OQL051 / OnQuality Pharma - LARVOL DELTA

OnQuality Announces FDA Clearance of IND Application for OQL051, for the Prophylaxis of Chemotherapy-Induced Diarrhea (PRNewswire) - "OnQuality Pharmaceuticals...announced today the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its drug candidate, OQL051, for the prophylaxis of chemotherapy-induced diarrhea (CID)....OnQuality plans to initiate a Phase I/II clinical trial in coming months to evaluate the safety in healthy volunteers, as well as safety and preliminary efficacy of the drug in cancer patients who plan to receive fluorouracil (5-FU) and irinotecan-based chemotherapy."

IND • New P1/2 trial • Gastrointestinal Disorder • Oncology

A preclinical toxicology and pharmacology study of OQL051, a gut-restricted CDK4/6 inhibitor for the prophylaxis of chemotherapy-induced diarrhea (AACR-NCI-EORTC 2022) - "Background: Chemotherapy-induced diarrhea (CID) from fluorouracil (5FU) and irinotecan (IRI, rate 50-80%) leads to therapy interruption/discontinuation and disruption of the intestinal microbiome. OQL051 safety was confirmed as there were no drug-related AEs observed for OQL051 repeat doses up to 500mg/kg/day for 7 days. CDK 4/6 inhibitor common AEs (neutropenia, leukopenia, thrombocytopenia, anemia, diarrhea, nausea, ALT) were absent indicating a low systemic exposure. The previously observed decrease in intestinal wall damage and CID from chemotherapy led to the maintenance of the gut microbiome and potentially enhanced the efficacy of chemotherapy plus immunotherapy anti-tumor efficacy at reducing tumor volume."

Preclinical • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

OnQuality Pharmaceuticals to Present Two Posters at the 34th EORTC-NCI-AACR Symposium (PRNewswire) - "OnQuality Pharmaceuticals...announced it will present two posters at the 34th EORTC-NCI-AACR Symposium, October 26 – 28, 2022. The first poster presents preclinical toxicology and pharmacology data for its therapeutic candidate OQL051, a gut-restricted CDK4/6 inhibitor for the prevention of chemotherapy-induced diarrhea (CID)."

Preclinical • Oncology

Preclinical study of OQL051, a gut-restricted CDK4/6 inhibitor for chemotherapy-induced diarrhea. (ASCO 2022) - "CID (irinotecan) model) was studied in Balb/c mice given OQL+ Irinotecan at 2 OQL doses (25 and 50 mg/kg, n = 5/ dose) plus IP Irinotecan... An oral CDK4/6 inhibitor, OQL051, was restricted to the intestinal lining and reduced 5FU intestinal cell apoptosis, necrosis, and inflammation. In a preclinical model, prophylactically used OQL051 improved not only diarrhea but also intestine damage status which supports the potential for a prophylactic CID treatment."

Preclinical • Immunology • Inflammation • CASP3 • CASP7

OnQuality Pharmaceuticals to Present Preclinical Data for OQL051, a Novel Chemotherapy-Induced Diarrhea Therapeutic, at AACR (PRNewswire) - "OnQuality Pharmaceuticals...today announced it will be giving an oral presentation highlighting preclinical data for its therapeutic candidate OQL051, a gut-restricted CDK4/6 inhibitor for the prevention of chemotherapy-induced diarrhea (CID), at the American Association for Cancer Research (AACR) Annual Meeting 2022. The conference will be held in New Orleans, La., and virtually from April 8-13, 2022...with a reported incidence rate as high as 80% depending on the chemotherapy agent. Cancer patients experiencing diarrhea have a 40% higher rate of therapy discontinuation compared to those who do not."

Preclinical • Oncology