CytoDyn Inc (OTCMKTS:CYDY) announced Friday it will begin its Phase 2 clinical trial of leronlimab (PRO 140) for the treatment of about 22 different solid tumor cancers.
In a statement, the company said it is launching the second study after receiving Institutional Review Board (IRB) approval to target melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, among other cancers.
“We currently have more than 70 patients eagerly waiting to participate in this basket trial and expect the first patient injection to take place within approximately 10 days. Furthermore, overall enrollment of the trial could be completed in as little as 30 to 60 days, as this is a 30-patient trial,” said CEO Nader Pourhassan.
READ: CytoDyn sees positive data for leronlimab in Phase 1b/2 mTNBC and expanded access studies for MBC
CytoDyn said the basket trial is a 30-patient, CCR5+ Phase 2 study with locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 milligrams. Patients participating in this study will be allowed to receive and continue the standard-of-care chemotherapy as determined by the treating physician.
The clinical trial will take place at multiple sites across the US, with preliminary results on each patient expected within three to four weeks after the initial treatment with leronlimab. The primary endpoint of the basket trial is progression-free survival.
Dr Bruce Patterson, CEO of IncellDx, a diagnostic partner and an advisor to CytoDyn, said recent studies have produced some positive outcomes.
“Peripheral blood sampling from Patient #1 in the mTNBC trial, who has been on leronlimab for approximately five months, revealed no cancer cells or cancer associated cells (0 CTC, 0 EMT and 0 CAML),” he said.
“In addition, Patient #2, who has been on leronlimab for almost 3 months in the MBC study, with brain metastasis, continues to show in the latest CT scan, stable lesions that are now described as scar-like, suggesting repair in the metastatic tumors … These data are substantiating the relationship between CCR5 and immune cell infiltrates and response which supports the current basket trial.”
Pourhassan noted that the current basket trial focuses on method of action (MOA) rather than a specific cancer type.
“We are extremely pleased the central IRB provided approval to proceed with the trial in a matter of weeks. This process can often take two months or more,” he said.
“If leronlimab proves to be as effective in this basket trial, as we have seen in our mTNBC and MBC patients, this opens up a strong potential for CytoDyn to file for another Breakthrough Therapy designation (BTD) for the 22 cancer indications being evaluated in this trial.”
About 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.
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