-2a clinical study of Orotecan (oral irinotecan HCl, VAL-413) in patients with recurrent pediatric solid tumors (AACR 2024) - P1 | "An off-label regimen of IRN-IV administered as a 60-min i.v. infusion daily for 5-10 days, bi-weekly in combination with other agents such as temozolomide has been recommended for use in treating children with solid tumors (Blaney. VAL-413 is a novel formulation developed to improve the palatability of oral irinotecan.This Phase 1-2a multi-center clinical trial seeks to examine the safety and tolerability of this novel formulation and assess pharmacokinetics compared to the already established oral regimen.This trial is ongoing (CT.gov: NCT04337177) and currently enrolling the 110mg/m2/day cohort, with no dose limiting toxicity observed to date. Initial pharmacokinetic observations demonstrate similarity for the VAL-413 formulation and i.v. irinotecan given orally for both the parent compound and SN38 active metabolite."

Clinical • P1/2 data • Brain Cancer • CNS Tumor • Colorectal Cancer • Ewing Sarcoma • Gastrointestinal Cancer • Hepatoblastoma • Medulloblastoma • Neuroblastoma • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Edison Oncology Reports Promising Interim Data from Ongoing Orotecan Clinical Trial for Recurrent Pediatric Cancers (PRNewswire) - P1/2a | N=20 | NCT04337177 | Sponsor: Valent Technologies, LLC | "Edison Oncology Holding Corp...today announced the presentation of positive interim data from the company's ongoing multicenter Phase 1/2a clinical trial of Orotecan (oral irinotecan HCL, VAL-413) at the American Association of Cancer Research (AACR) annual meeting...The trial is currently enrolling the highest dose (110mg/m²/day) cohort, with no dose-limiting toxicity observed in the lower dose (90mg/m²/day) cohort. The 90mg/m2/day dose matches the dose of unformulated irinotecan i.v. given orally to more than two hundred patients across multiple published investigator-initiated pediatric cancer trials conducted over several years with promising outcome results....Initial pharmacokinetic observations support equivalency between the Orotecan formulation and unformulated i.v. irinotecan given orally for both the parent compound and active metabolites SN-38 and SN-38 glucuronide."

P1/2 data • Oncology • Solid Tumor

Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Valent Technologies, LLC | Trial completion date: Sep 2023 ➔ Jun 2024 | Trial primary completion date: Sep 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Ewing Sarcoma • Gastrointestinal Cancer • Hepatoblastoma • Hepatology • Medulloblastoma • Neuroblastoma • Neuroendocrine Tumor • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

A pilot clinical study of oral irinotecan HCl (VAL-413) in patients with recurrent pediatric solid tumors. (ASCO 2023) - P1 | "Previously, a regimen of IRN-IV administered as a 60-min i.v. infusion daily for 5 days, bi-weekly in combination with other agents such as temozolomide has been recommended use in treating children with solid tumors (Blaney. This trial is ongoing (CT.gov: NCT04337177), with no DLT observed to date. Clinical trial information: NCT04337177."

Clinical • Brain Cancer • CNS Tumor • Colorectal Cancer • Ewing Sarcoma • Gastrointestinal Cancer • Gynecologic Cancers • Hepatoblastoma • Hepatology • Lung Cancer • Medulloblastoma • Nephrology • Neuroblastoma • Neuroendocrine Tumor • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor • Wilms Tumor

A pilot clinical study of orotecan (oral irinotecan HCl, VAL-413) in patients with recurrent pediatric solid tumors (AACR 2023) - P1 | "Previously, a regimen of IRN-IV administered as a 60-min i.v. infusion daily for 5 days in combination with other agents such as temozolomide has been recommended use in treating children with solid tumors (Blaney. A palatability survey instrument will assess palatability of VAL-413 vs. IRN-IVPO; comparative intrapatient pharmacokinetics of irinotecan and its metabolites will be assessed. This trial is ongoing (CT.gov: NCT04337177), with no DLT observed to date."

Clinical • Brain Cancer • CNS Tumor • Colorectal Cancer • Ewing Sarcoma • Gastrointestinal Cancer • Gynecologic Cancers • Hepatoblastoma • Lung Cancer • Medulloblastoma • Neuroblastoma • Neuroendocrine Tumor • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor • Wilms Tumor

Edison Oncology Announces Presentation of Two Scientific Posters at AACR Annual Meeting (PRNewswire) - P1/2a | N=NA | "Edison Oncology Holding Corp....is pleased to announce the presentation of two scientific posters at the annual meeting of the American Association of Cancer Research....In a presentation entitled 'A Pilot Clinical Trial of VAL-413 (Orotecan®, oral irinotecan HCl) in Patients with Recurrent Pediatric Solid Tumors,' the company reported that, to date in its ongoing Phase 1-2a clinical trial, of Orotecan, a novel oral formulation of irinotecan, no dose limiting toxicity has been observed in patients receiving Orotecan, and preliminary analysis of pharmacokinetic data suggests that plasma levels of irinotecan and its active metabolite, SN-38, are similar to levels observed following treatment with unformulated commercially available i.v. irinotecan given orally in the same patient."

