In a statement, the Vancouver, Washington-based late-stage biotechnology company said the human colon carcinoma cells were implanted in the colon walls of immunodeficient mice and treated with a control antibody or leronlimab.
After four weeks, the mice were sacrificed and the lungs and livers removed for analysis of invasion of the colon cancer cells. Leronlimab produced statistically significant inhibition of metastases to lung and liver in this mouse model, said the company.
“This is additional preclinical data supporting the clinical programs that CytoDyn has underway in the oncology space,” said CytoDyn CEO Nader Pourhassan.
Dr Pourhassan said CytoDyn planned to take advantage of the recent Food and Drug Administration (FDA) recommended master protocol design to simultaneously evaluate multiple drugs and disease populations in multiple sub-studies which accelerates drug development.
One example of the types of master protocol designs includes trials commonly referred to as basket trials.
“Under the master protocol design option, we will use the basket trial alternative for single therapeutic agents with enrollment of different cancer histologic types when a single biomarker is identified. In our case, patients with metastatic disease of different histologic types, all expressing CCR5, will be enrolled,” said Pourhassan.
A basket trial involves a single investigational drug or drug combination that is studied across multiple cancer populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers. It’s usually designed as a single-arm, activity-estimating trial with overall response rate as the primary endpoint. A strong response signal seen in a sub-study may allow for expansion to generate data that could potentially support a marketing approval.
In September, the US Food and Drug Administration greenlight CytoDyn’s Phase 2 protocol for a combination therapy of leronlimab and Regorafenib to treat patients with metastatic colorectal cancer. The 30-patient study is designed to test the hypothesis that a combination of injected leronlimab and Regorafenib taken orally will increase progression-free survival in patients with CCR5-positive metastatic colorectal cancer.
Leronlimab blocks CCR5, a cellular receptor, which has found to be important in HIV infection, tumor metastases, and other diseases including non-alcoholic fatty liver disease (NASH).
“CytoDyn will file for expanded access IND for patients with pancreatic, prostate, lung, breast, liver or melanoma cancers because we have been able to detect immune cell infiltrates expressing CCR5 that could impair the immune response against the tumor if CCR5 is not blocked,” said Bruce Patterson, CEO of IncellDX and science advisor to CytoDyn Inc.
“Having the ability to detect and quantify these target cell infiltrates puts leronlimab squarely in the personalized immune-oncology arena with a mechanism of action common to many tumors,” he added.
CytoDyn is developing leronlimab (PRO 140) to battle multiple diseases. Leronlimab has already completed nine clinical trials and been given to 800 patients in HIV treatment programs, without a single drug-related serious adverse event. CytoDyn is also exploring leronlimab's use in the treatment of cancer, inflammatory conditions and autoimmune diseases.
Contact Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive