New PR.... CytoDyn's Lead Product Candidate Ler
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Posted On: 11/19/2019 6:02:24 AM
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CytoDyn's Lead Product Candidate Leronlimab (PRO 140) Inhibits Colon Carcinoma Metastases to Liver and Lung in Preclinical Studies
Download as PDFNovember 19, 2019 6:00am EST
CytoDyn will file for expanded access IND for patients with pancreatic, prostate, lung, breast, liver and melanoma cancers
VANCOUVER, Washington, Nov. 19, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that leronlimab inhibited a human colon carcinoma cell line, SW480 cells, metastases to liver and lung in a well-accepted mouse model. These 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.
“This is additional preclinical data supporting the clinical programs that CytoDyn has underway in the oncology space,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. “We plan to take advantage of the recent FDA recommended Master Protocol design. 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,” concluded Dr. Pourhassan.
Bruce Patterson, M.D., Chief Executive Officer of IncellDX and science advisor to CytoDyn stated: “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. 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.”
The U.S. Food and Drug Administration recently announced the availability of a draft guidance for industry entitled “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.” This guidance provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials, intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In contrast to traditional trial designs, where a single drug is tested in a single disease population in one clinical trial, master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple substudies, allowing for efficient and accelerated drug development. One example of the types of master protocol designs includes trials commonly referred to as basket trials.
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, or demographic characteristics. It is 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.
CytoDyn has also recently been cleared by the FDA for a Phase 2 protocol to proceed for combination therapy of leronlimab and Regorafenib in patients with metastatic colorectal cancer (mCRC).
CytoDyn's Lead Product Candidate Leronlimab (PRO 140) Inhibits Colon Carcinoma Metastases to Liver and Lung in Preclinical Studies
Download as PDFNovember 19, 2019 6:00am EST
CytoDyn will file for expanded access IND for patients with pancreatic, prostate, lung, breast, liver and melanoma cancers
VANCOUVER, Washington, Nov. 19, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that leronlimab inhibited a human colon carcinoma cell line, SW480 cells, metastases to liver and lung in a well-accepted mouse model. These 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.
“This is additional preclinical data supporting the clinical programs that CytoDyn has underway in the oncology space,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. “We plan to take advantage of the recent FDA recommended Master Protocol design. 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,” concluded Dr. Pourhassan.
Bruce Patterson, M.D., Chief Executive Officer of IncellDX and science advisor to CytoDyn stated: “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. 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.”
The U.S. Food and Drug Administration recently announced the availability of a draft guidance for industry entitled “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.” This guidance provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials, intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In contrast to traditional trial designs, where a single drug is tested in a single disease population in one clinical trial, master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple substudies, allowing for efficient and accelerated drug development. One example of the types of master protocol designs includes trials commonly referred to as basket trials.
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, or demographic characteristics. It is 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.
CytoDyn has also recently been cleared by the FDA for a Phase 2 protocol to proceed for combination therapy of leronlimab and Regorafenib in patients with metastatic colorectal cancer (mCRC).
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