CytoDyn Inc (OTCMKTS:CYDY), a late-stage biotechnology company, said Thursday that it has filed a Phase 2 protocol for a basket trial with its lead drug leronlimab for treating all solid cancer tumors with the US Food and Drug Administration (FDA) under its cancer investigational new drug (IND) program.
In a statement, the Vancouver, Washington-based company said it can immediately initiate enrollment in the Phase 2 clinical trial for the treatment of 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, breast, testicular, ovarian, uterine, pancreas, bladder, and colon carcinoma among other indications.
The company expects to receive preliminary results on each patient within three to four weeks after the initial treatment with leronlimab. CytoDyn said it will continue to enroll patients in its metastatic breast cancer trials.
READ: CytoDyn to request an emergency Type C meeting with FDA to enroll 50 patients with solid cancer tumors
The basket trial is a Phase 2 study with 30 patients with CCR5+ locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 mg. Patients participating in the study will be allowed to continue chemotherapy as determined by the treating physician, said the company.
Recent data from the first patient enrolled in the company’s metastatic triple-negative breast cancer (mTNBC) Phase 1b/2 trial showed no detectable levels of circulating tumor cells (CTC) with leronlimab in combination with carboplatin at 16 weeks of treatment.
“The results so far in breast cancer patients have remarkably demonstrated the shrinking of primary tumors, the shrinking or elimination of metastatic lesions, and the reduction of CTCs to zero which has remained stable over weeks,” said IncellDx founder CEO Bruce Patterson, who is both a diagnostic partner and advisor to CytoDyn.
“In other studies, we have seen CTC levels in this cancer >5 and some as high as 20 per 4 milliliters of blood. Further, these data help define the relationship between CCR5 on immune cell infiltrates and response as we analyze these responding patients,” he added.
Rapid response to leronlimab
“If leronlimab proves to be as effective in this basket trial as we have seen in the first four patients in our MBC trials, we believe we will be able to file for another breakthrough therapy designation for the multiple cancer indications evaluated in this basket trial, which could cover approximately 22 different forms of cancers,” said CytoDyn CEO Nader Pourhassan.
Dr Pourhassan said more than 50 patients want to use leronlimab and the firm’s current basket trial will be able to “quickly screen all these patients.”
A basket trial involves a single investigational drug or drug combination that is studied across multiple cancer populations defined by disease stage, number of prior therapies, genetic or other biomarkers. "A strong response signal seen in a sub-study may allow for expansion to generate data that could potentially support a marketing approval," said the company.
CytoDyn is developing leronlimab to battle multiple diseases. The company has filed an IND application and a Phase 2 clinical trial protocol with the US FDA for leronlimab to treat patients with NASH.
Leronlimab has also already completed nine clinical trials and has been given to 800 patients in HIV treatment programs, without a single drug-related serious adverse event.
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