P1/2 data • PK/PD data • Oncology • Solid Tumor

A pilot clinical study of VAL-413 (oral irinotecan HCl) in patients with recurrent pediatric solid tumors. (ASCO 2022) - P1 | "Trial Design: Two different dose levels of VAL-413, 90mg/m2/day or 100mg/m2/day will be studied in combination with a fixed-dose of temozolomide using a standard 3 + 3 phase I design. This trial is ongoing (CT.gov: NCT04337177). Enrolment of the first dose level is ongoing, with no DLT observed to date."

Clinical • Brain Cancer • Colorectal Cancer • Ewing Sarcoma • Gastrointestinal Cancer • Gynecologic Cancers • Hepatoblastoma • Hepatology • Lung Cancer • Medulloblastoma • Nephrology • Neuroblastoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor • Wilms Tumor

[VIRTUAL] A pilot clinical trial of Orotecan (Val-413), a novel oral dosage formulation of irinotecan: Implications for pediatric brain tumors (SNO 2020) - P1 | "The current study (NCT04337177) evaluates the safety and pharmacokinetics of VAL-413 administered with temozolomide for treatment of recurrent pediatric solid tumors. Toxicity is evaluated based on CTCAEv5 and tumor response based on RECISTv1.1. An update on the progress of this trial will be presented."

Clinical • Colorectal Cancer • Gastrointestinal Cancer • Glioblastoma • Glioma • Medulloblastoma • Oncology • Pediatrics • Solid Tumor

A pilot clinical study of VAL-413 (Orotecan®, oral irinotecan HCl) in patients with recurrent pediatric solid tumors (AACR 2022) - "During the first cycle of treatment, each patient will receive four daily doses of VAL‑413 and one daily dose of IRN-IVPO, together with five (5) days of concurrent temozolomide. Up to 17 cycles of treatment may be administered on this study.Outcome Measures: Toxicity is assessed by NCI CCTCAEv5; tumor response is assessed by RECIST 1.1. A palatability survey instrument will assess palatability of VAL-413 vs. IRN-IVPO; and comparative intrapatient pharmacokinetics of irinotecan and its metabolites will be assessed in all patients."

Clinical • Brain Cancer • Colorectal Cancer • Ewing Sarcoma • Gastrointestinal Cancer • Gynecologic Cancers • Hepatoblastoma • Lung Cancer • Medulloblastoma • Neuroblastoma • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor • Wilms Tumor

Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Valent Technologies, LLC | Trial completion date: Nov 2022 ➔ Sep 2023 | Trial primary completion date: Nov 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Ewing Sarcoma • Gastrointestinal Cancer • Hepatoblastoma • Hepatology • Medulloblastoma • Neuroblastoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Edison Oncology Announces Treatment of First Patient in Orotecan (irinotecan HCI oral solution) Phase I/IIa Clinical Trial for Patients with Recurrent Pediatric Solid Tumors (PRNewswire) - "Edison Oncology Holding Corp...announced, that the first patient has received treatment with Orotecan (irinotecan HCI oral solution) in a Phase I/IIa clinical trial for patients with recurrent pediatric solid tumors....The clinical trial will enroll up to 20 patients with recurrent pediatric and solid tumors, including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma."

Trial status • Brain Cancer • CNS Tumor • Ewing Sarcoma • Hepatoblastoma • Medulloblastoma • Neuroblastoma • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Valent Technologies, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Brain Cancer • Ewing Sarcoma • Gastrointestinal Cancer • Hepatoblastoma • Hepatology • Medulloblastoma • Neuroblastoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Valent Technologies, Inc.; Trial completion date: Dec 2021 ➔ Nov 2022; Trial primary completion date: Dec 2021 ➔ Nov 2022

Trial completion date • Trial primary completion date • Brain Cancer • Ewing Sarcoma • Gastrointestinal Cancer • Hepatoblastoma • Hepatology • Medulloblastoma • Neuroblastoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

[VIRTUAL] A pilot pharmacokinetic study of VAL413 in patients with recurrent pediatric solid tumors (AACR-I 2020) - "Prior adult and pediatric trials demonstrate that the combination of intravenous irinotecan and temozolomide has significant antitumor activity in advanced EWS. The evaluation of two dose levels will help to formally define a recommended Phase II dose for further studies. Toxicity will be evaluated based on CTCAEv5 and tumor response based on RECISTv1.1."

Clinical • PK/PD data • Brain Cancer • CNS Tumor • Colorectal Cancer • Embryonal Tumor • Ewing Sarcoma • Gastrointestinal Cancer • Hepatoblastoma • Hepatocellular Cancer • Liver Cancer • Medulloblastoma • Neuroblastoma • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor

[VIRTUAL] Differentiation of liposomal irinotecan from dose-dense non-liposomal irinotecan in patient-derived pancreatic cancer xenograft tumor models. (ASCO 2020) - "Background: Liposomal irinotecan (ONIVYDE) is approved with 5-fluorouracil/leucovorin for metastatic pancreatic ductal adenocarcinoma (PDAC) post progression on gemcitabine-based therapy... In both PDAC models, TI was higher for weekly liposomal vs 5 x weekly non-liposomal irinotecan, suggesting potential benefits of the liposomal formulation in a clinical setting. N = 8 mice/group; aN = 4 mice. Collected b24 and c25 hours post-injection of third treatment cycle."

Gastrointestinal Cancer • Gene Therapies • Genetic Disorders • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Primary Immunodeficiency • Solid Tumor